Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.
Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA.
Contemp Clin Trials. 2020 Sep;96:106098. doi: 10.1016/j.cct.2020.106098. Epub 2020 Aug 6.
Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.
患有行动相关残疾（MRD）的成年人代表着一个服务不足的群体，他们普遍存在超重/肥胖问题，并且在体重管理方面选择有限。我们之前曾使用增强型红绿灯饮食（eSLD）对 MRD 成年人进行了为期 12 个月的临床有意义的减肥试验，结果显示体重减轻了 6.2%（基线体重的 36%≥5%），该饮食方案是通过在家中面对面的行为治疗和可选的体育活动进行的。然而，由于个别家访干预措施的实施成本/后勤问题限制了这种方法的推广和实施潜力。因此，我们将在 128 名患有 MRD 的超重/肥胖成年人中进行一项双臂随机试验，比较两种干预措施在 6 个月时的减肥效果（6 个月）和维持效果（12 个月），这两种干预措施均采用 eSLD、行为咨询以及增加的体育活动，通过家庭中的个别参与者或通过视频会议远程为家庭中的参与者小组提供服务。主要目标是比较两种干预措施在 6 个月时的减肥效果。其次，我们将比较体重减轻（0-18 个月）、从 0 到 6 个月和 0 到 18 个月期间达到临床意义上减肥（≥5%）的参与者比例、以及 0 到 6 个月和 0 到 18 个月期间生活质量的变化。我们还将进行成本、成本效益和意向性价值评估比较，并探讨行为治疗次数、饮食和体育活动建议的遵守情况、饮食和体育活动自我监测、体育活动障碍、睡眠质量和药物对 6 个月和 18 个月期间体重变化的影响。NCT 注册：NCT04046471。
