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 |