Clinical trial NCT01714271: Promotora-based Latino Family CVD Risk Reduction
Official title: Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Disease
Cancer
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-10-25
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

* 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.

Primary outcomes:
measure: Change in arterial stiffness as measured by pulse wave velocity
timeFrame: baseline, 6, 12, 24 months follow-up
measure: Change in arterial stiffness as measured by the Augmentation index
timeFrame: baseline, 6, 12 and 24 months follow-up
Secondary outcomes:
measure: Change in fasting glucose
timeFrame: baseline, 6, 12, 24 months
measure: Changes in glycosylated hemoglobin A1c (HbA1c)
timeFrame: baseline, 6, 12, 24 months follow-up
measure: Changes in answers to MyPlate evaluation questions
timeFrame: baseline, 6, 12, 24 months follow-up
measure: Changes in food frequency measure of fruit and vegetable intake
timeFrame: Baseline, 6, 12, 24 months follow-up
measure: Changes in waist circumference
timeFrame: baseline, 6, 12 and 24 months
measure: Change in aerobic capacity
timeFrame: Baseline, 6, 12, 24 months
measure: Change in metabolic syndrome score
timeFrame: Baseline, 6, 12, 24 months
measure: Change in plasma lipids
timeFrame: Baseline, 6, 12, 24 months
measure: Change in blood pressure
timeFrame: Baseline, 6, 12, 24 months
measure: Change in physical activity assessment
timeFrame: Baseline, 6, 12, 24 months
measure: Change in body mass index (BMI)
timeFrame: Baseline, 6, 12, 24 months
measure: Change in quality of life
timeFrame: Baseline, 6, 12, 24
measure: Change in weight loss strategies
timeFrame: Baseline, 6, 12, 24
measure: Change in endothelial function
timeFrame: Baseline, 6, 12, 24 months
measure: Change in self-efficacy to adhere to DASH-style dietary pattern
timeFrame: Baseline, 6, 12, 24 months
measure: Change in mental health status
timeFrame: Baseline, 6, 12, 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Roybal Comprehensive Health Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: William J McCarthy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: