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Improving the mother-infant relationship in the context of maternal eating disorder: a randomised controlled trial
ISRCTN ISRCTN95026274
DOI 10.1186/ISRCTN95026274
ClinicalTrials.gov identifier
EudraCT number
Public title Improving the mother-infant relationship in the context of maternal eating disorder: a randomised controlled trial
Scientific title The influence of maternal eating disorder on infant development: an intervention study
Acronym N/A
Serial number at source 050892
Study hypothesis Maternal eating disorders have been shown to be associated with adverse effects on mother-infant interaction and infant outcome. By the infants' first birthday mothers with eating disorders are considerably more likely to be involved in major episodes of mealtime conflict with their infants and controls. This study tested whether a video-feedback treatment targeted specifically at mother-child interaction improved that interaction, especially reducing mealtime conflict, and improving infant weight and autonomy, compared to a counselling treatment.
Lay summary Not provided at time of registration
Ethics approval Added 09/02/2009:
1. Oxfordshire Psychiatric Research Ethics Committee gave approval on the 4th August 1999 (ref: O99.35)
2. Royal Free Hospital & Medical School Local Research Ethics Committee gave approval on the 23rd June 1998 (ref: 76-97)
Study design Multicentre, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Bulimia nervosa
Participants - 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
Participants - exclusion criteria Mothers with severe co-morbid psychiatric disorders were excluded.
Anticipated start date 08/12/2004
Anticipated end date 01/01/2006
Status of trial Completed
Patient information material
Target number of participants 80
Interventions 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 measure(s) Level of conflict during the principal main meal of the day.
Secondary outcome measure(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
Sources of funding 1. The Wellcome Trust (UK) (grant ref: 050892)
2. The North Central London Research Consortium (NoCLoR) (UK) supported the recruitment process in primary care.
Trial website
Publications 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16648333
Contact name Prof  Alan  Stein
  Address Section of Child and Adolescent Psychiatry
University of Oxford
Warneford Hospital
  City/town Oxford
  Zip/Postcode OX3 7JX
  Country United Kingdom
Sponsor University of Oxford (and Royal Free and University College Medical School) (UK)
  Address Department of Psychiatry
Warneford Hospital
  City/town Oxford
  Zip/Postcode OX3 7JX
  Country United Kingdom
  Sponsor website: http://www.ox.ac.uk/
Date applied 25/09/2004
Last edited 29/01/2013
Date ISRCTN assigned 08/12/2004
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