FAME-H: Food as Medicine for HIV and Diabetes

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT05026723
Collaborator
Community Servings (Other), Massachusetts General Hospital (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
200
Enrollment
1
Location
2
Arms
51.9
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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, compared with a group that receives usual MTM.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: MTM + ILI
  • Behavioral: Standard MTM
N/A

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 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/m2 (≥ 23 kg/m2 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be assigned in 1:1 ratio to one of two intervention armsParticipants will be assigned in 1:1 ratio to one of two intervention arms
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

ArmIntervention/Treatment
Experimental: Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI)

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

Active Comparator: Standard MTM

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

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c at Month 6 [6 months]

    Hemoglobin A1c Level

Secondary Outcome Measures

  1. Hemoglobin A1c at Month 12 [12 months]

    Hemoglobin A1c Level

  2. Hemoglobin A1c at Month 18 [18 months]

    Hemoglobin A1c Level

  3. Bodyweight at Month 6 [6 months]

    Bodyweight measured in Kg

  4. Bodyweight at Month 12 [12 months]

    Bodyweight measured in Kg

  5. Bodyweight at Month 18 [18 months]

    Bodyweight measured in Kg

  6. Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6 [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 [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 [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. Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6 [6 months]

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

  10. Diabetes Distress Score as assessed by PAID-11 at Month 12 [12 months]

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

  11. Diabetes Distress Score as assessed by PAID-11 at Month 18 [18 months]

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

  12. Depressive Symptom Score at Month 6 [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.

  13. Depressive Symptom Score at Month 12 [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.

  14. Depressive Symptom Score at Month 18 [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.

Other Outcome Measures

  1. Food Insecurity Score at Month 6 [6 Months]

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

  2. Food Insecurity Score at Month 12 [12 Months]

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

  3. Food Insecurity Score at Month 18 [18 Months]

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

  4. Systolic Blood Pressure at Month 6 [6 Months]

    Systolic blood pressure in mm Hg

  5. Systolic Blood Pressure at Month 12 [12 Months]

    Systolic blood pressure in mm Hg

  6. Systolic Blood Pressure at Month 18 [18 Months]

    Systolic blood pressure in mm Hg

  7. Diastolic Blood Pressure at Month 6 [6 Months]

    Diastolic blood pressure in mm Hg

  8. Diastolic Blood Pressure at Month 12 [12 Months]

    Diastolic blood pressure in mm Hg

  9. Diastolic Blood Pressure at Month 18 [18 Months]

    Diastolic blood pressure in mm Hg

  10. Diet Quality Score at Month 6 [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 [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 [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 [6 months]

    Any affirmative response to cost-related medication underuse items

  14. Cost-Related Medication Underuse at Month 12 [12 months]

    Any affirmative response to cost-related medication underuse items

  15. Cost-Related Medication Underuse at Month 18 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [6 Months]

    CD4+ Count

  35. Self-Reported CD4+ Count at Month 6 [6 Months]

    Self-Reported CD4+ Count

  36. Self-Reported CD4+ Count at Month 12 [12 Months]

    Self-Reported CD4+ Count

  37. Self-Reported CD4+ Count at Month 18 [18 Months]

    Self-Reported CD4+ Count

  38. HIV Viral Load at Month 6 [6 Months]

    HIV Viral Load

  39. Self-Reported HIV Viral Load at Month 6 [6 Months]

    Self-Reported HIV Viral Load

  40. Self-Reported HIV Viral Load at Month 12 [12 Months]

    Self-Reported HIV Viral Load

  41. Self-Reported HIV Viral Load at Month 18 [18 Months]

    Self-Reported HIV Viral Load

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

    C-Reactive Protein

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of Type 2 Diabetes Mellitus

  • Diagnosis of HIV

  • Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months

  • Experiencing food insecurity as indicated by 2-item Hunger Vital Sign

  • English speaking

  • BMI ≥25 kg/m2 (≥ 23 kg/m2 if self-report Asian ancestry)

  • 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

  • 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 2 years

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • Community Servings
  • Massachusetts General Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Seth A Berkowitz, MD, MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT05026723
Other Study ID Numbers:
  • 20-3509
  • R01DK127365
First Posted:
Aug 30, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021