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临床试验/NCT06129461
NCT06129461Unknown不适用

A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People

University at Albany0 个研究点目标入组 130 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
130
主要终点
Gestational weight gain

研究概览

简要总结

Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in those engaged in binge and loss of control eating. This study will explore the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings as powerful and modifiable predictors of binge and LOC eating in pregnancy.

详细描述

Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to a range of adverse health outcomes in pregnancy, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater rates of deviation from recommended weight gain trajectories, especially in those engaged in binge and loss of control eating. Food cravings are powerful triggers of binge and loss of control eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors and greater weight gain in pregnancy as well. This study builds on preliminary evidence to suggest that acceptance-based approaches are effective in reducing the adverse impacts of cravings on behavior by exploring the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants as predictors of maladaptive eating behaviors and deviations from recommended gestational weight gain trajectories.

The efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants will be examined in a randomized controlled trial. Pregnant individuals in the second trimester (n = 130) who endorse current cravings will be randomly assigned to the intervention or an untreated control group. The intervention group will participate in a single-session, self-guided online workshop imparting skills grounded in Acceptance and Commitment Therapy, including acceptance, defusion, and present-moment awareness. Both groups will complete comprehensive assessments at baseline, one-month follow-up, and at full-term. The results of this initial efficacy trial will inform the integration of acceptance-based self-guided health coaching targeting food cravings into routine prenatal care to prevent adverse outcomes associated with disordered eating behaviors in pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age 18 and older
  • •Current residence in the United States
  • •Fluency in English
  • •Currently pregnant in the second trimester
  • •Experience of any food cravings

排除标准

  • •None beyond not meeting inclusion criteria

研究组 & 干预措施

Treatment

Experimental

The intervention group will participate in a single-session, self-guided online intervention imparting skills grounded in Acceptance and Commitment Therapy. The one-hour workshop guides participants through evidence-based exercises, brief video clips, and reflection activities designed to clarify values and teach skills to foster acceptance, defusion, and present-moment awareness.

干预措施: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy (Behavioral)

Control

No Intervention

Participants in the control group will not receive any intervention; they will complete assessments on the same schedule as the intervention group (baseline, 1 month, at full term)

结局指标

主要结局

Gestational weight gain

时间窗: From study entry in 2nd trimester of pregnancy through delivery

Deviations from recommended gestational weight gain trajectories (in U.S. lbs)

Prenatal Eating Behaviors Screening Tool

时间窗: From study entry in 2nd trimester of pregnancy through delivery

Eating disorder symptoms, including frequency of binge and loss-of-control eating

Food Craving Questionnaire - Trait - Reduced

时间窗: From study entry in 2nd trimester of pregnancy through delivery

Frequency and intensity of food craving experiences

次要结局

  • Obsessive Compulsive Eating Scale(Assessed at baseline and 1-month post-intervention)
  • White Bear Suppression Inventory(Assessed at baseline and 1-month post-intervention)
  • Food Craving Acceptance and Action Questionnaire(Assessed at baseline and 1-month post-intervention)
  • Detail and Flexibility Questionnaire(Assessed at baseline and 1-month post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Hormes

Associate Professor

University at Albany

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