An interventional study of Lifestyle behavior interventon grop and Placebo Comparator: Control group in Cardiovascular Diseases, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to female participants aged 35 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
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).
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 223 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.
Behavioral: Lifestyle behavior interventon grop
Disaster Preparedness/Home Safety group education and teaching
Other: Placebo Comparator: Control group
Also known as: Disaster Preparedness/Home Safety
Change in Body mass index (BMI)
Time frame: Baseline, 6 and 9 month follow-up.
Change in Physical Activity
Physical activity as determined by accelerometer readings,
Time frame: 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.
Time frame: Baseline, 6 and 9 month follow-up.
Change in Lifestyle behaviors
Self-reported eating and physical activity.
Time frame: Baseline, 6 and 9 month follow-up.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles