Clinical trial NCT06129461: A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy
Official title: A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University at Albany
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2023-11-13
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prenatal Eating Behaviors Screening Tool
timeFrame: From study entry in 2nd trimester of pregnancy through delivery
measure: Gestational weight gain
timeFrame: From study entry in 2nd trimester of pregnancy through delivery
measure: Food Craving Questionnaire - Trait - Reduced
timeFrame: From study entry in 2nd trimester of pregnancy through delivery
Secondary outcomes:
measure: Food Craving Acceptance and Action Questionnaire
timeFrame: Assessed at baseline and 1-month post-intervention
measure: Obsessive Compulsive Eating Scale
timeFrame: Assessed at baseline and 1-month post-intervention
measure: White Bear Suppression Inventory
timeFrame: Assessed at baseline and 1-month post-intervention
measure: Detail and Flexibility Questionnaire
timeFrame: Assessed at baseline and 1-month post-intervention
Other outcomes:
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