Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT05581095
Eligibility Criteria:
Inclusion Criteria:
* female (assigned sex at birth)
* able to read and write in English
* between the ages of 18-40
* lives in the United States
* between 13-16 weeks pregnant (gestation) with a singleton
* owns an iPhone or iPad
* reports engaging in recurrent binge eating (i.e., reporting engaging in at least 1 binge eating episode per week for the last 28 days according to the EDE-Qi)
* has access to a computer or tablet with Internet
* being regularly followed by a healthcare provider during their pregnancy
Exclusion Criteria:
* reports current smoking or substance abuse
* reports elevated depression (i.e., a score of 13 or higher on the EPDS)
* reports current suicidal ideation (assessed on the EPDS)
* reports anorexia, purging or compensatory behavior (both assessed on the EDE-Qi)
* reports a history of being hospitalized for mental health treatment in the last 6 months
* reports use of medications that are taken to affect appetite or metabolism (e.g., insulin)
* is currently in therapy for treating binge eating
* reports serious cardiovascular morbidity (e.g., hypertension)
* reports uncontrolled or untreated thyroid disease
* reports a history of 3 or more miscarriages, weakened cervix, or persistent bleeding during the first 12 weeks of pregnancy
* reports being unable to commit to participate fully in the 10-week program (i.e., read from the self-help book weekly, utilize the smartphone application daily, submit weekly logs of their experiences)
* individuals seeking a dieting approach to weight management during pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05581095
Study Brief:
Protocol Section:
NCT05581095