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Clinical Trials/NCT01714271
NCT01714271
Completed
Phase 2

Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment

University of California, Los Angeles1 site in 1 country204 target enrollmentOctober 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Disease
Sponsor
University of California, Los Angeles
Enrollment
204
Locations
1
Primary Endpoint
Change in arterial stiffness as measured by pulse wave velocity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.

Detailed Description

This is a randomized controlled trial involving non-diabetic residents of East Los Angeles, most of whom are low-income, mostly immigrant Mexican Americans. The family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The comparison condition is a more traditional health education approach to teaching residents about practical early cancer detection strategies designed to reduce risk of death from cancer. The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity. Secondary outcomes include: aerobic fitness, fruit and vegetable intake as assessed by food frequency questionnaire, endothelial function, body mass index, waist circumference, blood pressure, a metabolic syndrome score, and quality of life. Relative to the cancer early detection condition, the lifestyle change intervention is expected to improve fitness, increase fruit and vegetable intake, improve endothelial function, improve BMI, reduce excess waist circumference, improve blood pressure, and improve quality of life. If results confirm hypotheses, the results will support investing more public health resources into environmental and policy strategies design to make it easier for populations to adhere to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
October 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Resides in East Los Angeles
  • Home includes family member (spouse or 1st degree relative)who has been diagnosed with type 2 diabetes

Exclusion Criteria

  • Any condition that prevents engaging in daily physical activity / walking;
  • pregnant;
  • breast feeding;
  • cardiovascular (CVD) event within 12 months;
  • cancer requiring chemotherapy;
  • other medical condition requiring active lifestyle intervention/dialysis;
  • severe CVD or other disease known to significantly limit life expectancy.

Outcomes

Primary Outcomes

Change in arterial stiffness as measured by pulse wave velocity

Time Frame: baseline, 6, 12, 24 months follow-up

Pulse wave velocity is a measure of arterial stiffness that is sensitive to changes in health-related lifestyle changes.

Change in arterial stiffness as measured by the Augmentation index

Time Frame: baseline, 6, 12 and 24 months follow-up

Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.

Secondary Outcomes

  • Changes in glycosylated hemoglobin A1c (HbA1c)(baseline, 6, 12, 24 months follow-up)
  • Changes in waist circumference(baseline, 6, 12 and 24 months)
  • Change in blood pressure(Baseline, 6, 12, 24 months)
  • Change in endothelial function(Baseline, 6, 12, 24 months)
  • Change in self-efficacy to adhere to DASH-style dietary pattern(Baseline, 6, 12, 24 months)
  • Changes in food frequency measure of fruit and vegetable intake(Baseline, 6, 12, 24 months follow-up)
  • Change in metabolic syndrome score(Baseline, 6, 12, 24 months)
  • Change in plasma lipids(Baseline, 6, 12, 24 months)
  • Change in quality of life(Baseline, 6, 12, 24)
  • Change in weight loss strategies(Baseline, 6, 12, 24)
  • Change in aerobic capacity(Baseline, 6, 12, 24 months)
  • Change in mental health status(Baseline, 6, 12, 24)
  • Change in fasting glucose(baseline, 6, 12, 24 months)
  • Changes in answers to MyPlate evaluation questions(baseline, 6, 12, 24 months follow-up)
  • Change in physical activity assessment(Baseline, 6, 12, 24 months)
  • Change in body mass index (BMI)(Baseline, 6, 12, 24 months)

Study Sites (1)

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