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

Eating Disorders Clinical Trial

Official title:

A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06129461
• Other study ID #: 23E225
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 14, 2024

Study information

• Verified date: November 2023
• Source: University at Albany
• Contact: Julia M. Hormes, Ph.D.
• Phone: 518-442-4911
• Email: jhormes[@]albany.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: November 14, 2024
• Est. primary completion date: November 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Craving
• Eating Disorders
• Feeding and Eating Disorders
• Gestational Weight Gain
• Perinatal Problems
• Pregnancy Weight Gain
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University at Albany	Children's Hospital of Philadelphia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gestational weight gain	Deviations from recommended gestational weight gain trajectories (in U.S. lbs)	From study entry in 2nd trimester of pregnancy through delivery
Primary	Food Craving Questionnaire - Trait - Reduced	Frequency and intensity of food craving experiences	From study entry in 2nd trimester of pregnancy through delivery
Secondary	Food Craving Acceptance and Action Questionnaire	Acceptance of and willingness to experience food cravings	Assessed at baseline and 1-month post-intervention
Secondary	Obsessive Compulsive Eating Scale	Intrusive thoughts and urges related to a craved target	Assessed at baseline and 1-month post-intervention
Secondary	White Bear Suppression Inventory	Thought suppression	Assessed at baseline and 1-month post-intervention
Secondary	Detail and Flexibility Questionnaire	Cognitive flexibility	Assessed at baseline and 1-month post-intervention