Clinical trial NCT05048836: Healthy Food First
Official title: Healthy Food First
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Food Insecurity
Diet, Mediterranean
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of North Carolina
name: UNC Health Alliance
name: Duke University
First posted: 2021-09-17
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Thus, the investigators propose conducting a 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Office-based Systolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Office-based Systolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Office-based Systolic Blood Pressure at Month 18
timeFrame: 18 months
measure: Office-based Diastolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Office-based Diastolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Office-based Diastolic Blood Pressure at Month 18
timeFrame: 18 months
Secondary outcomes:
measure: Ambulatory Systolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Ambulatory Systolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Ambulatory Systolic Blood Pressure at Month 18
timeFrame: 18 months
measure: Ambulatory Diastolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Ambulatory Diastolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Ambulatory Diastolic Blood Pressure at Month 18
timeFrame: 18 months
measure: Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18
timeFrame: 18 months
measure: Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18
timeFrame: 18 months
measure: Food Insecurity Score at Month 6
timeFrame: 6 months
measure: Food Insecurity Score at Month 12
timeFrame: 12 months
measure: Food Insecurity Score at Month 18
timeFrame: 18 months
measure: Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6
timeFrame: 6 months
measure: Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12
timeFrame: 12 months
measure: Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18
timeFrame: 18 months
measure: Diet Quality at Month 6
timeFrame: 6 months
measure: Diet Quality at Month 12
timeFrame: 12 months
measure: Diet Quality at Month 18
timeFrame: 18 months
measure: Food/ medication trade-offs at Month 6
timeFrame: 6 months
measure: Food/ medication trade-offs at Month 12
timeFrame: 12 months
measure: Food/ medication trade-offs Month 18
timeFrame: 18 months
measure: Diet self-efficacy at Month 6
timeFrame: 6 months
measure: Diet self-efficacy at Month 12
timeFrame: 12 months
measure: Diet self-efficacy at Month 18
timeFrame: 18 months
measure: Physical Activity Levels at Month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Darren DeWalt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: