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

Sponsor
University at Albany (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129461
Collaborator
Children's Hospital of Philadelphia (Other)
130
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 14, 2024
Anticipated Study Completion Date :
Nov 14, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Prenatal Eating Behaviors Screening Tool [From study entry in 2nd trimester of pregnancy through delivery]

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

  2. Gestational weight gain [From study entry in 2nd trimester of pregnancy through delivery]

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

  3. Food Craving Questionnaire - Trait - Reduced [From study entry in 2nd trimester of pregnancy through delivery]

    Frequency and intensity of food craving experiences

Secondary Outcome Measures

  1. Food Craving Acceptance and Action Questionnaire [Assessed at baseline and 1-month post-intervention]

    Acceptance of and willingness to experience food cravings

  2. Obsessive Compulsive Eating Scale [Assessed at baseline and 1-month post-intervention]

    Intrusive thoughts and urges related to a craved target

  3. White Bear Suppression Inventory [Assessed at baseline and 1-month post-intervention]

    Thought suppression

  4. Detail and Flexibility Questionnaire [Assessed at baseline and 1-month post-intervention]

    Cognitive flexibility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University at Albany
  • Children's Hospital of Philadelphia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julia Hormes, Associate Professor, University at Albany
ClinicalTrials.gov Identifier:
NCT06129461
Other Study ID Numbers:
  • 23E225
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julia Hormes, Associate Professor, University at Albany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023