Pregnant Body Project for Eating Disorders

Overseen By Rachel Vanderkruik, PhD, MSc

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Bipolar, Psychotic disorder, Substance abuse, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Pregnant Body Project for Eating Disorders treatment?

The research suggests that pregnancy can sometimes lead to a natural improvement in eating disorder symptoms, as some women experience remission during this period. Additionally, early detection and a multidisciplinary approach, including nutritional support and therapy, are recommended to prevent adverse outcomes for both mother and baby. ^{1 2 3 4 5}

What makes the Pregnant Body Project treatment unique for eating disorders during pregnancy?

The Pregnant Body Project is unique because it is specifically adapted for pregnant women, focusing on body image and eating disorders during pregnancy, a time when body changes can be particularly challenging. Unlike other treatments, it is tailored to address the psychological and emotional aspects of body image in the context of pregnancy, which is not typically the focus of standard eating disorder treatments. ^{6 7 8 9 10}

Research Team

Rachel Vanderkruik, PhD, MSc

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

Within the first or second trimester of pregnancy at enrollment

Able to provide informed consent

Willing and able to comply with all group and study procedures

Exclusion Criteria

Diagnosis of bipolar or psychotic disorder, active mania or psychosis, substance abuse, or an active eating disorder

Immediate risk of self-harm

Lack access to a device with a camera

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in 6 weekly 1-hour group sessions via Zoom, focusing on either the Pregnant Body Project or Pregnancy Health Education

6 weeks

6 visits (virtual)

Post-intervention Assessment

Participants complete online surveys and a post-intervention exit interview

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months postpartum

6 months

2 visits (virtual)

Treatment Details

Interventions

• Pregnancy Health Education (PHE) (Behavioral Intervention)
• Pregnant Body Project (PBP) (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Pregnant Body Project (PBP) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Pregnant women are at a higher risk for eating disorders (EDs), which can lead to negative outcomes for both the mother and infant, highlighting the urgent need for effective screening methods.

Currently, there is no validated screening tool specifically for detecting EDs in pregnant women, and more research is needed to determine the best approaches for identifying these disorders during pregnancy, including the potential use of general mental health screeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening instruments for eating disorders in pregnancy: Current evidence, challenges, and future directions. Dörsam, AF., Bye, A., Graf, J., et al.[2022]

Women with eating disorders (EDs) are at a higher risk for adverse obstetric outcomes such as vomiting, hyperemesis, bleeding, and anemia, as well as perinatal depression, highlighting the need for careful monitoring during pregnancy.

Maternal anorexia nervosa and bulimia nervosa are linked to low birth weight and slow fetal growth, while binge eating disorders are associated with increased birth weight, indicating that different types of EDs can have varying effects on pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorders are associated with adverse obstetric and perinatal outcomes: a systematic review. das Neves, MC., Teixeira, AA., Garcia, FM., et al.[2022]

Eating disorders in pregnant women can lead to serious adverse outcomes such as miscarriage, preterm delivery, and poor fetal growth, primarily due to factors like maternal malnutrition and low pre-pregnancy body mass index.

Early detection and a multidisciplinary approach, including nutritional support and psychotherapy, are crucial for preventing long-term health issues for both the mother and the baby, highlighting the need for more research on effective interventions during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating Disorders During Gestation: Implications for Mother's Health, Fetal Outcomes, and Epigenetic Changes. Sebastiani, G., Andreu-Fernández, V., Herranz Barbero, A., et al.[2020]

Eating disorders during pregnancy can lead to serious risks for both the mother and child, but some women experience a remission of symptoms such as restrictive dieting and binging during this time.

The case report of five women highlights the importance of understanding the psychological, social, and hormonal factors that may contribute to symptom remission and relapse, emphasizing the need for healthcare professionals to be vigilant in identifying at-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remission of eating disorder during pregnancy: five cases and brief clinical review. Madsen, IR., Hørder, K., Støving, RK.[2015]

Early diagnosis and prompt treatment of acute fatty liver of pregnancy (AFLP) are crucial for improving outcomes for both mothers and their babies.

Intensive management of AFLP is essential to ensure the best possible health results during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute fatty liver of pregnancy. Obritsch, JM., Cardwell, MS.[2005]

Pregnancy alters liver function tests, making it crucial to understand different reference ranges to identify liver disorders, as conditions like primary biliary cirrhosis may become symptomatic during this time.

Certain liver disorders specific to pregnancy, such as acute fatty liver of pregnancy and obstetric cholestasis, require careful diagnosis and management to ensure the safety of both the mother and baby, as they can lead to serious health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver disease in pregnancy. Mackillop, L., Williamson, C.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Screening instruments for eating disorders in pregnancy: Current evidence, challenges, and future directions. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

What can qualitative studies tell us about the experiences of women who are pregnant that have an eating disorder? [2015]

3. Brazil pubmed.ncbi.nlm.nih.gov

Eating disorders are associated with adverse obstetric and perinatal outcomes: a systematic review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Eating Disorders During Gestation: Implications for Mother's Health, Fetal Outcomes, and Epigenetic Changes. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Remission of eating disorder during pregnancy: five cases and brief clinical review. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Pregnancy-Associated Liver Diseases. [2023]

7. Poland pubmed.ncbi.nlm.nih.gov

[Acute fatty liver in pregnancy: treatment, prognosis, rules of management]. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Acute fatty liver of pregnancy. [2005]

9. United States pubmed.ncbi.nlm.nih.gov

Etiology and management of acute fatty liver of pregnancy. [2004]

10. England pubmed.ncbi.nlm.nih.gov

Liver disease in pregnancy. [2022]