THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
研究概览
简要总结
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.
详细描述
Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.
The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 & 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.
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 (Outcomes Assessor)
盲法说明
Outcomes assessors and data analysts will be masked to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Self-identify as Black/African American
- •Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
- •Live in census tracts identified by Montgomery County Department of Planning as HFPA:
- •Healthy Food Availability Index score is low (0-9.5),
- •Median household income ≤185% of Federal Poverty Level
- •>30% households have no vehicle, Distance to supermarket >1/4 mile.
- •Participants must have refrigeration, food appliances (microwave, stove),
- •Cell phone to receive messages
排除标准
- •Age <18 years
- •Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
- •Diagnosis of end-stage renal disease (ESRD)
- •Condition which interferes with outcome measurement (e.g., dialysis)
- •Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)
- •Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
- •Patients with cognitive impairment or other condition preventing their participation in the intervention
- •Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
- •Current participation in another clinical trial that could interfere with the study protocol
- •Those planning to move out of the geographic area in 12 months
- •Unwillingness to provide informed consent
- •Other conditions or situations at the discretion of the Investigative team
研究组 & 干预措施
THRIVE Intervention Arm
The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services.
干预措施: THRIVE Intervention (Behavioral)
Comparator Arm
The comparator arm will receive standard produce bags; and linkages to social services.
干预措施: Active Comparator (Behavioral)
结局指标
主要结局
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
时间窗: 0, 12 weeks and 24 weeks
Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.
次要结局
- Cost of the intervention(0, 12 weeks, 24 weeks)
- Weight in pounds(0, 12 weeks and 24 weeks)
- Recruitment rate(0, 12 weeks, 24 weeks)
- Participant Accrual(0, 12 weeks and 24 weeks)
- Number of referrals to health and social need resources(0, 12 weeks and 24 weeks)
- Diastolic Blood pressure(0, 12 and 24 weeks)
- Systolic Blood pressure(0, 12 and 24 weeks)
- Hemoglobin A1c(0, 12 and 24 weeks)
- Height in inches(0, 12 and 24 weeks)