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5 Behavioral Change Techniques for Inactivity

Phase 1

Waitlist Available

Led By Karina Davidson, PhD, MASc

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up steps will be assessed continuously via worn activity tracker and step counts will be reported daily. step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in).

Awards & highlights

Study Summary

This trial is testing whether a multi-component behavior change intervention can increase physical activity levels in people at elevated risk for cardiovascular disease who are already taking statins. The intervention will be delivered in different doses (1-10 weeks) to different groups of 3 people, and the minimum effective dose will be defined as the shortest amount of time (in weeks) required to produce an increase in physical activity in 80% of the participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ steps will be assessed continuously via worn activity tracker and step counts will be reported daily. step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~steps will be assessed continuously via worn activity tracker and step counts will be reported daily. step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in).

This trial's timeline: 3 weeks for screening, Varies for treatment, and steps will be assessed continuously via worn activity tracker and step counts will be reported daily. step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Success or failure for change in Daily Steps.

Secondary outcome measures

Within-person change in Daily Steps.

Within-person change in Discrepancy in Behavior.

Within-person change in Environmental Context and Resources.

+4 more

Other outcome measures

Between-person heterogeneity in Treatment Response.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Dose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5 Behavioral Change Techniques

2022

Completed Phase 1

~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,017,021 Total Patients Enrolled

1 Trials studying Inactivity

104 Patients Enrolled for Inactivity

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,891 Total Patients Enrolled

Karina Davidson, PhD, MAScPrincipal InvestigatorNorthwell Health

6 Previous Clinical Trials

594 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of this research project?

"Affirmative. The clinical trial's website on clinicaltrials.gov reports that this research project, which was initially listed on March 22nd 2022, is now seeking to include 42 participants at a single medical site."

Answered by AI

Are the 5 Behavioral Change Techniques a secure way to promote personal transformation?

"The safety rating assigned to the 5 Behavioral Change Techniques is 1 due to a lack of existing clinical data that demonstrate efficacy and safety."

Answered by AI

Are there any opportunities for participants to join the experiment at this time?

"Affirmative, the clinical trial is currently recruiting. According to information on clinicaltrials.gov, which was last updated on May 17th 2022, 42 participants are needed at 1 specific site and it has been posted since March 22nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A BCT Intervention for Physical Activity Among Individuals on Statins

2022. "A BCT Intervention for Physical Activity Among Individuals on Statins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05273723.