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Table 4 Summary of analysis 2 – long-term effectiveness

From: The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan

Objective

Main methods

Analysts and timing*

Journal submit

Determine the effect of the AFLY5 intervention on primary outcomes assessed 12 months after the end of the intervention

ITT analysis

DAL LH TJP

Dec 2013 – Feb 2014

May 2014

Multivariable multi-level linear regression (continuously measured outcomes), with adjustment for baseline variables.

Determine the effect of the AFLY5 intervention on secondary outcomes assessed 12 months after the end of the intervention

ITT analysis

DAL

Dec 2013 – Feb 2014

May

2014

Multivariable multi-level linear (continuously measured outcomes) or logistic (binary) regression, with adjustment for baseline variables.

LH

TJP

Determine the effect of the AFLY5 intervention on change in primary outcomes between the baseline and the longer-term follow-up, including examining whether change in outcome between baseline and immediate follow-up differs from change in outcome between immediate and long-term follow-up.

ITT analysis

DAL

Dec 2013 – Feb 2014

May 2014

Multivariable multi-level repeat measures linear regression, with adjustment for baseline variables.

LH

TJP

Determine the effect of the AFLY5 intervention on change in secondary outcomes between the baseline and the longer-term follow-up, including examining whether change in outcome between baseline and immediate follow-up differs from change in outcome between immediate and long-term follow-up

ITT analysis

DAL

Dec 2013 –Feb 2014

May 2014

 

Multivariable multi-level repeat measures linear regression (continuously measured outcomes) and multivariable multi-level logistic regression (binary outcomes), with adjustment for baseline variables

LH TJP

  
  1. * These are as planned at the time of writing this document.