Healthy Lifestyle Behavior Intervention for Latino Women

November 5, 2019 updated by: Deborah Koniak-Griffin, University of California, Los Angeles

Community-Based Lifestyle Promotion With 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle behavior intervention group
The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.
Behavioral: Lifestyle behavior interventon grop
Sham Comparator: Control group
Disaster Preparedness/Home Safety group education and teaching
Other: Placebo Comparator: Control group
Other Names:
  • Disaster Preparedness/Home Safety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Body mass index (BMI)
Time Frame: Baseline, 6 and 9 month follow-up.
Baseline, 6 and 9 month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity
Time Frame: Baseline, 6 and 9 month follow-up
Physical activity as determined by accelerometer readings,
Baseline, 6 and 9 month follow-up
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.
Baseline, 6 and 9 month follow-up.
Change in Lifestyle behaviors
Time Frame: Baseline, 6 and 9 month follow-up.
Self-reported eating and physical activity.
Baseline, 6 and 9 month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Deborah Koniak-Griffin, RNC, EdD, UCLA School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 6, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G090405102
  • R01HL086931-A1 (Other Grant/Funding Number: NHLBI (ARRA grant))
  • R01HL086931 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Lifestyle behavior interventon grop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe