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The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans

Study acronym: LINKING GAINS
StatusCompleted
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Primary endpoint revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Cardiovascular disease (CVD) is a major and persistent health disparity for African Americans. Linking GAINS is a randomized pilot and feasibility study designed to evaluate whether receiving genetic risk information early in a community-based CVD risk reduction intervention improves engagement and health behavior change. Sixty African American adults from the Baton Rouge metropolitan area will be recruited and randomized to a Genetically Unblinded (GU) group or a Genetically Blinded (GB) group. All participants will complete a 14-session behavioral intervention delivered over approximately 16 weeks, including culturally responsive education, nutrition and cooking sessions, physical activity training, group support, and community-based health resources. The GU group will receive genetic results and genetic counseling early in the intervention, while the GB group will receive genetic results and counseling after the behavioral intervention and end-of-study assessment. The primary endpoint is intervention engagement measured by attendance. Secondary outcomes include physical activity, dietary intake, body mass index, blood pressure, genomic orientation/knowledge, and perceived racism. Exploratory/moderator analyses will examine whether social determinants of health, including income, food insecurity, health literacy, occupational prestige, and experiences of racism, influence intervention engagement and behavior change.
Trial Details
NCT Number NCT07833384
Lead Sponsor Pennington Biomedical Research Center
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)
Diabetes, Hypercholesterolaemia, Hypertension, Obesity Type 2 Diabetes Mellitus, Obesity & Overweight, Heart Failure, CAD - Coronary Artery Disease, Stroke Risk +6 more
Related terms Coronary Artery Disease, Diabetes Mellitus, Heart Failure, Hypercholesterolemia, Hypertension, Obesity, Overweight
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov