Trial record 3 of 212 for:    physical activity AND heart | Open Studies | NIH, U.S. Fed

Promotora-based Latino Family CVD Risk Reduction

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of California, Los Angeles
Sponsor:
Collaborators:
University of Southern California
Information provided by (Responsible Party):
William J. McCarthy, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01714271
First received: October 20, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Heart Disease
Cancer
Behavioral: Home environs-based lifestyle counseling
Behavioral: Cancer early detection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in arterial stiffness as measured by pulse wave velocity [ Time Frame: baseline, 6, 12, 24 months follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.


Secondary Outcome Measures:
  • Change in fasting glucose [ Time Frame: baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Fasting blood glucose

  • Changes in glycosylated hemoglobin A1c (HbA1c) [ Time Frame: baseline, 6, 12, 24 months follow-up ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin A1c. Measure of glucose control over several months.

  • Changes in answers to MyPlate evaluation questions [ Time Frame: baseline, 6, 12, 24 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Changes in food frequency measure of fruit and vegetable intake [ Time Frame: Baseline, 6, 12, 24 months follow-up ] [ Designated as safety issue: No ]
    Block Food Frequency assessment conducted in Spanish by interview. Information will include estimate of total fruit and vegetable intake over the last 6 months.

  • Changes in waist circumference [ Time Frame: baseline, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Measure of waist circumference, a common predictor of cardiovascular risk

  • Change in aerobic capacity [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Bruce protocol treadmill test. Estimate the VO2max (maximum aerobic capacity) using Foster's equation.

  • Change in metabolic syndrome score [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]

    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.

  • Change in plasma lipids [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Plasma lipids to be measured include LDL-cholesterol, HDL-cholesterol and triglycerides. Blood samples will be obtained by venipuncture.

  • Change in blood pressure [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Blood pressure will be assessed in study participants sitting quietly by trained personnel using regularly calibrated sphygmomanometry.

  • Change in physical activity assessment [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Change in body mass index (BMI) [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Change in quality of life [ Time Frame: Baseline, 6, 12, 24 ] [ Designated as safety issue: No ]
    The SF-12 is a well-accepted short form of the well-known SF-36 quality of life instrument.

  • Change in weight loss strategies [ Time Frame: Baseline, 6, 12, 24 ] [ Designated as safety issue: No ]
    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.

  • Change in endothelial function [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Change in self-efficacy to adhere to DASH-style dietary pattern [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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.

  • Change in mental health status [ Time Frame: Baseline, 6, 12, 24 ] [ Designated as safety issue: No ]
    Mental health index-5 (MHI-5) consists of 5 questionnaire items designed to assess emotional well-being.


Estimated Enrollment: 240
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home environs-based lifestyle counseling
Home environs-based lifestyle counseling Involves Spanish-speaking community health workers interacting with intervention subjects in home visits and phone calls - 12 contacts overall. The counseling focuses on promoting subject adherence to the Dietary Guidelines for Americans (DGA) and the Physical Activity Guidelines for Americans (PAGA) with special attention devoted to changing the home environment to make it optimally supportive of the lifestyle choices consistent with the DGA and PAGA. Study participants will also be provided 4 group education sessions that will be devoted to improving subject adherence to the DGA and PAGA.
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.
Experimental: Cancer early detection
Cancer Early Detection Spanish-speaking health educators will interact with study participants via a home visit and four telephone calls. The focus of the health education will be on practical strategies to detect cancer early to help prevent death from cancer. Cancer sites of interest will be: breast, cervical, skin, colon, prostate and testicular cancers. In addition, study participants will be provided two group education classes that will focus on the basics of the cancer process and why early detection and intervention can be life-saving.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714271

Contacts
Contact: Valerie Ruelas, LCSW 323-361-8416 VRuelas@chla.usc.edu

Locations
United States, California
Roybal Comprehensive Health Center Recruiting
Los Angeles, California, United States, 90022
Principal Investigator: Anne Peters, MD         
Sponsors and Collaborators
University of California, Los Angeles
University of Southern California
Investigators
Principal Investigator: William J McCarthy, Ph.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: William J. McCarthy, Ph.D., Adjunct Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01714271     History of Changes
Other Study ID Numbers: 1P50HL105188-6094, 1P50HL105188
Study First Received: October 20, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board
United States: National Heart, Lung, and Blood Institute (NHLBI)

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014