The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
This pragmatic trial compares the effectiveness of virtual culinary medicine classes vs. standard of care medical nutrition visits to improve glycemic control in patients with uncontrolled type 2 diabetes . Culinary medicine teaches healthy eating principles through a combination of experiential cooking classes and focused didactic sessions. The primary study outcome is glycemic improvement (A1c). Qualitative evaluation will assess participant experience, impact, and durability of behavior changes related to nutrition. A short term cost analysis will be conducted to inform program costs and cost effectiveness.
详细描述
A total of 130 participants with uncontrolled type 2 diabetes will be recruited from a safety-net health system that provides comprehensive care for the uninsured and underinsured residents of Dallas County, Texas. Eligible participants will be actively engaged in primary care and recruited from clinical practice. Participants will be randomized to two arms: Culinary Medicine and standard of care medical nutrition therapy (MNT). Certified culinary medicine instructors will deliver a series of 6 monthly Culinary Medicine classes virtually with participants cooking in their own homes. A series of 6 standard of care medical nutrition sessions will be delivered by the health system using a combination of individual and group sessions both in person and virtually. All participants will be enrolled in a 12 month food assistance program in partnership with community based partners to provide access to healthy foods. Classes will be delivered over 6 months, and participants will be followed for an additional 6 months to assess the durability of glycemic response and behavior changes. A cost analysis will examine the system cost to deliver the intervention and the short term cost effectiveness examining the cost per participant achieving a clinically meaningful reduction in A1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •No nutrition visit in the past 12 months.
- •Hemoglobin A1C ≥ 7.5% within the past six months.
- •Diagnosed with established Type 2 Diabetes > 12 months
- •Receiving primary care at Hatcher Station Health Center and an assigned primary care provider within the past 18 months.
- •Completion of at least 2 of the 4 Health Living with Diabetes (HLWD) virtual and/or in-person sessions.
排除标准
- •Patients who cannot hear virtual and/or in-person instruction
- •Patients who cannot read or speak English or Spanish
- •Patients who are unable to understand study information
- •Patients younger than 18 years of age
- •Patients who are unable to communicate with voice (for participation in phone surveys, focus groups and semi-structured interviews)
- •Patients without access to a smart phone or other device with internet and/or data capability to participate in virtual classes
- •We will exclude patients with chronic kidney disease (CKD) stage 4 or 5 (eGFR < 30 or on dialysis) because their renal function may require additional nutritional counseling and dietary modifications beyond the scope of the proposed culinary medicine and nutrition sessions delivered in this study.
结局指标
主要结局
Hemoglobin A1c
时间窗: 3, 6, and 12 months
A1c will be measured at baseline, 3, 6 and 12 months. Change in A1c will be assessed at 6 months (end of active intervention) and also at 12 months (i.e. 6 months after completion of active intervention) to assess the durability of the intervention on glycemic control. Pre-specified subgroup analyses will also examine A1c outcomes by: 1) prior participation in diabetes education and nutrition education. Stratified analyses by number of sessions attended will also be conducted.
次要结局
- Food security score(baseline, 6 months and 12 months)
- Change in weight(3, 6, and 12 months)
- Change in BMI(baseline, 6 and 12 months)
- Change in blood pressure(baseline, 6, and 12 months)
研究者
Michael Edward Bowen
Assistant Professor Internal Medicine
University of Texas Southwestern Medical Center