School of Public Health, Department of Epidemiology and Biostatistics, Indiana University Bloomington, 1025 E. 7th Street #111, Bloomington, IN 47405, USA.
Indiana University School of Nursing, Indiana University-Purdue University Indianapolis, 600 Barnhill Dr. Indianapolis, IN 46202, USA.
Contemp Clin Trials. 2021 Oct;109:106542. doi: 10.1016/j.cct.2021.106542. Epub 2021 Aug 14.
Childhood obesity disproportionately affects rural communities where access to pediatric weight control services is limited. Telehealth may facilitate access to these services.
This paper describes the rationale, curriculum, and methodology for conducting a randomized controlled pilot trial of a rural, family-based, telehealth intervention that aims to improve weight-related behaviors among children, compared to monthly newsletters.
A mixed-methods randomized design will randomly assign 44 rural families with one or more children aged 5 to 11 years identified as overweight or obese to an intervention or newsletter control group. The intervention group will attend 'eatNplay' group videoconferencing telehealth sessions, conducted weekly by a registered nurse and a motivational interviewing expert, to discuss diet, exercise, sleep, and peer group influences. The control group will receive newsletters covering these topics. Outcome measures at baseline, 12, and 26 weeks will assess 1) participant engagement and satisfaction with 'eatNplay'; 2) child's BMI, dietary behavior, physical activity, and sleep behavior; and 3) parent/guardians' self-reported beliefs, behaviors, attitudes, perceived stress, and perceived quality of life. Analyses will employ 1) thematic analysis of semi-structured parent/guardian interviews after follow-up to help refine the intervention (e.g., curriculum), and 2) linear mixed models to compare outcomes between groups pre- and post-intervention and reduce bias from unobserved variables. Results of this pilot study could refine methodology for conducting telehealth studies, acceptability of healthcare provider-involved recruitment, interdisciplinary team approach, and addressing childhood obesity in rural communities through telehealth.
儿童肥胖症在农村社区的发病率不成比例，这些社区获得儿科体重控制服务的机会有限。远程医疗可能有助于获得这些服务。
本文介绍了一项农村家庭为基础的远程医疗干预措施的随机对照试点试验的基本原理、课程和方法，该措施旨在改善超重或肥胖的儿童的体重相关行为，与每月通讯相比。
一项混合方法随机设计将随机分配 44 个农村家庭，每个家庭有一个或多个 5 至 11 岁的超重或肥胖儿童，分为干预组或通讯组。干预组将参加每周由注册护士和动机访谈专家进行的“eatNplay”小组视频会议远程医疗会议，讨论饮食、运动、睡眠和同伴群体的影响。对照组将收到涵盖这些主题的通讯。基线、12 周和 26 周的结果评估将包括 1）参与者对“eatNplay”的参与度和满意度；2）儿童的 BMI、饮食行为、体育活动和睡眠行为；以及 3）父母/监护人自我报告的信念、行为、态度、感知压力和感知生活质量。分析将采用 1）对随访后的半结构化父母/监护人访谈进行主题分析，以帮助完善干预措施（例如，课程），以及 2）线性混合模型，比较干预前后组间的结果，并减少未观察到的变量引起的偏差。这项试点研究的结果可以完善远程医疗研究的方法、医疗保健提供者参与招募的可接受性、跨学科团队方法，以及通过远程医疗解决农村社区的儿童肥胖问题。
