Healthy Food First (HFF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Food Insecurity; Diet, Mediterranean
• Intervention / Treatment: Other: Food Subsidy, 6 months; Other: Food Delivery, 6 months; Behavioral: Lifestyle Support, 6 months; Other: Food Subsidy, 12 months; Other: Food Delivery, 12 months; Behavioral: Lifestyle Support, 12 months

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.

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-1651
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27708
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food subsidy, no lifestyle support, 6 months; Participant will receive $40 healthy food subsidy for 6 months.	Other: Food Subsidy, 6 months; Food subsidy for 6 months
Experimental: Food delivery, no lifestyle support, 6 months; Participant will receive twice monthly healthy food delivery for 6 months.	Other: Food Delivery, 6 months; Twice monthly delivery of healthy food for 6 months
Experimental: Food subsidy, with lifestyle support, 6 months; Participants will receive food subsidy and healthy lifestyle support for 6 months.	Other: Food Subsidy, 6 months; Food subsidy for 6 months; Behavioral: Lifestyle Support, 6 months; lifestyle support intervention delivered by community health workers for 6 months
Experimental: Food delivery, with lifestyle support, 6 months; Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.	Other: Food Delivery, 6 months; Twice monthly delivery of healthy food for 6 months; Behavioral: Lifestyle Support, 6 months; lifestyle support intervention delivered by community health workers for 6 months
Experimental: Food subsidy, no lifestyle support, 12 months; Participants will receive food subsidy for 12 months.	Other: Food Subsidy, 12 months; Food subsidy for 12 months
Experimental: Food delivery, no lifestyle support, 12 months; Participants will receive twice monthly food box deliveries for 12 months.	Other: Food Delivery, 12 months; Twice monthly delivery of healthy food for 12 months
Experimental: Food subsidy, with lifestyle support, 12 months; Participant will receive food subsidy and lifestyle support for 12 months.	Other: Food Subsidy, 12 months; Food subsidy for 12 months; Behavioral: Lifestyle Support, 12 months; lifestyle support intervention delivered by community health workers for 6 months
Experimental: Food delivery, with lifestyle support, 12 months; Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.	Other: Food Delivery, 12 months; Twice monthly delivery of healthy food for 12 months; Behavioral: Lifestyle Support, 12 months; lifestyle support intervention delivered by community health workers for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office-based Systolic Blood Pressure at Month 6	Systolic blood pressure recorded at office-based healthcare visits	6 months
Office-based Systolic Blood Pressure at Month 12	Systolic blood pressure recorded at office-based healthcare visits	12 months
Office-based Systolic Blood Pressure at Month 18	Systolic blood pressure recorded at office-based healthcare visits	18 months
Office-based Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded at office-based healthcare visits	6 months
Office-based Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded at office-based healthcare visits	12 months
Office-based Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded at office-based healthcare visits	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Insecurity Score at Month 6	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	6 months
Food Insecurity Score at Month 12	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	12 months
Ambulatory Systolic Blood Pressure at Month 6	Systolic blood pressure recorded outside the healthcare system.	6 months
Ambulatory Systolic Blood Pressure at Month 12	Systolic blood pressure recorded outside the healthcare system.	12 months
Ambulatory Systolic Blood Pressure at Month 18	Systolic blood pressure recorded outside the healthcare system.	18 months
Ambulatory Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded outside the healthcare system.	6 months
Ambulatory Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded outside the healthcare system.	12 months
Ambulatory Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded outside the healthcare system.	18 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6	Systolic blood pressure recorded either inside or outside the healthcare system.	6 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12	Systolic blood pressure recorded either inside or outside the healthcare system.	12 months
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18	Systolic blood pressure recorded either inside or outside the healthcare system.	18 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded either inside or outside the healthcare system.	6 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded either inside or outside the healthcare system.	12 months
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded either inside or outside the healthcare system.	18 months
Food Insecurity Score at Month 18	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	18 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6	The Patient-Reported Outcomes Measurement Information System(PROMIS)-14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).	6 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12	The Patient-Reported Outcomes Measurement Information System (PROMIS) -14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).	12 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18	The Patient-Reported Outcomes Measurement Information System (PROMIS)-14 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data investigators will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).	18 months
Diet Quality at Month 6	Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.	6 months
Diet Quality at Month 12	Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.	12 months
Diet Quality at Month 18	Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.	18 months
Food/ medication trade-offs at Month 6	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	6 months
Food/ medication trade-offs at Month 12	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	12 months
Food/ medication trade-offs Month 18	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	18 months
Diet self-efficacy at Month 6	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	6 months
Diet self-efficacy at Month 12	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	12 months
Diet self-efficacy at Month 18	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	18 months
Physical Activity Levels at Month 12	Assessed by the International Physical Activity Questionnaire(Short Form). Higher scores indicate higher levels of physical activity.	12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Blue Cross Blue Shield of North Carolina; UNC Health Alliance
• Investigators: Principal Investigator: Darren DeWalt, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 21-0992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No