Promotora-based Latino Family CVD Risk Reduction

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714271
• Other study ID #: 1P50HL105188-6094
• Secondary ID: 1P50HL105188
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: October 2014

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Heart Disease
• Heart Diseases

Intervention

Behavioral:
• Home environs-based lifestyle counseling
Social learning theory-based behavior modification embedded in a social ecological framework is used to shape both the home environment and the lifestyle choices of the study participants to optimize their adherence to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
• Cancer early detection
Conventional health education is used to increase study participant knowledge of practical strategies for detecting and treating common cancers early, before cancers have metastasized. Additional instruction is devoted to the biology and physiology of the cancer process. Although some mention will be made of the importance of maintaining a healthy weight for minimizing lifetime risk of certain cancers, most of the focus will be on episodic cancer screening, e.g., mammograms, PAP smears, colonoscopies, etc. for prevention of death from cancer.

Locations

Country	Name	City	State
United States	Roybal Comprehensive Health Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Heart, Lung, and Blood Institute (NHLBI), University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial stiffness as measured by pulse wave velocity	Pulse wave velocity is a measure of arterial stiffness that is sensitive to changes in health-related lifestyle changes.	baseline, 6, 12, 24 months follow-up
Primary	Change in arterial stiffness as measured by the Augmentation index	Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.	baseline, 6, 12 and 24 months follow-up
Secondary	Change in fasting glucose	Fasting blood glucose	baseline, 6, 12, 24 months
Secondary	Changes in glycosylated hemoglobin A1c (HbA1c)	Glycosylated hemoglobin A1c. Measure of glucose control over several months.	baseline, 6, 12, 24 months follow-up
Secondary	Changes in answers to MyPlate evaluation questions	Self-report questions about adherence to MyPlate.gov recommendations. These include questions about daily fruit intake, vegetable intake, replacement of sugary beverages with water, effort to make at least 1/2 of grain intake whole grain, effort to seek out lower sodium options, and daily intake of non-fat or low-fat milk.	baseline, 6, 12, 24 months follow-up
Secondary	Changes in food frequency measure of fruit and vegetable intake	Block Food Frequency assessment conducted in Spanish by interview. Information will include estimate of total fruit and vegetable intake over the last 6 months.	Baseline, 6, 12, 24 months follow-up
Secondary	Changes in waist circumference	Measure of waist circumference, a common predictor of cardiovascular risk	baseline, 6, 12 and 24 months
Secondary	Change in aerobic capacity	Bruce protocol treadmill test. Estimate the VO2max (maximum aerobic capacity) using Foster's equation.	Baseline, 6, 12, 24 months
Secondary	Change in metabolic syndrome score	Metabolic syndrome marker levels. The ATP III criteria for metabolic syndrome markers include: sex-specific excess waist circumference (men > 102 cm, women >88 cm),; fasting plasma triglycerides >= 120 mg/dl,; fasting plasma HDL(men)<40 or (women)<50 mg/dl,; blood pressure >=135/85,; fasting glucose >=110 mg/dl). Each subject's metabolic syndrome marker level can range between zero and five, with zero representing no metabolic syndrome risk and five representing maximum risk. The a priori expectation is that each marker will be treated as equally important but this study will provide the opportunity to examine this assumption critically.	Baseline, 6, 12, 24 months
Secondary	Change in plasma lipids	Plasma lipids to be measured include LDL-cholesterol, HDL-cholesterol and triglycerides. Blood samples will be obtained by venipuncture.	Baseline, 6, 12, 24 months
Secondary	Change in blood pressure	Blood pressure will be assessed in study participants sitting quietly by trained personnel using regularly calibrated sphygmomanometry.	Baseline, 6, 12, 24 months
Secondary	Change in physical activity assessment	International Physical Activity Questionnaire - short form (IPAQ-short). Questions ask about the number of days in the last 7 days that the participant exercised vigorously or moderately vigorously. Follow-up questions query the participant about the time (minutes & hours) spent per day in doing vigorous or moderately vigorous physical activity on those days when they exercised.	Baseline, 6, 12, 24 months
Secondary	Change in body mass index (BMI)	Body mass index (BMI) obtained by taking the ratio of measured weight (kg) to measured height (m). Weight is obtained using a regularly calibrated balance beam scale. Height is obtained using a stationary stadiometer.	Baseline, 6, 12, 24 months
Secondary	Change in quality of life	The SF-12 is a well-accepted short form of the well-known SF-36 quality of life instrument.	Baseline, 6, 12, 24
Secondary	Change in weight loss strategies	Questionnaire includes 11 items that query the participant about weight control strategies used in the last year, including: exercise, restricting calories, fasting, diet pills, vomiting / laxative use, joining a gym, joining a commercial weight loss program such as WeightWatchers, meal replacement products, herbal medicines, diet bars, restriction on TV watching.	Baseline, 6, 12, 24
Secondary	Change in endothelial function	Flow-mediated dilation is the most widely used non-invasive test for assessing endothelial function, that is, the functional status of the inner lining of the major blood vessels. This technique measures endothelial function by inducing reactive hyperemia (blood volume expansion) via temporary arterial occlusion (blocking blood flow with inflated blood pressure cuff) and measuring the resultant relative increase in blood vessel diameter via ultrasound.	Baseline, 6, 12, 24 months
Secondary	Change in self-efficacy to adhere to DASH-style dietary pattern	List of 10 self-efficacy items that assess the study participant's confidence that she/he can adhere to various features of the Dietary Approaches to Stop Hypertension (DASH) diet.	Baseline, 6, 12, 24 months
Secondary	Change in mental health status	Mental health index-5 (MHI-5) consists of 5 questionnaire items designed to assess emotional well-being.	Baseline, 6, 12, 24