NCT03609463 - 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)

Fava GA
Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5.
Geiker NRW, Astrup A, Hjorth MF, Sjödin A, Pijls L, Markus CR
Does stress influence sleep patterns, food intake, weight gain, abdominal obesity and weight loss interventions and vice versa? Obes Rev. 2018 Jan;19(1):81-97. doi: 10.1111/obr.12603. Epub 2017 Aug 28. Review.
Hill JO
Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16. Review.
Phillips EG, Wells MT, Winston G, Ramos R, Devine CM, Wethington E, Peterson JC, Wansink B, Charlson M
Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial. Obesity (Silver Spring). 2017 May;25(5):833-841. doi: 10.1002/oby.21780. Epub 2017 Apr 5.
Phillips-Caesar EG, Winston G, Peterson JC, Wansink B, Devine CM, Kanna B, Michelin W, Wethington E, Wells M, Hollenberg J, Charlson ME
Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE. Contemp Clin Trials. 2015 Mar;41:118-28. doi: 10.1016/j.cct.2015.01.003. Epub 2015 Jan 26.
Ryff CD
Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19. Review.

Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention

Details for clinical trial NCT03609463

Clinical trial NCT03609463 - References