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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
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 belowSelect...
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:Select...
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
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 moreOther 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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Community ServingsUNKNOWN
3 Previous Clinical Trials
306 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,842 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,993 Previous Clinical Trials
13,230,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have participated in a study about diabetes, nutrition, or weight in the past year.I am 18 years old or older.I have had cancer other than non-melanoma skin cancer, but it was cured or has been in remission for over 5 years.I am considering or have had bariatric surgery within the last 2 years.My kidney function is severely reduced.I do not have a stable place to live or keep food.You don't always have enough food to eat.You weigh too much for your height.I have been diagnosed with HIV.I have been diagnosed with Type 2 Diabetes or am at high risk for it.You can freely choose and control what you eat.I have an illness that defines AIDS.I am either male or female.You have misused drugs or alcohol in the last 6 months.I occasionally use medications that can affect my blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)
- Group 2: Standard MTM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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