Evidence map›Paper›PMID 36470556›Full record

ArticleContemporary clinical trials2023

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

Seth A Berkowitz, Gina R Kruse, Katharine A Ball Ricks, Jessica Burch, Ethan Ouimet, Beth Kitzis, Colleen Forrest, Jean Terranova, Paul W Stewart, John B Buse and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04828785 (Food is Medicine), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04828785 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2021 to 2026Enrolled215ConditionsDiabetes Mellitus, Type 2ArmsMTM, Food Subsidy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Nutrition and Culinary Education in Food Is Medicine Interventions: A Scoping Review.Journal of the Academy of Nutrition and Dietetics · 2026
    Article
  3. Article
  4. Mixed Methods Evaluation of a Shipped Medically Tailored Meal Pilot Intervention.Journal of patient-centered research and reviews · 2026
    Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Seth A BerkowitzDivision of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, United States of America; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America. Electronic address: seth_berkowitz@med.unc.edu.
Gina R KruseDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.
Katharine A Ball RicksCecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
Jessica BurchCommunity Servings, Inc, Boston, MA, United States of America.
Ethan OuimetCommunity Servings, Inc, Boston, MA, United States of America.
Beth KitzisCommunity Servings, Inc, Boston, MA, United States of America.
Colleen ForrestCommunity Servings, Inc, Boston, MA, United States of America.
Jean TerranovaCommunity Servings, Inc, Boston, MA, United States of America.
Paul W StewartDepartment of Biostatistics, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
John B BuseDivision of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States of America.
Thomas C KeyserlingDivision of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, United States of America.
Deborah J WexlerHarvard Medical School, Boston, MA, United States of America; Diabetes Unit, Massachusetts General Hospital, Boston, MA, United States of America.
Linda M DelahantyHarvard Medical School, Boston, MA, United States of America; Diabetes Unit, Massachusetts General Hospital, Boston, MA, United States of America.

Funding

Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI P Darrell Neufer · 2020 to 2026
$11.0M
Research BaseP30DK092926 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARY ELLEN MICHELE HEISLER, ADESUWA B OLOMU · 2011 to 2026
$10.0M
New York Regional Center for Diabetes Translation Research - Translational Intervention Methodology CoreP30DK111022 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI JEFFREY GONZALEZ · 2016 to 2026
$7.8M
Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals with Type 2 Diabetes Mellitus and Food InsecurityR01DK125831 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BERKOWITZ, SETH A · 2020 to 2024
$2.9M
NIDDK NIH HHS P30 DK092926NIDDK NIH HHS P30 DK111022NIDDK NIH HHS P30 DK124723NIDDK NIH HHS R01 DK125831
6 · The paper itself

Abstract

backgroundFood insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear.

objectiveTo describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity.

methodsThe Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results.

conclusionResults from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions. CLINICALTRIALS: gov: NCT04828785.

Indexed as

Diabetes Mellitus, Type 2AdultFood InsecurityGlycated HemoglobinHumansMealsPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicGlycated HemoglobinFood insecurityFood subsidyGlycemic controlLifestyle interventionMedically tailored mealsMixed methods researchRandomized clinical trialType 2 diabetes mellitus

Identifiers

PMID36470556
PMCPMC9839527

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.