Cardiovascular Research Center, Division of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.
Department of Biostatistics, The University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.
Contemp Clin Trials. 2018 Apr;67:37-46. doi: 10.1016/j.cct.2018.02.006. Epub 2018 Feb 15.
Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are unlikely to be trained to provide effective weight management. Remote delivery using group phone conferences (GP) or individual phone calls (IP), by staff associated with rural clinics eliminates the need for travel to attend on-site meetings. The effectiveness of these approaches will be the focus of this trial. Staff at five primary care clinics, serving primarily rural residents, will be trained to deliver GP and IP interventions and an enhanced usual care (EUC), (i.e., individual face-to-face meetings (~45 min) at clinic site, four times across 18 mos.). Two hundred overweight/obese adults (BMI ≥ 25.0-45.0 kg/m, age ≥ 21 yrs.) will be recruited through each clinic and randomized to GP (n = 80), IP (n = 80), or EUC (n = 40) to compare weight loss (0-6 mos.), weight maintenance (7-18 mos.), and weight change during a 6 mo. no contact follow-up (19-24 mos.) between intervention arms. The GP and IP interventions will be identical in lesson plan content, diet, and physical activity. The only difference between groups will be the delivery format (group vs. individual) and session duration (GP ~45 min/session; IP ~15 min/session). Primary (body weight) and secondary outcomes (waist circumference, energy/macronutrient intake, physical activity) will be assessed at baseline, 6, 12, 18 and 24 mos. Cost and contingent valuation analyses will also be completed.
NCT02932748.
目的：肥胖症在农村居民中的患病率高于城市居民。农村健康诊所为提供体重管理提供了一个潜在的场所。然而，传统的项目需要前往现场参加会议，这对农村居民来说不切实际或不方便。大多数农村环境中的诊所工作人员不太可能接受过提供有效体重管理的培训。通过与农村诊所相关联的工作人员使用小组电话会议 (GP) 或个人电话 (IP) 进行远程交付，无需前往现场参加会议。本试验将重点关注这些方法的有效性。将培训五个主要为农村居民服务的初级保健诊所的工作人员，以提供 GP 和 IP 干预措施和增强的常规护理 (EUC)，（即在诊所现场进行 4 次、每次 45 分钟的个人面对面会议，共 18 个月）。将通过每个诊所招募 200 名超重/肥胖成年人（BMI≥25.0-45.0kg/m，年龄≥21 岁），并随机分配到 GP（n=80）、IP（n=80）或 EUC（n=40）组，以比较干预组之间 0-6 个月的体重减轻（体重减轻）、7-18 个月的体重维持（体重维持）和 6 个月无接触随访期间（19-24 个月）的体重变化。GP 和 IP 干预在课程计划内容、饮食和身体活动方面是相同的。组间唯一的区别是交付格式（小组与个人）和会议持续时间（GP 约 45 分钟/会议；IP 约 15 分钟/会议）。主要（体重）和次要结果（腰围、能量/宏量营养素摄入、身体活动）将在基线、6、12、18 和 24 个月进行评估。还将完成成本和 contingent 估值分析。
登记：NCT02932748。
