Clinical trial NCT04828785: Food As MedicinE for Diabetes
Official title: Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Food Insecurity
Socioeconomic Factors
Lifestyle Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Community Servings
name: Massachusetts General Hospital
First posted: 2021-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned in 1:1 ratio to one of two intervention arms
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c at Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin A1c at Month 12
timeFrame: 12 months
measure: Food Insecurity Score at Month 6
timeFrame: 6 months
measure: Food Insecurity Score at Month 12
timeFrame: 12 months
measure: Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
timeFrame: 6 months
measure: Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
timeFrame: 12 months
measure: Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
timeFrame: 6 months
measure: Diabetes Distress Score as assessed by PAID-11 at Month 12
timeFrame: 12 months
measure: Depressive Symptom Score at Month 6
timeFrame: 6 months
measure: Depressive Symptom Score at Month 12
timeFrame: 12 months
measure: Frequency of self-reported hypoglycemia at Month 6
timeFrame: 6 months
measure: Frequency of self-reported hypoglycemia at Month 12
timeFrame: 12 months
measure: Frequency of self-reported severe hypoglycemia at Month 6
timeFrame: 6 months
measure: Frequency of self-reported severe hypoglycemia at Month 12
timeFrame: 12 months
Other outcomes:
measure: Bodyweight at Month 6
timeFrame: 6 months
measure: Bodyweight at Month 12
timeFrame: 12 months
measure: Systolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Systolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Diastolic Blood Pressure at Month 6
timeFrame: 6 months
measure: Diastolic Blood Pressure at Month 12
timeFrame: 12 months
measure: Diet Quality Score at Month 6
timeFrame: 6 months
measure: Diet Quality Score at Month 12
timeFrame: 12 months
measure: Cost-Related Medication Underuse at Month 6
timeFrame: 6 months
measure: Cost-Related Medication Underuse at Month 12
timeFrame: 12 months
measure: ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
timeFrame: 6 months
measure: ARMS-D Medication Adherence Score at Month 12
timeFrame: 12 months
measure: Diabetes Self-Care Activities Medication Adherence Score at Month 6
timeFrame: 6 months
measure: Diabetes Self-Care Activities Medication Adherence Score at Month 12
timeFrame: 12 months
measure: Food/Medication Trade-offs at Month 6
timeFrame: 6 months
measure: Food/Medication Trade-offs at Month 12
timeFrame: 12 months
measure: Housing Insecurity at Month 6
timeFrame: 6 months
measure: Housing Insecurity Score at Month 12
timeFrame: 12 months
measure: Transportation Barriers at Month 6
timeFrame: 6 months
measure: Transportation Barriers at Month 12
timeFrame: 12 months
measure: Financial Strain
timeFrame: 6 months
measure: Financial Strain
timeFrame: 12 months
measure: Care Delay at Month 6
timeFrame: 6 months
measure: Care Delay at Month 12
timeFrame: 12 months
measure: Diet Self-Efficacy Score at Month 6
timeFrame: 6 months
measure: Diet Self-Efficacy Score at Month 12
timeFrame: 12 months
measure: Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
timeFrame: 6 months
measure: Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
timeFrame: 12 months
measure: Stress Score at 6 months
timeFrame: 6 months
measure: Stress Score at 12 months
timeFrame: 12 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC
name: Seth Berkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: