|- candidate number||21823|
|- NTR Number||NTR5043|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mrt-2015|
|- Secondary IDs||NA |
|- Public Title||FitSupport; leefstijlverbetering bij supporters|
|- Scientific Title||Implementation of a gamified online lifestyle intervention by Dutch professional soccer organisations |
|- hypothesis||The main objective of the FitSupport study is to include 3000 supporters of the soccer clubs into the intervention through two different inclusion strategies; one digital and one personal recruitment strategy. These participants will be divided in two groups; one using a normal intervention and the second using a gamified intervention. Our hypothesis is that the gamified intervention will be more effective in changing lifestyle behaviour. |
|- Healt Condition(s) or Problem(s) studied||Life style, Prevention, Cognition, Gaming, E-health|
|- Inclusion criteria||1. Regular Internet access|
2. Electronic informed consent
|- Exclusion criteria||1. Inability to understand the Dutch language|
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||31-dec-2016|
|- Target number of participants||3000|
|- Interventions||The Fit Support website provides participants with an overview of current lifestyle, and stimulates healthy behavior change over time in a feasible and structured manner using applied gaming techniques to improve intervention adherence and effectiveness.|
|- Primary outcome||1. How many people did we reach?|
2. How many became participants?
3. How long did they remain participants?
4. Qualitative rating of the intervention by participants
|- Secondary outcome||1. Lifestyle change as measured with self-reported, validated questionnaires|
2. Cognition, as measured with the BrainAgingMonitor Cognitive Assessment Battery
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Teun Aalbers|
|- CONTACT for SCIENTIFIC QUERIES|| Teun Aalbers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Nationaal Preventie Programma|
|- Brief summary||Rationale:|
Lifestyle improvement has proven very effective in English and Scottish Premier League soccer club initiatives to target hard-to-reach populations.
Implement a lifestyle eHealth intervention amongst the supporters of three Dutch professional soccer teams. Recruiting 3000 participants into the intervention program, half of them using a non-gamified intervention and the other half using a gamified intervention.
The FitSupport is a six months online, individually tailored lifestyle intervention. Aiming for six pillars of lifestyle change for which the literature suggests that these effect cognitive functioning. These pillars are physical activity, nutrition, smoking, alcohol consumption, sleep, and stress. In order to measure cognitive functioning online we developed a new online self monitor for cognitive functioning called the Brain Aging Monitor Cognitive Assessment Battery (BAM-COG), which has been validated in a healthy aging population. FitSupport first screens and compares current lifestyle to references that have been published by governmental institutions for public health in terms of physical activity norms, healthy diets, smoking recommendations, alcohol consumption, sleep patterns, and stress coping. After which FitSupport will measure cognition with the BAM-COG. Based on these measurements participants will set personally relevant behaviour change goals using Goal Attainment Scaling. Once the goals have been set the participant will be provided with several tool and tips on how to accomplish their goals and provided with a program they can follow to accomplish their goals. Participants are able to set their own reminder system on how frequently they want to be reminded about taking part in the program. To monitor progress a visually attractive way of presenting progress is used. The site is updated with the latest scientific information and breakthroughs on the subject of brain research, healthy living, and the psychology of behavior change. Furthermore, there are and messages by the fysiotherapists, coaches and players of the different soccer clubs to motivate participants. At 6 and, if participants want to enlengthen their participation, 12 months into the program the baseline measurement will be performed again to track lifestyle changes and cognition changes. Participants who will be recruited in the second stage of the research will have additional gaming elements available to them to keep them motivated to participate.
|- Main changes (audit trail)|
|- RECORD||19-mrt-2015 - 18-apr-2015|