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Can a short behavioral program get people on statins moving more?

NCT ID NCT05273723

Knowledge-focused Sponsor: Northwell Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests a multi-component behavioral intervention to find the minimum number of weeks needed to help adults on statin therapy increase their daily walking by 2,000 steps. Participants wear a Fitbit to track steps and receive techniques like goal setting, action planning, and feedback. The goal is to identify the smallest effective dose of the program that leads to lasting behavior change.

What this could mean

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

Active substance
Behavioral change techniques (goal setting, action planning, self-monitoring, feedback, prompts/cues)
What this could lead to
If successful, this could identify the shortest effective behavioral program to help people on statins become more active, potentially reducing heart disease risk.
What could go wrong
This is a small, early-phase pilot study (42 participants) designed to find the right dose, not to prove effectiveness. Results may not apply to broader populations.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

Mar 2022

Finished

Jul 2023

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

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: * Ages 18 or older; * Northwell Health employee/affiliate * Ambulatory without limitations: has never been advised by a clinician that increasing low-intensity walking would be unsafe; * Prescribed statin medication; * Self-reported low levels of physical activity * Access to and capable of using a smart cellular phone; * After 2 week run-in, objectively-verified low levels of physical activity as documented by a commercially available Fitbit device * English speaking. Exclusion Criteria: * Age less than 18 years; * Not a Northwell Health employee/affiliate * Non-ambulatory or unsafe/not recommended to participate in a walking program * Not prescribed statin medication; * History of CVD; * Inability to comply with study protocol during 2 week run-in; * Does not speak English; * Unavailable for follow-up; * Cognitive impairment; * Severe mental illness (e.g., bipolar disorder or schizophrenia); * Pregnancy

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Motor Activity

As listed by the trial registrant

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

Insufficient physical activity

Contacts and locations

Locations

  • Institute of Health System Science

    New York, New York, 10022, United States

More trials for these conditions

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