Trial Outcomes & Findings for MUMMIBODIES. Eating Disorders, Pregnancy and Post Partum Period. (NCT NCT04550364)
NCT ID: NCT04550364
Last Updated: 2025-05-02
Results Overview
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.
COMPLETED
24 participants
During pregnancy, Interview between week 9 and week 40.
2025-05-02
Participant Flow
Through study completion, an average on 14 months from the first time point in pregnancy and to the last time point in postpartum, located at clinic in Oslo
Participant milestones
| Measure |
Pregnant Women With a History of Eating Disorder
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Timepoint 1 Pregnancy
STARTED
|
24
|
|
Timepoint 1 Pregnancy
COMPLETED
|
24
|
|
Timepoint 1 Pregnancy
NOT COMPLETED
|
0
|
|
TImepoint 2: Postpartum
STARTED
|
24
|
|
TImepoint 2: Postpartum
COMPLETED
|
24
|
|
TImepoint 2: Postpartum
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MUMMIBODIES. Eating Disorders, Pregnancy and Post Partum Period.
Baseline characteristics by cohort
| Measure |
Pregnant Women With a History of Eating Disorder
n=24 Participants
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Self-reported history of eating disorder for anorekxia nervosa, bulimia nervosa, unspecified disorde
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During pregnancy, Interview between week 9 and week 40.Population: Number of Participants with each type of personal features associated with worsening or relapse of symptoms during pregnancy
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.
Outcome measures
| Measure |
Pregnant Women With a History of Eating Disorder
n=23 Participants
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
The chaotic mother
|
5 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
The rigid mother
|
3 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
the perfect mother to be
|
3 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
The worried mother
|
4 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
the shameful mother
|
4 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
The mother who fears motherhood
|
3 participants
|
|
Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1)
The mother with the lost identity
|
6 participants
|
PRIMARY outcome
Timeframe: 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).Population: IVF indcued pregnancy Anorexia nervosa
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".
Outcome measures
| Measure |
Pregnant Women With a History of Eating Disorder
n=7 Participants
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
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.
Anxiousness and fear
|
7 participants
|
|
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.
Shame and guilt
|
7 participants
|
|
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.
Sexual maladjustment
|
7 participants
|
|
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.
Non-disclosure of eating problems
|
7 participants
|
PRIMARY outcome
Timeframe: 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.Population: Eating disorder symptoms measured by EDE-Q and through EDE (DSM-5 diagnosis) in both pregnancy (Time point 1) and postpartum (Time point 2). Symptoms were averaged for all 24 women at both time points. Diagnosis were calcualted at both time pointswith diagnostic interview DSM 5 and EDE questionnaire for eating disorder symptoms
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.
Outcome measures
| Measure |
Pregnant Women With a History of Eating Disorder
n=24 Participants
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder
The succeeding mother
|
4 participants
|
|
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder
The inadequate. mother
|
7 participants
|
|
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder
The depressed mother
|
10 participants
|
|
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder
The overwhelmed mother
|
6 participants
|
|
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder
The mastering mother
|
3 participants
|
SECONDARY outcome
Timeframe: Mean scores collected during pregnancy and postpartumPopulation: The same group of women with a history of self-reported ED participating at two time points: During pregnancy and 6 months after birth. Scores on ED symptoms at both time points for descriptions of the participants.
EDE-Q is a self-report measures to screen for eating disorders. Clinical cutoff scores for self-report measures on EDE-Q provide a means of evaluating clinically significant pathology. A cutoff above 2.7 on the total score has been recommended to screen for eating disorders. Higher values represent higher symptoms. The total score is a average on the four subscales. To obtain a score on each subscale, the items that fall under the individual subscale are added and the sum is divided by the number of items. To obtain the total score, the 4 subscale scores are summed and the total is divided by 4 (number of scales). Minimum score: 0. No symptoms reported. Maximum: 6. Higher values represent higher symptom pressure. Mean score on the total score is reported on all 24 participants.
Outcome measures
| Measure |
Pregnant Women With a History of Eating Disorder
n=24 Participants
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Eating Disorder Symptoms Reported Through Self Report EDE-Q.
EDE-Q mean score time point 1 during pregnancy
|
3.54 score on a scale.
Interval 1.5 to 5.1
|
|
Eating Disorder Symptoms Reported Through Self Report EDE-Q.
EDE-Q mean score. time point 2. postpartum. Above 2.7 ED diagnosis.
|
3.41 score on a scale.
Interval 0.25 to 5.5
|
Adverse Events
Pregnant Women With a History of Eating Disorder
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregnant Women With a History of Eating Disorder
n=24 participants at risk
Inclusion criteria: Self-reported history of eating disorder Been in treatment for diagnosed ED within the past ten years Pregnant at the time of the first interview
Exclusion criteria: psychotic symptoms
|
|---|---|
|
Psychiatric disorders
Use of contingency plan
|
12.5%
3/24 • Number of events 3 • 14 months. Two time points for each participant: During pregnancy and between 4-6 months after birth. From two to one group of participants that were interviewed at two time points: Pregnancy and postpartum. There were sufficint pregnant women that were recruited, and this made it possible to follow the same group of women longitudinal. No one were recrutied to the other group at this time.
There were mad a contingency plan for all 24 participants in case of needed specialized from pregnancy to after birth at the two time points.
|
Additional Information
Psychologist and PhD Bente Sommerfeldt
Universoty of Oslo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place