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Lebensmittel als Medizin für Diabetes (FAME-D)

19. Oktober 2026 aktualisiert von: University of North Carolina, Chapel Hill

Essen ist Medizin: Eine randomisierte klinische Studie mit medizinisch maßgeschneiderten Mahlzeiten für Personen mit Typ-2-Diabetes mellitus und Ernährungsunsicherheit

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

215

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • University of North Carolina at Chapel Hill

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Medically Tailored Meal (MTM)

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.
Sonstiges: MTM

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.
Aktiver Komparator: Food Subsidy

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.
Sonstiges: Food Subsidy

$40/month food subsidy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemoglobin A1c at Month 6
Zeitfenster: 6 months

Hemoglobin A1c Level
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemoglobin A1c at Month 12
Zeitfenster: 12 months

Hemoglobin A1c Level
12 months
Food Insecurity Score at Month 6
Zeitfenster: 6 months

Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
6 months
Food Insecurity Score at Month 12
Zeitfenster: 12 months

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
Zeitfenster: 6 months

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. These scores are then used to 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
Zeitfenster: 12 months

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. These scores are then used to 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
Zeitfenster: 6 months

Score ranges from 0-44 with higher scores indicating greater diabetes distress
6 months
Diabetes Distress Score as Assessed by PAID-11 at Month 12
Zeitfenster: 12 months

Score ranges from 0-44 with higher scores indicating greater diabetes distress
12 months
Depressive Symptom Score at Month 6
Zeitfenster: 6 months

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
Zeitfenster: 12 months

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
Number of Participants With Self-reported Hypoglycemia at Month 6
Zeitfenster: 6 months

Reported hypoglycemia between 0 and 6 months after randomization
6 months
Number of Participants With Self-reported Hypoglycemia at Month 12
Zeitfenster: 12 months

Reported hypoglycemia between 6 and 12 months after randomization
12 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 6
Zeitfenster: 6 months

Reported severe hypoglycemia between 0 and 6 months after randomization
6 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 12
Zeitfenster: 12 months

Reported severe hypoglycemia between 6 and 12 months after randomization
12 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bodyweight at Month 6
Zeitfenster: 6 months

Bodyweight measured in Kg
6 months
Bodyweight at Month 12
Zeitfenster: 12 months

Bodyweight measured in Kg
12 months
Systolic Blood Pressure at Month 6
Zeitfenster: 6 months

Systolic blood pressure in mm Hg
6 months
Systolic Blood Pressure at Month 12
Zeitfenster: 12 months

Systolic blood pressure in mm Hg
12 months
Diastolic Blood Pressure at Month 6
Zeitfenster: 6 months

Diastolic blood pressure measured in mm Hg
6 months
Diastolic Blood Pressure at Month 12
Zeitfenster: 12 months

Diastolic blood pressure in mm Hg
12 months
Diet Quality Score at Month 6
Zeitfenster: 6 months

Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10). Total score equals the sum of the 3 subscales.
6 months
Diet Quality Score at Month 12
Zeitfenster: 12 months

Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10). Total score equals the sum of the 3 subscales.
12 months
Probability of Cost-Related Medication Underuse at Month 6
Zeitfenster: 6 months

Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU.
6 months
Probability of Cost-Related Medication Underuse at Month 12
Zeitfenster: 12 months

Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU.
12 months
ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
Zeitfenster: 6 months

Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.
6 months
ARMS-D Medication Adherence Score at Month 12
Zeitfenster: 12 months

Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.
12 months
Diabetes Self-Care Activities Medication Adherence Score at Month 6
Zeitfenster: 6 months

Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.
6 months
Diabetes Self-Care Activities Medication Adherence Score at Month 12
Zeitfenster: 12 months

Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.
12 months
Food/Medication Trade-offs at Month 6
Zeitfenster: 6 months

Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
6 months
Food/Medication Trade-offs at Month 12
Zeitfenster: 12 months

Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.
12 months
Housing Insecurity at Month 6
Zeitfenster: 6 months

Self-report of being worried about losing housing
6 months
Housing Insecurity Score at Month 12
Zeitfenster: 12 months

Self-report of being worried about losing housing
12 months
Transportation Barriers at Month 6
Zeitfenster: 6 months

Self-report of transportation barriers to attending medical appointments
6 months
Transportation Barriers at Month 12
Zeitfenster: 12 months

Self-report of transportation barriers to attending medical appointments
12 months
Financial Strain
Zeitfenster: 6 months

Self-report of financial strain
6 months
Financial Strain
Zeitfenster: 12 months

Self-report of financial strain
12 months
Care Delay at Month 6
Zeitfenster: 6 months

Self-report of delaying healthcare due to cost
6 months
Care Delay at Month 12
Zeitfenster: 12 months

Self-report of delaying healthcare due to cost
12 months
Diet Self-Efficacy Score at Month 6
Zeitfenster: 6 months

Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
6 months
Diet Self-Efficacy Score at Month 12
Zeitfenster: 12 months

Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.
12 months
Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
Zeitfenster: 6 months

Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy
6 months
Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
Zeitfenster: 12 months

Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy
12 months
Stress Score at 6 Months
Zeitfenster: 6 months

Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
6 months
Stress Score at 12 Months
Zeitfenster: 12 months

Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.
12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of North Carolina, Chapel Hill

Mitarbeiter

Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Community Servings

Ermittler

  • Hauptermittler: Seth Berkowitz, MD, UNC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Juli 2021

Primärer Abschluss (Tatsächlich)

11. September 2025

Studienabschluss (Tatsächlich)

12. Februar 2026

Studienanmeldedaten

Zuerst eingereicht

30. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2021

Zuerst gepostet (Tatsächlich)

2. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Oktober 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20-2847
  • R01DK125831 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD-Sharing-Zeitrahmen

Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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