Preventing Disordered Eating and Body Dissatisfaction Among High-risk Pregnant Individuals

NCT06659354 | Active Not Recruiting

• 1 other identifier: 2023P000630
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders; Body Dissatisfaction

Keywords

Eating Disorder; Body Dissatisfaction; Body Image; Pregnancy

Outcome Measures

Primary Outcomes (9)

• Feasibility of recruitment

  The investigators will consider the program feasible if the investigators meet recruitment targets (N=60).

  0 weeks

• Session attendance

  The investigators will assess what percentage of enrolled participants complete 4 or more sessions. The benchmark will be \> 50% of participants will complete 4 or more sessions.

  6 weeks

• Drop Out

  The investigators will assess what percentage of enrolled participants complete post-test assessments. The benchmark will be \> 50% of participants will complete the post-test surveys and interviews.

  6 weeks

• Client satisfaction questionnaire (CSQ-8)

  Assesses participants' satisfaction with the intervention. Scores range from 8 to 32 with higher scores indicating greater satisfaction. The benchmark will be that at least 70% of participants will have scores over and above the midpoint in both the PBP and PHE groups.

  6 weeks

• Credibility and Expectancy Questionnaire (CEQ)

  Assesses participants' perceptions that the treatment will work after learning about the study. The first three items measure credibility, and the latter three items measure expectancy. It is scored on a scale of 3-27 with higher scores indicating greater confidence in the treatment. The benchmark will be that at least 70% of participants will have scores over and above the midpoint in both the PBP and PHE groups.

  0 weeks

• Feasibility of data collection

  E.g.: The investigators will assess the feasibility of quantitative measures with the benchmark of no questionnaires fully missing in \>25% of participants

  Through the study completion, approximately 1 year depend on gestational at enrollment

• Adapted Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure

  Assesses acceptability, appropriateness, and feasibility of the intervention and Facilitators and Barriers to Participating. Acceptability, appropriateness, and feasibility subscales each consist of 4 items ranging from 1-5. Scores can be calculated by averaging the 4 items and range from 1-5. Higher scores indicate greater acceptability, appropriateness, and feasibility. The benchmark will be that at least 70% of participants will have scores over and above the midpoint for these subscales in both the PBP and PHE groups. Facilitators and Barriers to participating are open-ended questions and will be assessed with qualitative analyses.

  6 weeks

• Facilitator Adherence to Sessions

  The investigators will assess the percentage of sessions with ≥75% adherence. The benchmark will be ≥70% of sessions will have ≥75% adherence (checklist and audio recordings); 20% of sessions rated.

  Through the study completion, approximately 1 year depend on gestational at enrollment

• Participant Adherence to Homework

  The investigators will assess the percentage of participants that complete (i.e., upload/submit) ≥75% of the homework assignments. The benchmark will be ≥70% of participants will complete ≥75% of the homework assignments.

  6 weeks

Secondary Outcomes (14)

• Thin Ideal Internalization Scale

  0 weeks, 6 weeks, 3 months pp, 6 months pp

• Dutch Restrained Eating Scale

  0 weeks, 6 weeks, 3 months pp, 6 months pp

• The Satisfaction and Dissatisfaction with Body Parts Scale

  0 weeks, 6 weeks, 3 months pp, 6 months pp

• Body Image in Pregnancy Scale (BIPS)

  0 weeks, 6 weeks, 3 months pp, 6 months pp

• Eating Disorder Examination Questionnaire (EDEQ)

  0 weeks, 6 weeks, 3 months pp, 6 months pp

Study Arms (2)

Pregnant Body Project (PBP)

EXPERIMENTAL

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.

Behavioral: Pregnant Body Project (PBP)

Pregnancy Health Education (PHE)

PLACEBO COMPARATOR

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.

Behavioral: Pregnancy Health Education (PHE)

Interventions

Pregnant Body Project (PBP) BEHAVIORAL

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.

Pregnant Body Project (PBP)

Pregnancy Health Education (PHE) BEHAVIORAL

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.

Pregnancy Health Education (PHE)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Any birthing persons are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within the first or second trimester of pregnancy at enrollment
• 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

You may not qualify if:

• 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
• Do not have access to a device with a camera

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Vanderkruik R, Frisch CM, Woodworth EC, Scharner S, Bartels SJ, Freeman MP, Cohen LS, Stice E. The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals. Contemp Clin Trials. 2025 Sep;156:108039. doi: 10.1016/j.cct.2025.108039. Epub 2025 Jul 31.

  PMID: 40752822 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rachel Vanderkruik, PhD, MSc

  The Center for Women's Mental Health at Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research and Cognitive Behavioral Services

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 26, 2024
• Study Start: June 6, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)