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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.
Register: ISRCTN
Last refreshed on: 12 February 2013
Main ID:  ISRCTN95026274
Date of registration: 08/12/2004
Primary sponsor: University of Oxford (and Royal Free and University College Medical School) (UK)
Public title: Improving the mother-infant relationship in the context of maternal eating disorder: a randomised controlled trial N/A
Scientific title: The influence of maternal eating disorder on infant development: an intervention study
Date of first enrolment: Dec 8 2004
Target sample size: 80
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN95026274
Study type:  Interventional
Study design:  Multicentre, randomised controlled trial  
Countries of recruitment
United Kingdom
Contacts
Name: Alan  Stein
Address:  Section of Child and Adolescent Psychiatry University of Oxford Warneford Hospital OX3 7JX Oxford United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Bulimia nervosa
Intervention(s)
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.
Primary Outcome(s)
Level of conflict during the principal main meal of the day.
Secondary Outcome(s)
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
Secondary ID(s)
050892
Source(s) of Monetary Support
1. The Wellcome Trust (UK) (grant ref: 050892) 2. The North Central London Research Consortium (NoCLoR) (UK) supported the recruitment process in primary care.
Secondary Sponsor(s)
N/A
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