Leahey Tricia M, Gorin Amy A, Huedo-Medina Tania B, Denmat Zeely, Field Christiana, Gilder Carnisha, Wyckoff Emily P, O'Connor Kayla, Hahn Korina, Jenkins Kyrstyn, Unick Jessica L, Hand Grace, McManus-Shipp Katherine, Calcaterra Julianna, Falk Georgia
Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs.
Department of Clinical and Health Psychology and Research Methods, University of the Basque Country UPV/EHU, Donostia-San Sebastián, Spain.
JAMA Intern Med. 2025 May 27. doi: 10.1001/jamainternmed.2025.1345.
Weight loss maintenance (WLM) is one of the most difficult challenges in obesity treatment. Continuous care, which involves frequent behavioral weight management sessions delivered by professional staff, shows promise; however, this care is costly and unsustainable. Thus, new, efficacious treatment models are needed for WLM.
To examine the efficacy of an entirely patient-delivered treatment for WLM compared with professionally delivered standard-of-care treatment (SOC).
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial used a 2-phase WLM design. During phase 1, participants received an online weight loss program. Those who achieved 5% or greater weight loss in phase 1 were eligible for phase 2, the actual 18-month WLM trial. Participants in the maintenance trial were randomized to either an entirely patient-delivered lifestyle intervention for WLM or SOC delivered by professional staff. Participants aged 18 to 75 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 25 to 50 were recruited from a single academic research center. Data were collected from February 2018 to March 2023, and data were analyzed from September 2024 to February 2025.
Patient-to-patient treatment involved no professional staff; instead, mentors (successful weight losers) delivered intervention sessions and peers (fellow participants) provided ongoing, remotely delivered evidence-based social support. SOC was current best practice for WLM-group lifestyle intervention led by professionals. Both WLM interventions were 18 months in duration.
Primary outcome was weight change during the 18-month trial. Secondary outcomes included blood pressure, heart rate, physical activity, and sedentary behavior.
Among the 287 randomized participants (240 [83.6%] female; mean [SD] age, 53.6 [0.9] years), 268 (93.4%) completed the trial. There was a statistically significant difference in weight change by arm; patient-to-patient treatment yielded significantly less weight regain than SOC (month 6: -1.44 kg [95% CI, -2.35 to 0.54] vs -0.16 [95% CI, -1.13 to 0.82]; month 12: 0.04 kg [95% CI, -0.86 to 0.95] vs 0.77 [95% CI, -0.21 to 1.47]; month 18: 0.77 kg [95% CI, -0.14 to 1.68] vs 2.37 [95% CI, 1.40 to 3.34]; P = .002). Parallel findings were observed for diastolic blood pressure, heart rate, physical activity, and sedentary behavior.
In this trial, patient-delivered lifestyle intervention (mentor interventionists plus peer support) yielded significantly better WLM and cardiovascular risk outcomes compared with SOC delivered by professionals. Future research may examine the effectiveness of this novel treatment approach in community and clinical settings.
ClinicalTrials.gov Identifier: NCT03396653.
维持体重减轻(WLM)是肥胖症治疗中最具挑战性的难题之一。持续护理,即由专业人员进行频繁的行为体重管理课程,显示出一定前景;然而,这种护理成本高昂且难以持续。因此,需要新的、有效的WLM治疗模式。
研究与专业人员提供的标准护理治疗(SOC)相比,完全由患者自行实施的WLM治疗的疗效。
设计、设置和参与者:这项随机临床试验采用了两阶段的WLM设计。在第一阶段,参与者接受一个在线减肥计划。在第一阶段体重减轻达到5%或更多的人有资格进入第二阶段,即实际为期18个月的WLM试验。维持试验的参与者被随机分配到完全由患者自行实施的WLM生活方式干预组或由专业人员提供的SOC组。从一个单一的学术研究中心招募年龄在18至75岁、体重指数(以千克为单位的体重除以以米为单位的身高的平方)为25至50的参与者。数据收集时间为2018年2月至2023年3月,数据分析时间为2024年9月至2025年2月。
患者对患者的治疗不涉及专业人员;相反,指导者(成功减重者)进行干预课程,同伴(其他参与者)提供持续的、远程提供的循证社会支持。SOC是由专业人员主导的WLM组生活方式干预的当前最佳实践。两种WLM干预措施均为期18个月。
主要结局是18个月试验期间的体重变化。次要结局包括血压、心率、身体活动和久坐行为。
在287名随机分组的参与者中(240名[83.6%]为女性;平均[标准差]年龄为53.6[0.9]岁),268名(93.4%)完成了试验。两组的体重变化存在统计学显著差异;患者对患者的治疗导致的体重反弹明显少于SOC(第6个月:-1.44千克[95%置信区间,-2.35至0.54]对-0.16[95%置信区间,-1.13至0.82];第12个月:0.04千克[95%置信区间,-0.86至0.95]对0.77[95%置信区间,-0.21至1.47];第18个月:0.77千克[95%置信区间,-0.14至1.68]对2.37[95%置信区间,1.40至3.34];P = 0.002)。在舒张压、心率、身体活动和久坐行为方面也观察到了类似的结果。
在这项试验中,与专业人员提供的SOC相比,患者自行实施的生活方式干预(指导者干预加同伴支持)在WLM和心血管风险结局方面产生了显著更好的效果。未来的研究可以考察这种新型治疗方法在社区和临床环境中的有效性。
ClinicalTrials.gov标识符:NCT03396653。