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Title: Development of an Exergame to Deliver a Sustained Dose of HighIntensity Training: Formative Pilot Randomized Trial Document: Study Protocol NCT number: N/A Date: 19/03/2018Development of the
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A formative pilot randomized trial is a preliminary study designed to test and refine the processes of conducting a larger randomized trial. It helps in assessing feasibility, acceptability, and the overall methodology before the main trial.
Researchers or institutions conducting a formative pilot randomized trial are typically required to file the trial, especially if it involves human subjects and seeks funding or regulatory approval.
To fill out a formative pilot randomized trial, researchers must provide details regarding the study's design, objectives, methodology, participant criteria, and data collection methods, often using a standardized template provided by regulatory bodies.
The purpose of a formative pilot randomized trial is to identify potential issues in the trial design, refine intervention strategies, and evaluate the feasibility of the trial protocol before scaling up to a larger study.
Information that must be reported on a formative pilot randomized trial includes study objectives, design, methodology, participant demographics, data collection processes, and preliminary findings or conclusions.
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