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Life sciences · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · September 22, 2026
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Phase EARLY_PHASE1 Trial.
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Registry record from ClinicalTrials.gov (NCT07833384). This is a study registration, not published results. Lead sponsor: Pennington Biomedical Research Center. Recruitment status: COMPLETED. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 60 participants (ACTUAL). Conditions: Diabetes, Hypercholesterolaemia, Hypertension, Obesity Type 2 Diabetes Mellitus, Obesity & Overweight, Heart Failure, CAD - Coronary Artery Disease, Stroke Risk, Cardiac Arrythmias, Genetics Hypertension, Genetics, Pharmacogenomics, Pharmacogenomic Testing for Medication Management, Cancer Genetics. Interventions: GENETIC: Color Genomics Genetic Testing Panels. Primary outcome measures: Total Participant Engagement of health behavior interventions. , 14-weeks. Brief summary: 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.