Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.

Detailed Description
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Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.

Official Title
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Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management

Conditions
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Obesity, Hypertension, Pre-diabetes, Type 2 Diabetes

Intervention / Treatment
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* Other: Medically-tailored meals
* Other: Produce box and recipes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age or older who are patients at Akron General Center for Family Medicine Have body mass index (BMI) equal to or greater that 30kg/m2 AND Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes: Pre-type 2 diabetes mellitus Type 2 diabetes mellitus Hypertension Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months Exclusion Criteria: Food allergies Pregnant No access to internet Need English language interpretation Currently participating in a structured weight loss program or using weight loss medications Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A quasi-randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medically-Tailored Meals (MTM)<br>Medically-tailored meals delivered to participants' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. | Other: Medically-tailored meals<br>* Medically tailored meals delivered to patients' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.<br>|
| Experimental: Produce Box and Recipes<br>Weekly produce box delivered to participants' homes and access to recipes via the internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos. | Other: Produce box and recipes<br>* Weekly produce box and access to recipes via internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.<br>|
| No Intervention: Standard of Care<br>Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participants' body weight | Percent weight loss | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-type 2 diabetes mellitus: Change in number of medications | Absolute change in number of medications | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Pre-type 2 diabetes mellitus: Change in medication dosage | Percent change in medication dosage | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Pre-type 2 diabetes mellitus: Change in HbA1c | Absolute change in HbA1c | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Type 2 diabetes mellitus: Change in number of medications | Absolute change in number of medications | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Type 2 diabetes mellitus: Change in medication dosage | Percent change in medication dosage | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Type 2 diabetes mellitus: Change in HbA1c | Absolute change in HbA1c | From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline | 
| Hypertension: Change in number of medications | Absolute change in number of medications | Baseline visit (W1) to 16 week visit | 
| Hypertension: Change in medication dosage | Percent change in medication dosage | Baseline visit (W1) to 16 week visit | 
| Receipt of healthy food items: The Hunger Vital Sign scale | Values on the scale are: often true, sometimes true, and never true. A positive response to either or both of the first two values (often true, sometimes true) identifies households as being at risk for food insecurity | Baseline visit (W1) to week 16 visit | 
| Receipt of healthy food items: Eating at America's Table scale | Each reported frequency is expressed as a daily average ranging from 0 to 5. The estimate of the daily number of Pyramid/MyPyramid servings is calculated as average daily frequency x the number of Pyramid/MyPyramid servings for the portion size, summed across all food groups. A higher score for fruits and vegetables indicates a better outcome. | Baseline visit (W1) to week 16 visit | 
| Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale | Eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score. Overall score is the sum of the 8 items. A score of 10 or greater is considered major depression, 20 or more is severe major depression. | Baseline visit (W1) to week 16 visit | 
| Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale | Values on the scale are: Strongly disagree, disagree, neutral, agree, and strongly agree. Responses of agree and strongly agree indicate a better outcome. | Baseline visit (W1) to 16-week visit | 
| Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale | Six items, each of which is scored 0 to 10. Overall score is the mean of the 6 items. A higher score indicates a better outcome. | Baseline visit (W1) to 16-week visit |