Food As MedicinE for Diabetes

NCT04828785 | Completed

• 2 other identifiers: 20-2847R01DK125831
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Food Insecurity; Socioeconomic Factors; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c at Month 6

  Hemoglobin A1c Level

  6 months

Secondary Outcomes (13)

• Hemoglobin A1c at Month 12

  12 months

• Food Insecurity Score at Month 6

  6 months

• Food Insecurity Score at Month 12

  12 months

• Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6

  6 months

• Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12

  12 months

Other Outcomes (30)

• Bodyweight at Month 6

  6 months

• Bodyweight at Month 12

  12 months

• Systolic Blood Pressure at Month 6

  6 months

Study Arms (2)

Medically Tailored Meal (MTM)

EXPERIMENTAL

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

Food Subsidy

ACTIVE COMPARATOR

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

Interventions

MTM OTHER

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.

Medically Tailored Meal (MTM)

Food Subsidy OTHER

$40/month food subsidy

Food Subsidy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Community Servings: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Berkowitz SA, Kruse GR, Ball Ricks KA, Burch J, Ouimet E, Kitzis B, Forrest C, Terranova J, Stewart PW, Buse JB, Keyserling TC, Wexler DJ, Delahanty LM. Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial. Contemp Clin Trials. 2023 Jan;124:107039. doi: 10.1016/j.cct.2022.107039. Epub 2022 Dec 5.

  PMID: 36470556 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seth Berkowitz, MD

  UNC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Owing to the nature of the intervention, participants, providers, and many study staff will know to which group individual participants have been randomized. However, efforts will be made to keep the study statistician and outcome assessors blinded to randomization group during the course of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned in 1:1 ratio to one of two intervention arms

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: July 2, 2021
• Primary Completion: September 11, 2025
• Study Completion: February 12, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.
• Access Criteria: Unless otherwise required by NIH policy, ability to deidentify data, plan for secure storage of data and agreement to protect participant privacy, relevant research question, to be assessed by study investigators.

Locations

US (1)