1 Alain Bertoni, MD, MPHJames Carson, PhD Ruey-Kang Chang, MD, MPHJoan Cook, PhD Laurie Greco, PhDKim Lebowitz, PhD Rebecca Thurston, PhD PULSO Unique Program for Optimal Health among Latinas

2004 Summer Institute on Behavior RCT Project PULSO 2 PULSO Programa Unico para Latinas llevando hacia Salud Optima

2004 Summer Institute on Behavior RCT Project PULSO 3  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

2004 Summer Institute on Behavior RCT Project PULSO 4  MET-S: >3 of these risk factors:  Glucose > 100, BP > 130/85, waist circum > 35 in, HDL 150  MET-S prevalence in post-menopausal Latinas is > 50%, highest among any US race/gender subgroup Background II

2004 Summer Institute on Behavior RCT Project PULSO 5 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

2004 Summer Institute on Behavior RCT Project PULSO 6 Objective To reduce the risk of CVD among post-menopausal Latinas

2004 Summer Institute on Behavior RCT Project PULSO 7 Primary Aim  To conduct an RCT to test hypothesis that a behavioral lifestyle intervention reverses MET-S among post-menopausal Latinas

2004 Summer Institute on Behavior RCT Project PULSO 8  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

2004 Summer Institute on Behavior RCT Project PULSO 9 Research Design

2004 Summer Institute on Behavior RCT Project PULSO 10 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

2004 Summer Institute on Behavior RCT Project PULSO 11 Exclusion Criteria  CVD  Failed exercise stress test  Using HRT within 6 month  BMI 40 kg/m 2  Medical condition that may be fatal  Severe psychiatric disorder  COPD  BP > 160/100 mmHg, HbA1c > 9%  Not transient

2004 Summer Institute on Behavior RCT Project PULSO 12 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

2004 Summer Institute on Behavior RCT Project PULSO 13 Screening and Informed Consent

2004 Summer Institute on Behavior RCT Project PULSO 14 Randomization  Permuted block design (6 & 8 cells), stratified by site  Blinded to PULSO staff  Internet-based randomization administered by Data Coordination Center

2004 Summer Institute on Behavior RCT Project PULSO 15 Study Flow Lifestyle Management Enriched Education

2004 Summer Institute on Behavior RCT Project PULSO 16 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 ( kcal/day, < 25% kcal from fat)

2004 Summer Institute on Behavior RCT Project PULSO 17 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)

2004 Summer Institute on Behavior RCT Project PULSO 18 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

2004 Summer Institute on Behavior RCT Project PULSO 19 PULSO Pilot Intervention  20 postmenopausal Latinas with MET-S  16 Weeks Lifestyle Management  Results:  Weight loss  Increased physical activity  4/20 women no longer met criteria for MET-S  Increased QoL; Decreased anxiety & depression

2004 Summer Institute on Behavior RCT Project PULSO 20 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

2004 Summer Institute on Behavior RCT Project PULSO 21 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

2004 Summer Institute on Behavior RCT Project PULSO 22 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

2004 Summer Institute on Behavior RCT Project PULSO 23 Measurements I Primary Outcome: Reduction in MET-S, assessed as dichotomous outcome (Yes/No)  Requires the following measures:  Fasting blood glucose  Blood pressure  Waist circumference  Lipid panel (Triglycerides, HDL)

2004 Summer Institute on Behavior RCT Project PULSO 24 Measurements II Secondary Outcome: Reduction in weight and metabolic risk factors  Assessed as continuous variables:  Fasting blood glucose  Blood pressure  Waist circumference  Triglycerides  HDL  Weight/BMI

2004 Summer Institute on Behavior RCT Project PULSO 25 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 format  2 weekdays and 1 weekend day in a 7-day period  Delivered by NP in person or by phone *Versions available in English and Spanish

2004 Summer Institute on Behavior RCT Project PULSO 26 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

2004 Summer Institute on Behavior RCT Project PULSO 27 Assessment Schedule Baseline4 Months8 Months12 Months MET-SXXXX BMIXXXX IPAQXXXX Stress TestXXX Food RecallXXXX SF-36XXXX BDI-II XXXX BAI XXXX

2004 Summer Institute on Behavior RCT Project PULSO 28 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

2004 Summer Institute on Behavior RCT Project PULSO 29 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 VO 2

2004 Summer Institute on Behavior RCT Project PULSO 30 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

2004 Summer Institute on Behavior RCT Project PULSO 31 Power Calculation Sensitivity Analysis Power % MET-S* 80%85%90%95% 75% % % % * % of participants in the Lifestyle Management Group at 12 months Power % MET-S* 80%85%90%95% 75% % % % Power % MET-S* 80%85%90%95% 75% % % %

2004 Summer Institute on Behavior RCT Project PULSO 32 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

2004 Summer Institute on Behavior RCT Project PULSO 33 Project Tasks and Timeline First Subject EntersLast Subject Enters Last Subject Completes

2004 Summer Institute on Behavior RCT Project PULSO 34 Budget

2004 Summer Institute on Behavior RCT Project PULSO 36 Special Thanks to….  Carlos Mendes De Leon, PhD  Bill Chapman, PhD  Nina Schooler, PhD  Karina Davidson, PhD