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Supplementary Material 5 OnePlus Subproject Title: A Cluster Randomized Controlled Trial (CRT) of the OnePlus (Dose for Adjustment for Normal Eating) intervention: A lifelong approach to promote effective
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Start by reading the instructions and guidelines for filling out the protocol-for-a-cluster-randomised-controlled-trial-of-form.
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Gather all the necessary information and data related to the cluster randomised controlled trial.
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Begin by filling out the basic details of the trial such as the title, trial ID, and contact information.
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Provide a brief background and rationale for the trial, explaining the research question and objectives.
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Clearly describe the study design, including information on how clusters will be selected and randomized.
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Outline the interventions or treatments being compared and provide details on the methods of implementation.
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Specify the primary and secondary outcome measures that will be evaluated during the trial.
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Include details on the sample size calculation and describe the recruitment and consent process for participants.
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Provide a comprehensive description of the data collection methods and instruments that will be used.
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Outline the statistical methods that will be employed for data analysis and specify any interim or subgroup analyses.
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Describe the potential risks and benefits associated with participating in the trial, along with the ethical considerations.
12
Include a detailed timeline for the trial, outlining the various stages and milestones.
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Finally, review the completed protocol-for-a-cluster-randomised-controlled-trial-of-form for accuracy and completeness before submission.

Who needs protocol-for-a-cluster-randomised-controlled-trial-of-form?

01
Researchers who are planning to conduct a cluster randomised controlled trial require the protocol-for-a-cluster-randomised-controlled-trial-of-form.
02
Funding agencies and ethics committees often require the protocol to assess the scientific and ethical validity of the trial.
03
Healthcare professionals and clinicians may need the protocol to understand the study design and interventions being evaluated.
04
Journal editors may request the protocol to verify the pre-specified objectives and methods of the trial.
05
Regulatory authorities may require the protocol to evaluate the safety and efficacy of the interventions being studied.

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The protocol for a cluster randomised controlled trial (cRCT) is a detailed plan that outlines the objectives, design, methodology, statistical considerations, and organization of the trial. It guides researchers and participants in understanding how the study will be conducted.
Researchers or study sponsors conducting a cluster randomised controlled trial are required to file the protocol form. This typically includes academic institutions, clinical research organizations, and other entities involved in the trial.
To fill out the protocol form, researchers should follow the provided guidelines which usually include sections for the trial’s objectives, methodology, participant criteria, data collection methods, statistical analysis plans, and ethical considerations. Clarity, precision, and compliance with regulatory standards are essential.
The purpose of the protocol form is to ensure that the trial is conducted rigorously and ethically, promoting transparency and reproducibility. It serves as a reference for regulatory bodies, ethical review boards, stakeholders, and participants.
The information that must be reported includes the study title, objectives, design, methodology, statistical analysis plan, participant inclusion/exclusion criteria, ethical considerations, timelines, and funding sources.
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