Pregnant Body Project for Eating Disorders

N/A

Recruiting

Led By Rachel Vanderkruik, PhD, MSc

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the intervention program completion, approximately 1 year

Summary

This trial will test a program called The Body Project, adapted for pregnancy, to see if it can help pregnant individuals with a history of eating disorders. The goal is to see if this program can reduce

Who is the study for?

This trial is for pregnant individuals who have a history of eating disorders. It's designed to see if a special program can help prevent disordered eating and negative body image during pregnancy and after giving birth.

What is being tested?

The study compares two programs: the Pregnant Body Project (PBP), which is adapted from an existing eating disorder prevention program, against Pregnancy Health Education (PHE). The goal is to see which one better reduces the risk of disordered eating.

What are the potential side effects?

Since this trial involves educational programs rather than medications, there are no typical drug side effects. Participants may experience emotional or psychological discomfort when discussing sensitive topics related to body image and eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the intervention program completion, approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the intervention program completion, approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the intervention program completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Client satisfaction questionnaire (CSQ-8)

Credibility and Expectancy Questionnaire (CEQ)

+6 more

Secondary study objectives

Body Image in Pregnancy Scale (BIPS)

Dutch Restrained Eating Scale

Eating Disorder Diagnostic Scale (EDDS)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pregnant Body Project (PBP)Experimental Treatment1 Intervention

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.

Group II: Pregnancy Health Education (PHE)Placebo Group1 Intervention

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.

0 / 1Eligibility criteria met