NCT05862506 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Breheny K, Passmore S, Adab P, Martin J, Hemming K, Lancashire ER, Frew E
Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial. Int J Obes (Lond). 2020 Apr;44(4):812-822. doi: 10.1038/s41366-019-0511-0. Epub 2020 Jan 28.
Brustio PR, Mulasso A, Marasso D, Ruffa C, Ballatore A, Moise P, Lupo C, Rainoldi A, Boccia G
The Daily Mile: 15 Minutes Running Improves the Physical Fitness of Italian Primary School Children. Int J Environ Res Public Health. 2019 Oct 15;16(20):3921. doi: 10.3390/ijerph16203921.
Chesham RA, Booth JN, Sweeney EL, Ryde GC, Gorely T, Brooks NE, Moran CN
The Daily Mile makes primary school children more active, less sedentary and improves their fitness and body composition: a quasi-experimental pilot study. BMC Med. 2018 May 10;16(1):64. doi: 10.1186/s12916-018-1049-z.

Effects of the Daily Mile Program on Health - Related Physical Fitness and Sleep Quality in Overweight/Obese Schoolchildren: a Non- Randomized Clinical Trial

Details for clinical trial NCT05862506

Clinical trial NCT05862506 - References