1 Alain Bertoni, MD, MPHJames Carson, PhD Ruey-Kang Chang, MD, MPHJoan Cook, PhD Laurie Greco, PhDKim Lebowitz, PhD Rebecca Thurston, PhD PULSO Unique.

1

Alain Bertoni, MD, MPH James Carson, PhD

Ruey-Kang Chang, MD, MPH Joan Cook, PhD

Laurie Greco, PhD Kim Lebowitz, PhD

Rebecca Thurston, PhD

PULSOUnique Program for Optimal Health

among Latinas

22004 Summer Institute on Behavior RCT Project PULSO

PULSOPrograma

Unico para

Latinas llevando hacia

Salud

Optima


CVD is the leading cause of death among women,

including Latinas

Metabolic syndrome (MET-S) important risk factor

for CVD

MET-S most common risk factor among post-

menopausal Latinas

Behavioral interventions may be helpful in reducing

CVD risk

Background I


MET-S: >3 of these risk factors: Glucose > 100, BP > 130/85, waist circum > 35 in,

HDL < 50, triglycerides >150

MET-S prevalence in post-menopausal

Latinas is > 50%, highest among any US

race/gender subgroup

Background II


Background III Recommended treatment for MET-S is weight loss

and exercise (ATP III, 2001)

No RCT has evaluated whether these

recommendations, when implemented, are effective

Weight loss and exercise have improved

components of MET-S

Latina population is an ideal group to test this

treatment for reduction in MET-S


Objective

To reduce the risk of CVD among

post-menopausal Latinas


Primary Aim

To conduct an RCT to test hypothesis that a

behavioral lifestyle intervention reverses MET-S

among post-menopausal Latinas


To test the efficacy of a behavioral lifestyle intervention in

reducing weight and ameliorating individual components of

MET-S

To test the impact of the intervention on increasing physical

fitness and decreasing caloric intake

To test the impact of the intervention on quality of life and

mental health functioning

To evaluate the safety of the intervention

Secondary Aims


Research Design UCLA

U. TexasSan Antonio

U. Miami

Screening

Baseline Assessment

RandomizationN=300

Lifestyle ManagmentN=150

Enriched EducationN=150

Maintenance

4, 8 and 12 months assessment


Inclusion Criteria Post-Menopausal Latinas (45-79 yrs) Proficient in Spanish or English Able to consent MET-S (> 3 ATP III criteria):

Waist circumference > 35 inches Blood pressure > 130/85 mmHg Triglyceride > 150 mg/dl Fasting glucose >100 mg/dl HDL <50 mg/dL


Exclusion Criteria CVD Failed exercise stress test Using HRT within 6 month BMI < 25 or > 40 kg/m2

Medical condition that may be fatal Severe psychiatric disorder COPD BP > 160/100 mmHg, HbA1c > 9% Not transient


Recruitment Community Advisory Board

Bilingual Latino recruitment staff from community

Community Approach Churches

Community centers

Spanish language media

Local retail

Health centers that serve Latinas

Community cultural events and health fairs


Screening and Informed Consent

EnrichedEducation

EnrichedEducation

Telephone screen

ScreeningConsent

ScreeningConsent

LifestyleManagement

LifestyleManagement

Physical Examand Blood Test

FullConsent

FullConsent

Exercise StressTest

RandomizationRandomization


Randomization

Permuted block design (6 & 8 cells),

stratified by site

Blinded to PULSO staff

Internet-based randomization administered

by Data Coordination Center


Study Flow

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 4 months 4 months

Second Assessment Third Assessment Fourth Assessment

0 month 12 month8 month4 month

First Assessment

NE Visit NE Visit

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 4 months 4 months

16 weeks weekly visit

Second Assessment Third Assessment Fourth Assessment

0 month 12 month8 month4 month

First Assessment

monthly visit

Lifestyle Management

Enriched Education


Lifestyle Management I Modeled after DPP Lifestyle Intervention

16 weekly individual sessions + Maintenance (delivered by

bilingual nurse educator)

Goals of Intervention:

Weight loss (>7% body weight)

Physical activity (>150 min/week)

Dietary modification (1200-2000 kcal/day,

< 25% kcal from fat)


Lifestyle Management II

Sessions 1-8: Values assessment; Health education (MET-S,

physical activity, dietary modification)

Sessions 9-16: ACT approach (Acceptance strategies; Values

Clarification; Goal setting w/in context of personal values;

Problem-solving; Self-monitoring)

Maintenance Phase: Eight monthly individual or group sessions

(Reinforce progress & skills; Provide support; Address barriers to

health behavior maintenance)


Lifestyle Management III Examples of culturally sensitive adaptations:

Provide transportation & child care

Emphasize affordable, healthy, regional and ethnic food

choices

De-emphasize cognitive focus

Emphasize personal values Tailor to individual

Enhance motivation


PULSO Pilot Intervention

20 postmenopausal Latinas with MET-S16 Weeks Lifestyle ManagementResults:

Weight lossIncreased physical activity4/20 women no longer met criteria for MET-SIncreased QoL; Decreased anxiety & depression


Control: Enriched Education Enhanced usual care

Trained nurse educator AHA, CDC education materials Review materials & answer questions Two one-hour sessions

Weeks 5 and 10 Session 1: Diet Session 2: Physical activity


PULSO Staff Bilingual, diverse staff, drawn from

communities Interventionists (Nurse Educators) will

undergo central training by dietician, psychologist and cultural sensitivity training

Interventionists will deliver one treatment arm Nurse Practitioners blinded to treatment

assignment will perform assessments


Treatment Fidelity Treatment-specific manuals developed

All sessions recorded and a random sample reviewed throughout study, coded for adherence to protocol, and feedback delivered

Coordinating center will monitor quality of data


Measurements I

Primary Outcome: Reduction in MET-S, assessed as dichotomous outcome (Yes/No)

Requires the following measures:Fasting blood glucoseBlood pressureWaist circumferenceLipid panel (Triglycerides, HDL)


Measurements II

Secondary Outcome: Reduction in weight and metabolic risk factors

Assessed as continuous variables:Fasting blood glucoseBlood pressureWaist circumferenceTriglycerides HDLWeight/BMI


Measurements III

Secondary Outcome: Increased physical activity and reduced caloric intake

International Physical Activity Questionnaire, Long Version (IPAQ)*, Interview format

Exercise stress test

24-hour Food Recall (FR)*, Interview format2 weekdays and 1 weekend day in a 7-day periodDelivered by NP in person or by phone

*Versions available in English and Spanish


Measurements IV

Secondary Outcome: Change in quality of life and mental health functioning

Quality of Life (SF-36)* Beck Depression Inventory (BDI-II)* Beck Anxiety Inventory (BAI)*

*Versions available in English and Spanish


Assessment Schedule

Baseline 4 Months 8 Months 12 Months

MET-S X X X X

BMI X X X X

IPAQ X X X X

Stress Test X X X

Food Recall X X X X

SF-36 X X X X

BDI-II X X X XBAI X X X X


Data Analysis: Primary Outcome

Intent to treat principle

Chi square test - Difference in proportion of MET-S

between groups at 12 months

Logistic regression model - Treatment impact on

MET-S controlling for study site and age at 12

months


Data Analysis: Secondary Outcomes

Mixed model – Adjusting for baseline value, test

impact of treatment on repeated follow-up

measurements: MET-S score, WC, HDL, TG,

glucose, BP, IPAQ, SF-36, BAI, BDI, 24FR,

Peak VO2


Power Calculation Alpha < 0.05, two sided test Power 90% Expected proportion of MET-S in Enriched

Education at study end: 95% Expected proportion of MET-S in Lifestyle

Management at study end: 80% Total number of subjects needed = 228 Expected attrition: 20% Total Sample = 300


Power Calculation Sensitivity Analysis

Power

% MET-S*

80% 85% 90% 95%

75% 116 130 150 180

80% 176 198 228 272

85% 318 358 414 502

90% 948 1072 1240 1516

* % of participants in the Lifestyle Management Group at 12 months

Power

% MET-S*

80% 85% 90% 95%

75% 116 130 150 180

80% 176 198 228 272

85% 318 358 414 502

90% 948 1072 1240 1516

Power

% MET-S*

80% 85% 90% 95%

75% 116 130 150 180

80% 176 198 228 272

85% 318 358 414 502

90% 948 1072 1240 1516


Data and Safety Monitoring Board

Psychologist, cardiologist, nutritionist, bioethicist

and biostatistician independent of study

Meet every 6 months, PI will submit reports to

the Board 2 weeks prior to the meeting

All adverse events will be reported according to

NIH guidelines


Project Tasks and Timeline

Year 1 Year 2 Year 3 Year 4 Year 5

Training PersonnelTraining Personnel

Intervention and AssessmentIntervention and Assessment

DevelopingMaterial

DevelopingMaterial

Subject Recruitment and ScreeningSubject Recruitment and Screening

Data Analysis &Reporting

Data Analysis &Reporting

First Subject Enters Last Subject EntersLast Subject Completes


Budget


Special Thanks to….

Carlos Mendes De Leon, PhD

Bill Chapman, PhD

Nina Schooler, PhD

Karina Davidson, PhD

1 Alain Bertoni, MD, MPHJames Carson, PhD Ruey-Kang Chang, MD, MPHJoan Cook, PhD Laurie Greco, PhDKim Lebowitz, PhD Rebecca Thurston, PhD PULSO Unique.

Documents

behavior rct project

summer institute

mets slide

cvd mets

transient slide

mets prevalence

mgdl hdl slide

research design slide