The MsFLASH 02 study entitled, “Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation” is a multicenter factorial design randomized controlled trial (RCT) testing three low-risk interventions for reducing the frequency and/or relieving the bothersomeness of vasomotor symptoms (VMS). This study is the second clinical trial to be conducted as part of the Menopausal Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) study, a National Institute of Aging funded network of investigators that is conducting clinical trials designed to test alternative methods to alleviate the most common, bothersome symptoms of the menopausal transition.
In this factorial design RCT, 374 women aged 40-62 in the late menopausal transition or postmenopause, who are having an average of 4 or more VMS per day, will be randomized to one of three behavioral intervention groups: yoga, exercise, or the usual activity; simultaneously, all will be randomized to receive omega-3 fatty acid supplementation from fish oil or a matching placebo from olive oil.
The research team is studying how well yoga, exercise, and omega-3 fatty acids (fish oil) work to ease hot flashes and night sweats. A total of 375 women will be participating in this study across the United States at three research sites: Indiana University School of Nursing, in Indianapolis, Kaiser Permanente Northern California, in Oakland, Calif., and Group Health Research Institute, in Seattle. The Call to Action for this study was sent to Army of Women members on June 15, 2011. When the researchers closed enrollment on January 5, 2012, the Army of Women had provided them with 145 women who were interested in enrolling in the study.