Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c at Month 6
研究概览
简要总结
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
详细描述
Food insecurity, "lack of access to enough food for an active, healthy life", affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes.
Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies-offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called 'food as medicine', as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions.
Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed.
This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, 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 usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $40/month food subsidy, along with usual diabetes care.
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
- •Diagnosis of Type 2 Diabetes Mellitus
- •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/m^2 (≥ 23 kg/m^2 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
排除标准
- •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 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 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
研究组 & 干预措施
Food Subsidy
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy.
干预措施: Food Subsidy (Other)
Medically Tailored Meal (MTM)
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-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 (Other)
结局指标
主要结局
Hemoglobin A1c at Month 6
时间窗: 6 months
Hemoglobin A1c Level
次要结局
- Depressive Symptom Score at Month 6(6 months)
- Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12(12 months)
- Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6(6 months)
- Frequency of self-reported severe hypoglycemia at Month 12(12 months)
- Hemoglobin A1c at Month 12(12 months)
- Food Insecurity Score at Month 6(6 months)
- Food Insecurity Score at Month 12(12 months)
- Diabetes Distress Score as assessed by PAID-11 at Month 12(12 months)
- Frequency of self-reported hypoglycemia at Month 6(6 months)
- Frequency of self-reported hypoglycemia at Month 12(12 months)
- Frequency of self-reported severe hypoglycemia at Month 6(6 months)
- Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6(6 months)
- Depressive Symptom Score at Month 12(12 months)
- Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6(6 months)
- Health-Related Quality of Life Score as Assessed by PROMIS-29 at Month 12(12 months)
- Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6(6 months)
- Diabetes Distress Score as Assessed by PAID-11 at Month 12(12 months)
- Number of Participants With Self-reported Hypoglycemia at Month 6(6 months)
- Number of Participants With Self-reported Hypoglycemia at Month 12(12 months)
- Number of Participants With Self-reported Severe Hypoglycemia at Month 6(6 months)
- Number of Participants With Self-reported Severe Hypoglycemia at Month 12(12 months)