Improving the mother-infant relationship in the context of maternal eating disorder: a randomised controlled trial
| ISRCTN | ISRCTN95026274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95026274 |
| Secondary identifying numbers | 050892 |
- Submission date
- 25/09/2004
- Registration date
- 08/12/2004
- Last edited
- 29/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Alan Stein
Scientific
Scientific
Section of Child and Adolescent Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
Study information
| Study design | Multicentre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | The influence of maternal eating disorder on infant development: an intervention study |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 08/12/2004 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 |
| Key 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 |
| Key exclusion criteria | Mothers with severe co-morbid psychiatric disorders were excluded. |
| Date of first enrolment | 08/12/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Child and Adolescent Psychiatry
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Sponsor information
University of Oxford (and Royal Free and University College Medical School) (UK)
University/education
University/education
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 050892)
No information available
The North Central London Research Consortium (NoCLoR) (UK) supported the recruitment process in primary care.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
