Healthy Food First

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Diet, Mediterranean; Food Insecurity
• Interventions: Other: Food Subsidy, 12 months; Other: Food Subsidy, 6 months; Other: Food Delivery, 12 months; Behavioral: Lifestyle Support, 6 months; Other: Food Delivery, 6 months; Behavioral: Lifestyle Support, 12 months

• Registration Number: NCT05048836
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Study Start: 2021-10-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 540

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Food subsidy, with lifestyle support, 6 months	Lifestyle Support, 6 months	Participants will receive food subsidy and healthy lifestyle support for 6 months.
Food delivery, with lifestyle support, 6 months	Lifestyle Support, 6 months	Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.
Food delivery, with lifestyle support, 6 months	Food Delivery, 6 months	Participants will receive twice monthly food box deliveries and lifestyle support for 6 months.
Food subsidy, no lifestyle support, 12 months	Food Subsidy, 12 months	Participants will receive food subsidy for 12 months.
Food subsidy, no lifestyle support, 6 months	Food Subsidy, 6 months	Participant will receive $40 healthy food subsidy for 6 months.
Food delivery, no lifestyle support, 6 months	Food Delivery, 6 months	Participant will receive twice monthly healthy food delivery for 6 months.
Food subsidy, with lifestyle support, 6 months	Food Subsidy, 6 months	Participants will receive food subsidy and healthy lifestyle support for 6 months.
Food delivery, no lifestyle support, 12 months	Food Delivery, 12 months	Participants will receive twice monthly food box deliveries for 12 months.
Food subsidy, with lifestyle support, 12 months	Food Subsidy, 12 months	Participant will receive food subsidy and lifestyle support for 12 months.
Food subsidy, with lifestyle support, 12 months	Lifestyle Support, 12 months	Participant will receive food subsidy and lifestyle support for 12 months.
Food delivery, with lifestyle support, 12 months	Lifestyle Support, 12 months	Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.
Food delivery, with lifestyle support, 12 months	Food Delivery, 12 months	Participants will receive twice monthly food box deliveries and lifestyle support for 12 months.

Primary Outcome Measures

Name	Time	Method
Office-based Systolic Blood Pressure at Month 12	12 months	Systolic blood pressure recorded at office-based healthcare visits
Office-based Systolic Blood Pressure at Month 6	6 months	Systolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 18	18 months	Diastolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 6	6 months	Diastolic blood pressure recorded at office-based healthcare visits
Office-based Diastolic Blood Pressure at Month 12	12 months	Diastolic blood pressure recorded at office-based healthcare visits
Office-based Systolic Blood Pressure at Month 18	18 months	Systolic blood pressure recorded at office-based healthcare visits

Secondary Outcome Measures

Name	Time	Method
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6	6 months	Systolic blood pressure recorded either inside or outside the healthcare system.
Diet Quality at Month 12	12 months	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.
Ambulatory Systolic Blood Pressure at Month 6	6 months	Systolic blood pressure recorded outside the healthcare system.
Ambulatory Systolic Blood Pressure at Month 18	18 months	Systolic blood pressure recorded outside the healthcare system.
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12	12 months	Systolic blood pressure recorded either inside or outside the healthcare system.
Ambulatory Systolic Blood Pressure at Month 12	12 months	Systolic blood pressure recorded outside the healthcare system.
Ambulatory Diastolic Blood Pressure at Month 18	18 months	Diastolic blood pressure recorded outside the healthcare system.
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6	6 months	Diastolic blood pressure recorded either inside or outside the healthcare system.
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18	18 months	Diastolic blood pressure recorded either inside or outside the healthcare system.
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 18	18 months	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)).
Diet Quality at Month 6	6 months	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.
Ambulatory Diastolic Blood Pressure at Month 6	6 months	Diastolic blood pressure recorded outside the healthcare system.
Ambulatory Diastolic Blood Pressure at Month 12	12 months	Diastolic blood pressure recorded outside the healthcare system.
Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18	18 months	Systolic blood pressure recorded either inside or outside the healthcare system.
Food/ medication trade-offs at Month 12	12 months	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Food/ medication trade-offs Month 18	18 months	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Food Insecurity Score at Month 6	6 months	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Food Insecurity Score at Month 12	12 months	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Food Insecurity Score at Month 18	18 months	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Diet Quality at Month 18	18 months	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.
Physical Activity Levels at Month 12	12 months	Assessed by the International Physical Activity Questionnaire(Short Form). Higher scores indicate higher levels of physical activity.
Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12	12 months	Diastolic blood pressure recorded either inside or outside the healthcare system.
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 6	6 months	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)).
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-14 at Month 12	12 months	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)).
Food/ medication trade-offs at Month 6	6 months	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
Diet self-efficacy at Month 6	6 months	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Diet self-efficacy at Month 12	12 months	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
Diet self-efficacy at Month 18	18 months	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.

Trial Locations

Locations (2)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States