Healthy Food First

Hypertension Clinical Trial

— HFF  

Official title:

Healthy Food First

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05048836
• Other study ID #: 21-0992
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diet, Mediterranean
• Food Insecurity
• Hypertension

Intervention

Other:
• Food Subsidy, 6 months
Food subsidy for 6 months
• Food Subsidy, 12 months
Food subsidy for 12 months

Behavioral:
• Lifestyle Support, 6 months
lifestyle support intervention delivered by community health workers for 6 months
• Lifestyle Support, 12 months
lifestyle support intervention delivered by community health workers for 6 months

Other:
• Food Delivery, 6 months
Twice monthly delivery of healthy food for 6 months
• Food Delivery, 12 months
Twice monthly delivery of healthy food for 12 months

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Blue Cross Blue Shield of North Carolina, Duke University, UNC Health Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office-based Systolic Blood Pressure at Month 6	Systolic blood pressure recorded at office-based healthcare visits	6 months
Primary	Office-based Systolic Blood Pressure at Month 12	Systolic blood pressure recorded at office-based healthcare visits	12 months
Primary	Office-based Systolic Blood Pressure at Month 18	Systolic blood pressure recorded at office-based healthcare visits	18 months
Primary	Office-based Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded at office-based healthcare visits	6 months
Primary	Office-based Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded at office-based healthcare visits	12 months
Primary	Office-based Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded at office-based healthcare visits	18 months
Secondary	Ambulatory Systolic Blood Pressure at Month 6	Systolic blood pressure recorded outside the healthcare system.	6 months
Secondary	Ambulatory Systolic Blood Pressure at Month 12	Systolic blood pressure recorded outside the healthcare system.	12 months
Secondary	Ambulatory Systolic Blood Pressure at Month 18	Systolic blood pressure recorded outside the healthcare system.	18 months
Secondary	Ambulatory Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded outside the healthcare system.	6 months
Secondary	Ambulatory Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded outside the healthcare system.	12 months
Secondary	Ambulatory Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded outside the healthcare system.	18 months
Secondary	Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 6	Systolic blood pressure recorded either inside or outside the healthcare system.	6 months
Secondary	Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 12	Systolic blood pressure recorded either inside or outside the healthcare system.	12 months
Secondary	Combined (Office-based and Ambulatory) Systolic Blood Pressure at Month 18	Systolic blood pressure recorded either inside or outside the healthcare system.	18 months
Secondary	Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 6	Diastolic blood pressure recorded either inside or outside the healthcare system.	6 months
Secondary	Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 12	Diastolic blood pressure recorded either inside or outside the healthcare system.	12 months
Secondary	Combined (Office-based and Ambulatory) Diastolic Blood Pressure at Month 18	Diastolic blood pressure recorded either inside or outside the healthcare system.	18 months
Secondary	Food Insecurity Score at Month 6	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	6 months
Secondary	Food Insecurity Score at Month 12	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	12 months
Secondary	Food Insecurity Score at Month 18	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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