对减肥手术后患者饮食行为的正念和同情计划:两阶段临床试验方案

IF 1.6 Q2 MULTIDISCIPLINARY SCIENCES MethodsX Pub Date : 2024-08-09 DOI:10.1016/j.mex.2024.102885
Erika Blamires S. Porto , Jesus Montero-Marin , Luiz Gustavo Quadros , Jean Kristeller , Vicente Sarubbi Junior , Luis Augusto Mattar , Javier Garcia-Campayo , Marcelo Demarzo
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引用次数: 0

摘要

导言:减肥手术后的体重反弹仍是一个相关且令人担忧的话题,需要人们进一步了解并参与新辅助疗法的研究。本研究旨在比较 "正念健康促进 "项目和 "基于情感的同情疗法 "项目与常规治疗(工作坊)对巴西一家私人诊所减肥手术后体重逐渐增加的患者饮食行为的初步有效性和可行性。假设这两种干预措施都是可行的,而且自我同情项目可能比正念项目更有效。研究方法研究将分为两个阶段:对接受减肥手术的患者进行交叉分析研究;仅对体重反弹的患者进行随机对照试验。干预将同步进行八周,有三个评估点(基线、干预后和 6 个月随访),均在线进行。主要结果是饮食行为的改变。次要结果将包括生活质量的改善、身体形象满意度的提高和失真度的降低(巴西成人轮廓量表)、更好的体重管理(维持或减轻体重)、活动频率的增加以及手术团队的监督。此外,还将通过对参与者的子样本进行在线识别来收集定性数据。结果:预计饮食行为、体重、逆向渐进式体重增加、自我形象分类、生活质量以及正念、自我同情和焦虑水平都会有所改善。结论本研究旨在收集有关正念和同情训练对减肥后患者进行性体重增加的辅助治疗效果的初步证据。Clinical Trials.gov 注册编号:NCT04171713:NCT04171713。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Mindfulness and compassion-based programs on eating behavior of post-bariatric surgery patients: A two phased clinical trial protocol

Introduction: Weight regain after bariatric surgery remains a relevant and worrisome topic, requiring greater understanding and involvement in research into new adjuvant treatments. This study aims to compare the preliminary effectiveness and feasibility of the Mindfulness-Based Health Promotion and Attachment-Based Compassion Therapy programs as opposed to usual treatments (workshops) on the eating behavior of patients with progressive weight gain after bariatric surgery in Brazilian patients at a private clinic. It was hypothesized that both interventions are feasible and that the self-compassion program may be more effective than the mindfulness program. Methods: The study will be divided into two phases: a cross-analytical study of those who underwent bariatric surgery and a randomized controlled trial only with the ones who had weight regain. Interventions will be conducted for eight weeks synchronously with three assessment points (baseline, post intervention, and 6-month follow-up), both online. The primary outcome will be a change in eating behavior. Secondary outcomes will include improved quality of life, enhanced body image satisfaction and reduced distortion (Brazilian Silhouette Scales for adults), better weight management (maintenance or weight reduction), increased frequency of activity and monitoring with the surgery team. Qualitative data will also be collected by online identification of a sub-sample of participants. Results: Improvements are expected in eating behavior, weight, reverse progressive weight gain, classification of self-image, quality of life, and levels of mindfulness, self-compassion, and anxiety. Conclusion: This study seeks to gather preliminary evidence on the effectiveness of mindfulness and compassion training for the adjunctive treatment of progressive weight gain in post-bariatric patients.

Clinical Trials.gov Registration ID: NCT04171713.

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来源期刊
MethodsX
MethodsX Health Professions-Medical Laboratory Technology
CiteScore
3.60
自引率
5.30%
发文量
314
审稿时长
7 weeks
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