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Behavioral Intervention

Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes (FAME-H Trial)

N/A

Recruiting

Led By Seth A Berkowitz, MD, MPH

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

Aged ≥18 years

Diagnosis of HIV

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 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of a medically tailored meal and an intensive lifestyle intervention can help adults with food insecurity, HIV, and Type 2 diabetes, compared to those who just receive a medically tailored meal.

Who is the study for?

Adults over 18, who speak English and are not planning to move for a year, can join this trial if they're food insecure with HIV and Type 2 Diabetes or at high risk of it. They must be able to control their diet and consent to all study activities. Pregnant individuals, those in similar studies recently, with certain illnesses or drug misuse cannot participate.

What is being tested?

The trial is testing whether specially prepared meals plus an intensive lifestyle program (MTM + ILI) help adults with HIV and diabetes better than the usual medical treatment for diabetes alone. Participants will be randomly assigned to one of these two groups.

What are the potential side effects?

Since the interventions involve medically tailored meals and lifestyle changes rather than medications, side effects may include dietary adjustments or discomfort from new physical activities but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with HIV.

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I have been diagnosed with Type 2 Diabetes or am at high risk for it.

Exclusion Criteria

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

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My kidney function is severely reduced.

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

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I have an illness that defines AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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

Bodyweight at Month 6

Secondary study objectives

Bodyweight at Month 12

Bodyweight at Month 18

Depressive Symptom Score at Month 12

+11 more

Other study objectives

ARMS-D Medication Adherence Score at Month 12

ARMS-D Medication Adherence Score at Month 18

Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6

+39 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) + Intensive Lifestyle Intervention (ILI)Experimental Treatment1 Intervention

The Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-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: Standard MTMActive Control1 Intervention

The Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian.

0 / 6Eligibility criteria met