孕妇体项目试点RCT方案:预防高危孕妇饮食失调行为。

IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Contemporary clinical trials Pub Date : 2025-09-01 Epub Date: 2025-07-31 DOI:10.1016/j.cct.2025.108039
Rachel Vanderkruik, Caroline M Frisch, Emily C Woodworth, Sophie Scharner, Stephen J Bartels, Marlene P Freeman, Lee S Cohen, Eric Stice
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引用次数: 0

摘要

简介:怀孕和产后(即围产期)可能会引发对身体的不满和饮食失调。对于减少这种增加的风险以减少对围产期个体及其后代的负面影响的有效方法所知甚少。为了满足这一需求,我们正在测试一项针对有饮食失调史的孕妇的基于证据的饮食失调预防计划的可行性。本文的目的是描述一个独特的试点随机对照试验(RCT)的方案和状态。方法:我们正在进行一项基于群体、同伴交付的饮食失调预防项目(妊娠体项目;PBP)与剂量和时间匹配的教育对照相比。该研究将评估参与者在治疗和控制条件下的经验,以及领导PBP项目的同伴促进者。参与者将完成定量和定性评估,以衡量干预的可行性、可接受性、依从性、饮食失调症状、身体不满和心理健康。项目现状及讨论:截至2025年3月,数据收集正在进行中,我们的目标是招募N = 共60人。为了解决一个关键的公共卫生问题,需要制定一个计划,以减轻怀孕期间和产后饮食行为失调和对身体不满的风险增加。如果PBP方案和控制条件达到可行性和可接受性基准,我们将进行后续的PBP方案与健康教育控制的全功率有效性试验。临床试验NCT06659354。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals.

Introduction: Pregnancy and the postpartum (i.e., the perinatal period) can be a trigger for body dissatisfaction and disordered eating. Little is known about effective approaches to mitigate this increased risk and reduce the potential negative impact on perinatal individuals and their offspring. To begin addressing this need, we are testing the feasibility of an adapted evidence-based eating disorder prevention program for pregnant individuals with a history of disordered eating. The purpose of this paper is to describe the protocol of a unique pilot randomized controlled trial (RCT).

Methods: We are conducting a single-blind feasibility RCT of a group-based, peer-delivered eating disorder prevention program (Pregnancy Body Project; PBP) compared to a dose- and time-matched educational control. The study will assess the experiences of participants in the treatment and control conditions as well as the peer-facilitators leading the PBP program. Participants will complete quantitative and qualitative assessments to measure feasibility, acceptability, adherence to the intervention, eating disorder symptomology, body dissatisfaction, and mental health.

Project status and discussion: Data collection is in process as of March 2025 and we aim to recruit N = 60 total. A program to mitigate the increased risk of disordered eating behaviors and body dissatisfaction during pregnancy and postpartum is needed to address a critical public health issue. If the PBP program and control condition meet feasibility and acceptability benchmarks, we will pursue a subsequent, fully powered effectiveness trial of the PBP program vs the health education control. Clinical Trials NCT06659354.

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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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