pulso

Slide1: 

PULSO Unique Program for Optimal Health among Latinas

PULSO: 

PULSO Programa Unico para Latinas llevando hacia Salud Optima

Background I: 

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

Background II: 

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: 

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: 

Objective To reduce the risk of CVD among post-menopausal Latinas

Primary Aim: 

Primary Aim To conduct an RCT to test hypothesis that a behavioral lifestyle intervention reverses MET-S among post-menopausal Latinas

Secondary Aims: 

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 : 

Research Design

Inclusion Criteria : 

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 : 

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: 

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: 

Screening and Informed Consent

Randomization: 

Randomization Permuted block design (6 & 8 cells), stratified by site Blinded to PULSO staff Internet-based randomization administered by Data Coordination Center

Study Flow: 

Study Flow Lifestyle Management Enriched Education

Lifestyle Management I: 

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 : 

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: 

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: 

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

Control: Enriched Education: 

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: 

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 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: 

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)

Measurements II: 

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

Measurements III: 

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

Measurements IV: 

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: 

Assessment Schedule

Data Analysis: Primary Outcome: 

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: 

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: 

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

Data and Safety Monitoring Board: 

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: 

Project Tasks and Timeline First Subject Enters Last Subject Enters Last Subject Completes

Budget: 

Budget

Special Thanks to….: 

Special Thanks to…. Carlos Mendes De Leon, PhD Bill Chapman, PhD Nina Schooler, PhD Karina Davidson, PhD