An interventional study of Adaptive Daily Goal Setting and Interim Goal Prompt in Physical Inactivity, Walking and Cognitive Health, sponsored by Milton S. Hershey Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Basic science
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria*:
Note: The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study. These details will be added after study closure.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the adaptive daily step goal mHealth intervention
Behavioral: Adaptive Daily Goal Setting
Participants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day
Behavioral: Adaptive Daily Goal Setting · Behavioral: Interim Goal Prompt
Daily step goals displayed by the study application
Short-term step goals
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).
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
Started Mar 2024 (actual). Primary completion is estimated for May 2027, 38 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 38 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Milton S. Hershey Medical Center →