Cardiovascular Risk Reduction for Adults With Food Insecurity Using Structured Incentives (CVD-FIT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CVD Risk - PREVENT
研究概览
简要总结
The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.
详细描述
Study Overview: 200 African American adults at risk for CVD with food insecurity will be randomized 1:1 to CVD-FIT or enhanced usual care (CVD risk reduction education). Each patient will be followed for 12 months, with study visits at baseline, 3, 6, and 12 months. The primary outcome will be 10-year CVD risk using the Pooled Cohort Equation at 12 months post-randomization while the secondary outcomes will be quality of life at 12 months post-randomization and cost-effectiveness of the CVD-FIT intervention compared to enhanced usual care.
Patient Randomization. A permuted block randomization method will be used to assign subjects to intervention or control. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines.
Description of the CVD-FIT Intervention: The CVD-FIT intervention will incorporate 1) $100 monthly income supplementation; 2) $50 weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training.
Enhanced Usual Care Control Group: Participants randomized to the enhanced usual care group will receive the same mailed education and health educator delivered education and skills training sessions as the CVD-FIT intervention group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-report as African American/non-Hispanic Black
- •screen positive for food insecurity over the past 12-months using a food insecurity risk tool developed through completion of the research team's current NIH funded R01 (R01MD013826)
- •at risk for CVD defined as age ≥40 years and having a clinical diagnosis of diabetes, or hypertension, or hyperlipidemia, or being overweight/obese (defined as a BMI>25), or being a current smoker
- •able to communicate in English.
排除标准
- •Mental confusion on interview suggesting significant dementia
- •Participation in other cardiovascular disease clinical trials
- •Alcohol or drug abuse/dependency based on screening using CAGE questionnaire
- •Active psychosis or acute mental disorder based on self-report
- •Life expectancy <12 months.
研究组 & 干预措施
Enhanced Usual Care
Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
干预措施: Enhanced Usual Care (Behavioral)
CVD-FIT
The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.
干预措施: CVD-FIT (Behavioral)
结局指标
主要结局
CVD Risk - PREVENT
时间窗: baseline, 3-months, 6-months, and 12-months post randomization
CVD Risk will be measured using the PREVENT equation
10-Year CVD Risk
时间窗: baseline, 3-months, 6-months, and 12-months post randomization
10-year CVD risk will be measured by the Pooled Cohort risk reduction equation recommended for race- and sex- specific risk calculation for African Americans 40 to 79 years of age.
次要结局
- Physical and Mental Health Related Quality of Life(baseline, 3-months, 6-months, and 12-months post randomization)
研究者
Rebekah Jo Walker
Principal Investigator
State University of New York at Buffalo