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

Early Phase 1CompletedNCT07833384

Pennington Biomedical Research Center60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Diabetes

Interventions

Color Genomics Genetic Testing PanelsGENETIC

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

Total Participant Engagement of health behavior interventions.

Measured by total health behavior sessions attended between groups.

Time frame: 14-weeks

Data from ClinicalTrials.gov

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