Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
31/10/2012
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 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 measures

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

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

http://www.rug.nl/umcg/index?lang=en

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23108941

Publication citations

  1. 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.

Additional files

Editorial Notes