Remote Delivery of Weight Management in Adults with IDD

项目摘要/摘要 成人智力和发育障碍(IDD)是美国服务不足的一部分 肥胖率高、肥胖相关慢性病、体重选择有限的人群 管理层。我们已经在两个成人试验中证明了有临床意义的体重减轻6.4%和7.0% 使用增强型停车灯饮食(ESLD)和每月在家面对面(FTF)相结合的IDD 行为会议(成人/照顾者)，以及增加体力活动的建议(PA)。ESLD 建议每日摄入2~200卡路里的份量控制的主菜，2~100卡路里的奶昔，5份 水果/蔬菜和即兴无热量饮料，以及额外的低能量食物 SLD系统：绿色(低能)、黄色(中能)、红色(高能)。尽管这一干预 体重显著减轻，FTF交付(旅行+会议)相关的时间和成本限制了 有推广和实施的潜力，并建议有必要评估成本较低和 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 体重管理干预措施(6个月。减肥，12个月。维护，6个月。无接触跟进) 在家中使用视频会议(Zoom软件)远程(RD)提供给患有IDD的成年人 平板电脑(IPad Mini)，或在FTF访问期间。这两个干预部门都将包括个人每月在家 行为会话(参与者和照顾者)、ESLD和增加的PA。研发部门将包括PA组 (2节/周。)使用视频会议交付，并将使用商用的基于Web的应用程序 用于自我监控/参与者反馈饮食(丢掉它！)、PA(Fitbit活动跟踪器)和体重(Wi-Fi秤)。 FTF臂将与我们先前试验中显示有效的干预措施(DK83539)相同，并将 包括自我指导PA，使用纸和铅笔自我报告的饮食和PA的自我监控，以及体重 在每月家访期间进行评估。主要目标将确定RD是否不逊于FTF 体重减轻(0-6个月)。如果研发的平均体重损失不低于FTF，在以下范围内将被宣布为非劣质 统计可变性，差值为-3公斤。其次，我们将比较RD组和FTF组的平均值 体重减轻，临床有意义的体重减轻的参与者的比例，以及质量的变化 历时24个月。我们亦会进行成本、成本效益和或有估值分析，以 比较RD组和FTF组。我们还将探索行为会议出席率的影响， 遵守饮食建议(能量摄入量、主菜/奶昔次数、 水果/蔬菜，PA(最低中等强度PA)，自我监测饮食和PA，性别，年龄，IDD诊断， 照顾者的自我效能/更替，以及18个月内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.