Condition category
Mental and Behavioural Disorders
Date applied
25/09/2004
Date assigned
08/12/2004
Last edited
29/01/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alan Stein

ORCID ID

Contact details

Section of Child and Adolescent Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

050892

Study information

Scientific title

The influence of maternal eating disorder on infant development: an intervention study

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Bulimia nervosa

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Level of conflict during the principal main meal of the day.

Secondary outcome measures

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

Overall trial start date

08/12/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

Mothers with severe co-morbid psychiatric disorders were excluded.

Recruitment start date

08/12/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Child and Adolescent Psychiatry
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (and Royal Free and University College Medical School) (UK)

Sponsor details

Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 050892)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The North Central London Research Consortium (NoCLoR) (UK) supported the recruitment process in primary care.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16648333

Publication citations

  1. Results

    Stein A, Woolley H, Senior R, Hertzmann L, Lovel M, Lee J, Cooper S, Wheatcroft R, Challacombe F, Patel P, Nicol-Harper R, Menzes P, Schmidt A, Juszczak E, Fairburn CG, Treating disturbances in the relationship between mothers with bulimic eating disorders and their infants: a randomized, controlled trial of video feedback., Am J Psychiatry, 2006, 163, 5, 899-906, doi: 10.1176/appi.ajp.163.5.899.

Additional files

Editorial Notes