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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN95026274 |
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Date of registration:
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08/12/2004 |
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Primary sponsor: |
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Public title:
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Improving the mother-infant relationship in the context of maternal eating disorder: a randomised controlled trial
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Scientific title:
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The influence of maternal eating disorder on infant development: an intervention study |
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Date of first enrolment:
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Dec 8 2004 |
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Target sample size:
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80 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN95026274 |
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Study type:
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Interventional |
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Study design:
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Multicentre, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Alan
Stein |
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Address:
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Section of Child and Adolescent Psychiatry
University of Oxford
Warneford Hospital
OX3 7JX
Oxford
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women between 18 and 45 years of age, with infants aged between four and six months
2. Met Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) diagnostic criteria for an eating disorder, either bulimia nervosa or a similar form of eating disorder of clinical severity (i.e. a subtype of Eating Disorder Not Otherwise Specified [EDNOS]) of the bulimic type
3. The inclusion criteria were:
3.1. The over evaluation of body shape or weight of clinical severity
3.2. Recurrent episodes of loss of control over eating (i.e. subjective or objective bulimic episodes)
3.3. Secondary social impairment
Exclusion criteria: Mothers with severe co-morbid psychiatric disorders were excluded.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Bulimia nervosa
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Intervention(s)
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Eighty mothers attending routine baby clinics with bulimia nervosa or a similar eating disorder (i.e. a subtype of EDNOS) of the bulimic type, with infants aged four to six months, were randomised to the following:
1. Intervention group: video-feedback interactional treatment
2. Control group: non-directive supportive counselling
Both groups also received guided cognitive behavioural self-help for their eating disorder. Each group received 13 sessions altogether.
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Primary Outcome(s)
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Level of conflict during the principal main meal of the day.
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Secondary Outcome(s)
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1. Infant weight
2. Other mother-infant mealtime interaction variables including maternal facilitation, maternal picking up of infant to cues (verbal and non-verbal), and maternal intrusiveness
3. Infant autonomy involving self-feeding initiatives
4. Maternal eating disorder psychopathology
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Source(s) of Monetary Support
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1. The Wellcome Trust (UK) (grant ref: 050892)
2. The North Central London Research Consortium (NoCLoR) (UK) supported the recruitment process in primary care.
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