NCT07833384CompletedEarly phase 1
The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Sept 2026
- Start date
- 22 Sept 2025
- Primary completion date
- 26 Mar 2026
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Heart failure, Obesity, Coronary artery disease, Stroke, High blood pressure, Type 2 diabetes
- NCT number
- NCT07833384
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 60
- From 22 Sept 2025 to the primary completion date, 26 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Cannot safely engage in physical activity.
- Has current knowledge of genetic contributions to CVD that would compromise the study comparison.
- Pregnant at the time of eligibility assessment, because the study observes body weight and physiologic outcomes without pregnancy as a confounder.
Who the study is looking for
- Age 18 years or older.
- Self-identification as African American.
- Willing to complete genetic testing using a saliva DNA collection kit.
- Willing to participate in a CVD risk reduction behavioral intervention lasting approximately 16 weeks.
- Able and willing to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.