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临床试验/NCT04152811
NCT04152811已完成不适用

Cooking Matters for Diabetes - Practical Application of Diabetes Self-Management Education

Ohio State University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change in Hemoglobin A1c over 4.5 months

研究概览

简要总结

Our primary objective is to improve glycemic control (Hemoglobin A1c [HbA1c]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care.

Our secondary objective is to improve health related quality of life, adherence to diabetes self-management behaviors (physical activity, diet, glucose monitoring, and medication adherence) over 3-months compared to usual care.

We hypothesize that participants in the cooking matters intervention will have significant improvement in glycemic control (HbA1c), HRQOL, and adherence to diabetes self- management compared to usual care. Our study is significant as it examines a novel approach to improving diabetes care and addressing glycemic control in diabetes.

详细描述

We will enroll 60 participants with diabetes and HbA1c ≥ 7% in a Cooking Matters (CM) program using a waitlist control design with 30 participants in the intervention group and 30 participants in the waitlist control group, separated into two arms.Participants will be stratified by sex and randomized using a random number generator program to either the intervention or wait list control group. Each CM course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate (the current nutrition guide published by the USDA Center for Nutrition Policy and Promotion, a food circle depicting a place setting with a plate and glass divided into five food groups), the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management. Five of the 6 classes will include hands-on cooking instruction and nutrition instruction; one of the 6 classes will be a grocery store tour held in a grocery store of the groups' choosing. This class will provide nutrition instruction with the focus on meal planning for optimal glucose control under the constraints of a budget. Each class will be interactive and provides participants opportunities to demonstrate their understanding of the lesson. Participants are encouraged to ask questions, offer solutions and share their experiences. At the end of each class, when food preparation is highlighted, the class and instructors will gather to sample all recipes and have open discussion. Each participant will take home a bag of groceries with the ingredients to replicate the recipes made in class. At the beginning of each class, participants are encouraged to share with the group how they used of the previous week's groceries and reflect on cooking at home. We will administer validated surveys measuring health-related quality of life, diabetes self-management behaviors, and dietary patterns and perform point of care HbA1c assessment of both groups (intervention and waitlist control) when intervention 1 begins the program in week 1. We will then proceed with the CM intervention with intervention 1 in weeks 1 thru 6 and the post test will be administered to the intervention group at the end of the intervention, 3, 6 and 12 months post intervention. In week 18-23, we will administer CM to the original waitlist control group and they will follow the same protocol as intervention 1. The second arm of the study will follow the same design, beginning in week 12 of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor are blinded

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Hemoglobin A1c over 4.5 months

时间窗: Change in Hemoglobin A1c from baseline (0 months) to 4.5 months

Change in Hemoglobin A1c over 4.5 months

次要结局

  • Change in Health Related Quality of Life over 4.5 months using SF-12 Survey(Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Joseph, MD

Assistant Professor of Medicine

Ohio State University

研究点 (2)

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