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临床试验/NCT05048836
NCT05048836已完成不适用

Healthy Food First

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2021年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
525
试验地点
4
主要终点
Office-based Systolic Blood Pressure at Month 12

研究概览

简要总结

Socioeconomic barriers to healthy eating, particularly food insecurity, are a major reason for poor blood pressure control and hypertension complications. Healthy diet patterns have been shown to improve health. Unfortunately, food insecurity makes it difficult for individuals to maintain healthy diet patterns. This pragmatic randomized trial will compare two food insecurity interventions (a healthy food subsidy versus a delivered food box), with or without lifestyle support delivered by community health workers, for 6 versus 12 months duration. Key outcomes include blood pressure, food insecurity, and other patient reported outcomes.

详细描述

Socioeconomic barriers to healthy eating, particularly food insecurity ("insufficient or uncertain access to enough food for an active, healthy life") are a major reason for poor blood pressure control, and hypertension complications. Healthful dietary patterns, such as a Mediterranean (Med)-style diet, improve blood pressure control and reduce cardiovascular risk, risk for other chronic diseases, and premature mortality. However, food insecurity incentivizes individuals away from healthful diet patterns, resulting in wide disparities in diet-related diseases such as hypertension. Though two major ways to address food insecurity are commonly proposed-- providing subsidies for healthy food and home delivery of healthy food boxes--investigators do not know which will have the greater effect. Further, as these interventions cannot be provided indefinitely, investigators need to determine whether adding an intervention to support healthy lifestyle change, such as a culturally-tailored Med-style diet intervention, can lead to improved health even after provision of the food insecurity intervention ends.

Thus, the study team proposes to conduct 2x2x2 factorial design randomized trial to compare two food insecurity interventions, with or without a lifestyle support intervention that provides culturally tailored Med-style dietary pattern education, disease self-management support, and navigation to community resources for health related social needs, over 2 different time periods. To realize the vision of "food as medicine" to promote equity in clinical care, the study team has drawn on an extensive background of previously tested programs to create the novel multi-component interventions that will be tested in this trial. This novel intervention focuses on lowering blood pressure and addressing food insecurity. Specifically, participants will be separately randomized to receive 1) a food subsidy versus home delivery of a healthy food box, and 2) a structured lifestyle support intervention, delivered by community health workers and supervised by a registered dietitian versus usual care for 3) either 6 or 12 months. The proposed study will be conducted in central NC, enrolling 1400 participants with a history of hypertension and food insecurity. Six months after the end of each participant's intervention, investigators will re-assess study outcomes to evaluate for sustained effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of hypertension with systolic blood pressure > 130 mm Hg
  • Report of food insecurity by 2-item 'Hunger Vital Sign'
  • English or Spanish speaking
  • Age ≥ 18 years
  • Lives within delivery area of intervention services.

排除标准

  • Pregnancy
  • Malignancy
  • Advanced kidney disease (estimated creatinine clearance < 30 mL/min assessed by Chronic Kidney Disease Epidemiology Collaboration formula)

研究组 & 干预措施

Food subsidy, no lifestyle support, 6 months

Experimental

Participant will receive $40 healthy food subsidy for 6 months.

干预措施: Food Subsidy, 6 months (Other)

Food delivery, no lifestyle support, 6 months

Experimental

Participant will receive twice monthly healthy food delivery for 6 months.

干预措施: Food Delivery, 6 months (Other)

Food subsidy, no lifestyle support, 12 months

Experimental

Participants will receive food subsidy for 12 months.

干预措施: Food Subsidy, 12 months (Other)

Food delivery, no lifestyle support, 12 months

Experimental

Participants will receive twice monthly food box deliveries for 12 months.

干预措施: Food Delivery, 12 months (Other)

Food subsidy, with lifestyle support, 12 months

Experimental

Participant will receive food subsidy and lifestyle support for 12 months.

干预措施: Food Subsidy, 12 months (Other)

Food subsidy, with lifestyle support, 12 months

Experimental

Participant will receive food subsidy and lifestyle support for 12 months.

干预措施: Lifestyle Support, 12 months (Behavioral)

Food delivery, with lifestyle support, 12 months

Experimental

Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.

干预措施: Lifestyle Support, 12 months (Behavioral)

Food delivery, with lifestyle support, 12 months

Experimental

Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.

干预措施: Food Delivery, 12 months (Other)

Food subsidy, with lifestyle support, 6 months

Experimental

Participants will receive food subsidy and healthy lifestyle support for 6 months.

干预措施: Food Subsidy, 6 months (Other)

Food subsidy, with lifestyle support, 6 months

Experimental

Participants will receive food subsidy and healthy lifestyle support for 6 months.

干预措施: Lifestyle Support, 6 months (Behavioral)

Food delivery, with lifestyle support, 6 months

Experimental

Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.

干预措施: Lifestyle Support, 6 months (Behavioral)

Food delivery, with lifestyle support, 6 months

Experimental

Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.

干预措施: Food Delivery, 6 months (Other)

结局指标

主要结局

Office-based Systolic Blood Pressure at Month 12

时间窗: 12 months

Systolic blood pressure recorded at office-based healthcare visits

Office-based Systolic Blood Pressure at Month 18

时间窗: 18 months

Systolic blood pressure recorded at office-based healthcare visits

Office-based Systolic Blood Pressure at Month 6

时间窗: 6 months

Systolic blood pressure recorded at office-based healthcare visits

Office-based Diastolic Blood Pressure at Month 18

时间窗: 18 months

Diastolic blood pressure recorded at office-based healthcare visits

Office-based Diastolic Blood Pressure at Month 6

时间窗: 6 months

Diastolic blood pressure recorded at office-based healthcare visits

Office-based Diastolic Blood Pressure at Month 12

时间窗: 12 months

Diastolic blood pressure recorded at office-based healthcare visits

次要结局

  • Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6(6 months)
  • Diet Quality at Month 12(12 months)
  • Ambulatory Systolic Blood Pressure at Month 6(6 months)
  • Ambulatory Systolic Blood Pressure at Month 18(18 months)
  • Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12(12 months)
  • Ambulatory Systolic Blood Pressure at Month 12(12 months)
  • Ambulatory Diastolic Blood Pressure at Month 18(18 months)
  • Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6(6 months)
  • Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18(18 months)
  • Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18(18 months)
  • Diet Quality at Month 6(6 months)
  • Ambulatory Diastolic Blood Pressure at Month 6(6 months)
  • Ambulatory Diastolic Blood Pressure at Month 12(12 months)
  • Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18(18 months)
  • Food/ medication trade-offs at Month 12(12 months)
  • Food/ medication trade-offs Month 18(18 months)
  • Food Insecurity Score at Month 6(6 months)
  • Food Insecurity Score at Month 12(12 months)
  • Food Insecurity Score at Month 18(18 months)
  • Diet Quality at Month 18(18 months)
  • Physical Activity Levels at Month 12(12 months)
  • Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12(12 months)
  • Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6(6 months)
  • Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12(12 months)
  • Food/ medication trade-offs at Month 6(6 months)
  • Diet self-efficacy at Month 6(6 months)
  • Diet self-efficacy at Month 12(12 months)
  • Diet self-efficacy at Month 18(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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