|- candidate number||6593|
|- NTR Number||NTR2055|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-okt-2009|
|- Secondary IDs||243202 Behavioural Science Institute, Radboud University Nijmegen|
|- Public Title||Imitation of Food Intake and Choices in Children.|
|- Scientific Title||Imitation of Food Intake and Choices in Children.|
|- hypothesis||The majority of research in imitation and eating behaviour has been conducted in adolescents and adults in laboratory settings. The goal of this experimental research is to study imitation and eating behaviour in preadolescents with regard to the role of peers in their natural environment (primairy schools). Sex, age and weight differences will be investigated, together with the role of mothers and class mates. This research can contribute to more specific education at schools and at home regarding healthy and unhealthy food choices.|
|- Healt Condition(s) or Problem(s) studied||Overweight|
|- Inclusion criteria||1. The schools and parents/caretakers are fully informed and have to have given active consent; |
2. The participants are normal or overweight boys and girls between 8 and 13 years.
|- Exclusion criteria||All preadolescents who are underweight or have dietary constraints (e.g. diabetes, food allergy or intolerance) are excluded from this study.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||15-nov-2009|
|- planned closingdate||1-jan-2012|
|- Target number of participants||485|
|- Interventions||No intervention will take place. The participants and parents/caretakers will not be confronted with their behavior. |
|- Primary outcome||The primary outcome that is investigated is whether there is a difference in imitation and eating behavior between normal and overweight boys and girls. Also, the role of peers with regard to body weight and eating behaviour is investigated.|
|- Secondary outcome||The secondary outcome is whether the behavior of the primary outcome will be related to the preadolescent's body weight one and two years later.|
|- Timepoints||Primary outcomes: |
Timepoint: 2 months screening in the first year in order to use randomized stratified sampling in the following studies.
Screening: gather information on bodyweight, height, age, sex and a sociometric questionnaire concerning class mates.
2 studies during 6 months of the first year:
1. An observational study with video equipment with regard to imitation behaviour, 3 eating conditions with M&M's, a confederate and the participant, and a questionnaire about self-esteem, social acceptance and impulsivity;
2. An observational social influence study with video equipment and palatable food, a questionnaire concerning background information, the Dutch Eating Behaviour Questionnaire, and the Child Feeding Questionnaire.
Timepoint: 2 follow-up timepoints.
Information about body weight, height, age, sex and a sociometric questionnaire concerning class mates.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc Kris Bevelander|
|- CONTACT for SCIENTIFIC QUERIES||MSc Kris Bevelander|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Radboud Universiteit Nijmegen, Behavioural Science Institute|
|- Brief summary||Summary of imitation study:
Preadolescents are asked to perform a cover task in two different sessions in which the participant has to cooperate with a same-sex confederate and in which the participant has to work alone on a puzzle for 10 minutes.
In the first session, normal-weight confederates are secretly signaled by a buzzer to consume a large or small amount of M&Mís, or are asked to eat no M&Mís at all. Participants are overweight or normal-weight children, who are not class mates of the confederates.
In the second session the participant is alone with the puzzle and palatable food in order to investigate food intake without social influence.
In both experiments the participant's food intake is measured in grams. All studies take place at primary schools in The Netherlands.
|- Main changes (audit trail)|
|- RECORD||13-okt-2009 - 26-okt-2009|