Healthy Food First

Study Overview
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Brief Summary
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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
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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.

Official Title
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Healthy Food First

Conditions
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Hypertension, Food Insecurity, Diet, Mediterranean

Intervention / Treatment
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* Other: Food Subsidy, 6 months
* Other: Food Subsidy, 12 months
* Behavioral: Lifestyle Support, 6 months
* Behavioral: Lifestyle Support, 12 months
* Other: Food Delivery, 6 months
* Other: Food Delivery, 12 months


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 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 | 
| 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 |