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ISRCTN
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ISRCTN36146436
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ClinicalTrials.gov identifier
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Public title
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The effect of lifestyle treatment on childhood obesity
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Scientific title
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A randomised controlled trial evaluating the effect of family-based multidisciplinary cognitive behavioural treatment in children with obesity
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Acronym
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Haagse Maatjes
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Serial number at source
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06-091
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Study hypothesis
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During 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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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The Dutch National Medical Ethical Committee approved on the 13th of February 2007 (ref: METC-nr. 06-091)
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Study design
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Longitudinal single centre single blind randomised clinical trial, with stratification for gender and ethnicity
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Childhood obesity
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Participants - inclusion criteria
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1. 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
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Participants - exclusion criteria
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1. 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
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Anticipated start date
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13/03/2007
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Anticipated end date
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30/09/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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35 per group, 70 in total
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Interventions
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The 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.
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Primary outcome measure(s)
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Do 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?
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Secondary outcome measure(s)
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1. 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?
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Sources of funding
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Juliana Children's Hospital, HagaHospital (Netherlands) - unrestricted educational grand
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Trial website
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Publications
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2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21548919
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Contact name
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Dr
Mieke
Houdijk
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Address
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Sportlaan 600
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City/town
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the Hague
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Zip/Postcode
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2566 JM
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Country
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Netherlands
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Sponsor
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Haga Teaching Hospital (HagaZiekenhuis) (Netherlands)
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Address
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c/o E.C.A.M. Houdijk
Sportlaan 600
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City/town
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the Hague
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Zip/Postcode
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2566 JM
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Country
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Netherlands
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Date applied
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06/04/2010
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Last edited
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21/09/2011
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Date ISRCTN assigned
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13/07/2010
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