NCT01503281 - 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)

Conwell LS, Trost SG, Spence L, Brown WJ, Batch JA
The feasibility of a home-based moderate-intensity physical activity intervention in obese children and adolescents. Br J Sports Med. 2010 Mar;44(4):250-5. doi: 10.1136/bjsm.2008.046359. Epub 2008 May 7.
Deforche B, De Bourdeaudhuij I, Debode P, Vinaimont F, Hills AP, Verstraete S, Bouckaert J
Changes in fat mass, fat-free mass and aerobic fitness in severely obese children and adolescents following a residential treatment programme. Eur J Pediatr. 2003 Sep;162(9):616-22. Epub 2003 Jun 13.
Watts K, Jones TW, Davis EA, Green D
Exercise training in obese children and adolescents: current concepts. Sports Med. 2005;35(5):375-92. Review.

Effects of Group Vs. Home-Based Combined Exercise-Diet Program In Childhood Obesity: A Randomised Controlled Trial

Clinical trial NCT01503281 - References