|- candidate number||13204|
|- NTR Number||NTR3600|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-aug-2012|
|- Secondary IDs||06072051 OZ|
|- Public Title||Feasibility of implementing the Dutch multidisciplinary guideline obesity for children.
Haalbaarheid van implementatie van de Nederlandse zorgstandaard obesitsas voor kinderen.
|- Scientific Title||Feasibility of implementing the Dutch multidisciplinary guideline obesity for children.
Haalbaarheid van implementatie van de Nederlandse zorgstandaard obesitas voor kinderen.
|- hypothesis||The primary aim of this study is to investigate the process of implementation of the Dutch multidisciplinary guideline for obese children according to the implementation process of Grol and Wensing. The secondary aim is to investigate whether the implementation leads to a bigger satisfaction for general practitioners, municipal doctors and paediatricians, improvement in quality of live and decrease in BMI for obese children.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||Inclusion criteria for health care professionals (Municipal doctors/nurses, general practitioners, paediatricians):|
1. Willing to participate;
2. Working in the Western district of Amsterdam;
3. Working with obese children;
4. GP’s must be member of the Free University of Amsterdam GP Network.
General practitioners in controlgroup:
1. Member of the the Free University of Amsterdam GP Network;
2. Working area Haarlem.
Parents of obese childeren:
1. Child is obese child according to Cole criteria;
2. Age (4-12);
3. Willing to participate;
4. Sufficient understanding of Dutch language.
|- Exclusion criteria||No sufficient understanding of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2014|
|- Target number of participants||100|
|- Interventions||In the intervention practices the care for children with overweight is innovated. The innovation is the intervention. As part of the innovation we:|
1. We shall make a multidisciplinary treatment program in which the general practitioners, the health care workers and paediatricians have protocolised the multidisciplinary care and the communication with each other during (2-6 meetings, each meeting 1 hour);
2. We shall train the general practitioners (3 hour training, once for every general practitioner) about this program;
3. We shall make a social map of the region. Every general practitioner receives a map with contact information of the interventions available in the region for children with obesity.
The control practices perform usual care. The control practises are selected from the Academic Network of General Practitioners of the department of general practice & elderly care medicine of the Free University Medical Centre in Amsterdam. The control practises are located in a different region then the intervention practices, but have a comparable target group.
It is an controlled non randomised trial.
|- Primary outcome||Our primary outcome is the process evaluation of the implementation processes according to Grol and Wensing in terms of RE-AIM.|
|- Secondary outcome||1. Quality of live of the child;|
2. Change in BMI;
3. Experiences of parents about the received care.
|- Timepoints||1. Baseline and 1-year follow-up;|
2. Interviews with parents start 6 months after inclusion.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Annemarie Schalkwijk|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Giel Nijpels|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Academic Network General Practitioners (ANH)|
|- Brief summary||Feasibility of implementing the multidisciplinary guideline obesity ("Zorgstandaard Obesitas") for children.
Primarily the aim of this study is to investigate the process of implementation of the multidisciplinary guideline according to the implementation process of Grol and Wensing. Secondary aim is does implementation leads to a bigger satisfaction, improvement in quality of live and decrease in BMI for obese children.
Over the last few decades, childhood obesity has been increasing in the Netherlands. The prevalence of childhood obesity increased in 2009 to 1.8% of the boys and 2.2% of the girls, a four to six fold increase since 1980. Problems caused by this increase are the relating multiple medical complications of childhood obesity like, psychosocial problems which can lead to social isolation, a lack of self confidence and self esteem, and a greater likelihood of obesity in adulthood. Consequently a number of new lifestyle interventions have been developed. Successful intervention is know to consist of a multidisciplinary approach, combining the components of diet, physical activity, psychological support and parental involvement. A problem in daily care is the lack of communication between health care professionals treating obese children. This leads to fragmented care, because there is no coordination between health care professionals. Therefore, obese children receive suboptimal care and inefficient use of health care services. Implementation of a multidisciplinary guideline is a possible way to optimize coordination of care for obese children.
Data will be available winter 2015.
The study is a non-randomized controlled intervention trial with a multiple intervention group(n=20 general practitioners) to either usual care or with obese children (n=100). The GP’s must be member of the Free University of Amsterdam GP Network and work in the western disctrict of Amsterdam.
Primary outcome is the process evaluation of the implementation processes according to Grol and Wensing in terms of RE-AIM. Secondary outcome measures are:
1. Quality of live of the child;
2. Change in BMI;
3. Experiences of parents about the received care
Data collection will be quantitative - review of the patients’ medical record at the GP at baseline and at 12 months – as well as qualitative - insight in factors favoring and hampering implementation of the program using semi- structured in-depth interviews and focus groups.
|- Main changes (audit trail)|
|- RECORD||6-aug-2012 - 22-sep-2012|