To the Graduate Council: I am submitting herewith a dissertation written by Michael R. Bamman entitled “Determinants of physical activity in rural African-American adolescents.” I have examined the final copy of this dissertation for form and content and recommend that it be accepted in partial fulfillment of the requirements for the degree of Doctor of Philosophy, with a major in Exercise Science. ______________________________ Jeffrey S. Hallam, Major Professor We have read this thesis and recommend its acceptance: _____________________________________ Ed Acevedo Associate Professor _____________________________________ Scott Owens Assistant Professor _____________________________________ John Bentley Assistant Professor Accepted for the Council: ____________________________ Dean of the Graduate School
290
Embed
Determinants of Physical Activity in Rural African …mbamman.huntingdon.edu/SSPE499/finaldraft.doc · Web viewDETERMINANTS OF PHYSICAL ACTIVITY IN RURAL AFRICAN-AMERICAN ADOLESCENTS
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
To the Graduate Council:
I am submitting herewith a dissertation written by Michael R. Bamman entitled “Determinants of physical activity in rural African-American adolescents.” I have examined the final copy of this dissertation for form and content and recommend that it be accepted in partial fulfillment of the requirements for the degree of Doctor of Philosophy, with a major in Exercise Science.
______________________________Jeffrey S. Hallam, Major Professor
We have read this thesisand recommend its acceptance:
_____________________________________Ed Acevedo Associate Professor
_____________________________________Scott Owens Assistant Professor
_____________________________________John Bentley Assistant Professor
Accepted for the Council:
____________________________ Dean of the Graduate School
DETERMINANTS OF PHYSICAL ACTIVITY IN RURAL AFRICAN-AMERICAN
This work is dedicated to Joyce Bamman. Without her love and support this
would not have been possible.
4
ACKNOWLEDGMENTS
I would like to thank my parents James and Gale Bamman, and my wife Joyce
Bamman for believing in me when not many others did. I would also like to thank
my major advisor Dr. Jeff Hallam, for his help and guidance throughout my time
at The University of Mississippi, and my committee for their assistance and
direction over the past year. I would like to thank Alena Cushman for her help in
collecting data for this project. Finally, I would like to acknowledge two
classmates, Gina Blunt and Danielle Wadsworth, whose friendship and support
have made The University of Mississippi a much better place these last three
years.
v
ABSTRACT
The purpose of this study was to identify the determinants of PA of
African-American schoolchildren ages 12-18 in Tunica County, Mississippi. A
secondary purpose of this study was to determine the relationships among and
identify differences between recognized determinants of PA (age, body mass
index, perceived SE, and perceived barriers to PA) of the students. Assessment
included height and weight measurements, completion of the Physical Activity
Recall, self-efficacy and barriers to PA questionnaires. Subjects wore an MTI
accelerometer for seven consecutive days, except when sleeping or bathing.
Correlation matrices were conducted for male and female groups for the
independent variables self-efficacy, barriers to PA, BMI and age, and the
dependent variable, PA. Nonsignificant correlations in the male group were found
between PA and barriers to PA (r =-0.005, p = 0.977), and self-efficacy (r =
0.102, p = 0.0.527). Nonsignificant correlations in the female group were found
between and between PA and barriers to PA (r = 0.411, p = 0.119), and age (r =
0.101, p = 0.518). Stepwise multiple regression analyses were performed with
independent variables that were related to the dependent variable, PA. In males
(n = 41) the independent variables of age (r = 0.426, p<0.05), and BMI (r = 0.543,
p<0.05), were regressed on the dependent variable, PA. The final regression
model (with BMI and Age) accounted for 34% of the variance in PA. For females
(n = 43), the independent variables of BMI (r = 0.508, p<0.05), and self-efficacy (r
= 0.411, p<0.05), were regressed on the dependent variable, PA. It was
vi
discovered that the final regression model (with BMI and self-efficacy) accounted
for 34% of the variance in PA. The Chow test was conducted to compare the
regression equations for males and the regression equation for females. The
comparison of both male and female regression equations’ with the Chow test
results in a nonsignificant regression model (F = 2.848, Fcv = 3.564). The results
of this study demonstrate that rural African-American adolescent males’ PA is
predicted by BMI and age but not self-efficacy and that females’ PA is predicted
by BMI and self-efficacy, but not age. The results also show that barriers to PA
are not predictive of PA in rural African-American adolescents.
vii
TABLE OF CONTENTS
CHAPTER PAGE
I. INTRODUCTION................................................................................................1
PURPOSE OF STUDY.......................................................................................3 HYPOTHESES..................................................................................................4
VALIDATION OF PA MEASURE......................................................................60
EFFECT OF BARRIERS TO PA ON PA LEVEL..............................................62
EFFECT OF GRADE LEVEL ON PA LEVEL ..................................................62
DETERMINANTS OF PA IN FEMALES...........................................................63 DETERMINANATS OF PA IN MALES.............................................................66
COMPARISON OF REGRESSION EQUATIONS............................................68
Have you had any previous injuries that prevent you from performing any physical activity? ___ Yes ___ No
If yes, please list:__________________________________________________________________________________________________________________________________________________________________________________
Have you had any previous surgeries that prevent you from performing any physical activity? ___ Yes ___ No
If yes, please list:__________________________________________________________________________________________________________________________________________________________________________________
Are you currently taking any medications or supplements? ___Yes ___No
If yes, please list:______________________________________________________________
MTI Health Services Users Manual Actisoft Analysis Software 3.2
TECHNICAL INFORMATION
The MTI ActiGraph has a built-in single axis accelerometer designed to measure and record time varying accelerations ranging in magnitude from approximately 0.05 to 2 G's. The accelerometer is band limited with a frequency response from 0.25 to 2.5 hertz. These parameters have been carefully chosen to detect normal human motion and to reject motion from other sources. The acceleration signal is filtered by an analog bandpass filter and digitized by an 8-bit Analog to Digital Converter (A/D) at 10 samples per second. The A/D quantizes the magnitude of the
105
acceleration giving a linear response to accelerations within the passband. Each A/D value is summed over a user specified interval of time called an ‘cycle’.
The hardware in the ActiGraph includes an 8 bit microcontroller with on chip 8 bit A/D, 64K of nonvolatile RAM in the AM7164-2.2 and 256K in AM71256, a low power operational amplifier, an accelerometer built from a cantilevered rectangular piezoelectric bimorph plate and seismic mass, a charge amplifier, analog bandpass filters, and a voltage regulator. The circuitry is surrounded in a metal shield and packaged into a plastic enclosure measuring 2.0 x 1.6 x 0.6 inches. The ActiGraph weight is 1½ ounces. A 3V (2430) coin cell lithium battery supplies power. Battery life is in excess of 4000 hours. The case is transparent to infrared light. Communications with the ActiGraph is via coded infrared light using a Reader Interface Unit (RIU) connected to a PC serial port. Microsoft Windows compatible software is supplied with the RIU to support PC communications with the MTI ActiGraph.
Cycles can be from one second to several minutes. When using a one-minute cycles and collecting Activity data only, the MTI ActiGraph AM7164-2.2 can collect 22 consecutive days of data. At the end of each cycle, the summed value is stored in memory and the numerical integrator is reset. This process repeats until memory is filled at which point the ActiGraph stops collecting data for that session and waits for the data to be downloaded or to be reinitialized. The data collected by the ActiGraph is a series of numbers representing the level or intensity of movement for each cycle. The first number in the data series represents the activity measured for the first cycle, which starts at the user specified start time and date. The numbers that follow in the series represent activity over each cycle in chronological order.
For AM71256-T ActiGraph: The AM71256-T measures skin temperature in addition to Activity. The probe is located flush on the back of the ActiGraph and must be worn against bare skin. The probe is an epoxy coated NTC Thermistor, type MS. Its operating range is 0oC to 50oC, +/- 1oC @ 25oC. It Dissipation Constant is 1.4 mW/oC.
For AM71256-L ActiGraph: The AM71256-L measures ambient light in addition to Activity. The sensor, a planar silicon photodiode, is located inside the ActiGraph to the right of the notch. The operating range is from 0-3000 Lux with 12 Lux Resolution.
For further information contact: MTI Health Services
709 Anchors Street, NW Fort Walton Beach, Florida 32548 USA
1. I am confident that I can exercise consistently 1 2 3 4 5 6 three times per week for the next 6 months.
2. I am confident that I can exercise consistently 1 2 3 4 5 6five times per week for the next 6 months.
3. I am confident that I can make time for 1 2 3 4 5 6exercise no matter how busy my day.
4. I am confident that I can motivate myself to 1 2 3 4 5 6exercise no matter how tired I may feel.
5. I am confident that I can motivate myself to 1 2 3 4 5 6exercise no matter how stressed I feel.
6. I am confident that I can motivate myself to 1 2 3 4 5 6exercise even when Id rather be doing something else.
7. I am confident that I can motivate myself to 1 2 3 4 5 6exercise if my friends criticize me for it.
8. I am confident that I can motivate myself 1 2 3 4 5 6to exercise even when I am feeling down.
112
APPENDIX E
Campbell Questionnaire
INSTRUCTIONS: The questions in this section ask you about barriers to physical
activity. Please read each question carefully and circle the answer that best
describes how you feel.
How important are each of the following in preventing you from being more
113
physically active?
not at all important Very important
Lack of time due to school or work 1 2 3 4 5
Lack of time due to family obligations 1 2 3 4 5
Lack of time due to other interests 1 2 3 4 5
Lack of energy, too tired 1 2 3 4 5
Lack of athletic ability 1 2 3 4 5
Lack of programs, leaders or accessible facilities 1 2 3 4 5
Lack of a partner 1 2 3 4 5
Lack of support from family or friends 1 2 3 4 5
Lack of babysitting services 1 2 3 4 5
Cost 1 2 3 4 5
Lack of self-discipline or willpower 1 2 3 4 5
Self-consciousness, ill at ease 1 2 3 4 5
Long-term illness, disability or injury 1 2 3 4 5
Fear of injury 1 2 3 4 5
Thank you for your participation
114
APPENDIX F
IRB Application
115
APPLICATION PACKET FOR
RESEARCH WITH HUMAN SUBJECTS
This packet includes all forms and instructions needed for an IRB application for research with human subjects. Please indicate on the checklist below which items are included (or explain why they are not necessary for your study). The review process will not be initiated until the complete application is on file with the IRB, and research may not begin until approval has been granted.
Please submit the original and one copy of this form tothe Office of Research and Sponsored Programs at the above
address.Faxes are not acceptable.
CHECKLIST Completed CHECKLIST and application (with appropriate
signatures) Copies of all instruments/questionnaires Informed Consent form(s) – modeled after standard form on the
IRB website Recruitment notices/announcements Debriefing statement and summary of procedure If conducting research off-campus, approval letter from other
IRB(s) or Single Project Assurance(s) signed by the appropriate parties
THE UNIVERSITY OF MISSISSIPPI Institutional Review Board for the Protection of
Human Subjects
125 Old ChemistryP. O. Box 907
University, MS 38677662-915-7482 662-915-7577 (fax)
www.olemiss.edu/depts/research/irb
OFFICE USE ONLY:
Date Received Protocol No.
Investigator(s)
Title ______________________________________________________________________________
Application to Conduct Research with Human Subjects 1. Title of Project: Determinants of Physical Activity in Rural African-American Adolescents______ If Student Project: Dissertation Thesis Class Project Other
2. Principal Investigator: Mike Bamman Department Health, Exercise Science, and Recreation Management Work Phone 662-363-4019 Mailing Address 1241 Pendulum Drive __________________ Home Phone 662-429-3514
___Hernando________________MS__________38632__________ City State Zip Code
3. Research Advisor (for student researchers): Jeffrey S. Hallam, PhD
Department __Health, Exercise Science and Recreation Management Work Phone 662-915-5140 E-Mail Address [email protected] Fax Number 662-915-5525 4. Funding Source (if grant or contract):
5. Anticipated Beginning and Ending Dates Beginning Date (mm/dd/yy) 02/01 /04
of Human Subjects Contact: Ending Date (mm/dd/yy) 03/15/ 04
6. Subject Characteristics: Number _80_ Age Range 12-18 (If under 18, parental consent required)
7. Briefly describe subject population:Participants for this study will be recruited in Tunica County MS, at Rosa Fort High School.
Permission has been obtained from the Tunica County School Assistant Superintendent, Fernando Bearden
117
and from Rosa Fort High School Principal, Larry Ball, and will be obtained from each student and from his or her parents/guardians, to assess all county students ages 12-18.
8. Special Risk Subjects Involved: (Check all applicable groups) Pregnant Females Prisoners Elderly Fetal Tissue/Fetuses Mentally Ill Cognitively Impaired HIV+ Children/Adolescents Other Use of blood, other bodily fluids, or tissues (IBC approval needed. See Instructions.)
9. Recruitment Procedures:
a. How will subjects be recruited? Copy of the recruitment notice/announcement attached?
Subjects will be recruited for this study via permission that has been obtained from the Tunica County School Board, and the principal of Rosa Fort High School. Permission has been given to the researcher to utilize children enrolled in Physical Education classes at Rosa Fort High School. All students enrolled in Physical Education classes will be given the consent forms and information about the study. Students that decline to be included in the study will continue to take part in normal class activities, while students in the study will be excused from class work during study times.
b. Describe compensation or incentives for subjects, if any.
On the fifth day of their participation in the study, the investigator will meet with the subjects during their school day, and present each with a water bottle (donated by the Tunica County Recreation Commission) as an incentive to continue with the study protocol. Upon completion of the study, when the data shows full adherence to the study protocol by the participant, the investigator will provide the subjects with t-shirts donated by the Tunica County Recreation Commission.
10. Consent Procedures Information letter (attached)
Informed Consent form (attached)
An information packet will be distributed to all eligible students to take to their parents. The packet will include a cover letter, an informational page concerning the study design, technical information concerning the MTI accelerometer and the parental informed consent.
The informational packet is attached, which includes:1. Cover letter2. Study information page3. MTI Technical information page
There are 3 informed consent forms attached.1. Parental/guardian consent for participation by a child2. Child ages 12-13 oral assent script3. Child ages 14-18 written assent
11.Where will the study be conducted?
This study will take place in Tunica County Mississippi. Permission to utilize existing classroom space at Rosa Fort High School has been obtained.
Approval letter from another IRB attached
118
Single Project Assurance from cooperating organization attached
One Single Project Assurance forms is attached.1. Rosa Fort High School
If survey research, will surveys be mailed or distributed in another way? Give details.
Surveys consisting of Medical history questionnaire, Seven-day physical Activity Recall, modified Stanford Adolescent Heart Health Program Questionnaire, and modified Campbell’s Questionnaire will be administered to students in a classroom setting at Rosa Fort High School. Each student will have access to the investigator and a technician in order to answer any questions or provide any guidance required to complete the surveys.
1. Copies of each questionnaire are attached.
The MTI has been shown to be a valid measure of PA in adolescents (.71) against energy expenditure measured by indirect calorimetery (Freedson, Melanson, & Sirand, 1998). Ekelund (2001) and colleagues found activity counts from the MTI to contribute significantly to the explained variation in total energy expenditure (R2 = 0.54) and was found, in combination with sex, to be the best (compared with VO2 and anthropometric data) predictor of activity energy expenditure (R2 = 0.45) in a sample of 9 year old children. Data taken as part of the Amherst Health and Activity Study (Trost, Pate, Freedson, Sallis & Taylor, 2000) show that the optimal duration for PA monitoring with the MTI is 7 days. Researchers found that a 7-day protocol in school-age children (grades 1-12) resulted in acceptable estimation of moderate to vigorous PA (R2 = 0.76 – 0.87).The physical activity recall has been validated in comparisons with objective fitness measures such as VO2max and percent body fat (..33-.50) (Blair et al., 1985) direct observation (.64) (Wallace, McKenzie & Nader, 1985) as well as with activity monitors (.40) (.77-.82)(Rauh, Hovell, Sallis & Hofstetter, 1992; Matthews & Freedson, 1995). Sallis, Buono, Roby, Micale, & Nelson, (1993) report a test-retest reliability of the PAR of (.81) in a large sample of elementary and secondary schoolchildren. Very hard PA is shows good reliability (.53) when correlated with direct heart rate measurements above 160 beats per minute.
Self-efficacy will be assessed through the questionnaire utilized in the Stanford Adolescent Heart Health Program (SAHHP) (Reynolds et al, 1990). After controlling for baseline levels of physical activity and BMI, associations were found between physical activity levels and self-efficacy ((-.46) – (-.51)). Cronbach’s alpha generated for the self-efficacy scale in this study was 0.89.
Subject’s perceived barriers to exercise will be assessed with a subset of Campbell’s Study of Well Being (Stephens & Craig, 1990). This measure has been shown to be reliable in an adolescent population (.60-.79) (Allison, Dwyer, & Makin, 1999).
12.What are the possible risks (physical, psychological, social, work-related, financial, etc.) that might be experienced by the subject?
MTI health services lists no physical risks from the MTI accelerometer. However, misuse, disassembly, or destruction of the MTI accelerometer may pose physical risks such as bruises, cuts and abrasions. There will be no financial risks assumed by the subjects in this study. Psychological and social risks in this study may be a result of subjects’:
o ‘Competing’ with other subjects to accumulate as much or as little physical activity as possible.
o Disappointment when the results of their MTI physical activity log are discussed when the study is completed.
119
o Disappointment and/or teasing by other adolescents or subjects if MTI accelerometer malfunctions, is worn improperly, is damaged or is lost.
Specify the precautions that will be taken to minimize any risks.
Subjects will be informed as a group and individually that they are to maintain a normal physical activity schedule, and that their results are not a comparison to other subjects in the study. Subjects will be informed both as a group and individually of the proper care and use of the MTI accelerometer and given contact information in case of malfunction, loss, or damage to the MTI accelerometer.
13.What are the potential benefits, if any, to the subject? [Potential benefits do not include incentives offered for participation.] Explain:
Subjects will be eligible receive information regarding their Body Mass Index, their activity level, their physical activity self-efficacy, and their perceived barriers to exercise.
14.What are the penalties, if any, the subject can experience from participation in the study?
There are no penalties associated with this study.
15.How will you maintain subject confidentiality?
Include a statement regarding where data will be kept, who will have access to it, how you will ensure confidentiality, and what will be done with the data when the study is finished.
NOTE: Federal law requires de-linking identifying information from the data as soon as identifiers are no longer needed for analysis.
Original hard copies of the completed Medical History Questionnaire, completed consent/assent forms, completed questionnaires, MTI ActiGraph printouts will be kept in a locked file cabinet in Mr. Bamman’s office at the G.W. Henderson Health and Wellness Pavilion (1165 Abbay Drive, Tunica, MS). Electronic data generated by the MTI ActiGraph, Excel spreadsheets, and SPSS data analysis files will be downloaded to removable disks and stored in the locked file cabinet in Mr. Bamman’s. Only Mr. Bamman and Dr. Hallam will have access to the locked file cabinet in his office. Confidentiality will be maintained by assigning a random 4-digit number for each subject. No identifiers such as name or social security number will be used. In addition, confidentiality will be maintained by de-linking the identifying information from the files as soon as identifiers are no longer needed for analysis. Data, but no identifiers will be shared with Dr. Hallam. Original hard copy data will be kept on file for a period of one year and then shredded. De-linked electronic data will be kept indefinitely.
16. Please attach a Project Description. Include a ٱ problem statement , ٱ brief literature review citing evidence for need of research, ٱ research design, ٱ data
120
collection method, ٱ data analysis methods, and ٱ debriefing procedure and statement (if applicable).
A project Description is attached to the document. Included with the project description is a copy of the adherence flyer that will be handed out to the subjects.
INVESTIGATOR ASSURANCE
Please read and sign below. Obtain signatures of your research advisor and co-investigators, if applicable, and of your department chair. Return this original and one copy, along with any attachments, to the Office of Research and Sponsored Programs. Please allow up to four weeks for a response from the Office of Research and Sponsored Programs and/or the IRB. You will be contacted for any modifications and/or clarifications needed, and once approval is granted, you will be notified in writing. Approvals under the Expedited and Full Review categories are subject to continuing review by the IRB.
I understand that no research activities should be conducted with human participants prior to obtaining the required approvals from the IRB. I will inform the IRB at the earliest possible date of (1) any significant changes in the project with respect to human subject participation, (2) any adverse reactions or unexpected responses observed involving human subjects, and
121
(3) any need for continuation of the project activities beyond the approval date.
Failure to comply with Federal Regulations (45 CFR 46) can result in confiscation and possible destruction of data, suspension of all current and future research involving human subjects, or other institutional sanctions, until compliance is assured.
__________________________ ________ _______________________________ _________Principal Investigator Date Research Advisor (if student project) Date
__________________________ _______ ________________________________ _________Co-Investigator Date Department Chair Date
OFFICE USE ONLY:
Administrative Review
Office of Research Representative Date
Expedited Review* Full Review*
IRB Chair Date
Dear Parents:
My name is Mike Bamman. I am the manager of the fitness center here in Tunica. I am also a student at the University of Mississippi. I am doing a study in Tunica County looking at exercise and county teen-agers.
The Principal at Rosa Fort High School, Mr. Ball has approved the study. The University of Mississippi’s Institutional Review Board has also approved the study. Your child can be in this study if your child wants to. Your child will not be punished in any way if your child does not want to be included in the study.
122
There is a consent form for you to sign in this packet. Your child can start the study after you sign this form and it is returned to the school. After we get the form, we will ask your child if he/she wants to be in the study.
Also in this packet is information about the study and about the piece of equipment that your child will be using. I ask that you please read the packet before signing the form.
After the study is over you will have a chance to see you child’s results if you wish. Just get in touch with me and we will get together to discuss them. Please contact me if you have any questions about anything in this packet.
This study will help us learn about the amount of exercise teen-agers get in Tunica County. We feel that learning more about this can help us offer better programs for your children.
After you say its okay and your child says its okay, your child will be in the study. We will only work with your child during their PE class at school. The first time will take about 30 minutes and the second time will take no more than 5 minutes.
If your child is in the study, he or she will be asked to fill out a survey. The survey will be about how your child feels about exercise. They will also be asked to wear a small device that measures how much exercise they do. Your child will be asked to wear this device for seven days in a row.
On the first visit we will measure your child’s height and weight. We will then ask them to fill out the survey. We will then tell your child about the exercise device. We will also describe the study. We will also give them written directions about the exercise device. Each child will be given directions on how to use the device and take care of the device. This device measures exercise by measuring the movements that your child makes. To help you we have put more information about this device in the packet.
The device will be attached to your child’s hip with an elastic belt. Each child will then get instructions on how to wear the device. We will give each child a small notebook. We will ask them to write down the times when they take it off each day. Each child will be given a flyer to hang up in a place that they see all the time (like the refrigerator or the door to go outside) to remind it to wear the device.
On the fourth day, Mr. Bamman will call each student to remind them to wear the device. On the fifth day, Mr. Bamman will visit the school and hand out water bottles to the children that are wearing the device.
On the second visit, each child will turn in their device and their notebook. If your child has worn the device every day, they will receive a free t-shirt.
If you have any questions about the study or the device, please contact Mr. Bamman.
MTI Health Services Users Manual Actisoft Analysis Software 3.2
TECHNICAL INFORMATION
The MTI ActiGraph has a built-in single axis accelerometer designed to measure and record time varying accelerations ranging in magnitude from approximately 0.05 to 2 G's. The accelerometer is band limited with a frequency response from 0.25 to 2.5 hertz. These parameters have been carefully chosen to detect normal human motion and to reject motion from other sources. The acceleration signal is filtered by an analog bandpass filter and digitized by an 8-bit Analog to Digital Converter (A/D) at 10 samples per second. The A/D quantizes the magnitude of the
124
acceleration giving a linear response to accelerations within the passband. Each A/D value is summed over a user specified interval of time called an ‘cycle’.
The hardware in the ActiGraph includes an 8 bit microcontroller with on chip 8 bit A/D, 64K of nonvolatile RAM in the AM7164-2.2 and 256K in AM71256, a low power operational amplifier, an accelerometer built from a cantilevered rectangular piezoelectric bimorph plate and seismic mass, a charge amplifier, analog bandpass filters, and a voltage regulator. The circuitry is surrounded in a metal shield and packaged into a plastic enclosure measuring 2.0 x 1.6 x 0.6 inches. The ActiGraph weight is 1½ ounces. A 3V (2430) coin cell lithium battery supplies power. Battery life is in excess of 4000 hours. The case is transparent to infrared light. Communications with the ActiGraph is via coded infrared light using a Reader Interface Unit (RIU) connected to a PC serial port. Microsoft Windows compatible software is supplied with the RIU to support PC communications with the MTI ActiGraph.
Cycles can be from one second to several minutes. When using a one-minute cycles and collecting Activity data only, the MTI ActiGraph AM7164-2.2 can collect 22 consecutive days of data. At the end of each cycle, the summed value is stored in memory and the numerical integrator is reset. This process repeats until memory is filled at which point the ActiGraph stops collecting data for that session and waits for the data to be downloaded or to be reinitialized. The data collected by the ActiGraph is a series of numbers representing the level or intensity of movement for each cycle. The first number in the data series represents the activity measured for the first cycle, which starts at the user specified start time and date. The numbers that follow in the series represent activity over each cycle in chronological order.
For AM71256-T ActiGraph: The AM71256-T measures skin temperature in addition to Activity. The probe is located flush on the back of the ActiGraph and must be worn against bare skin. The probe is an epoxy coated NTC Thermistor, type MS. Its operating range is 0oC to 50oC, +/- 1oC @ 25oC. It Dissipation Constant is 1.4 mW/oC. For AM71256-L ActiGraph: The AM71256-L measures ambient light in addition to Activity. The sensor, a planar silicon photodiode, is located inside the ActiGraph to the right of the notch. The operating range is from 0-3000 Lux with 12 Lux Resolution. For further information contact:
The University of Mississippi246 Turner CenterUniversity, MS 38677
125
Parental/Guardian Consent for Child to Participate in an Experimental Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Description:
This study will help us learn more about physical activity of teen-agers in Tunica County. If your child takes part in this study he or she will be asked to complete a short survey. The survey will measure how they feel about exercise. Your child will also be asked to wear a small exercise device that measures exercise. The device is the size of a watch.
We ask that you complete this consent form about your child. After you return the consent form, we will ask your child if he or she wants to be in the study. We will give your child all the details of the study before we ask his or her permission.
Then we will work with your child on two different times during their PE class. The first time will take about 30 minutes and the second time will be about 5 minutes.
On the first visit we will measure your child’s height and weight. We will then ask your child to fill out the survey. We will also give your child directions about the device. We will also tell them about the study. Each child will be given directions on the use and care of the activity device. We will then place the device around their hips with an elastic belt. Each child will then receive directions about how to wear and care for the device. We will then give your child a small notebook. We will ask them to write down when they take off the device each day. Each child will then be given a flyer to post in a highly visible place at home to remind them to wear the device.
On the fourth day, Mr. Bamman will call your child to remind him or her to wear the device. On the fifth day of the study, Mr. Bamman will visit the school and hand out water bottles to the children that are wearing the device.
126
On the second visit, each child will turn in his or her device and logbook. If your child has worn the device every day, they will receive a free t-shirt.
Risks and Benefits:
The risks to your child of taking part in this study are minimal. The use of the physical activity device is a safe method of measuring physical activity.
The benefits to your child for taking part in this study include gaining information about his or her physical activity level. After we get the data you and your child will have a chance to discuss the results with Mr. Bamman.
Costs and Payments:
Participation in this project will incur no cost to you or your child. As a benefit to your child for participation, they may receive a water bottle and a t-shirt.
Confidentiality/Privacy:
Any information obtained about your child from this research, including any medical history or findings on physical measures will be kept confidential. If the study results are published in a science journal, the data will be presented so that no one can identify your child.
Protected Health Information: Protected health information is any personal health information through which you can be identified. The data collected in this study includes: medical history, body mass index, and physical activity level. A decision to participate in this research means that you agree to the use of your health information for the study described in this form. This information will not be released beyond the purposes of conducting this study. The information collected for this study will be kept indefinitely. While this study is ongoing you may not have access to the research information, but you may request it after the research is completed.
Right to Withdraw:
You or your child are free to refuse to take part in this study or to withdraw from this study at any time by simply informing Mr. Bamman in person, by letter (1165 Abbay Drive, Tunica, MS 38676) or by telephone (363-4019). If you decide to withdraw your child from the study, you will not upset us. Whether or not you and your child choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University, or with the Tunica County Recreation Commission, and it will not cause you or your child to lose any benefits to which you are entitled.
Compensation for Illness or Injury:
127
"I understand that I am not waiving any legal rights or releasing the institution or their agents from liability for negligence. I understand that in the event of physical injury resulting from a research procedure, the University of Mississippi does not have the funds budgeted for compensation either for lost wages or medical treatment or reimbursement for such injuries. The University will help, however, obtain any medical attention which my child may require while involved in the study by securing transportation to the nearest medical facility."
IRB Approval:
The University of Mississippi’s Institutional Review Board (IRB) has reviewed this study. The IRB has determined that this study meets the ethical obligations required by federal and university standards. If you have any questions, concerns or reports regarding this study, please contact the IRB at 915-7482.
Statement of Consent:
I have read the above information. I have been given a copy of this form. I have had an opportunity to ask questions, and I have received answers. I consent to have my child participate in the study.
Please Print Child’s Name
_________________________________________ Date: ________________Signature of Parent/Guardian
__________________________________________ Date: ________________Signature of Investigator
128
The University of Mississippi 246 Turner Center University, MS 38677
Oral Assent Script for Child (ages under 14) to Participate in an Experimental
Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Script to be read to child by experimenter:
Description:
“This study is going to help us find out more about how physically active a person is. If you decide to take part in this study, we will meet with you two times. Each time will be during your PE class.
On the first visit, after we collect the forms signed by your parents, we will tell everything about the study. Then we will check your height and your weight. We will ask you to complete a short survey for us at this time. This survey takes about 15 minutes to fill out. Then you will be given an activity device to wear for 7 days. We will show you how to wear it and we will tell you the proper use of the device. We will also give you a notebook to write down the times when you take the device off and put it back on every day.
On the final visit, we will take the activity device back and if it shows that you have worn if everyday, you will get a free t-shirt.”
129
Risks and Benefits:
“All the tests you will do in this study are safe and easy to do. They do not involve any pain or discomfort. For being in this study you will learn how many calories your body uses during a week. Costs and Payments:
“It will not cost you or your family anything to be in this study. By participating in this study you may receive a water bottle and a t-shirt if you wear the device every day.”
Confidentiality/Privacy:
“The only people who will ever see the results of your measurements will be you, your parents or guardian, and the people who record the measurements. “
Right to Withdraw:
“You do not have to be in this study if you do not want to be. And, once you start this study, you can stop before you finish if you want to. If you want to stop being in the study all you or your parent or guardian needs to do is tell Mr.Bamman. Whether or not you choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University of Mississippi or with the Tunica County Recreation Commission, and it will not cause you to lose any benefits to which you are entitled.”
IRB Approval:
“All the measurements we will make in this study are safe and have been reviewed and approved by doctors, professors, and other people associated with the university. The group of people who have reviewed and approved all the measurements are known as the University of Mississippi's Institutional Review Board (IRB). If you or your parents or guardians have any questions, concerns or reports regarding this study you can call the IRB at 915-7482.”
Voluntary Assent: “Do you have any questions? Do you want to be in this study?”
Child’s Response: Yes________ No ________
______________________________________ Date ______________
Print child’s name
130
______________________________________ Date _______________
Witness
The University of Mississippi 246 Turner Center University, MS 38677
Child (ages 14-18) Written Assent to Participate in an Experimental Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Description:
This study is going to help us find out more about how physically active a person is. If you decide to take part in this study, we will meet with you two times. Each time will be during your PE class.
On the first visit, after we collect the forms signed by your parents, we will tell everything about the study. Then we will check your height and your weight. We will ask you to complete a short survey for us at this time. This survey takes about 15 minutes to fill out. Then you will be given an activity device to wear for 7 days. We will show you how to wear it and we will tell you the proper use of the device. We will also give you a notebook to write down the times when you take the device off and put it back on every day.
131
On the final visit, we will take the activity device back and if it shows that you have worn it everyday, you will get a free t-shirt.
Risks and Benefits:
All the tests you will do in this study have been reviewed and approved and are safe and easy to do. For being in this study you will learn how many calories your body uses during a week.
Costs and Payments:
It will not cost you or your family anything to be in this study. As part of this study, you may receive a water bottle or a t-shirt.
Right to Withdraw:
You do not have to be in this study if you do not want to be. And, once you start this study, you can stop before you finish if you want to. If you want to stop being in the study all you or your parent or guardian needs to do is tell Mr. Bamman in person, send him a letter (Tunica County Recreation, 1165 Abbay Drive, Tunica, MS 38632) or call Mr. Bamman (363-4019). Whether or not you choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University of Mississippi or with the Tunica County Recreation Commission, and it will not cause you to lose any benefits to which you are entitled.
IRB Approval:
All the measurements we will make in this study are safe and have been reviewed and approved by doctors, professors, and other people associated with the university. The group of people who have reviewed and approved all the measurements are known as the University of Mississippi's Institutional Review Board (IRB). If you or your parents or guardians have any questions, concerns or reports regarding this study you can call the IRB at 915-7482.
Statement of Assent:
I have read the above information. I have been given a copy of this form. I have had an opportunity to ask questions, and I have received answers. I assent to participate in the study.
Signature of Investigator: _________________________ Date: ____________
Assurance of Compliance with DHHS Regulations for
Protection of Human Research Subjects
Rosa Fort High School , hereinafter known as the "institution," hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects (45 CFR 46) as specified below.
Part I
Ethical Principles and Institutional Policies Governing
Research Involving Human Subjects
I. Applicability
Except for research exempted or waived under the DHHS regulations 45 CFR 46.101, Part I of this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of whether the research is otherwise subject to federal regulation, if:
a. the research is sponsored by this institution, orb. the research is conducted by or under the direction of any employee or agent of this institution in
connection with institutional responsibilities, orc. the research is conducted by or under the direction of any employee or agent of this institution using
any property or facility of this institution, ord. the research involves the use of this institution's nonpublic information to identify or contact human
research subjects or prospective subjects.
II. Ethical Principles Governing Human Subjects Research
This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for theProtection of Human Subjects of Research (the "Belmont Report") and as specified below.
A. This institution recognizes the principles of respect for persons, beneficence (including
133
minimization of harms and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered by this Assurance.
B. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human research subjects.
III. Policies
A. This institution acknowledges that it and its investigators bear full responsibility for the performance of all research covered by this Assurance, including full responsibility for complying with federal, state, and local laws as they may relate to such research.
B. This institution assures that before human subjects are involved in research, proper consideration will be given to:
(1) the risks to the subjects,(2) the anticipated benefits to the subjects and others,(3) the importance of the knowledge that may reasonably be expected to result,(4) the informed consent process to be employed,(5) the provisions to protect the privacy of subjects, and(6) the additional safeguards for vulnerable populations.
C. This institution recognizes the need for appropriate additional safeguards in research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
D. This institution encourages and promotes constructive communication among the institutional officials, research administrators, department heads, research investigators, clinical care staff, human subjects, and all other relevant parties as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
E.This institution will exercise appropriate administrative overview carried out at least annually to assure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied.
134
Part 2
IRB, Institution, and Investigator Compliance with 45 CFR 46
I. Applicability
Part 2 of this Assurance applies to the following research project which is conducted or sponsored by this institution in collaboration with The University of Mississippi.
Project title Determinants of Physical Activity in Rural African-American Adolescents
Project Investigator Mike Bamman
Research Advisor (if applicable) Jeffrey S. Hallam, PhD
II. Institutional Responsibilities
A. This institution has complied and will continue to comply with the requirements of 45 CFR 46 as specified below.
B. This institution has reviewed and sponsors the project referenced above, and is responsible for continuing review of this project in conjunction with the Institutional Review Board at The University of Mississippi.
III. IRB Review
A. The IRB at The University of Mississippi shall review, and have the authority to approve, require modification in, or disapprove this research activity or proposed changes in it before human subjects become involved.
B. The convened IRB reviewed and approved the above project.
C. The IRB determined, in accordance with the criteria found at 45 CFR 46.111, and where applicable, 45 CFR 46 Subparts B, C, and D, that protections for human research subjects are adequate.
D. The IRB has the authority to suspend or terminate approval of the above referenced research in accordance with 45 CFR 46.113 for (1) noncompliance with 45 CFR 46, and this Assurance document or the IRB's requirements, and (2) for elimination of unexpected serious harm to subjects.
135
E. The IRB has determined that legally effective informed consent [copy of document must be attached unless specified otherwise by the IRB Chair] will be obtained in a manner and method which meets the requirements of 45 CFR 46.116 and 46.117.
F. Continuing reviews by the IRB shall be conducted at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109[e]). The IRB may be called into an interim review session by the Chairperson at the request of any IRB member or Institutional Official to consider any matter concerned with the rights and welfare of any subject.
G.The IRB shall prepare and maintain adequate documentation of its activities with respect to this project in accordance with 45 CFR 4.115.
H.The IRB shall report promptly to institutional officials:
(1) any serious or continuing noncompliance by investigators with the requirements of the IRB,
(2) any suspension or termination of IRB approval,(3) any unanticipated problems or injuries involving risks to subjects or others, and(4) any changes in this research activity which are reviewed and approved by the IRB.
I. Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children as required under Subparts B, C, and D of 45 CFR 46.
J. The IRB will comply fully with the requirements of all applicable Federal policies and guidelines, including those concerning notification of sero-positivity, counseling, and confidentiality of subjects.
IV. Research Investigator Reporting Responsibilities
A.Investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance and 45 CFR 46.
B. Research investigators shall report promptly to the IRB proposed changes in this research activity and the changes shall not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the subjects.
C. Research investigators shall report promptly to the IRB any unanticipated problems involving risks to subjects and others.
136
Part 3
Certification of IRB Approval and Institutional Endorsement
Project Title Determinants of Physical Activity in Rural African-American Adolescents
IRB Project number
Project Investigator/Research Advisor Mike Bamman Date of IRB approval Date of Next Scheduled IRB Review
The officials signing below assure that the project referenced above was approved by the IRB on the date indicated and that the project will be conducted in accordance with the requirements of Part 46, Title 45 of the Code of Federal Regulations and this Assurance document.
I. Authorized Official of the Institution Providing This Assurance
Signature Date
Name and Title: Larry Ball, Principal – Rosa Fort High School
Address: 1100 Rosa Fort Drive Tunica, MS 38676
Telephone: 662-363-1343 FAX: 662-357-4222
II. Authorized Official of the Institution with the IRB or IRB Chairperson
This institution authorizes the designation of its IRB for review of the project referenced in this Assurance.
Signature Date
Name and Title: Diane W. Lindley, Coordinator, Institutional Review BoardAddress: The University of Mississippi
Office of Research and Sponsored ProgramsP.O. Box 907University, MS 38677
Telephone: 662-915-7482FAX: 662-915-7577
137
III. Responsible Project Investigator or Director at Institution Providing this Assurance
I have attached copies of all IRB requested documents and approved Informed Consent Documents to be used in this project.
Signature Date
Name and Title: Mike Bamman, Project Investigator
Address: 1241 Pendulum Drive Hernando, MS 38632
Telephone: 662-363-4019 FAX: 662-363-4059
138
The University of Mississippi
246 Turner Center University, MS 38677
Abbreviated Medical History Questionnaire
Directions. Please answer the following questions to the best of your knowledge. All information given is CONFIDENTIAL. Name of Subject: ____________________________________
Age: ______ Date of Birth: _____________ Grade: _________
Sex: ______ male _______ female
Home Phone Number: ________________________
Are you currently playing on any school-sponsored sports teams?
___ Yes ___ No
Do you currently part of the school lunch program? ___ Yes ___ No
Do you have any form of respiratory (breathing) ailments?
___ Yes ___ No
139
If yes, please check all that apply:
__Asthma ___Emphysema ___Bronchitis
___COPD ___Unusual fatigue ___Common cold
Other (list)______________________________________________________
Do you have any form of metabolic disorder? ___ Yes ___ No
If yes, please check all that apply
___Diabetes ___hyperthyroidism ___hypothyroidism
Other (list) _______________________________________________________________________________________________________________________________________________________________________________________
Have you had any previous injuries that prevent you from performing any physical activity? ___ Yes ___ No
If yes, please list:__________________________________________________________________________________________________________________________________________________________________________________
Have you had any previous surgeries that prevent you from performing any physical activity? ___ Yes ___ No
If yes, please list:__________________________________________________________________________________________________________________________________________________________________________________
140
Are you currently taking any medications or supplements? ___Yes ___No
If yes, please list:______________________________________________________________
Correlates of vigorous exercise in a predominantly low SES and minority
high school population. Preventive Medicine, 23, 314-321.
APPENDIX G
Parental Consent Form
The University of Mississippi
246 Turner CenterUniversity, MS 38677
Parental/Guardian Consent for Child to Participate in an Experimental Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Description:
This study will help us learn which, of several factors significantly determines the amount of physical activity children in Tunica County, Mississippi accumulate in a one week time period. If your child takes part in this study he or she will be required to complete a short questionnaire concerning their attitudes toward exercise, their recent exercise history, and their perceived barriers to physical activity. He or she will also be required to wear the MTI accelerometer for 7 consecutive days. You will be asked to complete this consent form about your child. Upon return of this parental consent form, each child must then give its verbal or written assent to participate in the study.
Subjects ages 7-13 years of age will give oral assent with the responses recorded by a qualified technician. Subjects age 14-17 years will give assent using a separate written assent form. Subjects will then be given a detailed description and demonstration of the study procedures and instrumentation.
The initial assessment will include BMI measurements, paper and pencil questionnaire and instrumentation instructions and procedures. Each child will be weighed, with weight being recorded to the nearest 0.10 lb. and converted to kilograms. Height will be recorded in inches to the nearest 0.10-inch and converted to centimeters. Each child will be provided with written and oral
instructions on the use and care of the MTI accelerometer. At this time, the MTI accelerometer will be attached to the right hip with an elastic belt. The MTI accelerometer will be initialized and activated. Each child will then receive individual oral instruction relating to the proper procedures for wearing the MTI accelerometer. Written information will also be provided for your child yourself relating to the use and care of the MTI accelerometer. Each child will be instructed to wear the MTI during waking hours except during water activities or during bathing. Each child will be given a log book in order to record the times when the MTI accelerometer is removed and attached each day, which will allow for the calculation of sleep and active hours. Each child will be instructed to wear the MTI accelerometer for 7 consecutive days and will be encouraged to contact Mr. Bamman with any questions regarding the MTI accelerometer. Each child will then be given a handout to post in a highly visible place at home to remind them to wear their accelerometer daily. Each child will then complete the paper and pencil questionnaire.
On the final sessions, each child will turn in their MTI accelerometer and logbook. If the data shows full cooperation with the study procedures, your child will receive a free t-shirt.
Risks and Benefits:
The risks to your child of taking part in this study are minimal. The use of the MTI accelerometer has been shown to a safe method of measuring physical activity.
The benefits to your child for taking part in this study include gaining information about his or her body mass index, physical activity level, physical activity self-efficacy and barriers to physical activity. After data collection is complete, you and your child will have a chance to discuss the results with Mr. Bamman.
Costs and Payments:
Participation in this project will incur no cost to you or your child.
Confidentiality/Privacy:
Any information obtained about your child from this research, including medical history or findings on physical measures will be kept confidential. If the study results are published in a science journal, the data will be presented so that no one can identify your child.
Protected Health Information: Protected health information is any personal health information through which you can be identified. The data collected in this study includes: medical history, body mass index, and physical activity level. A decision to participate in this research means that you agree to the use of your health information for the study described in this form. This information will not be released beyond the purposes of conducting this study. The information collected for this study will be kept indefinitely. While this study is ongoing you
may not have access to the research information, but you may request it after the research is completed.
Right to Withdraw:
You or your child are free to refuse to take part in this study or to withdraw from this study at any time by simply informing Mr. Bamman in person, by letter (1165 Abbay Drive, Tunica, MS 38676) or by telephone (363-4019). If you decide to withdraw your child from the study, you will not upset us. Whether or not you and your child choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University, or with the Tunica County Recreation Commission, and it will not cause you or your child to lose any benefits to which you are entitled.
Compensation for Illness or Injury:
"I understand that I am not waiving any legal rights or releasing the institution or their agents from liability for negligence. I understand that in the event of physical injury resulting from the research procedures, the University of Mississippi does not have the funds budgeted for compensation either for lost wages or medical treatment or reimbursement for such injuries. The University will help, however, obtain any medical attention which my child may require while involved in the study by securing transportation to the nearest medical facility."
IRB Approval:
The University of Mississippi’s Institutional Review Board (IRB) has reviewed this study. The IRB has determined that this study meets the ethical obligations required by federal and university standards. If you have any questions, concerns or reports regarding this study, please contact the IRB at 915-7482.
Statement of Consent:
I have read the above information. I have been given a copy of this form. I have had an opportunity to ask questions, and I have received answers. I consent to have my child participate in the study.
_________________________________________ Date: ________________Signature of Parent/Guardian
Oral Assent Script for Child (ages under 14) to Participate in an Experimental Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Script to be read to child by experimenter:
Description:
“This study will help us learn more about what helps determine how physically active a person is. If you decide to take part in this study you will fill out a questionnaire, and wear a small device, called an accelerometer, for 7 days.
On the first day, after we collect the consent forms signed by your parents, we will explain everything about the study to you. Then we will measure your height and your weight. You will then be given an accelerometer to wear for 7 days. We will show you how to wear it and we will tell you the proper use of the accelerometer. We will give you a logbook to write down the times when you take the device off and put it back on every day. You will also complete a short questionnaire for us at this time. This questionnaire takes about 15 minutes to fill out.
On the final session, we will take the accelerometer back and if it shows that you have worn if everyday, you will get a free t-shirt.”
Risks and Benefits:
“All the tests you will do in this study have been reviewed and approved by a board of doctors and are safe and easy to do. They do not involve any pain or discomfort. For being in this study you will learn how many calories your body uses during a week.
Costs and Payments:
“It will not cost you or your family anything to be in this study.”
Confidentiality/Privacy:
“The only people who will ever see the results of your measurements will be you, your parents or guardian, and the people who record the measurements. “
Right to Withdraw:
“You do not have to be in this study if you do not want to be. And, once you start this study, you can stop before you finish if you want to. If you want to stop being in the study all you or your parent or guardian needs to do is tell Mr. Bamman in person, send him a letter (Tunica County Recreation, 1165 Abbay Drive, Tunica, MS 38632) or call Mr. Bamman (363-4019). Whether or not you choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University of Mississippi or with the Tunica County Recreation Commission, and it will not cause you to lose any benefits to which you are entitled.”
IRB Approval:
“All the measurements we will make in this study are safe and have been reviewed and approved by doctors, professors, and other people associated with the university. The group of people who have reviewed and approved all the measurements are known as the University of Mississippi's Institutional Review Board (IRB). If you or your parents or guardians have any questions, concerns or reports regarding this study you can call the IRB at 915-7482.”
Voluntary Assent: “Do you have any questions? Do you want to be in this study?”
Child’s Response: Yes________ No ________
______________________________________ Date ______________
Print child’s name
______________________________________ Date _______________
Witness
APPENDIX I
Written Assent Form
The University of Mississippi 246 Turner Center University, MS 38677
Child (ages 14-18) Written Assent to Participate in an Experimental Study
Title of Investigation: Determinants of physical activity in rural African-American adolescents
Principal Investigator: Mike BammanDepartment of HESRMUniversity of MississippiUniversity, MS 38677
Description:
This study will help us learn more about what helps determine how physically active a person is. If you decide to take part in this study you will fill out a questionnaire, and wear a small device, called an accelerometer, for 7 days.
On the first day, after we collect the consent forms signed by your parents, we will explain everything about the study to you. Then we will measure your height and your weight. You will then be given an accelerometer to wear for 7 days. We will show you how to wear it and we will tell you the proper use of the accelerometer. We will give you a logbook to write down the times when you take the device off and put it back on every day. You will also complete a short questionnaire for us at this time. This questionnaire takes about 15 minutes to fill out.
On the final session, we will take the accelerometer back and if it shows that you have worn if everyday, you will get a free t-shirt.
Risks and Benefits:
All the tests you will do in this study have been reviewed and approved by a board of doctors and are safe and easy to do. They do not involve any pain or discomfort. For being in this study you will learn how many calories your body uses during a week.
Costs and Payments:It will not cost you or your family anything to be in this study.
Confidentiality/Privacy:
The only people who will ever see the results of your measurements will be you, your parents or guardian, and the people who record the measurements. Protected Health Information: Protected health information is any personal health information through which you can be identified. The data collected in this study includes: medical history, and body mass index. A decision to participate in this research means that you agree to the use of your health information for the study described in this form. This information will not be released beyond the purposes of conducting this study. The information collected for this study will be kept indefinitely. While this study is ongoing you may not have access to the research information, but you may request it after the research is completed.
Right to Withdraw:
You do not have to be in this study if you do not want to be. And, once you start this study, you can stop before you finish if you want to. If you want to stop being in the study all you or your parent or guardian needs to do is tell Mr. Bamman in person, send him a letter (Tunica County Recreation, 1165 Abbay Drive, Tunica, MS 38632) or call Mr. Bamman (363-4019). Whether or not you choose to participate will not affect your standing with the Department of Health, Exercise Science and Recreation Management, with the University of Mississippi or with the Tunica County Recreation Commission, and it will not cause you to lose any benefits to which you are entitled.
IRB Approval:
All the measurements we will make in this study are safe and have been reviewed and approved by doctors, professors, and other people associated with the university. The group of people who have reviewed and approved all the measurements are known as the University of Mississippi's Institutional Review
Board (IRB). If you or your parents or guardians have any questions, concerns or reports regarding this study you can call the IRB at 915-7482.
Statement of Assent:
I have read the above information. I have been given a copy of this form. I have had an opportunity to ask questions, and I have received answers. I assent to participate in the study.
Signature of Investigator: _________________________ Date: ____________
APPENDIX J
Log Book
APPENDIX K
Adherence Flyer
170
APPENDIX L
Single Project Assurance Forms
171
Assurance of Compliance with DHHS Regulations for
Protection of Human Research Subjects
Rosa Fort High School , hereinafter known as the "institution," hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects (45 CFR 46) as specified below.
Part I
Ethical Principles and Institutional Policies Governing
Research Involving Human Subjects
I. Applicability
Except for research exempted or waived under the DHHS regulations 45 CFR 46.101, Part I of this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of whether the research is otherwise subject to federal regulation, if:
a. the research is sponsored by this institution, orb. the research is conducted by or under the direction of any employee or agent of this institution in
connection with institutional responsibilities, orc. the research is conducted by or under the direction of any employee or agent of this institution using
any property or facility of this institution, ord. the research involves the use of this institution's nonpublic information to identify or contact human
research subjects or prospective subjects.
II. Ethical Principles Governing Human Subjects Research
This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for theProtection of Human Subjects of Research (the "Belmont Report") and as specified below.
A. This institution recognizes the principles of respect for persons, beneficence (including minimization of harms and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered by this Assurance.
B. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human research subjects.
III. Policies
A. This institution acknowledges that it and its investigators bear full responsibility for the performance of all research covered by this Assurance, including full responsibility for complying with federal, state, and local laws as they may relate to such research.
172
B. This institution assures that before human subjects are involved in research, proper consideration will be given to:
(1) the risks to the subjects,(2) the anticipated benefits to the subjects and others,(3) the importance of the knowledge that may reasonably be expected to result,(4) the informed consent process to be employed,(5) the provisions to protect the privacy of subjects, and(6) the additional safeguards for vulnerable populations.
C. This institution recognizes the need for appropriate additional safeguards in research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
D. This institution encourages and promotes constructive communication among the institutional officials, research administrators, department heads, research investigators, clinical care staff, human subjects, and all other relevant parties as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
E.This institution will exercise appropriate administrative overview carried out at least annually to assure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied.
173
Part 2
IRB, Institution, and Investigator Compliance with 45 CFR 46
I. Applicability
Part 2 of this Assurance applies to the following research project which is conducted or sponsored by this institution in collaboration with The University of Mississippi.
Project title Determinants of Physical Activity in Rural African-American Adolescents
Project Investigator Mike Bamman
Research Advisor (if applicable) Jeff Hallam, PhD
II. Institutional Responsibilities
A. This institution has complied and will continue to comply with the requirements of 45 CFR 46 as specified below.
B. This institution has reviewed and sponsors the project referenced above, and is responsible for continuing review of this project in conjunction with the Institutional Review Board at The University of Mississippi.
III. IRB Review
A. The IRB at The University of Mississippi shall review, and have the authority to approve, require modification in, or disapprove this research activity or proposed changes in it before human subjects become involved.
B. The convened IRB reviewed and approved the above project.
C. The IRB determined, in accordance with the criteria found at 45 CFR 46.111, and where applicable, 45 CFR 46 Subparts B, C, and D, that protections for human research subjects are adequate.
D. The IRB has the authority to suspend or terminate approval of the above referenced research in accordance with 45 CFR 46.113 for (1) noncompliance with 45 CFR 46, and this Assurance document or the IRB's requirements, and (2) for elimination of unexpected serious harm to subjects.
E. The IRB has determined that legally effective informed consent [copy of document must be attached unless specified otherwise by the IRB Chair] will be obtained in a manner and method which meets the requirements of 45 CFR 46.116 and 46.117.
F. Continuing reviews by the IRB shall be conducted at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109[e]). The IRB may be called into an interim review session by the Chairperson at the request of any IRB member or Institutional Official to consider any matter concerned with the rights and welfare of any subject.
G.The IRB shall prepare and maintain adequate documentation of its activities with respect to this
174
project in accordance with 45 CFR 4.115.
H.The IRB shall report promptly to institutional officials:
(1) any serious or continuing noncompliance by investigators with the requirements of the IRB,
(2) any suspension or termination of IRB approval,(3) any unanticipated problems or injuries involving risks to subjects or others, and(4) any changes in this research activity which are reviewed and approved by the IRB.
I. Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children as required under Subparts B, C, and D of 45 CFR 46.
J. The IRB will comply fully with the requirements of all applicable Federal policies and guidelines, including those concerning notification of sero-positivity, counseling, and confidentiality of subjects.
IV. Research Investigator Reporting Responsibilities
A.Investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance and 45 CFR 46.
B. Research investigators shall report promptly to the IRB proposed changes in this research activity and the changes shall not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the subjects.
C. Research investigators shall report promptly to the IRB any unanticipated problems involving risks to subjects and others
175
Part 3
Certification of IRB Approval and Institutional Endorsement
Project Title Determinants of Physical Activity in Rural African-American Adolescents
IRB Project number 04-081
Project Investigator/Research Advisor Mike Bamman Date of IRB approval 02-25-2004 Date of Next Scheduled IRB Review
The officials signing below assure that the project referenced above was approved by the IRB on the date indicated and that the project will be conducted in accordance with the requirements of Part 46, Title 45 of the Code of Federal Regulations and this Assurance document.
I. Authorized Official of the Institution Providing This Assurance
Signature Date
Name and Title: Larry Ball, Principal – Rosa Fort High School
Address: 1100 Rosa Fort Drive Tunica, MS 38676
Telephone: 662-363-1343 FAX: 662-357-4222
II. Authorized Official of the Institution with the IRB or IRB Chairperson
This institution authorizes the designation of its IRB for review of the project referenced in this Assurance.
Signature Date
Name and Title: Diane W. Lindley, Coordinator, Institutional Review BoardAddress: The University of Mississippi
Office of Research and Sponsored ProgramsP.O. Box 907University, MS 38677
Telephone: 662-915-7482FAX: 662-915-7577
176
III. Responsible Project Investigator or Director at Institution Providing this Assurance
I have attached copies of all IRB requested documents and approved Informed Consent Documents to be used in this project.
Signature Date
Name and Title: Mike Bamman, Project Investigator
Address: 1241 Pendulum Drive Hernando, MS 38632
Telephone: 662-363-4019 FAX: 662-363-4059
177
Assurance of Compliance with DHHS Regulations for
Protection of Human Research Subjects
North Mississippi Delta Boys and Girls Club , hereinafter known as the "institution," hereby gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects (45 CFR 46) as specified below.
Part I
Ethical Principles and Institutional Policies Governing
Research Involving Human Subjects
I. Applicability
Except for research exempted or waived under the DHHS regulations 45 CFR 46.101, Part I of this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of whether the research is otherwise subject to federal regulation, if:
a. the research is sponsored by this institution, orb. the research is conducted by or under the direction of any employee or agent of this institution in
connection with institutional responsibilities, orc. the research is conducted by or under the direction of any employee or agent of this institution using
any property or facility of this institution, ord. the research involves the use of this institution's nonpublic information to identify or contact human
research subjects or prospective subjects.
II. Ethical Principles Governing Human Subjects Research
This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for theProtection of Human Subjects of Research (the "Belmont Report") and as specified below.
A. This institution recognizes the principles of respect for persons, beneficence (including minimization of harms and maximization of benefits), and justice as stated in the Belmont Report and will apply these principles in all research covered by this Assurance.
B. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human research subjects.
178
III. Policies
A. This institution acknowledges that it and its investigators bear full responsibility for the performance of all research covered by this Assurance, including full responsibility for complying with federal, state, and local laws as they may relate to such research.
B. This institution assures that before human subjects are involved in research, proper consideration will be given to:
(1) the risks to the subjects,(2) the anticipated benefits to the subjects and others,(3) the importance of the knowledge that may reasonably be expected to result,(4) the informed consent process to be employed,(5) the provisions to protect the privacy of subjects, and(6) the additional safeguards for vulnerable populations.
C. This institution recognizes the need for appropriate additional safeguards in research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
D. This institution encourages and promotes constructive communication among the institutional officials, research administrators, department heads, research investigators, clinical care staff, human subjects, and all other relevant parties as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
E.This institution will exercise appropriate administrative overview carried out at least annually to assure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied.
179
Part 2
IRB, Institution, and Investigator Compliance with 45 CFR 46
I. Applicability
Part 2 of this Assurance applies to the following research project which is conducted or sponsored by this institution in collaboration with The University of Mississippi.
Project title Determinants of Physical Activity in Rural African-American Adolescents
Project Investigator Mike Bamman
Research Advisor (if applicable) Jeff Hallam, PhD
II. Institutional Responsibilities
A. This institution has complied and will continue to comply with the requirements of 45 CFR 46 as specified below.
B. This institution has reviewed and sponsors the project referenced above, and is responsible for continuing review of this project in conjunction with the Institutional Review Board at The University of Mississippi.
III. IRB Review
A. The IRB at The University of Mississippi shall review, and have the authority to approve, require modification in, or disapprove this research activity or proposed changes in it before human subjects become involved.
B. The convened IRB reviewed and approved the above project.
C. The IRB determined, in accordance with the criteria found at 45 CFR 46.111, and where applicable, 45 CFR 46 Subparts B, C, and D, that protections for human research subjects are adequate.
D. The IRB has the authority to suspend or terminate approval of the above referenced research in accordance with 45 CFR 46.113 for (1) noncompliance with 45 CFR 46, and this Assurance document or the IRB's requirements, and (2) for elimination of unexpected serious harm to subjects.
E. The IRB has determined that legally effective informed consent [copy of document must be attached unless specified otherwise by the IRB Chair] will be obtained in a manner and method which meets the requirements of 45 CFR 46.116 and 46.117.
F. Continuing reviews by the IRB shall be conducted at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109[e]). The IRB may be called into an interim review session by the Chairperson at the request of any IRB member or Institutional Official to consider any matter concerned with the rights and welfare of any subject.
G.The IRB shall prepare and maintain adequate documentation of its activities with respect to this
180
project in accordance with 45 CFR 4.115.
H.The IRB shall report promptly to institutional officials:
(1) any serious or continuing noncompliance by investigators with the requirements of the IRB,
(2) any suspension or termination of IRB approval,(3) any unanticipated problems or injuries involving risks to subjects or others, and(4) any changes in this research activity which are reviewed and approved by the IRB.
I. Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children as required under Subparts B, C, and D of 45 CFR 46.
J. The IRB will comply fully with the requirements of all applicable Federal policies and guidelines, including those concerning notification of sero-positivity, counseling, and confidentiality of subjects.
IV. Research Investigator Reporting Responsibilities
A.Investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance and 45 CFR 46.
B. Research investigators shall report promptly to the IRB proposed changes in this research activity and the changes shall not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the subjects.
D. Research investigators shall report promptly to the IRB any unanticipated problems involving risks to subjects and others
181
Part 3
Certification of IRB Approval and Institutional Endorsement
Project Title Determinants of Physical Activity in Rural African-American Adolescents
IRB Project number 04-081
Project Investigator/Research Advisor Mike Bamman Date of IRB approval 02-25-204 Date of Next Scheduled IRB Review
The officials signing below assure that the project referenced above was approved by the IRB on the date indicated and that the project will be conducted in accordance with the requirements of Part 46, Title 45 of the Code of Federal Regulations and this Assurance document.
I. Authorized Official of the Institution Providing This Assurance
Signature Date
Name and Title: Yolanda Kemp, Director North MS Delta Boys and Girls Club
Address: 1165 Abbay Drive Tunica, MS 38676
Telephone: 662-357-0523 FAX: 662-363-2242
II. Authorized Official of the Institution with the IRB or IRB Chairperson
This institution authorizes the designation of its IRB for review of the project referenced in this Assurance.
Signature Date
Name and Title: Diane W. Lindley, Coordinator, Institutional Review BoardAddress: The University of Mississippi
Office of Research and Sponsored ProgramsP.O. Box 907University, MS 38677
Telephone: 662-915-7482FAX: 662-915-7577
182
III. Responsible Project Investigator or Director at Institution Providing this Assurance
I have attached copies of all IRB requested documents and approved Informed Consent Documents to be used in this project.