NCT04550364

Brief Summary

MUMMIEBODIES is a research study when women with eating disorders encounter pregnancy, childbirth and postpartum. These are some condensed months that represent major challenges for this group. There are both a scientific and clinical basis for the mother's mental health to influence care and interaction with the child. In the case of eating disorders, there is also a risk of harmful consequences for the fetus as well as for more complicated pregnancies and births. This is a very important field of knowledge, but also a field about which there is far too little scientific knowledge. There is too little scientific knowledge about how women with eating disorders physically and mentally relate to their bodies and food during and after pregnancy. There is a great need for research that promotes expertise in how to help and meet women with eating disorders in these important phases of life. The aim of the study is to bring out the users' experiences. The investigators interview face-to-face pregnant women and mothers with eating disorders about their subjective experiences both during pregnancy and during childbirth. Recruitment of participants will be via health stations. The investigators will identify the course, experiences and solutions when women with eating disorders encounter pregnancy, childbirth and postpartum. The investigators focus on three themes: 1) experience of course and change, 2) experience of emotional, cognitive and relational core experiences, and 3) women's own perceptions of what is the best help. The three themes have in common that they are fundamental for later development of help for this vulnerable group. The investigators have a clear idea that some of the best preventive work can be done before life really starts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

August 24, 2020

Results QC Date

December 11, 2023

Last Update Submit

April 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)

    How do women with a history of eating disorders experience being pregnant? How do they understand and describe worsening and relapse and perceived triggers in such eventual changes? Delivery: Categorization, characterization, identification of possible dimensions and experiential descriptions of assumed critical, typical and atypical experiences. Ideal type analysis indicate seven different personal features associated with worsening or relapse: chaotic, rigid, perfect, worried, shameful, motherhood fearing and lost identity. Perceived triggers of worsening or relapse were: loss of control, unpredictability, competition, change of appearance, shame and nausea and loss of identity. All women included in the study reported DSM-5 diagnosis at time point 1.

    During pregnancy, Interview between week 9 and week 40.

  • Core Experiences Among 7 Women With a History of Severe Eating Disorders That Have Gone Through IVF-induced Pregnancy and Become Mothers. Time Point 1 and 2 for 7 Participants.

    How do women with a history of severe eating disorders who have undergone IVF experience the process of becoming a mother through IVF, pregnancy and the postpartum period? The two time points are summed together in core experiences from pregnancy to brith and after birth. There were four core phenomena that were reported that were strikingly similar across all participants: "anxiousness and fear", "Shame and guilt", "sexual aladjustment" and "Non-disclosure of eating problems".

    Two time points is summed together and included both. interview timepoints (interview between week 9 and week 40 during pregnancy and Postpartum, on average 4-6 months following birth).

  • Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder

    This study was based on interviews conducted with 24 participants during both pregnancy and postpartum. Additionaly, both diagnostic descriptions (DSM 5) and self-report (EDE-Q) were reported at both time points (Pregnancy and postpartum). How they experienced pregnancy and postpartum were summed up in five different trajectories. How do women with a history of severe ED experience their ED pathology during the process from pregnancy to postpartum? Is it possible to identify trajectories through pregnancy and early motherhood? Delivery: Empirically based hypothetical model for prototypical processes. Elements of Grounded theory were employed. Diagnosis (DSM-5) were summarized for both time points and symptoms (EDE-Q) were averaged from both time points.

    Through study completion, an average of 14 months. Both time points (During pregnancy between week 9 and 40. Postpartum, on average 4-6 months following birth) were summed up in five trajectories from pregnancy to postpartum.

Secondary Outcomes (1)

  • Eating Disorder Symptoms Reported Through Self Report EDE-Q.

    Mean scores collected during pregnancy and postpartum

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen experience of pregnancy and post partum period.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with eating disorders who are pregnant and in labor (the child's first year of life). In this round, we seek to identify different experiences one may have.

You may qualify if:

  • Woman
  • age between 20-40 years
  • Diagnostic diagnosis anorexia nervosa or bulimia nervosa
  • Must be pregnant
  • Must have been interviewed in pregnancy and be in labor/post partum.

You may not qualify if:

  • Ongoing psychosis
  • Drug addiction
  • Organic brain damage / disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Eating Disorders

Oslo, 0263, Norway

Location

MeSH Terms

Conditions

Mental DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Representative of women with ED. Past history of ED, including diangosis severity, as well as treatment history was self-reported with no verification with health records. Multi-diagnostic approach. The same person have conducted the semi-structured interview and EDE clinical interviews that might have influenced the respons or outcome of the diagnosis. Different interview points during pregnancy. Lack of corroborating information.

Results Point of Contact

Title
Psychologist and PhD Bente Sommerfeldt
Organization
Universoty of Oslo

Study Officials

  • INGELA LUNDIN KVALEM, PROFESSOR

    University of Oslo

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist in clinical psychology

Study Record Dates

First Submitted

August 24, 2020

First Posted

September 16, 2020

Study Start

May 20, 2020

Primary Completion

January 31, 2022

Study Completion

February 11, 2022

Last Updated

May 2, 2025

Results First Posted

May 2, 2025

Record last verified: 2025-04

Locations