Rachel Vanderkruik, Caroline M Frisch, Emily C Woodworth, Sophie Scharner, Stephen J Bartels, Marlene P Freeman, Lee S Cohen, Eric Stice
{"title":"孕妇体项目试点RCT方案:预防高危孕妇饮食失调行为。","authors":"Rachel Vanderkruik, Caroline M Frisch, Emily C Woodworth, Sophie Scharner, Stephen J Bartels, Marlene P Freeman, Lee S Cohen, Eric Stice","doi":"10.1016/j.cct.2025.108039","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Project status and discussion: </strong>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.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108039"},"PeriodicalIF":1.9000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals.\",\"authors\":\"Rachel Vanderkruik, Caroline M Frisch, Emily C Woodworth, Sophie Scharner, Stephen J Bartels, Marlene P Freeman, Lee S Cohen, Eric Stice\",\"doi\":\"10.1016/j.cct.2025.108039\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Project status and discussion: </strong>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.</p>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\" \",\"pages\":\"108039\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cct.2025.108039\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cct.2025.108039","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/31 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.
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.