Food As MedicinE for Diabetes

Study Overview
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Brief Summary
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The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.

Detailed Description
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Food insecurity, lack of access to enough food for an active, healthy life, affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes. Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies-offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called 'food as medicine', as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions. Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed. This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, Hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) will be enrolled and randomly assigned to intervention or usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $40/month food subsidy, along with usual diabetes care.

Official Title
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Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: MTM
* Other: Food Subsidy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months Experiencing food insecurity as indicated by 2-item Hunger Vital Sign English speaking BMI ≥25 kg/m^2 (≥ 23 kg/m^2 if self-report Asian ancestry) No plans to move from the area for at least 1 year Free living to the extent that participant has control over dietary intake Willing and able to provide written informed consent and participate in all study activities Exclusion Criteria: Participant in diabetes, nutrition, or weight research intervention in last 12 months Another family member or household member is a study participant. Only one member of each household may take part in this study. Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years Lack of safe, stable residence and ability to store meals Lack of telephone Pregnancy/breastfeeding or intended pregnancy in the next year History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured > 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded. Advanced kidney disease (estimated creatinine clearance < 30 mL/min) Known drug or alcohol misuse in the past 2 years Known psychosis or major psychiatric illness that prevents participation with study activities Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar

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: Participants will be assigned in 1:1 ratio to one of two intervention arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medically Tailored Meal (MTM)<br>The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. | Other: MTM<br>* weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.<br>|
| Active Comparator: Food Subsidy<br>As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy. | Other: Food Subsidy<br>* $40/month food subsidy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c at Month 6 | Hemoglobin A1c Level | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c at Month 12 | Hemoglobin A1c Level | 12 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 | 
| Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6 | The PROMIS-29 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 we 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 PROMIS-29 at Month 12 | The PROMIS-29 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 we will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 12 months | 
| Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 6 months | 
| Diabetes Distress Score as assessed by PAID-11 at Month 12 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 12 months | 
| Depressive Symptom Score at Month 6 | Depressive Symptoms as assessed by PROMIS SF (Short Form) v1.0 - Depression 4a. Raw scores 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 depression indicates more severe depressive symptoms. | 6 months | 
| Depressive Symptom Score at Month 12 | Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores 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 depression indicates more severe depressive symptoms. | 12 months | 
| Frequency of self-reported hypoglycemia at Month 6 | Categorized by number of episodes on prior 3 months | 6 months | 
| Frequency of self-reported hypoglycemia at Month 12 | Categorized by number of episodes on prior 3 months | 12 months | 
| Frequency of self-reported severe hypoglycemia at Month 6 | Categorized by number of episodes on prior 3 months | 6 months | 
| Frequency of self-reported severe hypoglycemia at Month 12 | Categorized by number of episodes on prior 3 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Socioeconomic Factors, Lifestyle Intervention