Food as Medicine for HIV and Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention

Conditions
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Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes

Intervention / Treatment
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* Behavioral: MTM + ILI
* Behavioral: Standard MTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned in 1:1 ratio to one of two intervention arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)<br>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. | Behavioral: MTM + ILI<br>* Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program<br>|
| Active Comparator: Standard MTM<br>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. | Behavioral: Standard MTM<br>* Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bodyweight at Month 6 | Bodyweight measured in Kg | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bodyweight at Month 12 | Bodyweight measured in Kg | 12 months | 
| Bodyweight at Month 18 | Bodyweight measured in Kg | 18 months | 
| Hemoglobin A1c at Month 6 | Hemoglobin A1c Level | 6 months | 
| Hemoglobin A1c at Month 12 | Hemoglobin A1c Level | 12 months | 
| Hemoglobin A1c at Month 18 | Hemoglobin A1c Level | 18 months | 
| Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 6 months | 
| Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 12 months | 
| Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 18 months | 
| Depressive Symptom Score at Month 6 | Depressive Symptoms as assessed by PROMIS Short Form (PROMIS SF) v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 6 months | 
| Depressive Symptom Score at Month 12 | Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 12 months | 
| Depressive Symptom Score at Month 18 | Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 18 months | 
| Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 6 months | 
| Diabetes Distress Score as assessed by PAID-11 at Month 12 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 12 months | 
| Diabetes Distress Score as assessed by PAID-11 at Month 18 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Socioeconomic Factors, Lifestyle Intervention