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Medically Tailored Meals for Type 2 Diabetes (FAME-D Trial)

N/A
Recruiting
Led By Seth Berkowitz, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type 2 Diabetes Mellitus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

FAME-D Trial Summary

This trial will test the efficacy of a medically tailored meal intervention for adults with food insecurity and Type 2 Diabetes Mellitus.

Who is the study for?
This trial is for adults with food insecurity and Type 2 Diabetes Mellitus who speak English, plan to stay in the area for a year, have specific levels of Hemoglobin A1c and BMI, can control their diet, consent to participate, and aren't planning pregnancy. Excluded are those with severe psychiatric issues or substance misuse, involved in similar research recently, without stable housing or phone access, certain medical conditions including advanced kidney disease or recent cancer (except some localized cases).Check my eligibility
What is being tested?
The study compares two approaches: one group receives medically tailored meals (MTM) plus lifestyle calls for six months; the other gets usual diabetes care plus a monthly food subsidy. The MTM includes weekly delivery of ready-to-eat meals covering half of weekly intake.See study design
What are the potential side effects?
Since this trial involves dietary interventions rather than medications, side effects may include changes in digestion or appetite but are generally expected to be minimal compared to drug trials. Lifestyle adjustments might also cause temporary stress or discomfort.

FAME-D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 Diabetes.

FAME-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin A1c at Month 6
Secondary outcome measures
Depressive Symptom Score at Month 12
Depressive Symptom Score at Month 6
Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
+10 more
Other outcome measures
ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
ARMS-D Medication Adherence Score at Month 12
Bodyweight at Month 12
+26 more

FAME-D Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meal (MTM)Experimental Treatment1 Intervention
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.
Group II: Food SubsidyActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Community ServingsUNKNOWN
3 Previous Clinical Trials
306 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,953 Previous Clinical Trials
13,211,430 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,525 Previous Clinical Trials
4,196,937 Total Patients Enrolled

Media Library

Food As Medicine Clinical Trial Eligibility Overview. Trial Name: NCT04828785 — N/A
Type 2 Diabetes Research Study Groups: Medically Tailored Meal (MTM), Food Subsidy
Type 2 Diabetes Clinical Trial 2023: Food As Medicine Highlights & Side Effects. Trial Name: NCT04828785 — N/A
Food As Medicine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04828785 — N/A
~54 spots leftby Aug 2025