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Healthy Women Prepared for Life

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of California, Los Angeles.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01333241
First received: April 6, 2011
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

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 diet, reduce weight and increase physical activity (PA) of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by promotoras will demonstrate a greater decrease in BMI and a higher increase in physical activity than those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (blood pressure [BP], measures of cholesterol and blood sugar, waist circumference), and self-reported lifestyle behaviors (diet, PA). of these participants are also e


Condition Intervention Phase
Cardiovascular Disease
 Behavioral: Lifestyle behavior intervention
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-Based Lifestyle Promotion With Latino Women

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in Body mass index (BMI) [ Time Frame: Baseline, 6 and 9 month follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Physical Activity [ Time Frame: Baseline, 6 and 9 month follow-up ] [ Designated as safety issue: No ]
    Physical activity as determined by accelerometer readings,

  • Change in Physiologic measures [ Time Frame: Baseline, 6 and 9 month follow-up. ] [ Designated as safety issue: No ]
    Blood pressure, cholesterol (total, HDL, LDL, and triglycerides), fasting blood sugar, and waist circumference.

  • Change in Lifestyle behaviors [ Time Frame: Baseline, 6 and 9 month follow-up. ] [ Designated as safety issue: Yes ]
    Self-reported eating and physical activity.


Estimated Enrollment: 240
Study Start Date: August 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle behavior intervention
The 6-month lifestyle behavior intervention includes group education and individual teaching and coaching.
 Behavioral: Lifestyle behavior intervention
6 months of group education and individual teaching and coaching.

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 promotoras and a control condition (disaster preparedness and home safety program) on BMI (primary outcome) and selected physiologic outcomes (secondary outcomes i.e., physical activity, blood pressure, measures of cholesterol, fasting blood sugar, waist circumference, self-reported lifestyle behaviors - diet and physical activity) of Latinas who are overweight/obese. Exploratory analysis will examine the relationship between theoretical variables (stage of change and support for nutrition and physical activity), the LSBI and selected outcomes (BMI, self-reported lifestyle behaviors). The LSBI includes group education and individual teaching and coaching.

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333241

Locations
United States, California
UCLA School of Nursing
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Deborah Koniak-Griffin, RNC, EdD UCLA School of Nursing
  More Information

No publications provided

Responsible Party: Deborah Koniak-Griffin, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01333241     History of Changes
Other Study ID Numbers: G090405102
Study First Received: April 6, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Hispanic Americans
Cardiovascular disease
Obesity
Intervention

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013