Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals with Type 2 Diabetes Mellitus and Food Insecurity

食物就是药物：针对 2 型糖尿病和食物不安全患者的医学定制膳食的随机临床试验

• 批准号: 10460166
• 负责人: Seth A Berkowitz
• 金额: $ 54.21万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10460166
• 关键词: Address; Adult; Affect; Aftercare; American; Asian ancestry; Attention; Behavior; Behavioral; Blood Glucose; Body mass index; Caring; Clinical; Cognitive; Communities; Complement; Complications of Diabetes Mellitus; Data; Diabetes Mellitus; Diet; Dietitian; Dimensions; Disease; Distress; Education; Educational Intervention; Enrollment; Ethnic Origin; Food; Food Access; Future; Glycosylated hemoglobin A; Health; Health Food; Health Policy; Healthy Eating; Home; Hypoglycemia; Incentives; Individual; Intervention; Interview; Knowledge; Lead; Life; Measures; Mediating; Medicaid; Medical; Medicine; Mental Health; Methods; Modification; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Nutritionist; Outcome; Participant; Pathway interactions; Patient Care; Patient Outcomes Assessments; Pharmaceutical Preparations; Physiological; Positioning Attribute; Psychological Factors; Quality of life; Race; Randomized; Randomized Clinical Trials; Reporting; Research; Resources; Risk Factors; Self Efficacy; Self Management; Socioeconomic Factors; Stress; Testing; Time; Variant; Weight; Work; base; contextual factors; design; diabetes control; diabetes distress; diabetes management; diabetes self-management; disparity reduction; efficacious intervention; ethnic minority; evidence base; experimental study; food insecurity; food quality; group intervention; health related quality of life; improved; indexing; innovation; intervention delivery; intervention program; lifestyle intervention; low socioeconomic status; nutrition; prevent; primary outcome; programs; psychologic; psychosocial; racial and ethnic; randomized trial; recruit; response; secondary analysis; secondary outcome; skills; socioeconomic disadvantage; treatment as usual; treatment effect

PROJECT SUMMARY/ABSTRACT 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 is 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. MTM was highly successful in improving diet quality in a pilot randomized clinical trial. What is missing is an explanatory (efficacy) randomized trial testing whether this medically tailored meal intervention can lead to improvements in diabetes outcomes such as Hemoglobin A1c, and in patient-reported outcomes such as diabetes distress, quality of life, and hypoglycemia. Thus, we propose a 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 $30/month healthy food subsidy, along with usual diabetes care. Outcomes will be assessed at 6 and 12 months. The primary outcome is Hemoglobin A1c at 6 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures.

项目总结/文摘