The effectiveness of multidisciplinary treatment in young overweight children: GECKO outpatients clinic, a randomised controlled trial

ISRCTN	ISRCTN47185691
DOI	https://doi.org/10.1186/ISRCTN47185691
Secondary identifying numbers	N/A

Submission date: 08/02/2007
Registration date: 08/02/2007
Last edited: 31/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H Oude Luttikhuis
Scientific

Universitair Medisch Centrum Groningen (UMCG)
Beatrix Kinderkliniek
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 0585
Email	h.oudeluttikhuis@bkk.umcg.nl

Study information

Study design	Randomised active-controlled parallel group single-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	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)?
Ethics approval(s)	Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen, 19th January 2006 (amendment approved 2nd February 2007), ref: METc 2005/261
Health condition(s) or problem(s) studied	Obesity, Overweight
Intervention	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.
Intervention type	Other
Primary outcome measure	Difference in progression of BMI between both groups.
Secondary outcome measures	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
Overall study start date	10/10/2006
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	6 Years
Sex	Both
Target number of participants	180
Key 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
Key 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
Date of first enrolment	10/10/2006
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Universitair Medisch Centrum Groningen (UMCG)

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Website	http://www.rug.nl/umcg/index?lang=en
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Industry

Menzis Zorgverzekeraar (The Netherlands)

No information available

A.S. Watson (Europe) Holding BV (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No