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Step up against dementia: fitbit app aims to boost walking in middle age

NCT ID NCT05826379

Prevention Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether a smartphone app that sets daily step goals can help middle-aged adults (30-70 years old) who are overweight walk more. Participants use a Fitbit and receive adaptive goals to increase light physical activity. The goal is to see if this simple approach can improve adherence to walking, which may help prevent Alzheimer's disease and related dementias later in life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adaptive daily goal setting via Fitbit app
What this could lead to
If successful, this approach could offer a simple, low-cost way to increase physical activity and potentially reduce the risk of Alzheimer's and related dementias in at-risk adults.
What could go wrong
This is an early-stage behavioral study, not a treatment trial. It focuses on adherence to walking, not directly on preventing dementia, so any impact on cognitive health is uncertain and may take years to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight Sedentary Behavior Self-Control

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive health Overweight and obesity Physical inactivity Self regulation Walking

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.