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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

Must not have

Advanced kidney disease (estimated creatinine clearance < 30 mL/min)

Lack of safe, stable residence and ability to store meals

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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).

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys are not working well (very low filtration rate).

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I do not have a stable place to live or keep food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1c at Month 6

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met