MsFLASH02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
Over 33 million U.S. women will transition through menopause in the next decade. Among
women with natural menopause, the transition typically lasts four years, with a mean age at
menopause of 51 years. Menstrual irregularity (90%) and vasomotor symptoms (VMS) (80%) are
the most common symptoms associated with the transition. Hormone therapy has been the gold
standard for treating VMS symptoms against which other therapies are measured. However,
resistance to hormone therapy use due to its risks and side effects continues to fuel the
search for safer alternatives.
This research study will evaluate three low risk interventions (yoga, exercise, and omega-3
supplements) compared to either a usual activity group or a placebo pill. This factorial
design is motivated by the desire to have all women receive some intervention. Neither
comparisons between yoga and exercise nor tests of interaction between the behavioral
interventions (yoga, exercise, usual activity) and omega-3 motivated this design. However,
these aspects can be examined in secondary analyses in a more rigorous fashion through this
design than would be permitted by separate trials.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Frequency and bother of hot flashes measured by self-report diaries.
Andrea Z. LaCroix, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Indiana University||Indianapolis, Indiana 46202|
|Group Health Research Institute||Seattle, Washington 98101|
|Kaiser Division of Research||Oakland, California 94611|