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Can a fitness tracker help smokers kick the habit for good?

NCT ID NCT06629467

Disease control Sponsor: University of Oviedo 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether adding a Fitbit activity tracker to standard cognitive-behavioral therapy (CBT) helps people quit smoking more effectively than CBT alone. Adult smokers who smoke at least 10 cigarettes per day will be randomly assigned to either CBT plus a Fitbit or CBT only. Researchers will measure quit rates, physical activity levels, sleep quality, and mental health outcomes to see if the tracker provides an extra boost.

What this could mean

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

Active substance
cognitive-behavioral therapy plus a Fitbit activity tracker
What this could lead to
If it works, this could point toward a more effective, tech-enhanced approach to smoking cessation that also boosts physical activity.
What could go wrong
This is a small, early feasibility study, so results may not generalize. The added benefit of the tracker over therapy alone may be modest.

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

128 people

The number who actually took part.

Started

May 2023

Finished

Dec 2025

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Being aged 18 or over. * Smoking at least 10 cigarettes per day. Exclusion Criteria: * Being currently receiving other psychological or pharmacological treatment for smoking cessation. * Being diagnosed with substance use disorder or severe psychiatric disorder. * Active suicidal ideation.

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Conditions

The condition(s) this trial relates to.

Motor Activity Tobacco Use Cessation

As listed by the trial registrant

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

Physical activity Tobacco use cessation

Contacts and locations

Locations

  • Clinical Unit of Addictive Behaviors

    Oviedo, Principality of Asturias, 33003, Spain

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