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

Phase 2
18 Years
Open (Enrolling)
Heart Disease, Cancer

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Trial Information

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

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
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

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:

- BMI>40;

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in arterial stiffness as measured by pulse wave velocity

Outcome Description:

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

Outcome Time Frame:

baseline, 6, 12, 24 months follow-up

Safety Issue:


Principal Investigator

William J McCarthy, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

October 2014

Related Keywords:

  • Heart Disease
  • Cancer
  • Heart Diseases



Roybal Comprehensive Health CenterLos Angeles, California  90022