Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals (NCT06659354) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals
United States60 participantsStarted 2024-06-06
Plain-language summary
The investigators aim to conduct a feasibility randomized controlled trial (RCT) of an eating disorder prevention program (The Body Project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ED. The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Within the first or second trimester of pregnancy at enrollment
. 18 years or older
. Able to provide informed consent
. Endorse a self-reported history of an eating disorder or disordered eating behaviors
. Are willing and able to comply with all group and study procedures
. English fluency and literacy
Exclusion criteria
. A diagnosis of bipolar or psychotic disorder, active mania or psychosis or substance abuse, an active eating disorder (active eating disorder symptomology informed by the Screening, Brief Intervention, and Referral to Treatment for Eating Disorders (SBIRT-ED) tool and clinician discretion), being at immediate risk of self-harm
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of recruitment
Timeframe: 0 weeks
2
Session attendance
Timeframe: 6 weeks
3
Drop Out
Timeframe: 6 weeks
4
Client satisfaction questionnaire (CSQ-8)
Timeframe: 6 weeks
5
Credibility and Expectancy Questionnaire (CEQ)
Timeframe: 0 weeks
6
Feasibility of data collection
Timeframe: Through the study completion, approximately 1 year depend on gestational at enrollment
7
Adapted Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure