|- candidate number||23997|
|- NTR Number||NTR5755|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-feb-2016|
|- Secondary IDs||1) SAS-2014-01236, 2) 2015-1931 1) Provincie Limburg, 2) CMO regio Arnhem-Nijmegen|
|- Public Title||Strengthening parenting styles and practices in the existing intervention KERNgezond to prevent overweight and obesity in children.|
|- Scientific Title||Strengthening parenting styles and practices in the existing intervention KERNgezond to prevent overweight and obesity in children, a cluster randomized controlled study.|
|- ACRONYM||ELVO 3 Study|
|- hypothesis||We hypothesized that 5 and 12 months after baseline measurements were collected, the children of parents
who received the e-learning program would i) have a healthier diet (e.g., they eat more vegetables and fruits, have breakfast more often, and drink fewer sweetened
beverages); ii) be less sedentary (e.g., will engage in a lower amount of screen-viewing time); and iii) have a
higher level of physical activity compared to both their baseline values and the control group.
Other objectives of the e-learning program include strengthening parenting styles (parents use more often an authoritive parenting style), improving parenting practices (parents sets more rules regarding healthy diet and physical activity, are better role models and monitor better dietary and physical activity behaviours of their child), and increasing parental self-efficacy.
|- Healt Condition(s) or Problem(s) studied||Obesity, Children|
|- Inclusion criteria||Parents of children from group 6 and 7 from primary schools, who participate in the already excisting programme 'KERNgezond' in the nothern part of province Limburg, in the Netherlands. The inclusion criteria for the children are that their parents participate in our research.|
|- Exclusion criteria||Insufficient understanding of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||1-dec-2016|
|- Target number of participants||322|
|- Interventions||Interventiongroup: |
Parents who receive a folder and the E-learning module “Making a healthy deal with your child” about how to stimulate their child to eat healthy and have enough physical activity and less inactivity using parenting skills.
Parents who receive only a folder about healthy eating and physical activity for children.
|- Primary outcome||Changing dietary and physical activity behaviour in children The differences (between the intervention group and the control group) in changes in dietary and physical activity behaviour of children between baseline and t=1 and t=2. These dietary and physical activity behaviours are measured by questionnaires filled out by children and their parents. Variables are: having breakfast, eating fruit, eating vegetable, drinking sugar sweetened beverages, hours being physical active, hours of screen-time activities.|
|- Secondary outcome||1. Authoritative parentingstyle (general parenting);|
2. Parenting practices measured by: to set rules, modelling and monitoring of healthy eating and physical (in)activity;
3. Parental selfefficacy.
|- Timepoints||1. Baseline mearurements September-October 2015;|
2. End of the intervention March-April 2016;
3. 6 Months after the intervention: September 2016.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Emilie Ruiter|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Emilie Ruiter|
|- Sponsor/Initiator ||Behavioural Science Institute, Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|Province of Limburg|
|- Brief summary||The purpose of this cluster randomized controlled study is to investigate whether the dietary and physical activity behaviors of children between 9 and 12 years at the school participate in the intervention 'KERNgezond' is healthier if the parents of these children follow the E-learning “Making a healthy deal with your
child”, compared to children whose parents only receive a folder about healthy diet and physical activity.
In the E-learning we teach parents how they can encourage their child to have healthier dietary and physical activity behaviors and solving conflicts about these topics by using parenting skills and practices.|
|- Main changes (audit trail)|
|- RECORD||22-feb-2016 - 22-mei-2016|