The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total Participant Engagement of health behavior interventions.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Participants are randomized to timing of genetic risk disclosure: early disclosure for the Genetically Unblinded group and delayed disclosure for the Genetically Blinded group. The design allows the study team to estimate whether knowledge of genetic risk is associated with engagement and changes in CVD risk reduction behaviors. Unblinded participants received their genetic test results ( Cancer, CVD, and Pharmacogenomics) and a 1:1 genetic counseling session.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Genetically Unblinded
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.
Intervention: Color Genomics Genetic Testing Panels (Genetic)
Genetically Blinded
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.
Intervention: Color Genomics Genetic Testing Panels (Genetic)
Outcomes
Primary Outcomes
Total Participant Engagement of health behavior interventions.
Time Frame: 14-weeks
Measured by total health behavior sessions attended between groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Caldwell
Assistant Professor
Pennington Biomedical Research Center