Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/04/2010
Date assigned
13/07/2010
Last edited
21/09/2011
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 Mieke Houdijk

ORCID ID

Contact details

Sportlaan 600
the Hague
2566 JM
Netherlands

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

Sponsor information

Organisation

Haga Teaching Hospital (HagaZiekenhuis) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes