Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Bodyweight at Month 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: MTM + ILI (Behavioral)
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.
干预措施: Standard MTM (Behavioral)
结局指标
主要结局
Bodyweight at Month 6
时间窗: 6 months
Bodyweight measured in Kg
次要结局
- Bodyweight at Month 12(12 months)
- Hemoglobin A1c at Month 18(18 months)
- Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6(6 months)
- Bodyweight at Month 18(18 months)
- Hemoglobin A1c at Month 6(6 months)
- Hemoglobin A1c at Month 12(12 months)
- Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12(12 months)
- Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18(18 months)
- Depressive Symptom Score at Month 18(18 months)
- Diabetes Distress Score as assessed by PAID-11 at Month 12(12 months)
- Depressive Symptom Score at Month 6(6 months)
- Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6(6 months)
- Depressive Symptom Score at Month 12(12 months)
- Diabetes Distress Score as assessed by PAID-11 at Month 18(18 months)