Contemporary clinical trials · 2025
The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Vanderkruik Rachel, Frisch Caroline M, Woodworth Emily C, Scharner Sophie, Bartels Stephen J, Freeman Marlene P, Cohen Lee S, Stice Eric
Аннотация
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.
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.