Obesity — Fitbit / Healthy Weight Management Study
Citation(s)
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Sjöström CD, Lissner L, Wedel H, Sjöström L Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention Study. Obes Res. 1999 Sep;7(5):477-84.
Smith BR, Schauer P, Nguyen NT Surgical approaches to the treatment of obesity: bariatric surgery. Endocrinol Metab Clin North Am. 2008 Dec;37(4):943-64. doi: 10.1016/j.ecl.2008.08.001. Review.
Thompson WG, Kuhle CL, Koepp GA, McCrady-Spitzer SK, Levine JA "Go4Life" exercise counseling, accelerometer feedback, and activity levels in older people. Arch Gerontol Geriatr. 2014 May-Jun;58(3):314-9. doi: 10.1016/j.archger.2014.01.004. Epub 2014 Jan 15.
Unick JL, O'Leary KC, Bond DS, Wing RR Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. ISRN Obes. 2012 Sep 5;2012. doi: 10.5402/2012/465158.
Wang J, Sereika SM, Chasens ER, Ewing LJ, Matthews JT, Burke LE Effect of adherence to self-monitoring of diet and physical activity on weight loss in a technology-supported behavioral intervention. Patient Prefer Adherence. 2012;6:221-6. doi: 10.2147/PPA.S28889. Epub 2012 Mar 22.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
