|- candidate number||15228|
|- NTR Number||NTR4144|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2013|
|- Secondary IDs||NA |
|- Public Title||Een gezonder brein met de Brain Aging Monitor|
|- Scientific Title||Healthy Brain Aging with the Brain Aging Monitor|
|- hypothesis||The main objective of the Brain Aging Monitor study is to examine whether a two year online health-behavior change intervention can influence brain aging patterns in a population 40 years and older. Our hypotheses is that successful lifestyle change will result in different brain aging patterns.
To test the hypotheses participants that succesfully alter their behavior will be compared to unsuccesful participants on brain aging patterns.
|- Healt Condition(s) or Problem(s) studied||Life style, Dementia, Prevention, Healthy living, Cognitive aging|
|- Inclusion criteria||1. Age: 40 years and older|
2. Regular internet access
3. Electronic informed consent
|- Exclusion criteria||1. Inability to understand the Dutch language|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2012|
|- planned closingdate||1-jan-2015|
|- Target number of participants||200|
|- Interventions||The Brain Aging Monitor website provides participants with an overview of current lifestyle, and stimulates healthy behavior change over time in a feasible and structured manner. |
|- Primary outcome||Cognitive aging measured with the Brain Aging Monitor - Cognitive Assessment Battery (BAM-COG)|
|- Secondary outcome||Lifestyle change using Goal Attainment Scaling.
Absolute behavior change using standardized lifestyle questionnaires.
Self-efficacy using the Dutch General Self Efficacy Scale.
|- Trial web site||www.brainagingmonitor.nl |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Teun Aalbers|
|- CONTACT for SCIENTIFIC QUERIES|| Marcel Rikkert|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Nationaal Initiatief Hersenen & Cognitie (NIHC)|
|- Publications||T. Aalbers et al. Characteristics of effective Internet-mediated interventions to change lifestyle in people aged 50 and older: A systematic review. Ageing Research Reviews. 2011; 10: 487-497.
Letter to the editor:
T. Aalbers et al. (2013) The Mediterranean Diet as prevention strategy for dementia as a multicausal geriatric syndrome. American Journal of Clinical Nutrition|
|- Brief summary||Rationale:|
Cognitive decline is already measurable in people aged 45-49. So it becomes increasingly important and necessary to come up with scientifically validated ways in which we enable and train people how they can maintain normal levels of cognitive functioning for a longer period of time.
The main objective of the Brain Aging Monitor study is to examine whether a two year online health-behavior change intervention can influence brain aging patterns in a population 40 years and older.
The Brain Aging Monitor (BAM) is a two year 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.
The BAM 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 the BAM will measure cognition with the BAM-COG.
Based on these measurements participants will set themselves up in a goal setting module (using Goal Attainment Scaling) where they are guided to set their own realistic goals aiming for behavior change on those lifestyle pillars that they want to change.
Once the goals have been set the participant will be provided with several tool and tips on how to accomplish his 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 blogs by the researchers and participants, and healthy recipes are uploaded weekly.
At 12 and 24 months into the program the baseline measurement will be performed again to track lifestyle changes and cognition changes both halfway and at the end of the program.
Primary outcome measure:
The primary outcome measure is the Brain Aging Monitor Cognitive Assessment Battery.
|- Main changes (audit trail)|
|- RECORD||2-aug-2013 - 16-sep-2013|