Top Banner
Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007
92

Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Dec 23, 2015

Download

Documents

Jordan Greer
Welcome message from author
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
Page 1: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Pediatric Obesity Interventions

Marsha D. Marcus, Ph.D.

June 7, 2007

Page 2: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Overview

• Obesity in children

• Efficacious lifestyle interventions

• Family-Based Treatment of Severe Pediatric Obesity

• Obesity Prevention Trial

Page 3: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Definition of Obesity

• Obesity refers to an excess of adiposity that increases the risk for medical morbidity

• Body weight in excess of a standard weight has been the most common index of obesity

• However, overweight does not always reflect adiposity, especially in children

Page 4: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• There is now consensus that Body Mass Index [BMI; weight (kg)/height (m)2] is the most desirable index of adiposity in children– BMI is strongly associated with other

measures of fatness– BMI is clearly associated with medical

morbidity and persistence of obesity into adulthood

Page 5: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• The National Center for Health Statistics provides pediatric growth charts that provide age and sex specific norms for BMI

http://www.cdc.gov/growthcharts

Page 6: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Definition of Obesity

BMI for Age and Sex

At Risk for Overweight 85th to 95th Percentile

Overweight > 95th Percentile

Page 7: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

BMI Differs by Age in Children

Boys: 2 to 20 years

BMI BMI

BMI BMI

Page 8: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

97th Percentile of BMI by Age and Sex

Age Girls Boys

8 22.0 21.2

9 23.2 22.4

10 24.6 23.7

11 25.9 25.0

12 27.2 26.0

Page 9: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Can you see risk?

• This boy is 3 years, 3 weeks old.

• Is his BMI-for-age

- >85th to <95th percentile: at risk for overweight?

- > 95th percentile?

Photo from UC Berkeley Longitudinal Study, 1973

Page 10: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Measurements:

Age=3 years, 3 wks

Height=100.8 cm (39.7 in)

Weight=18.6 kg (41 lb)

BMI=18.3

BMI-for-age= >95th %ile %ilepercentile overweight

Plotted BMI-for-Age

Boys: 2 to 20 years

BMI BMI

BMI BMI

Page 11: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Prevalence

• Rates of pediatric obesity have increased dramatically– 18.8 % of children aged 6-11 years are

now overweight– More than 20% of children are at risk for

overweight

Page 12: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Overweight in Children and Adolescents*

0

2

4

6

8

10

12

14

16

Per

cent

Ove

rwei

ght

2-5 Years 6-11 Years 12-19 Years

1988-1994

1999-2000

*Ogden, Flegal, Carroll, Johnson, JAMA, 2002

Page 13: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Ethnic Differences in Prevalence

• Minority children (i.e., African American, Native American, and Hispanic children) are more likely than White children are to be overweight

• Minority children also are likelier than White children are to suffer from obesity-related medical morbidity

Page 14: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Differential Increase in Severe Obesity

• Of note, the greatest increase in obesity prevalence has been among the heaviest children, i.e., the heaviest children are getting heavier

• 4% of American children are now > 99th percentile for age and sex

Page 15: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Obesity-Related Morbidity

• Obese children suffer the same medical consequences that obese adults do:– Hypertension– Hyperlipidemia– Hyperinsulinemia– Type 2 diabetes

Page 16: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Psychosocial Consequences

• There is an association between higher BMI and psychological distress

• Severely obese children and children who seek obesity treatment are likelier to suffer psychological morbidity than are more mildly affected children

Page 17: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• Severely obese children and adolescents report significant impairment in health-related quality of life compared to healthy children and adolescents [Schwimmer et al., 2003]

– Impairments are similar to those reported by children with cancer

Page 18: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.
Page 19: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Body Weight is Heritable

• 40-70% of the variability in body weight is accounted for by genetic factors

• However, increases in severe obesity are suggestive of “profound environmental determinants in a population with a high degree of susceptibility”*

*Flegal & Troiano, 2000

Page 20: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

What’s Going On?*• We’re producing more food• Food is cheaper

– In 1950 US families spent 21% of income on food; in 2000 we spent 11%

• Food is easy to buy and prepare• We eat out more often• We are less physically active

*Center for Science in the Public Interest, 2001

Page 21: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.
Page 22: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

POPCORN20 Years Ago Today

270 calories 5 cups

630 calories11 cups

Calorie Difference: 360 calories

Page 23: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Dunkin’ Donuts Glazed

Donut

Milk

340

180

Big Mac

Large Fries

Large Coke

570

540

310

Sbarro Sausage & Pepperoni Stuffed Pizza

(2 Slices)

Root Beer

1760

250

GRAND TOTAL 3950

Page 24: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Change in Type of Food Intake in Children 2-18 Over

Time*

0

1

2

3

4

5

6

SaltySnacks

SoftDrinks

FrenchFries

Pizza

1977-78

1994-96

% Energy Intake

*Nielsen et al., 2002

Page 25: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.
Page 26: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Relationship Between Prevalence of Overweight and Daily TV

Hours*

0

5

10

15

20

25

30

35

0-2Hours

2-3Hours

3-4Hours

4-5Hours

>5Hours

% Overweight

*Gortmaker et al., 1996

Page 27: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Benefits of Weight Loss

• Weight loss is associated with significant improvements

• Adiposity

• Blood pressure

• Lipid profiles

• Insulin resistance

• Psychosocial parameters

Page 28: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Can We Help Children Lose Weight and Change

Behavior?

• There is strong evidence for the efficacy of multi-component behavioral weight control programs in the treatment of pediatric obesity*

*Jelalian & Saelens, 1999

Page 29: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

10-Year Outcomes of Family-Based Treatment*

• *Epstein and colleagues (1994) reported results of four randomized trials– 34% of children decreased percentage of

overweight by > 20%– 30% of children were no longer obese

Page 30: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Components of Behavioral Weight Control Programs

• Information

• Diet

• Exercise

• Behavior Modification Strategies

Page 31: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Behavioral Targets

• Decrease intake of high fat, high calorie, low nutrient foods

• Increase intake of lower fat, lower calorie, nutrient dense foods

• Decrease sedentary behaviors

• Increase activity and exercise

Page 32: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Stoplight Diet*

• Green -- Go ahead – Nutrient dense, lower calorie

• Yellow--Proceed with caution– Nutrient adequate, more calories

• Red--Stop!! Think before you eat– High in fat, sugar, and “empty” calories

*Epstein & Squires, 1988

Page 33: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Behavior Therapy

• Self-monitoring

• Reinforcement

• Contingency contracting

• Stimulus control

• Social assertion

• Relapse prevention

Page 34: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Summary• Dramatic increases in pediatric obesity are

associated with changes in eating behavior and increases in sedentary behavior

• Family-based behavioral weight control programs are associated with long-term reductions in overweight

• Comprehensive family-based behavioral lifestyle interventions should be the cornerstone of obesity treatment

Page 35: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• Successful Programs– Use balanced calorie-deficit diets– Incorporate state-of-the-art behavioral

strategies– Target parents as well as children – Include an emphasis on increasing

physical activity• Lifestyle interventions • Decreasing sedentary behavior,

particularly “recreational screen time”

Page 36: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Caveats

• Although the efficacy of behavioral programs is well-documented, there is less information about their effectiveness– There is little third party coverage for obesity

treatment– There are relatively few well trained behavioral

interventionists• Not all children have parents or guardians

willing to participate• Most research has been conducted with

moderately obese children

Page 37: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• There is less evidence of the utility of family-based behavioral treatment for– Adolescents– Ethnically diverse samples– Severely overweight children

Page 38: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

• Given the scope of obesity-related health problems, further research in the development of effective lifestyle interventions is critically important

• Our research group has focused on family-based treatment of severely overweight children

Page 39: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Family-Based Treatment of Severe Pediatric Obesity

Principal Investigator : Marsha D. Marcus, Ph.D.

Support: NICHD [R01 HD 038425]Pittsburgh ONRC [DK046204]Children’s Hospital of Pittsburgh PCTRC

Page 40: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Melissa Kalarchian, Ph.D.

Michele Levine, Ph.D.

Silva Arslanian, MD

Linda Ewing, Ph.D., RN

Monique Higginbotham, MD*

Lisa Weissfeld, Ph.D.

*NICHD Research Supplement for Underrepresented Minorities

Page 41: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Specific Aims

• To evaluate the efficacy of a family-based behavioral weight control program for severe pediatric overweight

• To examine the relationships among gender, ethnicity, compliance and psychosocial factors and treatment outcome

Page 42: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Study Design

• Randomized controlled trial

• 192 children assigned to a six-month family based behavioral weight management program or usual care condition and followed for one year post-treatment

Page 43: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Study ParticipantsChildren were:

Between 8 and 12 years of age at enrollment

Have a parent or guardian who is willing to participate with the child

> 97th percentile of BMI for age and sex

Page 44: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Exclusion Criteria• Acute or severe medical conditions, including

diabetes• Inability to engage in moderate exercise• Previously diagnosed genetic obesity

syndrome (e.g., Prader Willi)• Current obesity treatment• Developmental disorder or psychosis• Psychiatric symptoms requiring immediate

treatment• Recent initiation of drugs that affect body

weight (< 4 months)

Page 45: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Treatment vs. Usual Care• Family-Based

– Medical monitoring– 20 weekly

sessions during first 6 months

• Separate parent & child meetings

• Brief family coaching

– Booster sessions over next 6 months

• 3 group meetings• Monthly phone

coaching

• Usual Care– Medical monitoring – 2 sessions with

pediatric nutritionist during first 6 months

– Family-based treatment offered after final assessment (Month 18)

Page 46: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Adaptations for Severely Overweight Children

• Coping with emotional, impulsive and “sneak” eating

• Coping with teasing from peers  

• Enhancing body image and increasing self-acceptance

Page 47: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

PRE POST 6-Mo. F.U. 12-Mo. F.U.MEASURES OF CHILD ENERGY 3-Day Food Records x x x x3-Day Activity Record x x x x3-Day Pedometer x x x xHeight x x x xWeight x x x xWaist/Hip Circumference x x x xDEXA x x xMEASURES OF CHILD MEDICAL FACTORSBlood Pressure x x x xOral Glucose Tolerance* x x xLipid Profile* x x xIntravenous Glucose Tolerance* x x xMEASURES OF CHILD PSYCHOSOCIAL FACTORS x x x x

Assessment Summary

Page 48: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Participant CharacteristicsIntervention

[n = 97]

Usual Care

[n = 95]

Age [Years] 10.1 10.3

Sex [% Female] 55.7 57.9

Race [% Black] 26.8 27.4

BMI 31.7 32.5

BMI %ile 99.16 99.18

% Above 50th

%ile of BMI88.3 91.7

Page 49: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Parent/Guardian Characteristics

Intervention

[n = 97]

Usual Care

[n = 95]

BMI 35.6 34.8

> High School Graduate [%]

88.8 83

Income < $30,000 [%]

27 27

Page 50: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

% over 50th percentile of BMI change over time(based on the 'true' means)

88.61

77.62

82.81

92.02 92.74

84.21

91.5890.16

70.00

75.00

80.00

85.00

90.00

95.00

100.00

0 6 12 18Months

% o

ver 5

0th

%til

e of

BM

I

Treatment

Usual Care

Page 51: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

BMI Changes in Children Attending < 5 vs. > 5 Sessions During Active Treatment

Weeks

% O

ver

50th

Per

cent

ile o

f B

MI

% over 50th %tile of BMI during the active treatment sessions

0

20

40

60

80

100

120

140

160

180

200

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Weeks

% o

ve

r 5

0th

%ti

le o

f B

MI

Attended <=5 sessions

Attended >5 sessions

Page 52: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Change in % Overweight by Dose of Treatment

40

60

80

100

120

140

160

0 6 12

Months

% O

ver

50th

Perc

en

tile

of

BM

I

<= 10sessions

> 10sessions

Page 53: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Factors Associated with Attrition

• Children who dropped out of treatment were more likely to come from families with incomes < $30,000 (p’s = .02)

• Children who were heavier at baseline tended to drop out of treatment (p = .07) and to be lost to long-term follow-up (p = .003)

Page 54: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Change in CDI Over Time

0

1

2

3

4

5

6

7

8

0 6 12Months

CD

I

Intervention

Usual Care

Page 55: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Change in ChEAT over Time

0

2

4

6

8

10

12

14

16

0 6 12Months

Ch

EA

T

Intervention

Usual Care

Page 56: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Parent BMI Change Over Time

-1.5

-1

-0.5

0

0.5

1

0 6 12

Months

BM

I Intervention

Usual Care

Page 57: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Comment

• Intensive family-based intervention is associated with modest decreases in overweight relative to usual care and improvements in health-related parameters

• There are no untoward effects of intervention on mood or eating behavior

• However, longer-term benefits are minimal

Page 58: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Comment

• Families with lower SES and heavier children may be at increased risk for poor attendance and attrition

• Children with better attendance appear to have better BMI trajectory

Page 59: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Comment

• A family-based behavioral approach shows promise, but it is critical to enhance initial changes in BMI and sustain these improvements over time

• Our pilot work suggests that a more structured approach to dietary changes is feasible, acceptable to families, and associated with improved short-term weight losses

Page 60: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

A Look to the Future

• Intensive, structured dietary and activity interventions

• School-, community-, state-, and federally-based initiatives to promote activity and minimize exposure to unhealthy foods

• Numerous drugs in varying stages of development

• Research integrating lifestyle programs with medication

• Bariatric surgery for children and adolescents

Page 61: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Menu Provision

• We conducted a pilot study with families who were provided the standard KidQuest program along with tailored menus and meal plans

• All families received partial reimbursement for food, and some received prepared foods

• Three groups have been run, involving 19 families

Page 62: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Menu ProvisionMean Weight Change from Tx Week 1 to Tx

Week 8 for KQ and KQ-MP Participants

0

-7.4

0

-4.2

0

-2.7

-8

-7

-6

-5

-4

-3

-2

-1

0

We

igh

t (l

bs

)

KQ-MP

KQ

KQMatchedControls

Page 63: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Obesity Prevention

• There is consensus that there is a compelling need to prevent the development of obesity in pediatric populations

Page 64: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

STOPP-T2DStudies to Treat Or Prevent Pediatric Type 2 Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases

National Institutes of Health

Page 65: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Rationale

• ‘Epidemic’ increase in rates of obesity and type 2 diabetes in children and youth

• Increase in environmental risk factors• Lack of large-scale, population-based

prevention studies investigating multiple integrated components

Page 66: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Map of the 7 Prevention Study Group Field Centers

Page 67: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Why Schools?• Reach 95% of children• Practice healthy mind, healthy body• Where children eat 1-2 meals per day• Offer physical education and sports• Presence of natural interventionists, role

models, and peers

Page 68: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

What will it take to affect T2D risk factors in the school?• Multi-level intervention• Greater duration and intensity of physical activity • More comprehensive changes to school food

environment• Behavioral strategies including individual goal

setting and achievement• Integrated promotional and educational

communications • Individual goal setting and achievement

Page 69: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Conceptual Model of Diet and Physical Activity Influences on Adiposity, Insulin, and Glucose

in Adolescence

INTERVENTION

Nutrition anddiet D

IABETES

RISK

Caloric intake

Sedentarybehavior

Physical activity

Energy balance

Caloricexpenditure

Cardiovascularfitness

Adiposity

Insulinresistance and

beta cell function

Page 70: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Winter 2003 OGTT Feasibility Study Percent with BMI 85th Percentile by Sex and Ethnicity

20

30

40

50

60

70

80

Male Female

White Black Hispanic Native American Other

Total 49.3%Males 51%Females 48%

Page 71: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Winter 2003 OGTT Feasibility Study- Pre-diabetes and Diabetes by ADA Cut-offs -

Fasting glucose

2-hour glucose

Normal

(< 140)

Pre-diabetes

(140-199)

Diabetes

( 200)

Normal

(< 100)57.6% 0.2% 0.0%

Pre-diabetes

(100-125)39.7% 2.0% 0.1%

Diabetes

( 126)0.4% 0.0% 0.1%

Page 72: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Winter 2003 OGTT Feasibility Study- Distribution of Risk Indicators -

BMI < 85th percentile

BMI 85th percentile

FI < 30 FI 30 FI < 30 FI 30

FG < 100 28.1% 4.1% 13.6% 13.5%

FG 100 14.5% 4.0% 7.4% 14.8%

Page 73: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

Winter 2003 OGTT Feasibility Study- Conclusions -

• A significant number of 8th grade students representing ethnic minorities are at risk for diabetes as assessed by risk factors of elevated fasting glucose and insulin levels and high BMI.

• School-based prevention strategies should be undertaken to improve diabetes risk factors.

Page 74: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY Study Design• 42 middle schools randomized to intervention or

control• Intervention

– Changes to school food environment and physical education class activities

– Educational and promotional communications campaigns

– Behavior change activities, messages, and goal setting

• Intervention goal: reduce risk factors for type 2 diabetes

Page 75: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Elements of Cluster Design -

• Focus is on public health impact.• The public is grouped in various collectives

called clusters, e.g., community, workplace, school.

• The cluster is the unit of sample size, randomization, intervention, and analysis—in our study, middle school.

• Observations are made at school, grade, class, and student levels.

Page 76: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Primary Outcomes -

1. BMI percentile* (BMI determined by height and weight, percentile adjusted for gender and age)

2. Fasting glucose (mg/dL)

3. Fasting insulin (U/mL)

* outcome for which the study is powered

Page 77: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Study Design -

• 42 middle schools (6 per center)• 21 randomized to intervention and 21 to control

(3 and 3 per center)• Cohort of students recruited in 6th grade and

followed through data collection– baseline 6th grade health screening– 2nd semester 7th grade height & weight– end of study 8th grade health screening

• 5 semesters of intervention• Additional students recruited in 8th grade for end

of study health screening

Page 78: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Study Design -

• Intervention schools– $2000 in year 1, $3000 in year 2, $4000 in year 3– ~ $15,000 of PE class equipment over 3 years to

implement PE intervention– $3000/year to food service department to implement

nutrition intervention• Control schools

– $2000 in year 1, $4000 in year 2, $6000 in year 3

Page 79: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Study Design: School Eligibility -

50% minority (African American, Hispanic/Latino, Native American) and/or > 50% eligible for free or reduced lunch

• Annual student attrition from all causes 25%

• Students attend PE class for a minimum of 225 minutes every 10 days

• School district operates under Federal Wide Assurance (FWA) to conduct research

Page 80: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Study Design: Student Eligibility -

• Student is able to participate in the school’s standard PE program

• Parent/guardian signs informed consent indicating understanding of the study and willingness for the child to participate in data collection and evaluation procedures

• Student (minor child) signs informed assent

Page 81: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Study Design: Data Collection -

• Baseline 1st semester of 6th grade– Health screening– Self-report questionnaires

• 2nd semester of 7th grade– Height and weight– Health related quality of life

• End of study 2nd semester of 8th grade– Health screening– Self-report questionnaires

Page 82: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Data Collection: Health Screening -

• Height• Weight• Waist circumference• Blood pressure• Fasting blood draw

– insulin and glucose– lipids (total cholesterol, HDL, LDL, triglycerides) – other laboratory indicators of diabetes and obesity

risk, such as HbA1c

Page 83: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Data Collection: Participant Forms -

• Socioeconomics and family/medical history (from parent/guardian)

• Pubertal Development Scale (Tanner)• Health Utility Index• EuroQoL Visual-analog Feeling Thermometer• 2-day Self-Administered Physical Activity Checklist

(2-D SAPAC)• Block Food Frequency Questionnaire (FFQ)

Page 84: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Data Collection: Other -

• Student Fitness (20-Meter Shuttle Test)• Student Behavior Self-Assessment• Economic Cost-Effectiveness• School Food Environment

– production, sales, servings– item-based nutrient analysis

• School Academic Performance– standard test scores, attendance, comportment

• Environmental Influences

Page 85: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention Components -

• Nutrition

• Physical Education

• Behavior

• Communications

Page 86: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Nutrition -

• Changes in the nutritional quality of food and beverage offerings throughout the total school food environment – cafeteria meals and after school snacks

offered through federal programs such as the National School Lunch Program (NSLP) and School Breakfast Program (SBP)

– a la carte (snack bars and student stores)– vending machines

Page 87: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Nutrition Goals -

• Goal I: Lower the average fat content of food served in school.

• Goal II: Serve at least 2 servings of fruit and/or vegetables per student on NSLP and at least 1 serving per student on SBP each day

• Goal III: Serve all dessert and snack foods with 200 calories per single serving size package.

Page 88: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY Intervention: Nutrition Goals (cont)

• Goal IV: Eliminate milk > 1%, all other added sugar beverages, and 100% fruit juice (100% fruit juice may only be served as 6 ounces as part of SBP).

• Goal V: Serve at least 2 servings of grain-based foods and/or legumes ( 2 g fiber per serving) per student on NSLP and at least 1 serving per student on SBP each day.

Page 89: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Physical Education -

• Changes in the physical education (PE) program and equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity when implemented by PE teachers as part of classroom lesson plans– ~$15,000 worth of equipment– classroom lesson plans– training, assistance, and guidance

Page 90: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Behavior -

• Brief classroom activities designed to increase knowledge, enhance decision making skills, promote peer involvement and interaction, and enhance social influence

• Individual and group behavior change initiatives aimed at promoting healthier behaviors through self monitoring, goal setting, and problem solving

• Involving family members by providing information and strategies to support youth in accomplishing behavioral goals

Page 91: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Communications -

• School-wide campaigns to enhance and promote changes in nutrition, activity, and behavior– core materials and actions– events designed to offer sites regional,

cultural, and operational flexibility– premiums, i.e., small items given to all

students that support the event and core options chosen for that semester’s intervention theme

• Team of student peer group helpers

Page 92: Pediatric Obesity Interventions Marsha D. Marcus, Ph.D. June 7, 2007.

HEALTHY - Intervention: Themes -

• 2nd Half 6th Grade

– Water versus Added Sugar Beverages• 1st Half 7th Grade

– Physical Activity vs. Sedentary Behavior• 2nd Half 7th Grade

– High Quality vs. Low Quality Food• 1st Half 8th Grade

– Energy Balance: Energy In/Energy Out• 2nd Half 8th Grade

– Strength, Balance, and Choice for Life