Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals
Purpose
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.
Conditions
- Eating Disorders
- Body Dissatisfaction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pregnant Body Project (PBP) |
The Body Project is typically delivered as four 1-hour weekly sessions consisting of written, verbal, and behavioral exercises. The sessions aim to induce cognitive dissonance by encouraging participants to challenge the thin-ideal, a theoretically and empirically supported component of ED prevention. This adapted version of the Body Project (the Pregnant Body Project; PBP) consists of 6 1-hour, weekly group sessions delivered via Zoom. Since the target population consists of individuals with histories of an ED or disordered eating behaviors, PBP also includes elements from a treatment intervention (i.e., the Body Project Treatment 8.0 manual). PBP was adapted iteratively with a needs assessment, expert stakeholder input, and participant feedback following a mock trial with individuals with lived experience (i.e., individuals with histories of an ED who have given birth). This condition will be peer-delivered by facilitators with lived experience. |
|
|
Placebo Comparator Pregnancy Health Education (PHE) |
This time- dose- and attention- matched control condition accounts for the potential effects of time spent and support from group members and facilitators. Participants assigned to the PHE group will also be asked to attend 6, 1-hour, weekly group sessions via Zoom. During the sessions participants receive psychoeducation on body image and disordered eating during pregnancy but will not engage in any dissonance-inducing exercises. Participants will also receive lifestyle education specific to pregnancy (e.g., proper nutrition, sleep, physical activity), tied back to body image and disordered eating. |
|
Recruiting Locations
Boston, Massachusetts 02114
Rachel Vanderkruik, PhD, MSc
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
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. The investigators will aim to recruit N=60 pregnant individuals (in their first or second trimester) with histories of an ED. Both the intervention and active control consist of 6, weekly, 1-hour group sessions (6-8 participants per group) delivered over Zoom. There are four assessment points: pre-intervention, post-intervention, 3 months postpartum, and 6 months postpartum. Participants will complete online surveys at each assessment point and a post-intervention exit interview (active intervention only).