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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Craving; Binge Eating; Eating Disorders; Perinatal Problems; Pregnancy Weight Gain
• Intervention / Treatment: Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia M. Hormes, Ph.D.; Phone Number: 518-442-4911; Email: jhormes@albany.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: University at Albany
• Collaborators: Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 14, 2024
• Study Completion (Estimated): November 14, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; gestational weight gain; binge eating; food craving; single session intervention; loss of control eating; mobile health intervention
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Body Weight; Hyperphagia; Body Weight Changes; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 23E225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified and aggregate data may be made available to other researchers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No