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The effectiveness of multidisciplinary treatment in young overweight children: GECKO outpatients clinic, a randomised controlled trial
ISRCTN ISRCTN47185691
DOI 10.1186/ISRCTN47185691
ClinicalTrials.gov identifier
EudraCT number
Public title The effectiveness of multidisciplinary treatment in young overweight children: GECKO outpatients clinic, a randomised controlled trial
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis So far there haven't been a lot of studies on the effects of treatment aimed at weight reduction of overweight and obese pre-school children. There is clear evidence, however, that the combination of cognitive behavioral therapy, dietary guidance and lifestyle activity change is very effective for weight reduction in older children.

Hypothesis:
Does a multidisciplinary treatment program consisting of dietary advice, life style activity and psychological counselling, aimed at preschool overweight children, as well as their parents, influence the progression of Body Mass Index (BMI)?
Lay summary Not provided at time of registration
Ethics approval Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen, 19th January 2006 (amendment approved 2nd February 2007), ref: METc 2005/261
Study design Randomised active-controlled parallel group single-blind trial
Countries of recruitment Netherlands
Disease/condition/study domain Obesity, Overweight
Participants - inclusion criteria 1. Children aged three to six years old, who are overweight (defined by BMI above the international cut off points for overweight by Cole et al.)
2. Living in the provinces of Groningen, Drenthe or Friesland
Participants - exclusion criteria 1. Children with mental retardation
2. Severe behavioural problems
3. Other criteria interfering with participation (for example not speaking Dutch)
4. Children with obesity due to known medical causes or eating disorders
Anticipated start date 10/10/2006
Anticipated end date 01/08/2009
Status of trial Completed
Patient information material
Target number of participants 180
Interventions Interventions will be divided in two groups: the intervention and the usual care group.

Intervention:
1. The intervention group will receive a three months multidisciplinary treatment program
2. The dietary intervention will consist of a normocaloric diet, based on the required daily intake for this age group, thus securing sufficient normal growth. In six meetings parents and child will receive education and advice to ameliorate their eating behaviours
3. The exercise program will focus on an active lifestyle. Children and parents will be encouraged to reduce sedentary activities. A physiotherapist will guide them once a week in a group training (ten children per group) session. The children will perform physical activity that mimics the type and intensity of elementary school exercise. These sessions will last one hour. The parents will be asked to add on an extra 60 minutes of physical activity of their own once per week, building up to every day according to the Dutch Standard of Healthy Activities
4. Parents will also receive six sessions of behavioural therapy. In these sessions they will learn to be a healthy role model, work with feasible goals and healthy rewards, sticker charts to motivate the children and keep track of the progress, change family attitudes towards healthy eating and physical activity, practical ways to remove unhealthy food triggers and the difference between hunger and cravings. These sessions are group sessions; to diminish the burden of appointments these sessions take place in the evening.

Usual Care:
In the usual care group a paediatrician will follow up the child and its parents. In a period of three months they will be seen three times, for 30 - 60 minutes. They will receive information on healthy eating behaviour and instructions to perform physical activity once per week for 60 minutes on their own, building up to every day according to the Dutch Standard of Healthy Activities.
Primary outcome measure(s) Difference in progression of BMI between both groups.
Secondary outcome measure(s) 1. Dietary intake
2. Physical activity
3. Behavioural modification
4. Body composition
5. Fat distribution
6. Metabolic syndrome
7. Insulin resistance
8. Blood lipid profile
9. Inflammatory markers
10. Quality of life
Sources of funding 1. Menzis Zorgverzekeraar (The Netherlands)
2. A.S. Watson (Europe) Holding BV (The Netherlands)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23108941
Contact name Dr  H  Oude Luttikhuis
  Address Universitair Medisch Centrum Groningen (UMCG)
Beatrix Kinderkliniek
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 361 0585
  Email h.oudeluttikhuis@bkk.umcg.nl
Sponsor University Medical Centre Groningen (UMCG) (The Netherlands)
  Address Beatrix Children's Hospital
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Sponsor website: http://www.rug.nl/umcg/index?lang=en
Date applied 08/02/2007
Last edited 31/10/2012
Date ISRCTN assigned 08/02/2007
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