This trial is active, not recruiting.

Condition cardiovascular disease
Treatment lifestyle behavior intervention
Phase phase 1
Sponsor University of California, Los Angeles
Start date August 2009
End date July 2012
Trial size 240 participants
Trial identifier NCT01333241, G090405102


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 diet, reduce weight and increase physical activity (PA) of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by promotoras will demonstrate a greater decrease in BMI and a higher increase in physical activity than those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (blood pressure [BP], measures of cholesterol and blood sugar, waist circumference), and self-reported lifestyle behaviors (diet, PA). of these participants are also e

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.
lifestyle behavior intervention
6 months of group education and individual teaching and coaching.

Primary Outcomes

Change in Body mass index (BMI)
time frame: Baseline, 6 and 9 month follow-up.

Secondary Outcomes

Change in Physical Activity
time frame: Baseline, 6 and 9 month follow-up
Change in Physiologic measures
time frame: Baseline, 6 and 9 month follow-up.
Change in Lifestyle behaviors
time frame: Baseline, 6 and 9 month follow-up.

Eligibility Criteria

Female participants from 35 years up to 64 years old.

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

Additional Information

Official title Community-Based Lifestyle Promotion With Latino Women
Principal investigator Deborah Koniak-Griffin, RNC, EdD
Description 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 promotoras and a control condition (disaster preparedness and home safety program) on BMI (primary outcome) and selected physiologic outcomes (secondary outcomes i.e., physical activity, blood pressure, measures of cholesterol, fasting blood sugar, waist circumference, self-reported lifestyle behaviors - diet and physical activity) of Latinas who are overweight/obese. Exploratory analysis will examine the relationship between theoretical variables (stage of change and support for nutrition and physical activity), the LSBI and selected outcomes (BMI, self-reported lifestyle behaviors). The LSBI includes group education and individual teaching and coaching.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.