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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06129461
Enrollment
130
Registered
2023-11-13
Start date
2023-11-15
Completion date
2024-11-14
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

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.

Sponsors

Children's Hospital of Philadelphia
CollaboratorOTHER
University at Albany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Prenatal Eating Behaviors Screening ToolFrom study entry in 2nd trimester of pregnancy through deliveryEating disorder symptoms, including frequency of binge and loss-of-control eating
Gestational weight gainFrom study entry in 2nd trimester of pregnancy through deliveryDeviations from recommended gestational weight gain trajectories (in U.S. lbs)
Food Craving Questionnaire - Trait - ReducedFrom study entry in 2nd trimester of pregnancy through deliveryFrequency and intensity of food craving experiences

Secondary

MeasureTime frameDescription
Food Craving Acceptance and Action QuestionnaireAssessed at baseline and 1-month post-interventionAcceptance of and willingness to experience food cravings
Detail and Flexibility QuestionnaireAssessed at baseline and 1-month post-interventionCognitive flexibility
Obsessive Compulsive Eating ScaleAssessed at baseline and 1-month post-interventionIntrusive thoughts and urges related to a craved target
White Bear Suppression InventoryAssessed at baseline and 1-month post-interventionThought suppression

Contacts

Primary ContactJulia M. Hormes, Ph.D.
jhormes@albany.edu518-442-4911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026