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NCT05273723 · ClinicalTrials.gov registry record · Phase 1
A BCT Intervention for Physical Activity Among Individuals on Statins
A Phase 1 study of Insufficient Physical Activity, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT05273723: Completed Phase 1 study of Insufficient Physical Activity, sponsored by Northwell Health.
NCT05273723 is a Phase 1 study of Insufficient Physical Activity that has completed, run by Northwell Health. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05273723, a Phase 1 study of Insufficient Physical Activity, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week baseline run-in period where PA levels will be measured using Fitbit wearable device. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a successful PA increase between the run-in and the follow-up periods (defined as walking an extra 2,000 more steps per day).
Primary Outcome
Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Average daily steps in the follow-up period will be compared to average daily steps in the run-in period. If the average steps in follow-up are 2,000 steps per day greater than during run-in, the outcome for the Time-to-Event Continual Reassessment Method (TiTE-CRM) will be judged successful.
Conditions Studied
Interventions
- BEHAVIORAL 5 Behavioral Change Techniques
Study Locations (1)
New York
- Institute of Health System Science - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 1 |
What the finished NCT05273723 record still lists
NCT05273723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Insufficient Physical Activity appearing as the primary indexed condition, and to 1 intervention - of which 5 Behavioral Change Techniques is the first listed.
NCT05273723 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05273723 about?
NCT05273723 is a clinical study titled "A BCT Intervention for Physical Activity Among Individuals on Statins". The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The...
What is the current status of trial NCT05273723?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2022-03-22. Estimated completion is 2023-07-28.
What conditions does trial NCT05273723 study?
This clinical trial studies the following conditions: Insufficient Physical Activity.
What interventions are being tested in trial NCT05273723?
The interventions under investigation include: 5 Behavioral Change Techniques (BEHAVIORAL).
Who is sponsoring clinical trial NCT05273723?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05273723 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05273723's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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