Clinical trial NCT05026723: Food as Medicine for HIV and Diabetes
Official title: Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
HIV Infections
PreDiabetes
Keywords: Food Insecurity
Socioeconomic Factors
Lifestyle Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Community Servings
name: Massachusetts General Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned in 1:1 ratio to one of two intervention arms
Primary purpose: TREATMENT

Brief summary: This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.

Detailed description: In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, "lack of access to enough food for an active, healthy life", is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications.

Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV.

The investigators has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention.

Thus, the investigators propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM or high risk for T2DM, referred for medically tailored meals. Adults with hemoglobin A1c less than 12.0%, and BMI ≥ 23 kg/m\^2 will be enrolled and randomly assigned to intervention or standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is weight at 6 months. Secondary outcomes include hemoglobin a1c, food security, quality of life, and diabetes distress.

Eligibility criteria: Inclusion Criteria

* Male or female
* Diagnosis of HIV
* Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus, defined as meeting CDC eligibility criteria for the diabetes prevention program. Specifically, an individual without a diagnosis of T2DM must 1) have had a blood test result in the prediabetes range within the past year (Hemoglobin A1C: 5.7-6.4% OR Fasting plasma glucose: 100-125 mg/dL OR Two-hour plasma glucose \[after a 75 g glucose load\]: 140-199 mg/dL), 2) Have been previously diagnosed with gestational diabetes, OR 3) have a high-risk result (score of 5 or higher) on the Prediabetes Risk Test (https://www.cdc.gov/prediabetes/pdf/Prediabetes-Risk-Test-Final.pdf)
* Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
* English speaking
* Aged ≥18 years
* BMI ≥ 23 kg/m2
* 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
* Current AIDS defining illness
* 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 6 months
* 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

Primary outcomes:
measure: Bodyweight at Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Bodyweight at Month 12
timeFrame: 12 months
measure: Bodyweight at Month 18
timeFrame: 18 months
measure: Hemoglobin A1c at Month 6
timeFrame: 6 months
measure: Hemoglobin A1c at Month 12
timeFrame: 12 months
measure: Hemoglobin A1c at Month 18
timeFrame: 18 months
measure: Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6
timeFrame: 6 months
measure: Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
timeFrame: 12 months
measure: Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18
timeFrame: 18 months
measure: Depressive Symptom Score at Month 6
timeFrame: 6 months
measure: Depressive Symptom Score at Month 12
timeFrame: 12 months
measure: Depressive Symptom Score at Month 18
timeFrame: 18 months
measure: Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6
timeFrame: 6 months
measure: Diabetes Distress Score as assessed by PAID-11 at Month 12
timeFrame: 12 months
measure: Diabetes Distress Score as assessed by PAID-11 at Month 18
timeFrame: 18 months
Other outcomes:
measure: Food Insecurity Score at Month 6
timeFrame: 6 Months
measure: Food Insecurity Score at Month 12
timeFrame: 12 Months
measure: Food Insecurity Score at Month 18
timeFrame: 18 Months
measure: Systolic Blood Pressure at Month 6
timeFrame: 6 Months
measure: Systolic Blood Pressure at Month 12
timeFrame: 12 Months
measure: Systolic Blood Pressure at Month 18
timeFrame: 18 Months
measure: Diastolic Blood Pressure at Month 6
timeFrame: 6 Months
measure: Diastolic Blood Pressure at Month 12
timeFrame: 12 Months
measure: Diastolic Blood Pressure at Month 18
timeFrame: 18 Months
measure: Diet Quality Score at Month 6
timeFrame: 6 months
measure: Diet Quality Score at Month 12
timeFrame: 12 months
measure: Diet Quality Score at Month 18
timeFrame: 18 months
measure: Cost-Related Medication Underuse at Month 6
timeFrame: 6 months
measure: Cost-Related Medication Underuse at Month 12
timeFrame: 12 months
measure: Cost-Related Medication Underuse at Month 18
timeFrame: 18 months
measure: Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6
timeFrame: 6 months
measure: ARMS-D Medication Adherence Score at Month 12
timeFrame: 12 months
measure: ARMS-D Medication Adherence Score at Month 18
timeFrame: 18 months
measure: Diabetes Self-Care Activities Medication Adherence Score at Month 6
timeFrame: 6 months
measure: Diabetes Self-Care Activities Medication Adherence Score at Month 12
timeFrame: 12 months
measure: Diabetes Self-Care Activities Medication Adherence Score at Month 18
timeFrame: 18 months
measure: Diet Self-Efficacy Score at Month 6
timeFrame: 6 months
measure: Diet Self-Efficacy Score at Month 12
timeFrame: 12 months
measure: Diet Self-Efficacy Score at Month 18
timeFrame: 18 months
measure: Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
timeFrame: 6 months
measure: Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
timeFrame: 12 months
measure: Perceived Diabetes Self-Management Self-Efficacy Score at Month 18
timeFrame: 18 months
measure: Stress Score at 6 months
timeFrame: 6 months
measure: Stress Score at 12 months
timeFrame: 12 months
measure: Stress Score at 18 months
timeFrame: 18 months
measure: Food/Medication Trade-offs at Month 6
timeFrame: 6 months
measure: Food/Medication Trade-offs at Month 12
timeFrame: 12 months
measure: Food/Medication Trade-offs at Month 18
timeFrame: 18 months
measure: Cluster of Differentiation 4 (CD4+) Count at Month 6
timeFrame: 6 Months
measure: Self-Reported CD4+ Count at Month 6
timeFrame: 6 Months
measure: Self-Reported CD4+ Count at Month 12
timeFrame: 12 Months
measure: Self-Reported CD4+ Count at Month 18
timeFrame: 18 Months
measure: HIV Viral Load at Month 6
timeFrame: 6 Months
measure: Self-Reported HIV Viral Load at Month 6
timeFrame: 6 Months
measure: Self-Reported HIV Viral Load at Month 12
timeFrame: 12 Months
measure: Self-Reported HIV Viral Load at Month 18
timeFrame: 18 Months
measure: C-Reactive Protein (CRP) at Month 6
timeFrame: 6 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Seth A Berkowitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: