Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience

• Published in: Contemporary clinical trials 2013-05, Vol.35 (1), p.25-34
• Main Authors: Sternfeld, Barbara, LaCroix, Andrea, Caan, Bette J, Dunn, Andrea L, Newton, Katherine M, Reed, Susan D, Guthrie, Katherine A, Booth-LaForce, Cathryn, Sherman, Karen J, Cohen, Lee, Freeman, Marlene P, Carpenter, Janet S, Hunt, Julie R, Roberts, Melanie, Ensrud, Kristine E
• Format: Article
• Language: English
• Subjects: Cardiovascular; Cost-Benefit Analysis; Exercise; Exercise Therapy; Factorial design; Fatty Acids, Omega-3 - therapeutic use; Female; Hematology, Oncology and Palliative Medicine; Hot Flashes - drug therapy; Hot Flashes - therapy; Humans; Middle Aged; Omega-3 fatty acids; Patient Selection; Randomized controlled trial; Research Design; Vasomotor symptoms; Yoga
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2013.02.009

Abstract Background Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. Purpose Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. Methods Women from three geographic areas with a weekly average of ≥ 14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12 weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. Results Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd = 3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd = 3.8). Adherence of ≥ 80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2% Conclusions Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.