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

NCT06129461 | Unknown

• 1 other identifier: 23E225
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Weight Gain; Eating Disorders; Perinatal Problems; Binge Eating; Craving

Keywords

gestational weight gain; loss of control eating; binge eating; food craving; mobile health intervention; single session intervention; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Food Craving Acceptance and Action Questionnaire

  Assessed at baseline and 1-month post-intervention

• Obsessive Compulsive Eating Scale

  Assessed at baseline and 1-month post-intervention

• White Bear Suppression Inventory

  Assessed at baseline and 1-month post-intervention

• Detail and Flexibility Questionnaire

  Assessed at baseline and 1-month post-intervention

Study Arms (2)

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.

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

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)

Interventions

Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University at Albany: lead
• Children's Hospital of Philadelphia: collaborator

Related Publications (2)

• Costello K, Timko CA, Anderson D, Hormes JM. Validation of the intolerance of uncertainty scale-12 in a sample of pregnant people. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):363. doi: 10.1186/s12884-025-07434-1.

  PMID: 40148844 DERIVED

• Hormes JM, Timko CA. A clinical trial protocol of a single-session self-guided acceptance-based online intervention targeting food cravings as predictors of disordered eating in pregnant people. Contemp Clin Trials. 2024 May;140:107515. doi: 10.1016/j.cct.2024.107515. Epub 2024 Mar 26.

  PMID: 38537903 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Feeding and Eating Disorders; Bulimia

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Hyperphagia

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Julia M. Hormes, Ph.D.

CONTACT

518-442-4911; jhormes@albany.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 13, 2023
• Study Start: November 15, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11