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Completed

NCT Number: NCT01333241

Healthy Lifestyle Behavior Intervention for Latino Women

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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Key information

Conditions

Cardiovascular Diseases Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA School of Nursing

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle behavior interventon grop

Behavioral

Placebo Comparator: Control group

Other

Other names: Disaster Preparedness/Home Safety

Primary outcomes

  1. Change in Body mass index (BMI)

    Time frame: Baseline, 6 and 9 month follow-up.

Secondary outcomes

  1. Change in Physical Activity

    Time frame: Baseline, 6 and 9 month follow-up

    Physical activity as determined by accelerometer readings,

  2. Change in Physiologic measures

    Time frame: Baseline, 6 and 9 month follow-up.

    Blood pressure, cholesterol (total, HDL, LDL, and triglycerides), fasting blood sugar, and waist circumference.

  3. Change in Lifestyle behaviors

    Time frame: Baseline, 6 and 9 month follow-up.

    Self-reported eating and physical activity.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Community-Based Lifestyle Promotion With Latino Women

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2011
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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