Preventing disordered eating and body dissatisfaction in high-risk pregnant individuals
Targeting Health and Resilience for Individuals with a Vulnerable Eating History (THRIVE)
This study is testing a new online program to help pregnant people with a history of eating disorders feel better about their bodies and reduce unhealthy eating habits during and after pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06659354 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and preliminary effectiveness of an adapted eating disorder prevention program called The Body Project for pregnant individuals with a history of eating disorders. Participants will be randomly assigned to either the intervention group, which will receive six weekly group sessions via Zoom, or a health education control group. The study will assess outcomes at four points: before the intervention, immediately after, and at three and six months postpartum. The goal is to reduce the risk of disordered eating and body dissatisfaction during and after pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals in their first or second trimester with a self-reported history of eating disorders or disordered eating behaviors.
Not a fit: Patients with active eating disorders, severe mental health issues, or those without access to a device with a camera may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of disordered eating and improve body image among pregnant individuals at risk.
How similar studies have performed: Previous studies have shown success with similar prevention programs for eating disorders, indicating potential for this adapted approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Within the first or second trimester of pregnancy at enrollment 2. 18 years or older 3. Able to provide informed consent 4. Endorse a self-reported history of an eating disorder or disordered eating behaviors 5. Are willing and able to comply with all group and study procedures 6. English fluency and literacy Exclusion Criteria: 1. 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 2. Do not have access to a device with a camera
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Vanderkruik, PhD, MSc — The Center for Women's Mental Health at Massachusetts General Hospital
- Study coordinator: Rachel Vanderkruik, PhD, MSc
- Email: rvanderkruik@mgh.harvard.edu
- Phone: 781-691-9071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.