Study protocol of the self-monitoring activity program: Effects of activity on incident dementia

INTRODUCTION: Numerous studies have focused on nonpharmacological interventions on cognitive function and the effects of cognitive function on daily living. However, effects of behavior change techniques that promote physical, cognitive, and social activities on cognitive function and incident dementia in the elderly are yet to be elucidated. In this study, we aimed to design a single-blind, randomized controlled trial to study dementia prevention effects of behavior change techniques, using an accelerometer and a newly developed daily activity booklet in community-living older adults. METHODS: The study cohort comprised 5390 individuals aged 65 years and older who were randomized into one of the following three groups: accelerometer group (n = 1508), accelerometer and daily activity booklet group (n = 1180), or a control group (n = 2702; vs. accelerometer group [n = 1509] vs. accelerometer and daily activity booklet group [n = 1193]). Incident dementia was diagnosed based on the Japanese Health Insurance System data. The participants without dementia at baseline, who are diagnosed with dementia over a 36-month follow-up period, are considered to have incident dementia. The participants of the accelerometer group were asked to wear the accelerometer everyday and visit a site having data readers to download the accelerometer data every month. The subjects of the booklet group were requested to not only wear the accelerometer but also record the physical, cognitive, and social activities. The participants receive a feedback report from the data of the accelerometer and booklet. DISCUSSION: The study has the potential to provide the first evidence of effectiveness of the self-monitoring tools in incident dementia. In case our trial results suggest a delayed dementia onset upon self-monitoring interventions, the study protocol will provide a cost-effective and safe method for maintaining a healthy cognitive aging.