Promotora-based Latino Family CVD Risk Reduction

NCT01714271 | Completed Phase 2

• 2 other identifiers: 1P50HL105188-60941P50HL105188
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (16)

• Change in fasting glucose

  baseline, 6, 12, 24 months

• Changes in glycosylated hemoglobin A1c (HbA1c)

  baseline, 6, 12, 24 months follow-up

• Changes in answers to MyPlate evaluation questions

  baseline, 6, 12, 24 months follow-up

• Changes in food frequency measure of fruit and vegetable intake

  Baseline, 6, 12, 24 months follow-up

• Changes in waist circumference

  baseline, 6, 12 and 24 months

Study Arms (2)

Home environs-based lifestyle counseling

EXPERIMENTAL

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

Cancer early detection

EXPERIMENTAL

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

Interventions

Home environs-based lifestyle counseling BEHAVIORAL

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.

Home environs-based lifestyle counseling

Cancer early detection BEHAVIORAL

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.

Cancer early detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Southern California: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Roybal Comprehensive Health Center

Los Angeles, California, 90022, United States

Location

MeSH Terms

Conditions

Heart Diseases; Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• William J McCarthy, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

US (1)