Pregnant Body Project for Eating Disorders

Overseen By Rachel Vanderkruik, PhD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Bipolar, Psychotic disorder, Substance abuse, others

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program to assist pregnant individuals with a history of eating disorders or disordered eating behaviors. The program, called the Pregnant Body Project (PBP), aims to reduce the risk of disordered eating and body dissatisfaction during and after pregnancy. Participants will attend group sessions via Zoom, engaging in activities and discussions that challenge harmful body image ideals. Those in their first or second trimester with a history of eating disorders might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for pregnant individuals with similar experiences.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research tested the Pregnant Body Project (PBP) with pregnant individuals who have had eating disorders. These studies have shown that participants find the PBP manageable, with no serious side effects reported. The online sessions encourage participants to question and rethink harmful beauty standards. This method adapts from the well-known Body Project, which has been safe for many groups.

Peers with similar experiences lead the PBP, creating a supportive environment. Although no major safety issues have been reported, individual experiences may vary. Prospective participants should discuss any concerns with their healthcare provider before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Pregnant Body Project (PBP) is unique because it directly challenges the thin-ideal through cognitive dissonance, which isn't a focus in most existing treatments for eating disorders. This approach encourages participants to confront and rethink societal beauty standards, offering a fresh perspective not usually emphasized in traditional therapies. Moreover, PBP is peer-delivered, meaning facilitators with lived experience lead the sessions, providing relatable insights and support that can enhance participant engagement. Researchers are excited about PBP as it combines targeted dissonance exercises with elements from established treatment manuals, potentially offering a more comprehensive and empathetic approach to managing eating disorders during pregnancy.

What evidence suggests that this trial's treatments could be effective for reducing disordered eating and body dissatisfaction during pregnancy?

Research has shown that the Pregnant Body Project (PBP), a treatment arm in this trial, is a version of the Body Project, which effectively prevents eating disorders. The PBP targets pregnant individuals with a history of eating disorders. Early results suggest it reduces dissatisfaction with body image and the risk of eating disorders during pregnancy. The program includes group sessions where participants question unhealthy body standards. These sessions aim to create mental conflict when beliefs and actions don't align, effectively changing harmful eating habits. Overall, the PBP shows promise in promoting a healthier body image and eating habits during pregnancy. Meanwhile, the Pregnancy Health Education (PHE) arm serves as a control, offering psychoeducation on body image and disordered eating during pregnancy without dissonance-inducing exercises. ^{1 2 3 4 6}

Who Is on the Research Team?

Rachel Vanderkruik, PhD, MSc

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Acute fatty liver of pregnancy (AFLP) is a rare but serious condition that requires immediate medical attention, with early diagnosis and prompt delivery being crucial for the safety of both mother and baby.

Symptoms such as nausea, vomiting, abdominal pain, jaundice, and abnormal liver function tests during the third trimester should raise suspicion for AFLP, and mothers who have had this condition should be monitored closely in future pregnancies due to the risk of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acute fatty liver in pregnancy: treatment, prognosis, rules of management]. Przepieść, J., Redźko, S., Urban, J.[2017]

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]

A systematic review of seven qualitative studies involving women with eating disorders during pregnancy revealed that these women often experience significant inner turmoil, driven by fears about their body image, their child's health, and societal pressures.

Midwives and healthcare practitioners should be aware of the potential for eating disorders in pregnant women and provide appropriate support and resources to address their nutritional and psychological needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can qualitative studies tell us about the experiences of women who are pregnant that have an eating disorder? Tierney, S., McGlone, C., Furber, C.[2015]

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]

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]

Pregnancy can lead to unique liver disorders such as hyperemesis gravidarum and HELLP syndrome, which can significantly impact both maternal and fetal health, leading to serious complications.

Timely diagnosis and a multidisciplinary care approach involving various healthcare specialists are crucial for managing these liver disorders effectively and minimizing risks to both the mother and baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy-Associated Liver Diseases. Terrault, NA., Williamson, C.[2023]

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]

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]

Acute fatty liver of pregnancy (AFLP) is a serious condition characterized by liver dysfunction and microvesicular fatty infiltration occurring in pregnant women, typically in the third trimester or shortly after delivery.

The primary management strategy for AFLP involves prompt delivery of the baby and providing supportive care to the mother, as the exact cause of the condition remains unknown.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etiology and management of acute fatty liver of pregnancy. Snyder, RR., Hankins, GD.[2004]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425002332

The pregnant body project pilot RCT protocol: Preventing ... The Body Project was adapted to prevent disordered eating in pregnancy. •. This study is a pilot RCT of the peer-delivered Pregnant Body Project intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06659354

Preventing Disordered Eating and Body Dissatisfaction ... This adapted version of the Body Project (the Pregnant Body Project; PBP) consists of 6 1-hour, weekly group sessions delivered via Zoom. Since ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40752822/

The pregnant body project pilot RCT protocol: Preventing ... The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals · Authors · Affiliations.

4. withpower.com withpower.com/trial/phase-feeding-and-eating-disorders-5-2024-e7778

Pregnant Body Project for Eating Disorders The investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/26334895251319811

Application of implementation science frameworks ... We describe the process of adapting the Body Project, an evidence-based eating disorder (ED) prevention program, for pregnant individuals with histories of ...

6. researchgate.net researchgate.net/publication/394168434_The_pregnant_body_project_pilot_RCT_protocol_Preventing_disordered_eating_behaviors_in_high-risk_pregnant_individuals

The pregnant body project pilot RCT protocol: Preventing ... We describe the process of adapting the Body Project, an evidence-based eating disorder (ED) prevention program, for pregnant individuals ...