Community Servings: Food as Medicine for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Healthy Eating Index 2010 Score
研究概览
简要总结
Food insecurity, defined as difficulty accessing food owing to cost, affects 1 in 5 diabetes patients. To address this, the investigators are conducting a pilot randomized controlled trial of medically tailored meal delivery (MTM). The pilot study has two specific aims:
Aim 1: To determine the effect of receiving MTM on dietary quality for food insecure diabetes patients with hyperglycemia Aim 2: To determine the feasibility and acceptability of the program as a medical intervention and refine the program as needed for testing in larger studies.
This study is a crossover randomized controlled pilot trial, where approximately 50 participants, 25 in each arm, will be randomized to receipt of 12 weeks of MTM, to begin immediately, or waitlist control. After 12 weeks, the groups will crossover, with the waitlist control group now receiving 12 weeks of MTM. At baseline, 12 weeks, and 24 weeks, the participants will complete assessments of their dietary quality (HEI score), psychosocial measures such as diabetes distress and food insecurity, along with measures of body mass index, blood pressure, hemoglobin A1c, and lipids.
详细描述
a. Historical background The Center for Disease Control and Prevention (CDC) estimates that there are currently 29 million people with diabetes and 86 million people with pre-diabetes in the U.S. One in 10 Americans has diabetes now, and, if current trends continue, 1 in 3 Americans will have diabetes by 2050. This chronic disease significantly impacts both quality of life and rapidly rising national healthcare costs. The estimated cost of diabetes in the U.S. in 2014 was $265 billion with $176 billion in direct medical costs and $89 billion is indirect medical costs (disability, work loss, premature mortality). Medical expenses for people with diabetes are 2.3 times higher than for people without diabetes.
Food insecurity, defined as limited access to nutritious food due to cost, has been associated with increased prevalence of diabetes and worse diabetes control. Food insecurity may worsen diabetes by decreasing consumption of fresh fruits and vegetables and increasing consumption of inexpensive, calorie-dense food, and which in turn leads to greater Hemoglobin A1c, an indicator of hyperglycemia, over time.
c. Rationale behind the proposed research, and potential benefits to participants and/or society
Approximately 20% of diabetes patients report food insecurity, a number that increases to over 25% among those with the worst metabolic control.5 The prevalence of food insecurity is also 20% in the MGH Population we surveyed (data not yet published). Hyperglycemia is particularly responsive to dietary changes,8 yet few interventions have attempted to address food insecurity in diabetes care. Prior studies have examined the impact of the Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp Program), but have not found important improvements in diabetes outcomes for participants9. This may be because neighborhood access to produce and other high quality food is low for many SNAP participants, or because making healthy food choices is difficult in resource-constrained environments. Additionally, recent sociological work has shown that expecting low-income women to cook healthy meals for their families induces a significant burden, and the burden of these expectations may drive less healthy food choices. Additionally, while significant time is needed for healthy food preparation, low-income patients often face limited leisure time, and multiple competing demands for both time and financial resources. Alternatively, direct provision of healthy foods was incidentally noted to improve diabetes outcomes in a prior randomized controlled trial, but this study was not conducted with the goal of addressing food insecurity.
In this study, we propose to test whether home delivery of freshly prepared meals specifically tailored to the needs of diabetes patients improves their dietary quality. We hypothesize that the delivery of the meals will help them eat more healthily and improve the food security of participants. Secondary outcomes in this pilot study will be weight and metabolic control, along with psychological aspects of diabetes care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older
- •HbA1c level >8.0%
- •Report food insecurity as indicated by the 2-item USDA Food Security Survey Module13
- •Willing to commit to random assignment to either receive CS meals immediately or as a waitlist control
- •Stable health, with no severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
- •Be willing to keep a food diary
- •Be willing to attend and complete a baseline, 12 week, and 24 week assessment at MGH
- •Be able to understand and communicate effectively in English
- •Have a primary care physician within the MGH practice based research network
- •Live in an area where Community Servings can deliver meals
- •Ability to store and prepare Community Servings meals
排除标准
- •• Must not be pregnant or planning pregnancy in the next year
- •Currently enrolled in another diabetes study Food allergy that would prohibit consumption of meals
- •Receiving episodic treatments that may increase blood glucose levels (e.g. prednisone)
结局指标
主要结局
Healthy Eating Index 2010 Score
时间窗: Average of 3 24-hour food recalls per study period (on and off meals; one in-person visit and 2 over the phone at 4 and 8 weeks into the study)
Calculated using data from ASA24 24-hour dietary recall tool Healthy Eating Index 2010 Score Minimum and Maximum range = 0 to 100 Higher scores indicate better diet quality The score is an average of the three-time periods that data was collected
次要结局
- Number of Participants With Food Insecurity(Measured at end of On-Meals Period and end of Off-Meals Period for each participant)
- Diabetes Distress Scale(Measured at end of On-Meals Period and end of Off-Meals Period for each participant)
研究者
Seth A Berkowitz
Instructor in Medicine
Massachusetts General Hospital
