Healthy Lifestyle Behavior Intervention for Latino Women

Study Overview
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Brief Summary
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The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure [BP], measures of cholesterol and blood sugar).

Detailed Description
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Overweight/obesity and physical inactivity are two significant predictors of illness and death from cardiovascular (heart) disease (CVD) in Latina adults. These risk factors may be reduced or eliminated through prevention efforts that focus on heart-healthy diets, weight reduction, and PA. The purpose of this study is to compare the effects of a 6-month community-based lifestyle behavior intervention (LSBI) conducted by lay health advisors and a control condition (disaster preparedness and home safety program) on lifestyle behaviors -dietary habits and physical activity(primary outcome) and selected physiologic outcomes (secondary outcomes) i.e., BMI, waist circumference, blood pressure, measures of cholesterol,and fasting blood sugar of Latinas who are overweight/obese. The LSBI includes group education (8 classes) and individual teaching and coaching (8 contacts by home visits and telephone calls) delivered over a 6-month period. Acceptability and feasibility of the intervention is evaluated through examination of women's retention rates and participation in classes and home visits.

Official Title
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Community-Based Lifestyle Promotion With Latino Women

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Lifestyle behavior interventon grop
* Other: Placebo Comparator: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Latina 35 to 64 years of age body mass index (BMI) >25 fluent in either Spanish or English. Exclusion Criteria: pregnant or planning to get pregnant in next year history of myocardial infarction or stroke currently under treatment for cancer orthopedic or joint problems that would prohibit participation in physical activity insulin-dependent diabetes

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle behavior intervention group<br>The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching. | Behavioral: Lifestyle behavior interventon grop<br> <br> |
| Sham Comparator: Control group<br>Disaster Preparedness/Home Safety group education and teaching | Other: Placebo Comparator: Control group<br> <br> * Other names: Disaster Preparedness/Home Safety;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body mass index (BMI) |  | Baseline, 6 and 9 month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity | Physical activity as determined by accelerometer readings, | Baseline, 6 and 9 month follow-up | 
| Change in Physiologic measures | Blood pressure, cholesterol (total, HDL, LDL, and triglycerides), fasting blood sugar, and waist circumference. | Baseline, 6 and 9 month follow-up. | 
| Change in Lifestyle behaviors | Self-reported eating and physical activity. | Baseline, 6 and 9 month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Intervention, Hispanic/Latina Americans, Cardiovascular diseases