Healthy Lifestyle Behavior Intervention for Latino Women

Cardiovascular Diseases Clinical Trial

Official title:

Community-Based Lifestyle Promotion With Latino Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333241
• Other study ID #: G090405102
• Secondary ID: R01HL086931-A1R0
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: July 2012

Study information

• Verified date: November 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle behavior interventon grop

Other:
• Placebo Comparator: Control group

Locations

Country	Name	City	State
United States	UCLA School of Nursing	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., Melendrez, M., & Balcázar, H. (2014). A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: Feasibility and outcomes of a randomized controlled trial. International journal of nursing studies. Koniak-Griffin, D., & Brecht, M.-L. (2014, July 30). Awareness of Cardiovascular Disease and Preventive Behaviors Among Overweight Immigrant Latinas. Journal of Cardiovascular Nursing [Epub ahead of print] Koniak-Griffin, D., Brecht, M. L., Takayanagi, S., Villegas, J., & Melendrez, M. (2013). Physical Activity and Cardiometabolic Characteristics in Overweight Latina Women. Journal of Immigrant and Minority Health, 1-9.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body mass index (BMI)		Baseline, 6 and 9 month follow-up.
Secondary	Change in Physical Activity	Physical activity as determined by accelerometer readings,	Baseline, 6 and 9 month follow-up
Secondary	Change in Physiologic measures	Blood pressure, cholesterol (total, HDL, LDL, and triglycerides), fasting blood sugar, and waist circumference.	Baseline, 6 and 9 month follow-up.
Secondary	Change in Lifestyle behaviors	Self-reported eating and physical activity.	Baseline, 6 and 9 month follow-up.