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NCT Number: NCT05026723

Food as Medicine for HIV and Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Blood-Borne Infections Communicable Diseases Diabetes Mellitus Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Katharine Ricks, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTM + ILI

Behavioral

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

Standard MTM

Behavioral

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

Primary outcomes

  1. Bodyweight at Month 6

    Time frame: 6 months

    Bodyweight measured in Kg

Secondary outcomes

  1. Bodyweight at Month 12

    Time frame: 12 months

    Bodyweight measured in Kg

  2. Bodyweight at Month 18

    Time frame: 18 months

    Bodyweight measured in Kg

  3. Hemoglobin A1c at Month 6

    Time frame: 6 months

    Hemoglobin A1c Level

  4. Hemoglobin A1c at Month 12

    Time frame: 12 months

    Hemoglobin A1c Level

  5. Hemoglobin A1c at Month 18

    Time frame: 18 months

    Hemoglobin A1c Level

  6. Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6

    Time frame: 6 months

    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)).

  7. Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12

    Time frame: 12 months

    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)).

  8. Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18

    Time frame: 18 months

    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)).

  9. Depressive Symptom Score at Month 6

    Time frame: 6 months

    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.

  10. Depressive Symptom Score at Month 12

    Time frame: 12 months

    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.

  11. Depressive Symptom Score at Month 18

    Time frame: 18 months

    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. Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6

    Time frame: 6 months

    Score ranges from 11-55 with higher scores indicating greater diabetes distress

  13. Diabetes Distress Score as assessed by PAID-11 at Month 12

    Time frame: 12 months

    Score ranges from 11-55 with higher scores indicating greater diabetes distress

  14. Diabetes Distress Score as assessed by PAID-11 at Month 18

    Time frame: 18 months

    Score ranges from 11-55 with higher scores indicating greater diabetes distress

Other outcomes

  1. Food Insecurity Score at Month 6

    Time frame: 6 Months

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

  2. Food Insecurity Score at Month 12

    Time frame: 12 Months

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

  3. Food Insecurity Score at Month 18

    Time frame: 18 Months

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

  4. Systolic Blood Pressure at Month 6

    Time frame: 6 Months

    Systolic blood pressure in mm Hg

  5. Systolic Blood Pressure at Month 12

    Time frame: 12 Months

    Systolic blood pressure in mm Hg

  6. Systolic Blood Pressure at Month 18

    Time frame: 18 Months

    Systolic blood pressure in mm Hg

  7. Diastolic Blood Pressure at Month 6

    Time frame: 6 Months

    Diastolic blood pressure in mm Hg

  8. Diastolic Blood Pressure at Month 12

    Time frame: 12 Months

    Diastolic blood pressure in mm Hg

  9. Diastolic Blood Pressure at Month 18

    Time frame: 18 Months

    Diastolic blood pressure in mm Hg

  10. Diet Quality Score at Month 6

    Time frame: 6 months

    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.

  11. Diet Quality Score at Month 12

    Time frame: 12 months

    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.

  12. Diet Quality Score at Month 18

    Time frame: 18 months

    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.

  13. Cost-Related Medication Underuse at Month 6

    Time frame: 6 months

    Any affirmative response to cost-related medication underuse items

  14. Cost-Related Medication Underuse at Month 12

    Time frame: 12 months

    Any affirmative response to cost-related medication underuse items

  15. Cost-Related Medication Underuse at Month 18

    Time frame: 18 months

    Any affirmative response to cost-related medication underuse items

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

    Time frame: 6 months

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

  17. ARMS-D Medication Adherence Score at Month 12

    Time frame: 12 months

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

  18. ARMS-D Medication Adherence Score at Month 18

    Time frame: 18 months

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

  19. Diabetes Self-Care Activities Medication Adherence Score at Month 6

    Time frame: 6 months

    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.

  20. Diabetes Self-Care Activities Medication Adherence Score at Month 12

    Time frame: 12 months

    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.

  21. Diabetes Self-Care Activities Medication Adherence Score at Month 18

    Time frame: 18 months

    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.

  22. Diet Self-Efficacy Score at Month 6

    Time frame: 6 months

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

  23. Diet Self-Efficacy Score at Month 12

    Time frame: 12 months

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

  24. Diet Self-Efficacy Score at Month 18

    Time frame: 18 months

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

  25. Perceived Diabetes Self-Management Self-Efficacy Score at Month 6

    Time frame: 6 months

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

  26. Perceived Diabetes Self-Management Self-Efficacy Score at Month 12

    Time frame: 12 months

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

  27. Perceived Diabetes Self-Management Self-Efficacy Score at Month 18

    Time frame: 18 months

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

  28. Stress Score at 6 months

    Time frame: 6 months

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

  29. Stress Score at 12 months

    Time frame: 12 months

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

  30. Stress Score at 18 months

    Time frame: 18 months

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

  31. Food/Medication Trade-offs at Month 6

    Time frame: 6 months

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

  32. Food/Medication Trade-offs at Month 12

    Time frame: 12 months

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

  33. Food/Medication Trade-offs at Month 18

    Time frame: 18 months

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

  34. Cluster of Differentiation 4 (CD4+) Count at Month 6

    Time frame: 6 Months

    CD4+ Count

  35. Self-Reported CD4+ Count at Month 6

    Time frame: 6 Months

    Self-Reported CD4+ Count

  36. Self-Reported CD4+ Count at Month 12

    Time frame: 12 Months

    Self-Reported CD4+ Count

  37. Self-Reported CD4+ Count at Month 18

    Time frame: 18 Months

    Self-Reported CD4+ Count

  38. HIV Viral Load at Month 6

    Time frame: 6 Months

    HIV Viral Load

  39. Self-Reported HIV Viral Load at Month 6

    Time frame: 6 Months

    Self-Reported HIV Viral Load

  40. Self-Reported HIV Viral Load at Month 12

    Time frame: 12 Months

    Self-Reported HIV Viral Load

  41. Self-Reported HIV Viral Load at Month 18

    Time frame: 18 Months

    Self-Reported HIV Viral Load

  42. C-Reactive Protein (CRP) at Month 6

    Time frame: 6 months

    C-Reactive Protein

Study contacts

Contact information is provided by the study sponsor or research team.

Katharine Ricks, PhD

CONTACT

[email protected]

919-843-6637

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FAME-H

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 30, 2021
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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