A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy Weight Gain, Eating Disorders, Perinatal Problems, Binge Eating, Craving

Intervention / Treatment
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* Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older Current residence in the United States Fluency in English Currently pregnant in the second trimester Experience of any food cravings Exclusion Criteria: None beyond not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy<br>* Participants in the intervention will learn acceptance-based strategies for reducing the adverse impact of food cravings on eating behaviors. Unlike control-based strategies, acceptance-based strategies do not attempt to change the content or frequency of thoughts; rather, they foster willingness to acknowledge and experience uncontrollable thoughts, urges, and emotions as what they are - nothing more, nothing less. Acceptance-based approaches have demonstrated efficacy in reducing the adverse impact of food cravings on eating behaviors in non-pregnant samples.<br>|
| No Intervention: Control<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prenatal Eating Behaviors Screening Tool | Eating disorder symptoms, including frequency of binge and loss-of-control eating | From study entry in 2nd trimester of pregnancy through delivery | 
| Gestational weight gain | Deviations from recommended gestational weight gain trajectories (in U.S. lbs) | From study entry in 2nd trimester of pregnancy through delivery | 
| Food Craving Questionnaire - Trait - Reduced | Frequency and intensity of food craving experiences | From study entry in 2nd trimester of pregnancy through delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Craving Acceptance and Action Questionnaire | Acceptance of and willingness to experience food cravings | Assessed at baseline and 1-month post-intervention | 
| Obsessive Compulsive Eating Scale | Intrusive thoughts and urges related to a craved target | Assessed at baseline and 1-month post-intervention | 
| White Bear Suppression Inventory | Thought suppression | Assessed at baseline and 1-month post-intervention | 
| Detail and Flexibility Questionnaire | Cognitive flexibility | Assessed at baseline and 1-month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational weight gain, loss of control eating, binge eating, food craving, mobile health intervention, single session intervention, Acceptance and Commitment Therapy