The effect of lifestyle treatment on childhood obesity

ISRCTN ISRCTN36146436
DOI https://doi.org/10.1186/ISRCTN36146436
Secondary identifying numbers 06-091
Submission date
06/04/2010
Registration date
13/07/2010
Last edited
21/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mieke Houdijk
Scientific

Sportlaan 600
the Hague
2566 JM
Netherlands

Study information

Study designLongitudinal single centre single blind randomised clinical trial, with stratification for gender and ethnicity
Primary study designInterventional
Secondary study designOther
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA randomised controlled trial evaluating the effect of family-based multidisciplinary cognitive behavioural treatment in children with obesity
Study acronymHaagse Maatjes
Study objectivesDuring the last three decades the prevalence of childhood obesity has increased dramatically in western countries, including the Netherlands. The rapidly increasing prevalence of childhood obesity seen during the last few decades, is mostly the result of an increased food consumption and a change from a more physically active lifestyle to a more sedentary one. The consequence of the increased prevalence of childhood obesity is the earlier appearance of co-morbidities.

The primary aim of this study is the effect evaluation of a family-based multidisciplinary cognitive behavioural treatment on obesity (expressed as body mass index [BMI]-standard deviation score [SDS]) compared to standard care (advice on increased physical activity and dietary changes) in children with obesity. The secondary aim of the study was to investigate the effect of this treatment on changes in waist circumference, insulin sensitivity, inflammation, secretion of gastrointestinal hormones and changes in physical fitness and quality of life, compared to standard care. Furthermore, we aimed at assessing the long-term effects and possible predictive factors for response treatment.
Ethics approval(s)The Dutch National Medical Ethical Committee approved on the 13th of February 2007 (ref: METC-nr. 06-091)
Health condition(s) or problem(s) studiedChildhood obesity
InterventionThe cognitive behaviour treatment program takes two years, with an intensive phase of three monthsat the beginning, followed by booster sessions. In the screening phase the children with their parents were seen at two separate occasions individually by a dietitian, a child-physiotherapist, a child-psychologist and a social worker. In this way individual family situations which could interfere with the treatment are evaluated and expectations of the program are checked. During the intensive phase of the program the experimental group is offered 7 group meetings of 2 1/2 hours and the parents are offered 5 separate parent meetings and 1 meeting together with the children. The control group is given an initial physical activity and nutritional advice. The control group is offered to participate in the treatment after 12 months. The normal weight control group is measured only once. A person blinded for the study design measures weight and height at baseline.
Intervention typeOther
Primary outcome measureDo children (8-17 yr.) with obesity show a significant decrease (> 0.5 BMI-SDS) in BMI (as defined by Cole et al.[2]) after 3 months of intensive treatment compared to children who were given advice on increased physical activity and dietary changes?
Secondary outcome measures1. Do children with obesity have a significantly more beneficial effect of 3 months intensive treatment compared to standard care on changes in waist circumference, insulin sensitivity, secretion of gastrointestinal hormones, cardiovascular fitness and quality of life?
2. Will the hypothesized beneficial effects of 3 months intensive treatment in children with obesity persist after 12 and 24 months of follow-up?
3. Are the genetic background of the children, the level of parental education, the social economic status or the ethnicity predictive variables for the degree of obesity in these children, and for the success of treatment?
Overall study start date13/03/2007
Completion date30/09/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit17 Years
SexBoth
Target number of participants35 per group, 70 in total
Key inclusion criteria1. Age 8-17 years (at baseline)
2. Obesity based on BMI values defined by Cole et al.
3. Children/ adolescents presented to the paediatrician
4. Written informed consent from parents and children
Key exclusion criteria1. Insufficient knowledge/understanding of the Dutch language
2. Children/adolescents following special education
3. Serious co-morbidity
4. Obesity caused by a syndrome (like Prader Willi, Laurence-Moon-Biedl)
5. Endocrine cause of obesity (like hypothyreoidy, Cushing)
6. Obesity caused by medication (like high dose of glucocorticoids)
7. Parents and children/adolescents not willing to invest 40 hours in the treatment
8. Children/adolescents with diabetes mellitus
9. Children/adolescents who already followed a multidisciplinary treatment, including psychological treatment and intensive parent involvement
Date of first enrolment13/03/2007
Date of final enrolment30/09/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Sportlaan 600
the Hague
2566 JM
Netherlands

Sponsor information

Haga Teaching Hospital (HagaZiekenhuis) (Netherlands)
Hospital/treatment centre

c/o E.C.A.M. Houdijk
Sportlaan 600
the Hague
2566 JM
Netherlands

ROR logo "ROR" https://ror.org/03q4p1y48

Funders

Funder type

Hospital/treatment centre

Juliana Children's Hospital, HagaHospital (Netherlands) - unrestricted educational grand

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/05/2011 Yes No