NCT03167489 - 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)

Eckert M, Ebert DD, Lehr D, Sieland B, Jazaieri H, Berking M
Teachers' Emotion Regulation Skills Facilitate Implementation of Health-related Intentions. Am J Health Behav. 2015 Nov;39(6):874-81. doi: 10.5993/AJHB.39.6.15.
Macht M, Simons G
Emotions and eating in everyday life. Appetite. 2000 Aug;35(1):65-71. doi: 10.1006/appe.2000.0325.
Neamah HH, Sebert Kuhlmann AK, Tabak RG
Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Diabetes Educ. 2016 Apr;42(2):153-65. doi: 10.1177/0145721716630386. Epub 2016 Feb 15.
Roosen MA, Safer D, Adler S, Cebolla A, van Strien T
Group dialectical behavior therapy adapted for obese emotional eaters; a pilot study. Nutr Hosp. 2012 Jul-Aug;27(4):1141-7. doi: 10.3305/nh.2012.27.4.5843.
Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC
Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.
Wallace LM, Masson PC, Safer DL, von Ranson KM
Change in emotion regulation during the course of treatment predicts binge abstinence in guided self-help dialectical behavior therapy for binge eating disorder. J Eat Disord. 2014 Dec 11;2(1):35. doi: 10.1186/s40337-014-0035-x. eCollection 2014.

Impact of Lifestyle Intervention Plus Emotion Regulation Group Intervention on Cardiovascular Risk Reduction in Women: A Pilot Study

Clinical trial NCT03167489 - References