|- candidate number||25461|
|- NTR Number||NTR6115|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-okt-2016|
|- Secondary IDs||ECSW2016-0905-403 |
|- Public Title||Prevention of Overweight in Children at Schools: ‘Born to Move’ and ‘Share H2O’.|
|- Scientific Title||Physical Activity and Water Consumption Interventions Combined: The Effects of Born to Move and Shared H2O in the Prevention of Overweight in Children.|
|- hypothesis||Childhood obesity is an important public health problem. Replacing Sugar Sweetened Beverages by the consumption of water and systematically increasing physical activity levels are promising health behavioral changes that may prevent childhood obesity. Peers are important in influencing health behaviors and are used in this study to stimulate water consumption (Share H2O intervention) and physical activity levels (Born to Move intervention). In a randomized controlled trial with four different conditions (a detailed description of both the interventions and the conditions can be found below) we will examine the effectiveness of these interventions in the prevention of childhood obesity.|
- The physical activity and physical activity enjoyment of the children will increase as a result of the physical activity intervention Born to Move.
- The sugar sweetened beverages consumption of the children will decrease and the water consumption of the children will increase as a result of the water intervention Shared H2O.
- BMI and fat percentage of the children will decrease as a result of both intervention.
- The combination of both intervention will be more effective than either one of these interventions in the prevention of overweight in children.
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity, Drinking water, Sugars, Physical activity|
|- Inclusion criteria||- Dutch elementary schools|
- Children within the age of 7 and 11 years old
|- Exclusion criteria||- Children following special education|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2016|
|- planned closingdate||23-apr-2017|
|- Target number of participants||180|
|- Interventions||In this study four schools will be randomly assigned to one of four conditions: (1) Combination of the Born to Move program and the Share H2O intervention, (2) Born to Move program, (3) Share H2O intervention, and (4) no intervention (control). Share H2O is an intervention based on social networks and uses peer influences to stimulate children’s water consumption. Through peer nominations, influential peers will be selected, who will then be trained in the advantages of drinking water and asked to stimulate their classmates to drink more water. A pilot study has found promising results with increased water consumption and decreased sugar-sweetened beverages consumption. The Born to Move is a newly developed sports program for children by the sports organization Les Mills and based on scientific research. This program is a 50 minute workout on age appropriate music and consists of a broad range of movements. Promising results have been found in both New Zealand and England with increased physical activity and physical activity enjoyment of the participating children. A peer component, similar to the influential peers in the Share H2O intervention, with popular peers potentially influencing physical activity levels through extra Born to Move activities at and outside school is added to the Born to Move condition. The same peers of the Share H2O intervention will be used in the condition with both the Born to Move program and the Share H2O intervention.|
|- Primary outcome||- BMI (kg/m2)|
- Fat Percentage
|- Secondary outcome||- Demographic information|
- Physical fitness
- Physical activity enjoyment
- Physical activities outside school
- Descriptive norms physical activity and water consumption
- Enjoyment and intensity regular school sports hours and - Born to Move lessons
- Peer nominations
- Sugar-sweetened beverages consumption
- Water consumption
- Eating behaviour
- Difficulty identifying feelings
|- Timepoints||All primary and secondary outcomes will be measured at baseline (November 2016), prior to the intervention period, and after the intervention period (March/April 2017). The secondary outcomes ‘water consumption’ and ‘SSBs consumption’ will also be measured during the intervention period with a short questionnaire. |
BMI and fat percentage will be measured using a weighing scale (Omron) and length measure.
Physical fitness will be measured with the shuttle run test.
All other secondary outcomes will be measured using a questionnaire.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marloes Polman|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Junilla Larsen|
|- Sponsor/Initiator ||Behavioural Science Institute, Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|Behavioural Science Institute, Radboud University Nijmegen|
|- Brief summary||The growing prevalence of overweight in children and the associated increased risk of developing serious health problems show the importance of the prevention of overweight/obesity in children. Replacing Sugar Sweetened Beverages by the consumption of water and systematically increasing physical activity levels are promising health behavioral changes that may prevent childhood obesity. Peers are important in influencing health behaviors and are used in this study to stimulate water consumption (Share H2O intervention) and physical activity levels (Born to Move intervention).|
Share H2O is an intervention based on social networks and uses peer influences to stimulate children’s water consumption. Therefore, the Share H2O intervention tackles the component of energy intake by using influential peers to drink more water and thus set a descriptive norm of drinking water. The Born to Move is a newly developed sports program for children by the fitness organization Les Mills. It tackles the component of physical activity by increasing the children’s enjoyment of physical activity. This intervention will also be combined with the influential peers to set a descriptive norm of being more physically active.
In November 2016, baseline measurements will start. During these measurements the children will be asked to complete a short questionnaire about physical activity and the consumption of water and sugar-sweetened beverages and to participate in a fittest. In addition, children’s height, weight, and fat percentage will be measured. After the baseline measurements, an intervention period of four months will start. In this period, four school will randomly be assigned to one of four conditions: (1) both interventions, (2) physical activity intervention, (3) water intervention, (4) control condition. From each school, two classes will participate, with children in the ages of 7 to 11 years old. In the physical activity intervention the regular school sports hours of the children will be replaced by Born to Move lessons. Moreover, the influential peers will get a training about the importance of physical activity and will be asked to stimulate their classmates in practicing the Born to Move steps outside the lessons. In the water intervention, the influential peers will get a training about the importance of drinking and will be asked to stimulate their classmates to drink more water, after which all children will receive a plastic water bottle. In the ‘both interventions condition’ the influential peers will be asked to stimulate both healthy behaviours. After four months, the post measurements will start, which are similar to the baseline measurements.
|- Main changes (audit trail)|
|- RECORD||27-okt-2016 - 11-dec-2016|