Physical InactivityNCT05826379
Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife
A study testing Adaptive Daily Goal Setting and Interim Goal Prompt in people with Physical Inactivity and Walking, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Walking, Cognitive Health
- What is being tested?
- Adaptive Daily Goal Setting and Interim Goal Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 30 and 70 years of age
- BMI ≥ 25
Who cannot join
- Clinical diagnosis of ADRD or other neurodegenerative disease
- Health condition contraindicated for increased physical activity
- Medical conditions or medications that would prohibit participation in an exercise test (e.g., decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndromes)
- Limitations in use of a smart phone (e.g., issues with manual dexterity or visual impairment)
- Inability to walk unassisted
- BMI > 50
Show all 12Show fewer
- Plan to have surgery or other procedure over the next 12 months that could affect mobility or light intensity physical activity maintenance
- Concurrent participation in a weight loss, physical activity, or cognitive training trial
- Failure to comply with Run-in Period activity monitoring (<70% valid wear days for the Fitbit and activPal)
- Anyone who will not discontinue the use of their own personal smartwatch during the training period.
- Anyone who scores below 19 on the MoCA-B would not be randomized after the Run-in Calibration Period.
- Note: The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study. These details will be added after study closure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias (ADRD)
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.
Read the detailed description
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.
- Being tested
- Adaptive Daily Goal Setting, Interim Goal Prompt
- Medical subject headings
- Sedentary Behavior, Self-Control, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Daily Goal SettingBehavioural
Daily step goals displayed by the study application
Interim Goal PromptBehavioural
Short-term step goals
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants receive the adaptive daily step goal mHealth intervention Receives: Behavioral: Adaptive Daily Goal Setting |
| Treatment | Experimental | Participants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day Receives: Behavioral: Adaptive Daily Goal Setting; Behavioral: Interim Goal Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term adherence
Average of 14-day step count totals collected via ActivPal monitors
Measured: 1-month follow-up
Long-term adherence
Average of 14-day step count totals collected via ActivPal monitors
Measured: 12-month follow-up
Secondary outcomes (6)
Self-Monitoring Behavior
Number of times participant checks their step count progress per day
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Twice daily during the final 2 weeks of the training phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 Mar 2024
- Primary completionMay 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Jonathan G Hakun, PhD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826379
- Sponsor's protocol ID
- STUDY00022087
- Other IDs
- R61AG078084
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias (ADRD)
- ClinicalTrials.gov ID
- NCT05826379
- Acronym / sponsor ID
- STUDY00022087
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Adaptive Daily Goal SettingParticipants receive the adaptive daily step goal mHealth intervention |
| Treatment | Experimental | Behavioral: Adaptive Daily Goal Setting, Behavioral: Interim Goal PromptParticipants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 30 and 70 years of age
- BMI ≥ 25
Key exclusion criteria (12 listed)
- Clinical diagnosis of ADRD or other neurodegenerative disease
- Health condition contraindicated for increased physical activity
- Medical conditions or medications that would prohibit participation in an exercise test (e.g., decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndromes)
- Limitations in use of a smart phone (e.g., issues with manual dexterity or visual impairment)
- Inability to walk unassisted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Daily Goal SettingDaily step goals displayed by the study application | Behavioural | Control, Treatment |
| Interim Goal PromptShort-term step goals | Behavioural | Treatment |
Primary outcome
Short-term adherence
Time frame: 1-month follow-up
Average of 14-day step count totals collected via ActivPal monitors
Long-term adherence
Time frame: 12-month follow-up
Average of 14-day step count totals collected via ActivPal monitors
6 secondary outcomes
Self-Monitoring Behavior
Time frame: Daily during intervention period
Change in Cognitive Health (Processing Speed)
Time frame: Change in mean performance between the 2-week calibration phase and 12-month follow-up
Change in Cognitive Health (Working Memory Binding)
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
Time frame: Change between pre-enrollment baseline survey and end of training phase (an average of 2 months)
Executive Control (Working Memory Capacity)
Time frame: Twice daily during the final 2 weeks of the training phase
Executive Control (Inhibitory Control)
Time frame: Twice daily during the final 2 weeks of the training phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan G Hakun, PhD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Daily Goal Setting and Interim Goal Prompt in people with Physical Inactivity and Walking, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term adherence (time frame: 1-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.