The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans

NCT07833384 | Completed Early Phase 1 DMC

• 2 other identifiers: PBRC 2024-043P50MD017338
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Total number of participants that completed health behavior interventions.

  Measured by total health behavior sessions attended between groups.

  14-weeks

Study Arms (2)

Genetically Unblinded

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

Color Genomics Genetic Testing Panels GENETIC

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.

Genetically Blinded; Genetically Unblinded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (16)

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• Horrow 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 BACKGROUND

• McNeilly 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.

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• Caldwell 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.

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• Sheppard 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 BACKGROUND

• Lima 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.

  PMID: 36227532 BACKGROUND

• Chirinos DA, Vargas E, Kamsickas L, Carnethon M. The role of behavioral science in addressing cardiovascular health disparities: A narrative review of efforts, challenges, and future directions. Health Psychol. 2022 Oct;41(10):740-754. doi: 10.1037/hea0001191. Epub 2022 Jul 18.

  PMID: 35849358 BACKGROUND

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  PMID: 12811228 BACKGROUND

• Keaton JM, Cooke Bailey JN, Palmer ND, Freedman BI, Langefeld CD, Ng MC, Bowden DW. A comparison of type 2 diabetes risk allele load between African Americans and European Americans. Hum Genet. 2014 Dec;133(12):1487-95. doi: 10.1007/s00439-014-1486-5. Epub 2014 Oct 2.

  PMID: 25273842 BACKGROUND

• Thornton RL, Glover CM, Cene CW, Glik DC, Henderson JA, Williams DR. Evaluating Strategies For Reducing Health Disparities By Addressing The Social Determinants Of Health. Health Aff (Millwood). 2016 Aug 1;35(8):1416-23. doi: 10.1377/hlthaff.2015.1357.

  PMID: 27503966 BACKGROUND

• Turner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Hutto B, Wilson M, Davey M, Bernhart JA, Okpara N, Bailey S, Hu E. Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250626. doi: 10.1001/jamanetworkopen.2022.50626.

  PMID: 36633848 BACKGROUND

• Newton RL Jr, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.

  PMID: 30143478 BACKGROUND

• Albert MA, Carnethon MR, Watson KE. Disparities in Cardiovascular Medicine. Circulation. 2021 Jun 15;143(24):2319-2320. doi: 10.1161/CIRCULATIONAHA.121.055565. Epub 2021 Jun 14. No abstract available.

  PMID: 34125568 BACKGROUND

• Zilbermint M, Hannah-Shmouni F, Stratakis CA. Genetics of Hypertension in African Americans and Others of African Descent. Int J Mol Sci. 2019 Mar 2;20(5):1081. doi: 10.3390/ijms20051081.

  PMID: 30832344 BACKGROUND

• Carnethon MR, Pu J, Howard G, Albert MA, Anderson CAM, Bertoni AG, Mujahid MS, Palaniappan L, Taylor HA Jr, Willis M, Yancy CW; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; and Stroke Council. Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 21;136(21):e393-e423. doi: 10.1161/CIR.0000000000000534. Epub 2017 Oct 23.

  PMID: 29061565 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypercholesterolemia; Hypertension; Obesity; Overweight; Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Jennifer L. Caldwell, PhD, MPH, MS

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 22, 2025
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting documentation will become available following publication of the primary study results or within 12 months after study completion, whichever occurs first. Data will remain available for at least five years following publication.
• Access Criteria: Access to de-identified data will be available to qualified researchers whose proposed use is consistent with the informed consent provided by study participants and applicable institutional policies. Investigators must submit a research proposal, statistical analysis plan, and data use agreement for review and approval by the Pennington Biomedical Research Center study team. Only de-identified data necessary to address the approved research question will be shared. Data will be provided through a secure institutional data-sharing process in accordance with institutional and NIH data-sharing policies.

Locations

US (1)