A pilot study of the effectiveness of maintenance treatment by Short Message Service (SMS) in overweight and obese children after short-term multidisciplinary cognitive behavioural group therapy
| ISRCTN | ISRCTN33476574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33476574 |
| Protocol serial number | METC -2007-129 |
| Sponsor | Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands) |
| Funders | Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands) - Grant No. 2006-26, Innovation Fund Insurances (Innovatiefonds Verzekeringen) (Netherlands) - Grant No. 06-334., Vodafone (Netherlands) |
- Submission date
- 13/04/2010
- Registration date
- 29/04/2010
- Last edited
- 29/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reinier Timman
Scientific
Scientific
Erasmus MC - Erasmus University Medical Center
Medical Psychology & Psychotherapy
Room GK 1253
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 704 3804 |
|---|---|
| r.timman@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Short Message Service Maintenance Treatment (SMSMT) and the influence on dropout, lifestyle behaviour, competence and quality of life: a randomized controlled trial |
| Study acronym | NTT-CO (New Technology in the Treatment of Childhood Overweight and Obesity) |
| Study objectives | Short Message Service Maintenance Treatment (SMSMT) reduces the dropout rates in a paediatric lifestyle program for overweight and obese children |
| Ethics approval(s) | The Ethics Committee of the Erasmus University of Rotterdam approved on the 3rd of July 2007 (ref: MEC-2007-129) |
| Health condition(s) or problem(s) studied | Childhood obesity |
| Intervention | Cognitive behavioural group therapy (CBGT): The Big Friends Club intervention. The BFC program is a family-based multidisciplinary cognitive behavioural group therapy (CBGT) intervention for children aged 7 to 12 years that is limited to groups of 10 children. The treatment team includes a psychologist, dietician, paediatrician, and physiotherapist. The therapy is aimed at reducing Body Mass Index (kg/m²)Standard Deviation Scores (BMI-SDS), preferably by maintaining weight during growth, adopting a healthy lifestyle and creating a positive self-image. The program provides for an intake session, 8 childrens sessions, and a minimum of 3 parents sessions during the first 3 months. At 6, 9, and 12 months after start of the program, childrens and parents sessions and individual appointments are organized. After the primary cognitive behavioural treatment participants will be randomised into two groups, maintenance treatment (SMSMT) and no maintenance treatment (no SMSMT) Short Message Service Maintenance Therapy (SMSMT): Over a 42-week period, the children will input self-monitoring data on relevant parameters (weight change, exercise, and eating pattern) in a standardized format directly into their mobile phone once a week. Once per week, they receive a feedback message on their progress via a semi-automated software program. Staff-members read incoming SMSs, check the feedback suggested by the program for plausibility, and send it to the participant. Feedback messages are formulated according to two rules: 1) signalling social support and 2) reinforcing positive changes and suggesting behaviour modification strategies in case of negative developments. The children must receive and send the messages by themselves. The parents are allowed to support them if necessary. |
| Intervention type | Other |
| Primary outcome measure(s) |
Dropout rate |
| Key secondary outcome measure(s) |
1. BMI-SDS, measured at baseline, 3, 6, 9 and 12 months |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Overweight and obese children (Body Mass Index-Standard Deviation Score [BMI-SDS] ≥ 1.1) 2. Aged 7 to 12 years 3. Youth Outcome Questionnaire [Y-OQ] < 46 4. Command of Dutch language 5. No drug-treatable disease as the cause of excess weight 6. No diagnosis of eating disorder as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) |
| Key exclusion criteria | 1. Behavioural problems defined as a score exceeding 70 on the Child Behaviour Checklist (CBCL) 2. Drug-treatable disease as the cause of excess weight 3. Mental retardation 4. Insufficiently fluent in the Dutch language 5. Parents or a child with insufficiently motivation to actively participate in the program |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC - Erasmus University Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/11/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
