Study on the efficacy of an Internet self-help program for binge eating disorder, used with the guidance of a coach

ISRCTN	ISRCTN89537427
DOI	https://doi.org/10.1186/ISRCTN89537427
Secondary identifying numbers	N/A

Submission date: 20/08/2010
Registration date: 20/09/2010
Last edited: 23/06/2011

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

Study website

Contact information

Prof Alain Golay
Scientific

Geneva University Hospitals
Service of Therapeutic Education for Chronic Diseases
Gabrielle-Perret-Gentil 4
Geneva
1211 Geneva 14
Switzerland

Study information

Study design	Single centre interventional randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Guided self-help treatment on the Internet for binge eating disorder: A randomised controlled trial
Study objectives	The Internet program group will report improvements of eating behaviour, psychological health and quality of life compared to a control group after 6 months of intervention. These improvements will be sustained after a 6-month follow-up
Ethics approval(s)	The ethical committee of the University Hospitals of Geneva, Department of Community Medicine, approved on 19/11/2007 (protocol no: 07-167, ref: Med 07-045)
Health condition(s) or problem(s) studied	Binge eating disorder
Intervention	Participants used an Internet self-help treatment program for binge eating disorder and benefited of a weekly e-mail contact with a psychologist during the time of intervention. First group received a 6-month Internet intervention and then a 6-month follow-up. Second group had a 6-month waiting period before receiving the 6-month Internet intervention. Assessors were not blinded to controlled conditions but assessments were conducted with self-report questionnaires, limiting biaises.
Intervention type	Other
Primary outcome measure	Eating Disorder Inventory (EDI-2) Bulimia subscale (Garner, Olmsted, & Polivy, 1983). Self reporting questionnaire which was chosen because it was sensitive to participants progress in previous studies using the Internet program. Assessments were carried out at baseline, after 6-month intervention/waiting-list, after 6-month follow-up/intervention (= 0-6-12 months)
Secondary outcome measures	Self-report questionnaires: 1. EDI-2 subscales (Garner, Olmsted, & Polivy, 1983) 2. Eating Disorder Examination-Questionnaire (EDE-Q) (Fairburn & Beglin, 1994) 2.1. total score 2.2. number of objective binge episodes 3. Proportion of patients abstinent from bingeing (=0 binge episodes in the last 28 days) 4. Three-Factor Eating Questionnaire (TFEQ) scales (Stunkard & Messick, 1985) 5. Beck Depression Inventory-II (BDI-II) score (Beck, Steer, & Brown, 1996) 6. Symptom Check-List (SCL-90R) global severity index (Derogatis, 1977) 7. Impact of Weight on Quality of Life (IWQOL-Lite) total score (Kolotkin, Crosby, Kosloski, & Williams, 2001) 8. Rosenberg self-esteem scale (RSES) score (Rosenberg, 1965) 9. BMI (body mass index, taken out of the EDE-Q) Assessments were carried out at baseline, after 6-month intervention/waiting-list, after 6-month follow-up/intervention (= 0-6-12 months)
Overall study start date	08/01/2008
Completion date	18/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	74
Key inclusion criteria	1. Women, age ≥ 18 years 2. Binge eating disorders and related eating disorders 3. 20<BMI<50
Key exclusion criteria	1. Drug or alcohol dependence 2. Suicide attempt during the last year 3. Unmanaged severe psychiatric disorder 4. Gastric bypass 5. Current cognitive and behavioural therapy
Date of first enrolment	08/01/2008
Date of final enrolment	18/02/2010

Locations

Countries of recruitment

Switzerland

Study participating centre

Geneva University Hospitals

Geneva
1211 Geneva 14
Switzerland

Sponsor information

University Hospitals of Geneva (Switzerland)
Hospital/treatment centre

c/o Prof Alain Golay
Service of Therapeutic Education for Chronic Diseases
Gabrielle-Perret-Gentil 4
Geneva
1211 Geneva 14
Switzerland

"ROR"	https://ror.org/01m1pv723

Funders

Funder type

Charity

Hans Wilsdorf Foundation (Switzerland)

No information available

Marie Curie Research Training Network (Europe) - Individually tailored stepped care for women with eating disorders (INTACT) (MRTN-CT-2006-035988)

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	01/08/2011		Yes	No