Clinical trial NCT01333241: Healthy Lifestyle Behavior Intervention for Latino Women
Official title: Community-Based Lifestyle Promotion With Latino Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Hispanic/Latina Americans
Cardiovascular diseases
Obesity
Intervention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-04-11
Enrollment: 223
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body mass index (BMI)
timeFrame: Baseline, 6 and 9 month follow-up.
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, 6 and 9 month follow-up
measure: Change in Physiologic measures
timeFrame: Baseline, 6 and 9 month follow-up.
measure: Change in Lifestyle behaviors
timeFrame: Baseline, 6 and 9 month follow-up.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Nursing
state: California
Study officials:
affiliation: UCLA School of Nursing
name: Deborah Koniak-Griffin, RNC, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.
citation: Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M. Physical activity and cardiometabolic characteristics in overweight Latina women. J Immigr Minor Health. 2014 Oct;16(5):856-64. doi: 10.1007/s10903-013-9782-z.