Contact information
Type
Scientific
Primary contact
Dr Reinier Timman
ORCID ID
Contact details
Erasmus MC - Erasmus University Medical Center
Medical Psychology & Psychotherapy
Room GK 1253
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 704 3804
r.timman@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
METC -2007-129
Study information
Scientific title
Short Message Service Maintenance Treatment (SMSMT) and the influence on dropout, lifestyle behaviour, competence and quality of life: a randomized controlled trial
Acronym
NTT-CO (New Technology in the Treatment of Childhood Overweight and Obesity)
Study hypothesis
Short Message Service Maintenance Treatment (SMSMT) reduces the dropout rates in a paediatric lifestyle program for overweight and obese children
Ethics approval
The Ethics Committee of the Erasmus University of Rotterdam approved on the 3rd of July 2007 (ref: MEC-2007-129)
Study design
Randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2007
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus MC - Erasmus University Medical Center
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands)
Sponsor details
c/o Rikard E. Juttmann MD PhD
Department of Research Policy
Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre / Medical Research Advice Commission (MRACE) (Netherlands) - Grant No. 2006-26
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Innovation Fund Insurances (Innovatiefonds Verzekeringen) (Netherlands) - Grant No. 06-334.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vodafone (Netherlands)
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
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22468714
Publication citations
-
Results
de Niet J, Timman R, Bauer S, van den Akker E, de Klerk C, Kordy H, Passchier J, Short message service reduces dropout in childhood obesity treatment: a randomized controlled trial., Health Psychol, 2012, 31, 6, 797-805, doi: 10.1037/a0027498.