Department of Population Health, University of Kansas Medical Center, Kansas City.
Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin.
JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.
Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed.
To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model.
DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019.
All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff.
The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg.
Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention.
Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance.
ClinicalTrials.gov Identifier: NCT02456636.
农村人口肥胖患病率较高，获得减肥项目的机会较少。需要在农村临床实践中找到有效的肥胖治疗模式。
将医疗保险强化行为治疗肥胖服务模式与 2 种替代方案进行比较：基于以患者为中心的医疗之家模式的门诊小组访问和基于疾病管理模式的电话小组访问。
设计、地点和参与者：在美国中西部农村的 36 个初级保健诊所进行的聚类随机试验。纳入标准包括年龄 20 至 75 岁，体重指数为 30 至 45。参与者于 2016 年 2 月至 2017 年 10 月期间入组。最终随访于 2019 年 12 月进行。
所有参与者都接受了以饮食、身体活动和行为改变策略为重点的生活方式干预。在服务收费干预组（n=473）中，由执业临床医生提供 15 分钟的门诊个人访问，其频率与医疗保险报销的频率相似（第 1 个月每周 1 次，第 5 个月每两周 1 次，此后每月 1 次）。在门诊小组干预组（n=468）中，执业临床医生提供每周 3 个月、每 3 个月 2 次、此后每月 1 次的小组访问。在电话小组干预组（n=466）中，患者接受与门诊小组干预组相同的干预，但由集中工作人员通过电话会议远程提供会话。
主要结局是 24 个月时的体重变化。定义了最小临床重要差异为 2.75 公斤。
在 1407 名参与者（平均年龄 54.7[标准差 11.8]岁；基线体重指数 36.7[标准差 4.0]；1081[77%]名女性）中，1220 名（87%）完成了试验。在门诊小组干预组中，24 个月时的平均体重减轻量为-4.4 公斤（95%CI，-5.5 至-3.4 公斤），在电话小组干预组中为-3.9 公斤（95%CI，-5.0 至-2.9 公斤），在门诊个人干预组中为-2.6 公斤（95%CI，-3.6 至-1.5 公斤）。与门诊个人干预相比，门诊小组干预的体重变化平均差异为-1.9 公斤（97.5%CI，-3.5 至-0.2 公斤；P=0.01），电话小组干预的体重变化平均差异为-1.4 公斤（97.5%CI，-3.0 至 0.3 公斤；P=0.06）。
在农村初级保健诊所中肥胖的患者中，与门诊个人访问相比，门诊小组访问（但不是基于电话的小组访问）导致 24 个月时体重减轻量具有统计学显著意义。然而，这些差异在幅度上较小，且在临床上的重要性不确定。
ClinicalTrials.gov 标识符：NCT02456636。
