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NCT04445740 · ClinicalTrials.gov registry record · NA
The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT04445740: Completed NA study, sponsored by Baylor College of Medicine.
NCT04445740 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445740, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study Summary
This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the intervention. This will ensure that all aspects of the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and retain participants, 2) deliver the intervention, 3) implement study and assessment procedures 4) assess the reliability of the proposed measures in this sample, 5) determine whether modifications to the intervention, procedures, and measures are needed prior to conducting a fully powered study, and 6) willingness of participants to participate in the intervention.
Primary Outcome
The feasibility of the intervention will be established by our ability to recruit the needed sample size and retain at least 80% at Time 1 and 60% at Time 3; favorable acceptability ratings by 80% of the sample, participation in greater than 60% of daily diaries, views of intervention materials by 80% of participants. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews. Decisions regarding changes to the inte
Interventions
- BEHAVIORAL i♥rhythm project
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-08-18 |
| Phase | NA |
What the finished NCT04445740 record still lists
NCT04445740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which i♥rhythm project is the first listed.
NCT04445740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04445740 about?
NCT04445740 is a clinical study titled "The i Heart Rhythm Project: Healthy Sleep and Behavioral Rhythms for Obesity Prevention". This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the intervention. This will ensure that all aspects of the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The p...
What is the current status of trial NCT04445740?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2021-03-15. Estimated completion is 2023-08-18.
What interventions are being tested in trial NCT04445740?
The interventions under investigation include: i♥rhythm project (BEHAVIORAL).
Who is sponsoring clinical trial NCT04445740?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04445740's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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