Trial document




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  DRKS00017541

Trial Description

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Title

MONA-Study
(Motherhood, Nutrition & Attachment)

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Trial Acronym

MONA-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Eating disorders particularly affect women of reproductive age. The term "Pregorexia" refers to the coincidence of pregnancy with a maternal (anorexic) eating disorder. Malnutrition during pregnancy has health and psychological effects on mother and child. Newborns are already born underweight as risk children, and there is also a risk that mothers with eating disorders will transfer their symptoms to their newborns. The few available studies show extreme problems in the mother-child interaction, since the mother controls the child's behavior strongly and has a critical attitude towards the child. A past eating disorder can also be triggered by the loss of control over the natural expansion of the body and cause symptoms that are detrimental to the mother-child relationship. Particularly in the German-speaking area, the risks of a maternal eating disorder have hardly been researched; there are almost no findings on the effects on the relationship between mother and child - it is conceivable, however, that the eating disorder influences the mother in her interaction and in the development of the relationship with the baby.

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Brief Summary in Scientific Language

Eating disorders particularly affect women in reproductive age; malnutrition during pregnancy is associated with negative health and psychological outcomes for mother and child (Langer & Wimmer-Puchinger, 2009). Underweight newborns start their lives as high-risk children, and the risk that mothers with eating disorders will transfer their symptoms to their newborns is given (Langer & Wimmer-Puchinger, 2009). The few available studies show extreme problems in the mother-child interaction since the mother controls the child's behaviour strongly and has a critical attitude towards the child (Stein, 2006). A past eating disorder can also be triggered through the loss of weight control during pregnancy and can cause symptoms that are detrimental to the mother-child relationship (Stewart, Raskin, Garfinkel, MacDonald, & Robinson, 1987).

Particularly in German-speaking countries, the risks of a maternal eating disorder have been neglected in research and little is known about the effects on the relationship between mother and child. However, it is possible that the symptoms of an eating disorder impair the sensitivity of the mother in the interaction with her child.

Potential study participants are recruited in cooperation with registered psychotherapist, counselling centres, midwives, gynaecologists, the Psychosomatic Day Clinic of the SALK, the University Clinic for Gynaecology and Gynaecology. If the informed consent is given, the eating behaviour of the mother (via the EDE-Q), the mentalisation ability (RFQ), the prenatal attachment of the mother to the unborn child (MAAS) and depression (BDI-II) are surveyed. Furthermore, the subjectively perceived impairment through physical and psychological symptoms of a person within a period of seven days (SCL-90-S) as well as the retrospective recording of stressful experiences in childhood and adolescence (ACE), as well as their bonding experience (via AAI) are measured. During the 6th month of the child's life, the video analysis of a feeding situation (via the Chatoor Feeding Scale) and a game interaction (via the Chatoor Play Scale) are carried out at the Institute's own video laboratory. At the age of 12 months, the child's pattern of attachment to his mother is determined (via the FST). In addition, postnatal examination results of the baby (mother-child passport) are collected.

It is assumed that the mother's eating disorder has an unfavourable effect on the mother-child interaction and on the health and development of the child. Children of an eating disordered mother should be less likely to develop a safe attachment, as the disorder affects mother-child interaction.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The study articles indicate that the data will be made available on request and with justification for what the data will be used for.
It will be decided on a case-by-case basis which data will be made available and in what form. However, in any case the data will be passed on anonymously.

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Organizational Data

  •   DRKS00017541
  •   2019/07/30
  •   [---]*
  •   yes
  •   Approved
  •   415-E/2521/2-2019, Amt der Salzburger Landesregierung Ethikkommission für das Bundesland Salzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   O00-O99 -  Pregnancy, childbirth and the puerperium
  •   F00-F99 -  Mental and behavioural disorders
  •   F50.0 -  Anorexia nervosa
  •   F50.2 -  Bulimia nervosa
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Interventions/Observational Groups

  •   Group 1: Experimental group "expectant mothers with acute anorectal symptoms".

    The experimental group consists of expectant mothers who show acute eating disorder symptoms / an eating disorder, recruitment is carried out in cooperation with professional bodies, so that it can be ensured that there is a connection to required treatments.
  •   Group 2: Experimental group "Becoming mothers with anorectal symptoms in their past".

    The experimental group consists of expectant mothers who show eating disorder symptoms / an eating disorder in the course of their lives, but just do not show any acute symptoms, so that the acquisition via a public application and a short online screening should be unproblematic.
  •   Group 3: Control group "expectant mothers who have never been affected by an eating disorder".

    The control group consists of expectant mothers who have no eating disorders in their curriculum vitae.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Classification of the child's attachment behaviour to mother
Method: Strange-Situation-Test (Ainsworth, Blehar, Waters, & Wall, 1978) with mother and child in the 12th month old child.
Possible classifications: secure attachment, anxious-ambivalent attachment, anxious-avoidant attachment, disorganized/disoriented attachment

To record the specific psychopathology of eating disorders in adults.
Method: Eating Disorder Examination Questionnaire (EDE-Q; Hilbert & Tuschen-Caffier, 2006), 17+Pregorexia-Index (P17I; Herrmann, 2017)

The mother's attachment representation is recorded with the established Adult Attachment Interview, AAI, (George, Kaplan, & Main, 1985), which retrospectively collects early experiences with important bond persons and current attitudes towards the bond in an approximately one-hour, partially standardized interview.

Measurement of ketone bodies in the mother's breath using the keton-breathalyzer (Ketonix, 2018). Due to the limited glucose uptake of the eating disordered mother, more fat is converted into ketone bodies by the liver, this process controls the weight loss of the mother and is also found in mothers with diabetes (Bronisz, Ozorowski, & Hagner-Derengowska, 2018).

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Secondary Outcome

Reflective Functioning Questionnaire (RFQ; Fongay et al., 2016), Maternal Antenatal Attachment Scale (MAAS; Condon, 2015), Beck-Depressions-Inventar (BDI-II; Hautzinger, Keller, & Kühner, 2009), Symptom-Checklist-90®-Standard (SCL-90-S; Franke, 2014), Adverse Childhood Experiences Questionnaire (ACE; Wingenfeld, 2011)

Feeding (Chatoor, Menville, Getson, & O´Donnell, 1986) & play observation (Chatoor, 1986)

Copy: mother-child-pass (Development of the child: height + weight)

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
  • other 
  • Doctor's Practice 
  • other 
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Recruitment

  •   Actual
  •   2019/07/30
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. minimum age: 18 years
2. eating problems (anorexia nervosa; bulimia nervosa) in the past or present
3. no acute physical or mental illness
4. sufficient knowledge of German

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Exclusion Criteria

1. no age of majority
2. additional acute physical (e.g. diabetes) or mental illness
3. insufficient knowledge of German

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Paracelsus Medizinische Privatuniversität Salzburg, Insitut für Early Life Care
    • Mr.  Univ.-Prof. Dr. med  Karl Heinz  Brisch 
    • Strubergasse 26
    • 5020  Salzburg
    • Austria
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    • Institut für Early Life CareParacelsus Medizinische Privatuniversität
    • Ms.  MSc  Leonie  Aap 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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    • Institut für Early Life CareParacelsus Medizinische Privatuniversität
    • Ms.  MSc  Leonie  Aap 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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Sources of Monetary or Material Support

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    • Paracelsus Medizinische Privatuniversität Salzburg, Insitut für Early Life Care
    • Mr.  Univ.-Prof. Dr. med  Karl Heinz  Brisch 
    • Strubergasse 26
    • 5020  Salzburg
    • Austria
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.