FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Systolic and diastolic changes from baseline to 12 weeks and 24 weeks
研究概览
简要总结
The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework. Participants will be randomized 1:1 to FIM+DASH or usual-care control. The 24-week trial includes a 12-week FIM+DASH intervention followed by a 12-week maintenance period and leverages existing partnerships with community-based organizations for home food delivery and culinary skill-skill building. The main questions it aims to answer are: (1) What is the effect of FIM+DASH vs. usual care control on blood pressure? (2) What is the effect of FIM+DASH vs. usual care control on DASH diet adherence (diet quality), body weight, and waist circumference? (3) How to identify factors associated with the sustainability and scalability of FIM+DASH in real-world settings?
详细描述
FIM+DASH is adapted from the FIM+DASH pilot and informed by prior NIH-funded dietary interventions integrating clinic-community partnerships for culinary skill building and home food delivery. The intervention is designed to strengthen clinic-to-community linkages that support adoption and maintenance of a DASH eating pattern and hypertension (HTN) self-management for weight and BP control. Core components include in-person group and on-demand culinary skill-building, group and on-demand didactic content for DASH adoption and adherence and HTN self-management, brief one-on-one check-ins with a nutrition professional, and weekly DASH-friendly home food delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years; diagnosis of hypertension in Electronic health record or most recent clinic blood pressure meeting inclusion thresholds (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥80 mmHg); BMI ≥30 kg/m²; able and willing to complete survey instruments and assessment procedures; able to speak/read English; access to a smartphone with text-messaging capability.
排除标准
- •inability to speak/read English; cognitive impairment that precludes informed consent or participation; severe food allergies or medically necessary dietary restrictions that would preclude adoption of a DASH eating pattern; inability to cook at home; current treatment for cancer; self-reported history of a recent major cardiovascular event within the past 12 months (myocardial infarction, cerebrovascular accident, cardiac surgery, or hypertensive emergency); known advanced liver or renal disease; severe mental illness that would preclude participation; pregnancy. Individuals with lactose intolerance will not be excluded because low-lactose alternatives are available within the intervention.
研究组 & 干预措施
FIM Usual Care Arm
Participants randomized to the usual care arm continue to receive routine clinical care. They do not receive the FIM+DASH intervention during the active intervention period, but they complete study assessments according to the same assessment schedule. If your protocol includes delayed intervention materials/equipment/classes/food support after the primary trial period, include that here.
干预措施: FIM Usual Care Arm (Combination Product)
FIM Intervention Arm
Participants randomized to the experimental arm receive the FIM+DASH intervention, which includes Food is Medicine support aligned with DASH dietary guidance. The intervention includes groceries/food support, cooking/nutrition education, behavioral support, self-monitoring tools, and participant follow-up as specified in the protocol.
干预措施: FIM intervention arm (Combination Product)
结局指标
主要结局
Systolic and diastolic changes from baseline to 12 weeks and 24 weeks
时间窗: Baseline, 12 weeks and 24 weeks
systolic and diastolic blood pressure
blood pressure
时间窗: From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase)
systolic and diastolic blood pressure
次要结局
- Weight changes from baseline to 12 weeks and 24 weeks(Baseline, 12 weeks and 24 weeks)
- Diet quality changes from baseline to 12 weeks and 24 weeks(Baseline,12 weeks and 24 weeks)
- Waist circumference changes from baseline to 12 weeks and 24 weeks(Baseline,12 weeks and 24 weeks)
- Weight management(From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase))
- DASH diet adherence score(From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase))
- Waist circumference(From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase))