Healthy Lifestyle Behavior Intervention for Latino Women

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Lifestyle behavior interventon grop

• Registration Number: NCT01333241
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle behavior intervention group	Lifestyle behavior interventon grop	The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.

Primary Outcome Measures

Name	Time	Method
Change in Body mass index (BMI)	Baseline, 6 and 9 month follow-up.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCLA School of Nursing; 🇺🇸 Los Angeles, California, United States