Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06-091
Study information
Scientific title
A randomised controlled trial evaluating the effect of family-based multidisciplinary cognitive behavioural treatment in children with obesity
Acronym
Haagse Maatjes
Study hypothesis
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.
Ethics approval
The Dutch National Medical Ethical Committee approved on the 13th of February 2007 (ref: METC-nr. 06-091)
Study design
Longitudinal single centre single blind randomised clinical trial, with stratification for gender and ethnicity
Primary study design
Interventional
Secondary study design
Other
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
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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?
Secondary outcome measures
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?
Overall trial start date
13/03/2007
Overall trial end date
30/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
35 per group, 70 in total
Participant exclusion criteria
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
Recruitment start date
13/03/2007
Recruitment end date
30/09/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Sportlaan 600
the Hague
2566 JM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Juliana Children's Hospital, HagaHospital (Netherlands) - unrestricted educational grand
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
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21548919
Publication citations
-
Protocol
Vos RC, Wit JM, Pijl H, Kruyff CC, Houdijk EC, The effect of family-based multidisciplinary cognitive behavioral treatment in children with obesity: study protocol for a randomized controlled trial., Trials, 2011, 12, 110, doi: 10.1186/1745-6215-12-110.