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 |
| Secondary identifying numbers | METC -2007-129 |
- 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
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | Dropout rate |
| Secondary outcome measures | 1. BMI-SDS, measured at baseline, 3, 6, 9 and 12 months 2. Problem behaviour, measured with Youth Outcome Questionnaire (YOQ) at baseline, 3 and 12 months 3. Family functioning, measured with the Dutch version of the Family Adaptability and Cohesion Evaluation Scale (FACES III) at baseline, 3 and 12 months 4. Health-related quality of life, measured with the Child Health Questionnaire-Parent Form (CHQ-PF-50) at baseline, 3, 6, 9 and 12 months 5. Perceived competence, measured with Dutch version of the Self-Perception Profile for Children (SPPC) at baseline, 3, 6 and 12 months 6. Eating behaviour, measured with the Dutch Eating Behaviour Questionnaire (DEBQ) at baseline, 3, 6, 9 and 12 months |
| Overall study start date | 01/07/2007 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Rikard E. Juttmann MD PhD
Department of Research Policy
Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://intranet.erasmusmc.nl/onderzoeksbeleid/subsidiesinvesteringen/internesubsidie/emczorgonderzoek/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands) - Grant No. 2006-26
No information available
Innovation Fund Insurances (Innovatiefonds Verzekeringen) (Netherlands) - Grant No. 06-334.
No information available
Vodafone (Netherlands)
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 | 01/11/2012 | Yes | No |
