Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife (NCT05826379) | Clinical Trial Compass
By InvitationNot Applicable
Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife
United States200 participantsStarted 2024-03-20
Plain-language 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.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria\*:
* Between 30 and 70 years of age
* BMI ≥ 25
Exclusion Criteria\*:
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.