Coughlin Steven S, Hatzigeorgiou Christos, Anglin Judith, Xie Ding, Besenyi Gina M, De Leo Gianluca, Stewart Jessica, Wilkins Thad
Department of Clinical and Digital Health Sciences, College of Allied Health Sciences, Augusta University, Augusta, GA.
Department of General Internal Medicine, Medical College of Georgia, Augusta University, Augusta, GA.
Diabetes Manag (Lond). 2017;7(2):197-204.
Diet and exercise therapy have been reported to be effective in improving blood glucose control and are an important part of treatment of type 2 diabetes mellitus.
The goal of this study is to examine the efficacy of a healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus, as measured by Hgb-A1c, cardiovascular indicators, physical activity, weight, and BMI. Also of interest are optimal strategies for subject recruitment, the number of intervention sessions attended, and participant use of the Fitbit watch to monitor their physical activity and track food and beverage consumption.
A pre/post-test design will be used in this pilot study. Non-institutionalized adult patients (n=50) aged 18-65 years who have been seen at the Augusta Health outpatient clinics (General Internal Medicine or Family Medicine) for type 2 diabetes in the past 12 months, and who are interested in reducing their risk of disease recurrence through healthy lifestyle behaviors, will be eligible to participate. At orientation visit, eligible individuals will be asked to provide written informed consent. Consenting volunteers (n=50) will be asked to complete the baseline and 6-month follow-up questionnaire and to participate in 12 weekly group sessions of 90 min duration, involving physical activity and to meet with a dietitian (baseline, one month, 90 days) to receive individualized advice on diet and nutrition. The technology-based intervention will use wrist-worn Fitbit Blaze physical activity monitoring devices.
This pilot study will provide important information about the feasibility and preliminary efficacy of a healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus. The use of consumer-facing devices such as the Fitbit watch has the potential advantage over the use of research accelerometers, pedometers, or actigraphs in increasing the likelihood that the intervention will be sustainable after the study ends.
据报道,饮食和运动疗法在改善血糖控制方面有效,是2型糖尿病治疗的重要组成部分。
本研究的目的是通过糖化血红蛋白(Hgb-A1c)、心血管指标、身体活动、体重和体重指数(BMI)来检验针对成年门诊2型糖尿病患者的健康生活方式干预的效果。还感兴趣的是受试者招募的最佳策略、参加干预课程的次数以及参与者使用Fitbit手表监测身体活动和记录食物及饮料摄入量的情况。
本试点研究将采用前后测试设计。过去12个月内在奥古斯塔健康门诊(普通内科或家庭医学科)因2型糖尿病就诊、年龄在18至65岁之间、非机构化且有兴趣通过健康生活方式行为降低疾病复发风险的成年患者(n = 50)有资格参与。在首次就诊时,符合条件的个体将被要求提供书面知情同意书。同意参与的志愿者(n = 50)将被要求完成基线和6个月随访问卷,并参加为期90分钟的12次每周小组课程,包括身体活动,并与营养师会面(基线、1个月、90天)以获得关于饮食和营养的个性化建议。基于技术的干预将使用腕戴式Fitbit Blaze身体活动监测设备。
本试点研究将提供关于针对成年门诊2型糖尿病患者的健康生活方式干预的可行性和初步效果的重要信息。与使用研究用加速度计、计步器或活动记录仪相比,使用如Fitbit手表这类面向消费者的设备可能具有优势,即增加研究结束后干预措施可持续的可能性。