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Can a fitness tracker and online coaching prevent heart disease?

NCT ID NCT04743856

Prevention Sponsor: University of Pittsburgh 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a 1-year online program designed to help adults aged 40-70 who are at risk for heart disease become more physically active. Participants either received a fitness tracker plus online coaching and goal-setting sessions, or just a fitness tracker with standard activity guidelines. The goal was to see if the coaching program helped people increase their step counts and meet weekly exercise targets better than the tracker alone.

What this could mean

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

Active substance
behavioral intervention (online coaching and physical activity tracker)
What this could lead to
If successful, this approach could offer a practical way for doctors to help patients prevent heart disease through increased physical activity.
What could go wrong
This was a small, completed study with only 54 participants, so results may not apply to everyone. The intervention required internet access and English literacy, limiting who can benefit.

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

54 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2024

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

40 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: * Age 40-70 years of age * Low physical activity (PA) levels (\<150 minutes/week) * At least one of the following common cardiometabolic risk factors: * high blood pressure:\> 129 mm hg SP or \>89 mm hg DP or medication * high fasting glucose:\>100 mg/dl or high HbA1c: ≥42 mmols/mol or medication * overweight/ obesity: BMI ≥25 kg/m2). * Have access to the internet * Able to read English at a 6th grade level * Have primary care provider (PCP) permission to increase physical activity without supervision. Exclusion Criteria: * Have participated in a physical activity intervention program with behavior tracking and goal setting in the past year. * Told by a physician that they have diabetes (other than previous gestational diabetes) or have received a diagnosis of cardiovascular disease, regardless of when. * Pregnant or planning a pregnancy in \<12 months * Non-ambulatory or planning a procedure that will lead to not being ambulatory in \<12 months. * Women who become pregnant during the study will be required to get an updated referral form from their primary care provider (PCP) stating that they are able to increase their physical activity without supervision .

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Conditions

The condition(s) this trial relates to.

hypertensive disorder Motor Activity Obesity obesity disorder prediabetes syndrome Sedentary Behavior cardiovascular disorder prevention target

As listed by the trial registrant

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

Blood pressure Cardiovascular risk factor Obesity Physical inactivity Prediabetes

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261, United States

More trials for these conditions

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