GECKO Outpatients Clinic

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR872
• Date of registration: 16/01/2007
• Primary sponsor: University Medical Center Groningen (UMCG), Beatrix Children's Hospital
• Public title: GECKO Outpatients Clinic
• Scientific title: The effectiveness of multidisciplinary treatment in young overweight: GECKO Outpatients Clinic, a randomized controlled trial -
• Date of first enrolment: 10/10/2006
• Target sample size: 180
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=872
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: H. Oude Luttikhuis

• Name: H. Oude Luttikhuis

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children aged 3 to 6 years old, who are overweight - 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.

Exclusion criteria: 1. Children with mental retardation;
2. Severe behavioral problems;
3. Other criteria interfering with participation (for example not speaking Dutch);
4. Children with obesity due to known medical causes or eating disorders.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Overweight, Obesity

Intervention(s)

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.
Interventions will be divided in two groups; the intervention and the usual care group.
The intervention group will receive a three months multidisciplinary treatment program.
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 behaviors.
The exercise program will focus on an active lifestyle. Children and parents will be encouraged to reduce sedentary activities. Also a physiotherapist will guide them once a week in a group training (10 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.
Parents will also receive six sessions of behavioral 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.
In the usual care group a pediatrician will follow up the child and its parents. In a period of 3 months they will b

Primary Outcome(s)

Difference in progression of BMI between both groups

Secondary Outcome(s)

Dietary intake, physical activity, behavioral modification, body composition, fat distribution, metabolic syndrome, insulin resistence, blood lipid profile, inflammatory markers, quality of life

Secondary ID(s)

ISRCTN47185691

N/A

Source(s) of Monetary Support

A.S. Watson (Europe) Holding BV, Menzis Zorgverzekeraar