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在线体重管理项目与人群健康管理相结合对体重变化的影响:一项随机临床试验。

Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial.

机构信息

Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, Massachusetts.

Harvard Medical School, Harvard University, Boston, Massachusetts.

出版信息

JAMA. 2020 Nov 3;324(17):1737-1746. doi: 10.1001/jama.2020.18977.

DOI:10.1001/jama.2020.18977
PMID:33141209
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7610192/
Abstract

IMPORTANCE

Online programs may help with weight loss but have not been widely implemented in routine primary care.

OBJECTIVE

To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.

DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.

INTERVENTIONS

Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.

MAIN OUTCOMES AND MEASURES

The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.

RESULTS

Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001).

CONCLUSIONS AND RELEVANCE

Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02656693.

摘要

重要性

在线项目可能有助于减肥,但尚未在常规初级保健中广泛实施。

目的

比较联合干预措施(包括在线体重管理计划加人群健康管理)与仅在线计划和常规护理的有效性。

设计、设置和参与者:在美国的 15 个初级保健实践中,于 2016 年 7 月 19 日至 2017 年 8 月 10 日进行了一项集群随机试验。符合条件的参与者有一个预定的初级保健就诊,年龄在 20 至 70 岁之间,体重指数在 27 至 40 之间,且患有高血压或 2 型糖尿病。随访于 2019 年 5 月 8 日结束。

干预措施

常规护理组(n=326)参与者收到有关体重管理的一般信息。仅在线计划组(n=216)和联合干预组(n=298)的参与者注册了在线计划。联合干预组的参与者还接受了与体重相关的人群健康管理,其中包括非临床工作人员的额外支持,他们监测他们在在线计划中的进展情况,并进行定期外展。

主要结果和措施

主要结局是根据电子健康记录中记录的体重在 12 个月时的体重变化。次要结局是 18 个月时的体重变化。

结果

在 840 名登记的参与者中(平均年龄,59.3 岁[SD,8.6 岁];60%为女性;76.8%为白人),732 名(87.1%)在 12 个月时有记录的体重,其余参与者的缺失体重进行了插补。组间 12 个月时体重变化存在显著差异,常规护理组体重平均减轻 1.2 公斤(95%CI,-2.1 至-0.3 公斤),仅在线计划组体重减轻 1.9 公斤(95%CI,-2.6 至-1.1 公斤),联合干预组体重减轻 3.1 公斤(95%CI,-3.7 至-2.5 公斤)(P<0.001)。联合干预组与常规护理组体重变化的差异为 1.9 公斤(97.5%CI,-2.9 至-0.9 公斤;P<0.001),联合干预组与仅在线计划组体重变化的差异为 1.2 公斤(95%CI,-2.2 至-0.3 公斤;P=0.01)。18 个月时,常规护理组体重平均减轻 1.9 公斤(95%CI,-2.8 至-1.0 公斤),仅在线计划组体重减轻 1.1 公斤(95%CI,-2.0 至-0.3 公斤),联合干预组体重减轻 2.8 公斤(95%CI,-3.5 至-2.0 公斤)(P<0.001)。

结论和相关性

在超重或肥胖且患有高血压或 2 型糖尿病的初级保健患者中,将人群健康管理与在线计划相结合,与常规护理或仅在线计划相比,在 12 个月时体重减轻量较小,但具有统计学意义。需要进一步研究以了解这些发现的普遍性、可扩展性和持久性。

试验注册

ClinicalTrials.gov 标识符:NCT02656693。

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