Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/04/2010
Date assigned
29/04/2010
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 children’s sessions, and a minimum of 3 parent’s sessions during the first 3 months. At 6, 9, and 12 months after start of the program, children’s and parent’s 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 SMS’s, 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

http://intranet.erasmusmc.nl/onderzoeksbeleid/subsidiesinvesteringen/internesubsidie/emczorgonderzoek/

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

  1. 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.

Additional files

Editorial Notes