Remote Delivery of Weight Management in Adults with IDD

项目总结/摘要 智力和发育障碍（IDD）的成年人代表了美国服务不足的部分 肥胖、肥胖相关慢性疾病和体重选择有限的高患病率人群 管理我们在2项成人试验中证明了具有临床意义的体重减轻6.4%和7.0% IDD患者使用增强的Stop Light Diet（eSLD）结合每月在家面对面（FTF） 行为会话（成人/护理人员），以及增加体力活动（PA）的建议。eSLD 建议每日摄入量为2 ~ 200千卡的控制型主菜，2 ~100千卡的奶昔，5份 水果/蔬菜，以及自由饮用的无热量饮料和使用 SLD系统：绿色（低能量）、黄色（中等能量）和红色（高能量）。虽然这次干预 产生了显着的体重减轻，与FTF交付（旅行+会议）相关的时间和成本限制了 扩大规模和实施的潜力，并建议需要评估成本较低和 实施干预措施的繁重战略。因此，我们建议24个月。随机试验比较2 体重管理干预（6个月，体重减轻，12个月维护，6个月无接触后续行动） 通过远程（RD）使用视频会议（Zoom软件）， 平板电脑（iPad mini）或FTF访视期间。两个干预组都将包括个人每月在家 行为会话（参与者和护理人员），eSLD和PA增加。研发组将包括PA组 （2次/周）通过视频会议提供，并将使用市场上现有的网络应用程序 对于饮食的自我监测/参与者反馈（失去它！），PA（Fitbit活动跟踪器）和体重（Wi-Fi秤）。 FTF组将与我们先前试验（DK 83539）中显示有效的干预相同， 包括自我指导PA、使用纸和铅笔自我报告的饮食和PA的自我监测以及体重 在每月的家访中进行评估。主要目的是确定RD是否不劣于FTF， 体重减轻（0-6个月）。如果RD的平均体重减轻不劣于FTF，则将宣布非劣效性，在 统计变异性，差值为-3 kg。其次，我们将比较RD组和FTF组的平均值 体重减轻，达到临床意义体重减轻的参与者比例，以及质量变化 在24个月内。我们亦会进行成本、成本效益及或有评估分析， 比较RD组和FTF组。我们还将探讨行为会议出席的影响， 遵守饮食建议（能量摄入、主菜/奶昔的数量、 水果/蔬菜，PA（中等-高强度PA的最小值），饮食和PA的自我监测，性别，年龄，IDD诊断， 照顾者自我效能/周转率，以及18个月内致肥胖药物对减肥的影响。

Project Summary/Abstract Adults with intellectual and developmental disabilities (IDD) represent an underserved segment of the US population with a high prevalence of obesity, obesity related chronic disease, and limited options for weight management. We have demonstrated clinically meaningful weight loss of 6.4% and 7.0% in 2 trials in adults with IDD using an enhanced Stop Light Diet (eSLD) in combination with monthly at-home face-to-face (FTF) behavioral sessions (adult/caregiver), and a recommendation for increased physical activity (PA). The eSLD recommended daily consumption of 2 ~ 200 kcal portion-controlled entrées, 2 ~100 kcal shakes, 5 servings of fruits/vegetables, and ad-libitum non-caloric beverages and additionally low energy foods selected using the SLD system: green (low energy), yellow (moderate energy), and red (high energy). Although this intervention produced significant weight loss, the time and cost associated with FTF delivery (travel + sessions) limits the potential for scaling and implementation, and suggests the need for the evaluation of less costly and burdensome strategies for intervention delivery. Therefore, we propose a 24 mo. randomized trial to compare 2 weight management interventions (6 mos. weight loss, 12 mos. maintenance, 6 mos. no-contact follow-up) delivered to adults with IDD in their home, either remotely (RD) using video conferencing (Zoom software) on a tablet computer (iPad mini), or during FTF visits. Both intervention arms will include individual monthly at-home behavioral sessions (participant & caregiver), an eSLD, and increased PA. The RD arm will include group PA (2 session/wk.) delivered using video conferencing and will use commercially available web-based applications for self-monitoring/participant feedback for diet (Lose it!), PA (Fitbit activity tracker), and weight (Wi-Fi scales). The FTF arm will be identical to the intervention shown to be effective in our previous trial (DK83539) and will include self-directed PA, self-monitoring of diet and PA using paper and pencil self-reports, and weight assessed during monthly home visits. The primary aim will determine whether RD is non-inferior to FTF for weight loss (0-6 mos.). Non-inferiority will be declared if mean weight loss for RD is no worse than FTF, within statistical variability, by a margin of -3 kg. Secondarily we will compare the RD and FTF groups on mean weight loss, the proportion of participants who achieve clinically meaningful weight loss, and changes in quality of across 24 months. We will also conduct cost, cost-effectiveness and contingent valuation analyses to compare the RD and FTF groups. We will also explore the influence of behavioral session attendance, compliance to recommendations for diet (energy intake, number of entrées/shakes, servings of fruits/vegetables, PA (min of moderate-vigorous PA), self-monitoring of diet and PA, sex, age, IDD diagnosis, caregiver self-efficacy/turnover, and obesogenic medications on weight loss across 18 months.