GECKO Outpatients Clinic|
|- candidate number||2410|
|- NTR Number||NTR872|
|- Date ISRCTN created||8-feb-2007|
|- date ISRCTN requested||7-feb-2007|
|- Date Registered NTR||16-jan-2007|
|- Secondary IDs||N/A |
|- Public Title||GECKO Outpatients Clinic|
|- Scientific Title||The effectiveness of multidisciplinary treatment in young overweight: GECKO Outpatients Clinic, a randomized controlled trial|
|- hypothesis||Does a multidisciplinary treatment program consisting of dietary advice, life style activity and psychological counseling, aimed at preschool overweight children , as well as their parents, influence the Body Mass Index?|
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||10-okt-2006|
|- planned closingdate||1-aug-2009|
|- Target number of participants||180|
|- Interventions||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 be seen three times, for 30-60 minutes. They will receive information on healthy eating behavior and instructions to perform physical activity 1x per week for 60 minutes on their own, building up to every day according to the Dutch Standard of Healthy Activities.
|- Primary outcome||Difference in progression of BMI between both groups|
|- Secondary outcome||Dietary intake, physical activity, behavioral modification, body composition, fat distribution, metabolic syndrome, insulin resistence, blood lipid profile, inflammatory markers, quality of life|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| H. Oude Luttikhuis|
|- CONTACT for SCIENTIFIC QUERIES|| H. Oude Luttikhuis|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Beatrix Children's Hospital|
(Source(s) of Monetary or Material Support)
|A.S. Watson (Europe) Holding BV, Menzis Zorgverzekeraar|
|- Brief summary||Childhood obesity is increasing worldwide. Also in the Netherlands the prevalence of overweight and obese children has expanded. Very alarming is the rise in prevalence among very young children. Obesity treatment in children is difficult. No consensus has been reached on the best intervention method. Although beneficial effects of multidisciplinary treatment in older children and adolescents have been demonstrated, little is known about treating younger children.
The aim of this study is to evaluate effects of a multidisciplinary intervention in overweight children aged 3-6 years old.
The study will be a randomized controlled clinical trial.Overweight children, 3-6 years old living in the provinces of Groningen, Drenthe and Friesland will be included in the study. Overweight defined according to the international cut off points for overweight. Children are randomized into usual care or an intense multidisciplinary treatment program, collaboratively given by a pediatrician, dietician, physiotherapist and behavioral therapist. Evening sessions will be held to augment parentís knowledge and understanding of healthy eating and activity patterns, obesity and its health risks. The intervention period runs 4 months, mean follow up afterwards will be 12 months.
Primary outcome in the study is the change in body mass index. Secondary outcomes include changes in body composition, fat distribution, physical activity, dietary intake, behavior modification, quality of life, metabolic syndrome, and obesity related inflammatory markers and hormones. A study population of 180 children should provide 80% power to detect a difference of 2 units kg/m2 in BMI. Analysis will be by intention-to-treat.
|- Main changes (audit trail)|
|- RECORD||16-jan-2007 - 9-feb-2007|
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