Healthy Lifestyle Behavior Intervention for Latino Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-07-31

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).

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle behavior intervention group

The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.

Group Type EXPERIMENTAL

Lifestyle behavior interventon grop

Intervention Type BEHAVIORAL

Control group

Disaster Preparedness/Home Safety group education and teaching

Group Type SHAM_COMPARATOR

Placebo Comparator: Control group

Intervention Type OTHER

Interventions

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Lifestyle behavior interventon grop

Intervention Type BEHAVIORAL

Placebo Comparator: Control group

Intervention Type OTHER

Other Intervention Names

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Disaster Preparedness/Home Safety

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes