Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.
Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.
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DOI：
10.1016/j.cct.2020.106098
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发表时间：
2020-08
影响因子：
2.2
通讯作者：
R. Washburn;L. Ptomey;A. Gorczyca;P. R. Smith;M. Mayo;Robert H. Lee;J. Donnelly
中科院分区：
文献类型：
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作者：
R. Washburn;L. Ptomey;A. Gorczyca;P. R. Smith;M. Mayo;Robert H. Lee;J. Donnelly
与行动能力相关的残疾(MRD)成年人是一个服务不足的群体，超重/肥胖率很高，体重管理选择有限。此前，我们通过在家中进行面对面的行为训练和可选的体力活动，对患有MRD的成年人进行了有临床意义的12个月体重减轻(−6.2%，≥基线体重的36%和5%)。然而，与通过个人家访提供干预措施相关的成本/后勤费用限制了这一方法的推广和实施的潜力。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，比较体重减轻(6个月)。和维护(12个月)在利用ESLD的干预、行为咨询和增加体力活动之间，向单个参与者提供家中的服务，或通过视频会议远程提供给家中的参与者群体。主要目标是比较6个月内不同干预措施的减肥效果。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个月实现临床有意义体重减轻的参与者的比例(≥5%)，以及从0到6个月和0到18个月的生活质量变化。我们还将进行成本、成本效益和条件估值比较，并探索行为课程出席、遵守饮食和体力活动建议、自我监控饮食和体力活动、体力活动障碍、睡眠质量和药物治疗对6个月和18个月体重变化的影响。NCT注册NCT04046471
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 registrationNCT04046471