ClinicalTrials.gg
Status unknownNCT06129461Updated Nov 13, 2023

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

An interventional study of Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy in Pregnancy Weight Gain, Eating Disorders and Perinatal Problems, sponsored by University at Albany. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by University at Albany · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Gestational Weight Gain

123 studies on the registry are indexed under Gestational Weight Gain; 20 are open to participants now.

This study's planned enrollment of 130 is above the median of 108 across 103 interventional studies indexed under Gestational Weight Gain.

Browse Gestational Weight Gain studies →

Lead sponsor

University at Albany is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None beyond not meeting inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • BehavioralSingle-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.

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What researchers measure

Primary outcomes

  1. Prenatal Eating Behaviors Screening Tool

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

    Time frame: From study entry in 2nd trimester of pregnancy through delivery

  2. Gestational weight gain

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

    Time frame: From study entry in 2nd trimester of pregnancy through delivery

  3. Food Craving Questionnaire - Trait - Reduced

    Frequency and intensity of food craving experiences

    Time frame: From study entry in 2nd trimester of pregnancy through delivery

Secondary outcomes

  1. Food Craving Acceptance and Action Questionnaire

    Acceptance of and willingness to experience food cravings

    Time frame: Assessed at baseline and 1-month post-intervention

  2. Obsessive Compulsive Eating Scale

    Intrusive thoughts and urges related to a craved target

    Time frame: Assessed at baseline and 1-month post-intervention

  3. White Bear Suppression Inventory

    Thought suppression

    Time frame: Assessed at baseline and 1-month post-intervention

  4. Detail and Flexibility Questionnaire

    Cognitive flexibility

    Time frame: Assessed at baseline and 1-month post-intervention

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 40148844 ↗
  • 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. PubMed 38537903 ↗

Individual participant data

Plan to share: Undecided — Deidentified and aggregate data may be made available to other researchers upon reasonable request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06129461
Lead sponsor
University at Albany
Responsible party
Julia Hormes (Associate Professor, University at Albany) — Principal investigator
First posted
Nov 13, 2023
Start date
Nov 15, 2023 (estimated)
Primary completion
Nov 14, 2024 (estimated)
Completion
Nov 14, 2024 (estimated)
Last update
Nov 13, 2023

Study contacts

Julia M. Hormes, Ph.D.
Contact
jhormes@albany.edu
518-442-4911

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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