The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.
The study is designed to examine the efficacy of a Fitbit-based, goal setting, mHealth intervention to increase light intensity physical activity. The study design is a 2-arm randomized controlled trial. Both groups will receive the underlying goal-setting intervention (adaptive daily step goals). The study involves 3 phases: a run-in ("calibration") phase, the intervention ("training") phase, and follow-up (1- and 12-months post-intervention). To support goal maintenance our team has developed a Fitbit application designed to operate on the Fitbit Versa series watch as a 'clockface'. The application will first calibrate participants' average level of physical activity by recording daily step counts for a period of 14 days (calibration phase). After this period (and following a health education session) the application will begin delivering the underlying intervention to both treatment and control groups for a period of 1 month. The intervention is composed of daily step goals presented via the Fitbit clockface. Each day the application will suggest a daily step goal. The algorithm used to make these suggestions relies on the participant's own activity during the calibration period and is updated each day in study, ensuring all proposed step goals are within their existing repertoire. Follow-up assessments will be completed at 1- and 12-monts post-intervention. Outcomes and moderators will be measured via activity monitors (the Fitbit application and activPals), surveys, and ecological momentary assessments (self-ratings and performance-based ambulatory cognitive assessments) conducted via the Mobile Monitoring of Cognitive Change ("M2C2") platform. Some of the details of the intervention, algorithm, experimental manipulations, and outcomes have been omitted to preserve the scientific integrity of the study. These details will be added after the study is closed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
200
Daily step goals displayed by the study application
Short-term step goals
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Short-term adherence
Average of 14-day step count totals collected via ActivPal monitors
Time frame: 1-month follow-up
Long-term adherence
Average of 14-day step count totals collected via ActivPal monitors
Time frame: 12-month follow-up
Self-Monitoring Behavior
Number of times participant checks their step count progress per day
Time frame: Daily during intervention period
Change in Cognitive Health (Processing Speed)
Change in performance on ambulatory cognitive assessments of processing speed (response time during the "Symbol Search" task). This task is administered twice daily (2 "sessions" per day) throughout the 2-week, baseline "calibration phase" and twice daily throughout the 2-week, 12-month follow-up phase. The outcome to be modeled is median response time to trials administered during each session. Aggregation of data collected over these 2-week data collection periods will be model-based (in other words, all 'session' data will be modeled nested within phase, within persons).
Time frame: Change in mean performance between the 2-week calibration phase and 12-month follow-up
Change in Cognitive Health (Working Memory Binding)
Change in performance on ambulatory cognitive assessments of working memory binding (corrected recognition rate during the "Color Shapes" task). This task is administered twice daily (2 "sessions" per day) throughout the 2-week, baseline "calibration phase" and twice daily throughout the 2-week, 12-month follow-up phase. The outcome to be modeled is corrected recognition rate (hit rate minus false alarm rate) for trials administered during each session. Aggregation of data collected over these 2-week data collection periods will be model-based (in other words, all 'session' data will be modeled nested within phase, within persons).
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Time frame: Change in mean performance between the 2-week calibration phase and 12-month follow-up
Change in Self-Efficacy for light intensity physical activity
Self-efficacy for exercise scale (adapted to light intensity physical activity; range 0-90 points; higher scores reflect better outcomes)
Time frame: Change between pre-enrollment baseline survey and end of training phase (an average of 2 months)
Executive Control (Working Memory Capacity)
Performance on ambulatory cognitive assessments of working memory capacity (span score during the "Rotation Span" task). This task is administered twice daily (2 "sessions" per day) during the last 2 weeks of the "training phase". The outcome to be modeled is the total recalled arrows across the 3 trials assessed during each session. Data will not be aggregated, but instead modeled as a time-varying covariate.
Time frame: Twice daily during the final 2 weeks of the training phase
Executive Control (Inhibitory Control)
Performance on ambulatory cognitive assessments of inhibitory control (commission errors during the "Go/NoGo" task). This task is administered twice daily (2 "sessions" per day) during the last 2 weeks of the "training phase". The outcome to be modeled is the total commission errors across the trials assessed during each session. Data will not be aggregated, but instead modeled as a time-varying covariate.
Time frame: Twice daily during the final 2 weeks of the training phase