Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.
Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.
Contemp Clin Trials. 2020 Aug;95:106026. doi: 10.1016/j.cct.2020.106026. Epub 2020 May 16.
Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m, and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.
在初级保健中需要可扩展且低成本的体重管理策略。我们进行了一项实用的、集群随机对照试验，以检验将在线体重管理计划与人群健康管理支持相结合的有效性。
我们对在线体重管理计划进行了改编，并将其与 15 个初级保健实践（24 个诊所）中的人群健康管理支持相结合。我们将 24 个诊所随机分配到常规护理（UC）、单独在线计划（OP）或联合干预（CI）组。合格参与者必须年龄在 20 至 70 岁之间，最近有过初级保健就诊，体重指数（BMI）≥27 且<40 kg/m，且患有高血压或 2 型糖尿病的诊断。参与者在 18 个月期间进行常规就诊并完成调查。主要结局是在入组后 12 个月（±90 天）的绝对体重变化，通过在初级保健就诊时测量的体重和电子健康记录中记录的体重计算得出。
我们在 2016 年 7 月至 2017 年 8 月期间招募了 840 名参与者（UC 组 326 人，OP 组 216 人，CI 组 298 人）。入组时，参与者的平均年龄为 59.3 岁，平均体重为 203.1 磅，平均 BMI 为 32.5 kg/m；60%的参与者为女性，76.8%为白人，96.4%患有高血压，24.4%患有 2 型糖尿病。
在初级保健中改编在线体重管理计划并将其与人群健康管理支持相结合是可行的。该试验的结果将为这些策略在初级保健环境中的有效性提供有价值的信息。临床试验注册号：NCT02656693。
