An Early Phase 1 interventional study of Color Genomics Genetic Testing Panels in Diabetes, Hypercholesterolaemia and Hypertension, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Pennington Biomedical Research Center · Early Phase 1, Interventional, and Health services research
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.
Exclusion Criteria:
Genetically unblinded participants received their genetic test results from Color Genomics: Cancer, CVD, and Pharmacogenomics panels before starting the health behavior intervention. In addition, they received a 1:1 genetic counseling session prior to the health behavior intervention completion.
Genetic: Color Genomics Genetic Testing Panels
Genetically blinded participants received their genetic test results from Color Genomics: Cancer, CVD, and Pharmacogenomics panels. In addition, they received a 1:1 genetic counseling session after the health behavior intervention was completed.
Genetic: Color Genomics Genetic Testing Panels
Participants gave a saliva sample to Color Genomics for an Ancestry, Hereditary Cancer, CVD, and Pharmacogenomics testing panel. Participants were able to get visuals of their results using their website and also discuss findings via zoom or phone call.
Total number of participants that completed health behavior interventions.
Measured by total health behavior sessions attended between groups.
Time frame: 14-weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the primary and secondary analyses reported in publications arising from the Linking GAINS study will be made available. Shared data may include participant demographic characteristics, intervention assignment, attendance and retention measures, genomic knowledge assessments, behavioral outcomes, clinical measures (e.g., blood pressure, body mass index), and de-identified genomic result classifications (e.g., positive/negative clinical findings). Personally identifiable information, dates, direct identifiers, genetic sequence data, and other information that could reasonably identify participants will not be shared.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pennington Biomedical Research Center