The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Participant Engagement of health behavior interventions.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Color Genomics Genetic Testing Panels (Genetic)
结局指标
主要结局
Total Participant Engagement of health behavior interventions.
时间窗: 14-weeks
Measured by total health behavior sessions attended between groups.
次要结局
未报告次要终点
研究者
Jennifer Caldwell
Assistant Professor
Pennington Biomedical Research Center