Healthy Lifestyle Behavior Intervention for Latino Women

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01333241
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 223
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Behavioral: Lifestyle behavior interventon grop; Other: Placebo Comparator: Control group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community-Based Lifestyle Promotion With Latino Women
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Body mass index (BMI) [Baseline, 6 and 9 month follow-up.]

Secondary Outcome Measures

1. Change in Physical Activity [Baseline, 6 and 9 month follow-up]

   Physical activity as determined by accelerometer readings,

2. 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.

3. Change in Lifestyle behaviors [Baseline, 6 and 9 month follow-up.]

   Self-reported eating and physical activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA School of Nursing	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Deborah Koniak-Griffin, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01333241
• Other Study ID Numbers: G090405102; R01HL086931-A1; R01HL086931
• First Posted: Apr 11, 2011
• Last Update Posted: Nov 7, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Deborah Koniak-Griffin, Professor, University of California, Los Angeles: Hispanic/Latina Americans; Cardiovascular diseases; Obesity; Intervention
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Nov 7, 2019