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一项随机非劣效性试验,比较异步远程提供与诊所提供的生活方式干预。

Randomized non-inferiority trial comparing an asynchronous remotely-delivered versus clinic-delivered lifestyle intervention.

作者信息

Pagoto Sherry L, Goetz Jared M, Xu Ran, Wang Monica L, Palmer Lindsay, Lemon Stephenie C

机构信息

Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.

Boston University School of Public Health, Boston, MA, USA.

出版信息

Int J Obes (Lond). 2025 Jan;49(1):76-83. doi: 10.1038/s41366-024-01617-0. Epub 2024 Aug 27.

DOI:10.1038/s41366-024-01617-0
PMID:39191926
Abstract

OBJECTIVE

Lifestyle interventions are effective, but those delivered via in-person group meetings have poor scalability and reach. Research is needed to establish if remotely delivered lifestyle interventions are non-inferior to in-person delivered lifestyle interventions.

METHODS

We conducted a randomized non-inferiority trial (N = 329) to compare a lifestyle intervention delivered remotely and asynchronously via an online social network (Get Social condition) to one delivered via in-person groups (Traditional condition). We hypothesized that the Get Social condition would result in a mean percent weight loss at 12 months that was not inferior to the Traditional condition. Additional outcomes included intervention delivery costs per pound lost and acceptability (e.g., convenience, support, modality preferences).

RESULTS

At 12 months, no significant difference in percent weight change was observed between the Get Social and Traditional conditions (2.7% vs. 3.7%, p = 0.17) however, criteria for non-inferiority were not met. The Get Social condition costs $21.45 per pound lost versus $26.24 for the Traditional condition. A greater percentage of Get Social condition participants rated participation as convenient (65% vs 44%; p = 0.001).

CONCLUSIONS

Results revealed a remotely-delivered asynchronous lifestyle intervention resulted in slightly less weight loss than an in-person version but may be more economical and convenient.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 .

摘要

目的

生活方式干预是有效的,但通过面对面小组会议进行的干预扩展性和覆盖面较差。需要开展研究以确定远程提供的生活方式干预是否不劣于面对面提供的生活方式干预。

方法

我们进行了一项随机非劣效性试验(N = 329),以比较通过在线社交网络远程异步提供的生活方式干预(社交组)和通过面对面小组提供的生活方式干预(传统组)。我们假设社交组在12个月时的平均体重减轻百分比不劣于传统组。其他结果包括每减轻一磅体重的干预成本和可接受性(如便利性、支持、方式偏好)。

结果

在12个月时,社交组和传统组之间的体重变化百分比没有显著差异(2.7%对3.7%,p = 0.17),然而,未达到非劣效性标准。社交组每减轻一磅体重的成本为21.45美元,而传统组为26.24美元。社交组中更高比例的参与者认为参与很方便(65%对44%;p = 0.0)。

结论

结果显示,远程异步提供的生活方式干预导致的体重减轻略少于面对面干预,但可能更经济、更方便。

试验注册

ClinicalTrials.gov NCT02646618;https://clinicaltrials.gov/ct2/show/NCT02646618 。

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