Contact information
Type
Scientific
Primary contact
Dr H Oude Luttikhuis
ORCID ID
Contact details
Universitair Medisch Centrum Groningen (UMCG)
Beatrix Kinderkliniek
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 0585
h.oudeluttikhuis@bkk.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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)?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
10/10/2006
Overall trial end date
01/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
180
Participant 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
Recruitment start date
10/10/2006
Recruitment end date
01/08/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universitair Medisch Centrum Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Menzis Zorgverzekeraar (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
A.S. Watson (Europe) Holding BV (The Netherlands)
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23108941
Publication citations
-
Results
Bocca G, Corpeleijn E, Stolk RP, Sauer PJ, Results of a multidisciplinary treatment program in 3-year-old to 5-year-old overweight or obese children: a randomized controlled clinical trial., Arch Pediatr Adolesc Med, 2012, 166, 12, 1109-1115, doi: 10.1001/archpediatrics.2012.1638.