Clinical trial · Interventional
The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CAD - Coronary Artery Disease | — | UNRESOLVED | — |
| Cancer Genetics | — | UNRESOLVED | — |
| Cardiac Arrythmias | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Genetics | — | UNRESOLVED | — |
| Genetics Hypertension | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Hypercholesterolaemia | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Obesity & Overweight |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Color Genomics Genetic Testing Panels | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Genetically Unblinded
- description
- 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.
- interventionNames
- Genetic: Color Genomics Genetic Testing Panels
- type
- EXPERIMENTAL
- label
- Genetically Blinded
- description
- 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.
- interventionNames
- Genetic: Color Genomics Genetic Testing Panels
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (16)
- BACKGROUNDMarteau TM, Lerman C. Genetic risk and behavioural change. BMJ. 2001 Apr 28;322(7293):1056-9. doi: 10.1136/bmj.322.7293.1056. No abstract available. PMID 11325776
- BACKGROUNDHorne J, Madill J, Gilliland J. Incorporating the 'Theory of Planned Behavior' into personalized healthcare behavior change research: a call to action. Per Med. 2017 Nov;14(6):521-529. doi: 10.2217/pme-2017-0038. Epub 2017 Nov 24. PMID 29749859
- BACKGROUNDHorrow C, Pacyna JE, Lee MK, Sharp RR. Measuring Attitudes About Genomic Medicine: Validation of the Genomic Orientation Scale (GO Scale). Value Health. 2021 Jul;24(7):1030-1037. doi: 10.1016/j.jval.2021.02.001. Epub 2021 Apr 2. PMID 34243827
- BACKGROUNDMcNeilly MD, Anderson NB, Armstead CA, Clark R, Corbett M, Robinson EL, Pieper CF, Lepisto EM. The perceived racism scale: a multidimensional assessment of the experience of white racism among African Americans. Ethn Dis. 1996 Winter-Spring;6(1-2):154-66. PMID 8882844
- BACKGROUNDCaldwell J, Jackson FLC. Evolutionary perspectives on African North American genetic diversity: Origins and prospects for future investigations. Evol Anthropol. 2021 Jul;30(4):242-252. doi: 10.1002/evan.21910. Epub 2021 Aug 13. PMID 34388300
- BACKGROUNDSheppard VB, Sutton AL, Hurtado-De-Mendoza A, Tariq F, Perera RA, Quillin J, Jeudy M, Gomez-Trillos S, Schwartz MD. Addressing disparities in the uptake of genetic counseling and testing in African American women; rationale, design and methods. Contemp Clin Trials. 2023 Jul;130:107210. doi: 10.1016/j.cct.2023.107210. Epub 2023 May 2. PMID 37142159
- BACKGROUNDLima SM, Nazareth M, Schmitt KM, Reyes A, Fleck E, Schwartz GK, Terry MB, Hillyer GC. Interest in genetic testing and risk-reducing behavioral changes: results from a community health assessment in New York City. J Community Genet. 2022 Dec;13(6):605-617. doi: 10.1007/s12687-022-00610-2. Epub 2022 Oct 13.