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 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funders | Menzis Zorgverzekeraar (The Netherlands), A.S. Watson (Europe) Holding BV (The Netherlands) |
- 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
Scientific
Universitair Medisch Centrum Groningen (UMCG)
Beatrix Kinderkliniek
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 0585 |
|---|---|
| h.oudeluttikhuis@bkk.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active-controlled parallel group single-blind trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Difference in progression of BMI between both groups. |
| Key secondary outcome measure(s) |
1. Dietary intake |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | All |
| Target sample size at registration | 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
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
