Food as Medicine for HIV and Diabetes

HIV Infections Clinical Trial

— FAME-H  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026723
• Other study ID #: 20-3509
• Secondary ID: R01DK127365
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: February 2027

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Katharine Ricks, PhD
• Phone: 919-843-6637
• Email: kathier1[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• HIV Infections
• PreDiabetes

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food Insecurity Score at Month 6	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	6 Months
Other	Food Insecurity Score at Month 12	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	12 Months
Other	Food Insecurity Score at Month 18	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	18 Months
Other	Systolic Blood Pressure at Month 6	Systolic blood pressure in mm Hg	6 Months
Other	Systolic Blood Pressure at Month 12	Systolic blood pressure in mm Hg	12 Months
Other	Systolic Blood Pressure at Month 18	Systolic blood pressure in mm Hg	18 Months
Other	Diastolic Blood Pressure at Month 6	Diastolic blood pressure in mm Hg	6 Months
Other	Diastolic Blood Pressure at Month 12	Diastolic blood pressure in mm Hg	12 Months
Other	Diastolic Blood Pressure at Month 18	Diastolic blood pressure in mm Hg	18 Months
Other	Diet Quality Score at Month 6	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.	6 months
Other	Diet Quality Score at Month 12	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 months
Other	Diet Quality Score at Month 18	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.	18 months
Other	Cost-Related Medication Underuse at Month 6	Any affirmative response to cost-related medication underuse items	6 months
Other	Cost-Related Medication Underuse at Month 12	Any affirmative response to cost-related medication underuse items	12 months
Other	Cost-Related Medication Underuse at Month 18	Any affirmative response to cost-related medication underuse items	18 months
Other	Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6	Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.	6 months
Other	ARMS-D Medication Adherence Score at Month 12	Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence.	12 months
Other	ARMS-D Medication Adherence Score at Month 18	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 months
Other	Diabetes Self-Care Activities Medication Adherence Score at Month 6	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.	6 months
Other	Diabetes Self-Care Activities Medication Adherence Score at Month 12	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.	12 months
Other	Diabetes Self-Care Activities Medication Adherence Score at Month 18	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.	18 months
Other	Diet Self-Efficacy Score at Month 6	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	6 months
Other	Diet Self-Efficacy Score at Month 12	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	12 months
Other	Diet Self-Efficacy Score at Month 18	Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy.	18 months
Other	Perceived Diabetes Self-Management Self-Efficacy Score at Month 6	Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy	6 months
Other	Perceived Diabetes Self-Management Self-Efficacy Score at Month 12	Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy	12 months
Other	Perceived Diabetes Self-Management Self-Efficacy Score at Month 18	Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy	18 months
Other	Stress Score at 6 months	Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.	6 months
Other	Stress Score at 12 months	Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.	12 months
Other	Stress Score at 18 months	Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress.	18 months
Other	Food/Medication Trade-offs at Month 6	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	6 months
Other	Food/Medication Trade-offs at Month 12	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	12 months
Other	Food/Medication Trade-offs at Month 18	Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off.	18 months
Other	Cluster of Differentiation 4 (CD4+) Count at Month 6	CD4+ Count	6 Months
Other	Self-Reported CD4+ Count at Month 6	Self-Reported CD4+ Count	6 Months
Other	Self-Reported CD4+ Count at Month 12	Self-Reported CD4+ Count	12 Months
Other	Self-Reported CD4+ Count at Month 18	Self-Reported CD4+ Count	18 Months
Other	HIV Viral Load at Month 6	HIV Viral Load	6 Months
Other	Self-Reported HIV Viral Load at Month 6	Self-Reported HIV Viral Load	6 Months
Other	Self-Reported HIV Viral Load at Month 12	Self-Reported HIV Viral Load	12 Months
Other	Self-Reported HIV Viral Load at Month 18	Self-Reported HIV Viral Load	18 Months
Other	C-Reactive Protein (CRP) at Month 6	C-Reactive Protein	6 months
Primary	Bodyweight at Month 6	Bodyweight measured in Kg	6 months
Secondary	Bodyweight at Month 12	Bodyweight measured in Kg	12 months
Secondary	Bodyweight at Month 18	Bodyweight measured in Kg	18 months
Secondary	Hemoglobin A1c at Month 6	Hemoglobin A1c Level	6 months
Secondary	Hemoglobin A1c at Month 12	Hemoglobin A1c Level	12 months
Secondary	Hemoglobin A1c at Month 18	Hemoglobin A1c Level	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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