Food as Medicine for HIV and Diabetes
- Conditions
- PreDiabetesDiabetes Mellitus, Type 2HIV Infections
- Interventions
- Behavioral: MTM + ILIBehavioral: Standard MTM
- Registration Number
- NCT05026723
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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 or high risk of T2DM, compared with a group that receives usual MTM.
- 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 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) MTM + 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. Standard MTM 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.
- Primary Outcome Measures
Name Time Method Bodyweight at Month 6 6 months Bodyweight measured in Kg
- Secondary Outcome Measures
Name Time Method Hemoglobin A1c at Month 18 18 months Hemoglobin A1c Level
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)).
Bodyweight at Month 12 12 months Bodyweight measured in Kg
Bodyweight at Month 18 18 months Bodyweight measured in Kg
Hemoglobin A1c at Month 6 6 months Hemoglobin A1c Level
Hemoglobin A1c at Month 12 12 months Hemoglobin A1c Level
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)).
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)).
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.
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
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.
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
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.
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
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States