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The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical
Trials
|July 26, 2013
Summary
This study details the analysis plan for the Active For Life Year 5 (AFLY5) trial, evaluating its effectiveness and cost-effectiveness. The plan ensures unbiased results by pre-specifying analyses before data access.
Area of Science:
- Public Health
- Pediatric Health
- Health Services Research
Background:
- The Active For Life Year 5 (AFLY5) trial protocol was initially published in 2011.
- This document provides an updated, detailed analysis plan for the AFLY5 randomized controlled trial.
- The trial investigates an intervention aimed at improving physical activity in children.
Purpose of the Study:
- To outline a detailed analysis plan for the AFLY5 intervention's effectiveness and cost-effectiveness.
- To specify quality control procedures for variables and criteria for derived variables.
- To detail four key analyses: immediate effectiveness, mediation, long-term effectiveness, and cost-effectiveness.
Main Methods:
- The analysis plan details intention-to-treat and per-protocol analyses.
- Sensitivity analyses for handling missing data are described.
- Quality control checks and definitions for derived variables are specified.
Main Results:
- Effectiveness analysis 1 examines outcomes at the end of the intervention school year.
- Mediation analyses explore the roles of self-efficacy, parental support, and knowledge.
- Effectiveness analysis 2 and cost-effectiveness analysis assess longer-term impacts and value.
Conclusions:
- This analysis plan was finalized before data access and approved by the AFLY5 Trial Steering Committee.
- Publication ensures analyses align with a priori objectives, preventing data-driven adjustments.
- The plan promotes transparency and rigor in evaluating the AFLY5 intervention.
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