Food as Medicine for HIV and Diabetes (FAME-H)

Community Servings, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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, compared with a group that receives usual MTM.

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 hemoglobin A1c, weight, 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, referred for medically tailored meals. Adults with hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m^2 (≥ 23 kg/m^2 for those with Asian ancestry) 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 hemoglobin A1c at 6 months. Secondary outcomes include weight, food security, quality of life, and diabetes distress.

Owing to the nature of the intervention, participants, providers, and many study staff will know to which group individual participants have been randomized. However, efforts will be made to keep the study statistician and outcome assessors blinded to randomization group during the course of the trial.

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.

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.

Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program

Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian

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)).

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)).

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)).

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.

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.

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.

Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.

Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.

Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.

Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.

Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.

Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality.

Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.

Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.

Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.

Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.

Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.

Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence.

Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.

Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.

Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.

Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy

Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy

Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy

Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.

Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.

Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.

Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.

Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.

Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.

Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus Diagnosis of HIV Hemoglobin A1c ≥ 6.5% and ≤ 12.0% in last 12 months Experiencing food insecurity as indicated by 2-item Hunger Vital Sign English speaking BMI ≥23 kg/m^2 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 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

Individual participant data (IPD) that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).

Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.

Unless otherwise required by NIH policy, ability to deidentify data, plan for secure storage of data and agreement to protect participant privacy, and relevant research question, to be assessed by study investigators.