|- candidate number||12171|
|- NTR Number||NTR3388|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2012|
|- Secondary IDs||NL38674.068.11 MEC Academic Hospital Maastricht|
|- Public Title||Cognitive training against obesity.|
|- Scientific Title||Training inhibitory skills against obesity.|
|- hypothesis||We hypothesize that training inhibitory skills will lead to more succes of a lifestyle based treatment of obesity in children.|
|- Healt Condition(s) or Problem(s) studied||Obesity|
|- Inclusion criteria||8-18 years old and in treatment for obesity in Maastricht University Medical Center.|
|- Exclusion criteria||1. Inadequate Dutch language skills;|
2. No at home access to internet.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2012|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||56|
|- Interventions||Training of inhibitory skills through 4-week internet based computerized cognitive training.|
Participants in the intervention group train their cognitive inhibition skills five days per week for four weeks. We use a 20-minute computerized task that participants can do via the internet. The training can thus be done at home. In the computer task the participant should press the left or right button as quickly as possible when a certain stimulus is presented. The stimuli are neutral and child friendly (pictures of the Smurfs, Cars, Shrek, etc.). In 75% of the trials this is the only task. In 25% of the cases a stop sign appears in the location where the stimulus is, indicating that participant should try not to react to the stimulus. Initially the task is quite easy, but it gradually becomes more difficult (the time interval between the presentation of the stimulus and the presentation of the stop sign becomes longer). Participants in the waiting list control group only participate in the pre- and post measurements. If the training turned out to be effective for the intervention group, they are offered to do the training after the study has ended. This is optional, and is not part of the trial. No measurements are taken.
|- Primary outcome||1. Lower BMI (measured height and weight);|
2. Less caloric intake of snack food in the lab (bogus taste test).
|- Secondary outcome||1. Better general inhibitory skills (measured with the stop signal task, a computerized task measuring general inhibition skills);|
2. Less impulsive behaviour in daily life (measured with a questionnaire).
|- Timepoints||1. TO;|
2. T1 (T0+4weeks);
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Ramona Guerrieri|
|- CONTACT for SCIENTIFIC QUERIES|| Ramona Guerrieri|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM)|
|- Brief summary||Prevalences of overweight and obesity are rising amongst young children. Besides the adjustment of one's diet and physical exercise, the role that impulsive behaviour plays in the obesity problem is now recognized. Previous studies have shown that impulsive behaviour, measured on a general level using a computerized task, is more prevalent amongst children who are in treatment for obesity en amongst obese children in the general population. Moreover, children who exhibit impulsive behaviour react less well to regular obesity treatments. It has been shown that impulsivity and its opposite behaviour inhibition can be manipulated or trained and that one-trial
training has at least a momentary effect on acute overeating behaviour.
In this study we want to investigate whether it is possible to train inhibition in the long term in order to support the effectiveness of lifestyle interventions that combat obesity.
|- Main changes (audit trail)|
|- RECORD||30-mrt-2012 - 19-apr-2012|