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

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.

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Key information

Conditions

Diabetes Arterial Occlusive Diseases Arteriosclerosis Body Weight CAD - Coronary Artery Disease Cancer Genetics Cardiac Arrythmias Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Dyslipidemias Endocrine System Diseases Genetics Genetics Hypertension Glucose Metabolism Disorders Heart Diseases Heart Failure Hypercholesterolaemia Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Obesity Type 2 Diabetes Mellitus Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pharmacogenomic Testing for Medication Management Pharmacogenomics Signs and Symptoms Stroke Risk Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Total Participant Engagement of health behavior interventions.

Time frame: 14-weeks

Measured by total health behavior sessions attended between groups.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: LINKING GAINS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 22, 2026
Registry last updated: Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed