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基于接受和承诺疗法或自我调节的两种低强度减肥维持干预措施的随机对照试验研究方案。

Study protocol for a randomized controlled trial comparing two low-intensity weight loss maintenance interventions based on acceptance and commitment therapy or self-regulation.

机构信息

Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.

Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University/The Miriam Hospital Weight Control and Diabetes Research Center, Providence, RI, USA.

出版信息

Contemp Clin Trials. 2021 Apr;103:106327. doi: 10.1016/j.cct.2021.106327. Epub 2021 Feb 22.

Abstract

BACKGROUND

Weight regain is common following behavioral obesity treatment and attenuates many of the benefits of initial weight loss. This paper describes a randomized controlled trial that will evaluate the efficacy of two low-contact weight loss maintenance interventions based on Acceptance and Commitment Therapy (ACT) and self-regulation (SR). Potential mechanisms of action and moderators of treatment effects will also be evaluated.

METHODS

Adults (anticipated N = 480) with overweight or obesity will complete an initial 3-month online weight loss program (Phase 1). Participants who achieve ≥4 kg weight loss (anticipated N = 288) will then be randomized to an ACT or SR weight loss maintenance intervention. Both interventions will entail four 2.5 h, face-to-face, group-based workshop sessions and 6 months of email contact. Assessments will be conducted at phase 1 baseline, phase 1 completion/pre-randomization, and 6, 12, 18, 24, and 30 months post-randomization. The primary outcome will be weight change for the period from randomization to 30 months. Potential process measures including ACT-based constructs (e.g., psychological acceptance, values-consistent behavior), self-weighing frequency, and motivation will be also be assessed, as will potential moderators (e.g., initial weight loss).

CONCLUSIONS

This study will compare the efficacy of two intervention approaches (ACT and SR) delivered in a scalable workshop format for long-term weight loss maintenance. Future research could examine efficacy and cost-effectiveness of these approaches in real world settings.

摘要

背景

行为肥胖治疗后体重反弹很常见,这削弱了初始体重减轻带来的许多益处。本文描述了一项随机对照试验,该试验将评估基于接纳与承诺疗法(ACT)和自我调节(SR)的两种低接触减肥维持干预措施的疗效。还将评估潜在的作用机制和治疗效果的调节剂。

方法

超重或肥胖的成年人(预计 N=480)将完成为期 3 个月的在线减肥计划(第 1 阶段)。体重减轻≥4kg 的参与者(预计 N=288)将被随机分配到 ACT 或 SR 减肥维持干预组。这两种干预措施都将包括四次 2.5 小时的面对面小组基础工作坊会议,以及 6 个月的电子邮件联系。评估将在第 1 阶段基线、第 1 阶段完成/预随机分组、6、12、18、24 和 30 个月后进行。主要结局将是从随机分组到 30 个月的体重变化。还将评估潜在的过程指标,包括基于 ACT 的构念(例如,心理接纳、价值观一致的行为)、自我称重频率和动机,以及潜在的调节剂(例如初始体重减轻)。

结论

本研究将比较两种干预方法(ACT 和 SR)在可扩展的工作坊形式下进行长期减肥维持的疗效。未来的研究可以在实际环境中检验这些方法的疗效和成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9f9/9015891/3321ece109f9/nihms-1794937-f0001.jpg

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