Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04550364 |
| Other study ID # |
MUMMIEBODIES |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2020 |
| Est. completion date |
February 11, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
University of Oslo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The epistemological approach is empirical realism (not constructivist) where the
investigators assume that experiences are real and that the informants is an expert on her
own experience. The strategy is to utilize the informant's experience as a source of
knowledge. The point of view is the informants's, where the investigators try to formulate,
categorize, characterize and analyze dimensions in eating problems in the face of pregnancy
and childbirth as the informants sees it.
There are three reasons for this choice: (1) The woman's experience is an underused source of
knowledge in this area. (2) Therapeutic and indicated preventive measures are dependent on an
alliance with the woman. Alliance formation is normally based on the woman's experience. (3)
The woman's subjective presentation of the course may deviate from what an external observer
would have reported. The measures the women themselves launch may run counter to what
research and experienced clinicians recommend. But objective measures that neglect the user's
own experience are unlikely to have a particularly lasting effect.
The issues require two qualitative research designs. For the first problem, the investigators
will use the method Grounded Theory (25, 26) because the purpose is to model processes.
Grounded Theory is a method for developing concepts and theoretical understandings that are
rooted in data through theoretical sampling, identification of similarities and differences
between categories, open coding and focused coding. The aim is to construct a theoretical
model for characteristic processes, anchored in empirical data from informants in the study.
For the other two issues, the method Interpretative Phenomenological Analysis (IPA) will be
used. IPA is a qualitative research method that is particularly suitable for psychological
topics (27). The aim of IPA is to analyze and systematize the informants' experience and
understanding of a phenomenon. Through this method, overall meaningful themes can be
identified. At the same time, one can bring out nuances and variation in the material and
look for any dimensions in the experiences.
Informants. The investigators will use a heterogeneous sample. This has several causes. We
currently know too little scientific to identify one scientifically and clinically
interesting homogeneous group. Our clinical experience indicates that there can be great
variation between different women in this life situation. In this round, the investigators
seek to identify different experiences one may have. Varied diagnoses have been chosen
because the investigators want to describe different courses, because these diagnoses are
often unstable, and because the investigators want to identify possible measures with
different experiences and courses. Such diversity has great clinical relevance and has not
been previously described scientifically. In practice, it facilitates the recruitment of
informants. A disadvantage of using a heterogeneous sample is that each individual informant
becomes relatively important. This is a small problem as long as the purpose is to identify
different experiences. The limitation lies in the cases where a supposedly important
experience is described in only one or very few informants and at the same time there is
basically little depth and nuance in the descriptions. This is compensated to some extent by
very high demands on the quality of the way the investigators interview the informants. The
investigators define the group of informants in pregnancy and follow longitudinally with two
measurement times: in pregnancy and after birth.
The number of informants for problem 1 will be determined on the basis of a saturation
criterion where we include informants until after at least ten interviews, three subsequent
interviews follow which do not add anything significantly new to the answer to the problems
(30). Based on previous experience with similar surveys, the number of informants for each
issue is expected to be somewhere around 20 informants, ie about 40 informants. From these, a
strategic choice will be made on issues 2 and 3. Strategic choice can mean looking for
differences in order to obtain different prototype experiences. Recruitment of informants
will take place continuously from the start of the project via a network.The project period
has been extended to four years to get a sufficient number of informants.
Before further inclusion in the study, eating disorders are mapped with a revised version of
the Eating Disorders Examination Questionnaire, EDE-Q adapted to pregnant women and women
immediately after birth (16). The form is scored by the research fellow before further
inclusion. EDE-Q is a self-completion form based on the "Eating Disorder Examination" (EDE)
interview. EDE-Q measures the core symptoms of eating disorders. EDE-Q adapted to pregnant
women and women immediately after birth is based on factor analysis. If the informant
satisfies diagnostic criteria for a cut-off equivalent to ≥ 2.8 for an eating disorder, we
will conduct a researcher-based interview, Eating Disorder Examination (EDE), for diagnosing
the informant, and obtain standard background information. EDE is designed to assess the
current condition, as well as to generate an operationalized defined eating disorder
diagnosis. The interview is conducted after the experience interview.
The informants' background will be thoroughly documented. Background information will include
data on age, gender, diagnosis, type of eating disorder, weight before, during and after
pregnancy, onset of illness, first contact with the support system, relationships, first-time
or multiple births. Background information is filled in by interviewer after the experience
interview.
Information about the issues is collected through a semi-structured, interactive face-to-face
interview. The aim of the interviews is to get descriptions as precise and close to the
participants' own experiences as possible. A semi-structured interview guide is designed in
advance. The Interview Guide is developed in close collaboration with user representatives in
the reference group and ensures that relevant input from the reference group is covered in
the interview. The interview guide contains all the topics we want the interview to cover in
advance. The interview guide is primarily a thematic guide and aims to prepare interviews as
an instrument. It is also used as a summary and checklist for interviews at the end of the
interview to ensure that all relevant topics are touched upon. The informants are thoroughly
informed in advance about what the interview will be about and why, and how it will proceed.
The better informed the informant is in advance, the better founded the voluntary
participation. The actual interview takes the form of improvisation on the topics as it is
natural from the dynamics that develop in the conversation. The informant can introduce their
own relevant topics independently of the interview guide. The supervisors have published a
double-digit number of scientific articles and trained thousands of clinicians and
researchers with this method, which is informally called the "Experience Interview" developed
by Arne Holte (19, 21-23). The interviews are quality assured by a professional who is not
directly involved, continuously listening through randomly selected sections of randomly
selected interviews and providing guiding comments. The purpose of this is to ensure that
consistency and validity in the interview format is maintained.
Data analysis. All interviews are transcribed verbatim, stored, organized, coded and analyzed
in the electronic software NVivo version 11. Data for problem 1 will be analyzed according to
the Grounded Theory method (25, 26). The analysis involves eight phases such as categories,
theoretical sampling, identification of similarities and differences between categories, open
coding, focused coding, negative case analysis, theoretical sensitivity, theoretical
sampling, theoretical saturation, memo writing. The analysis will be regularly discussed in
the research group and continuously monitored by the main supervisor to ensure reliability
and credibility. Data for issues 2 and 3 will be analyzed according to the IPA method (27).
Repeated listening and reading of each interview is carried out to get an overview and
context. Each text is then explored using open thematic coding according to the "bottom-up
principle". Each interview is divided into text excerpts that are given a definition based on
the content of meaning and distributed in a tree structure. The definitions of potential
constructions are finally tested against the text by confirmation and selective coding
according to the "top-down principle".
Validation of the results will take place through focus group interviews with informants from
the survey with varying stories. The number and selection of focus group participants depends
on the results. The participants will be briefly presented in advance with the most important
results in writing. The results will then be presented orally to the group. The group will be
asked to comment on the presentations. The purpose is to investigate whether the informants
recognize their experiences as they have been analyzed, presented and illustrated, and
possibly adjust and correct this. We make audio recordings of the focus group interview so
that a person who is not directly involved in the project will listen through and check the
conclusions the research fellow makes from the focus group interview.
Procedure. The informants will be asked orally and in writing for consent to participate as
described above: EDE-Q, EDE interview, "Experience interview" with audio recording, summary
check according to interview guide and background information. Based on previous experience,
the experience interview is expected to take 90-120 minutes. Total time spent per informant
is calculated for a total of 140-180 minutes of interview hours (EDE interview, experience
interview and background interview). The text is printed verbatim and stored electronically
in NVivo 11. Audio recordings are deleted immediately after electronic storage. The
electronically stored text is deidentified so that names and other clear characteristics
cannot be recognized. After the data has been analyzed and before the completion of articles,
validation is carried out using focus group methodology. All data is deleted when the survey
is completed in accordance with the agreement with REK.
