Healthy Women Prepared for Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333241
Recruitment Status : Unknown
Verified April 2011 by University of California, Los Angeles.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2011
Last Update Posted : April 11, 2011
Information provided by:
University of California, Los Angeles

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 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 or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Lifestyle behavior intervention Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-Based Lifestyle Promotion With Latino Women
Study Start Date : August 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in Body mass index (BMI) [ Time Frame: Baseline, 6 and 9 month follow-up. ]

Secondary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: Baseline, 6 and 9 month follow-up ]
    Physical activity as determined by accelerometer readings,

  2. 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.

  3. Change in Lifestyle behaviors [ Time Frame: Baseline, 6 and 9 month follow-up. ]
    Self-reported eating and physical activity.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333241

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Deborah Koniak-Griffin, University of California, Los Angeles Identifier: NCT01333241     History of Changes
Other Study ID Numbers: G090405102
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Cardiovascular Diseases