This proposal, submitted in conjunction with the MSI-FLASH network (Menopausal Symptoms Initiative- Finding Lasing Answers to Sweats and Hot Flashes), will compare the efficacy of two different doses of exercise against usual care (menopause education) for alleviating vasomotor symptoms. Both exercise arms will have a target exercise expenditure of 16 kcal/ kg/ wk, with the lower dose group performing at 50- 55% of predicted maximum heart rate (HRmax), and the higher dose group performing at 65-70% HRmax. The participants in the exercise trial will be drawn from 4 of the field sites participating in MSI-FLASH: Kaiser Permanente Northern California, Group Health in Seattle, University of Pennsylvania, and University of Indiana. The participants in the two exercise groups will meet once in-person with an exercise counselor at the start of the intervention and then by phone every week for the first two months and every other week for the last two months. The counseling will emphasize behavioral change strategies consistent with social cognitive theory, such as the setting of intermediate small-step goals, as well as practical knowledge and skills necessary for safe and effective exercise training. The control group will receive written health education material and counseling monthly by telephone. The recruitment period will extend over nine months, during which 450 women, who meet eligibility criteria, will be randomly assigned, in approximately equal numbers to each arm, using a design blocked on site, race/ethnicity and menopausal status. Because of the nature of the intervention, treatment assignments will not be blinded. Frequency of VMS, measured both subjectively and objectively will be assessed at the beginning, mid-point, and end of the intervention. Other shared network outcomes, including bother, severity, and interference of VMS, mood, sleep, and quality of life, will also be assessed before and after the intervention, as will important protocol-specific variables, such as physical activity, physical fitness, and body size. The overall goal of MSI-FLASH is to accelerate the identification of effective remedies to relieve vasomotor symptoms, the main objective of RFA-AG-08-004, by creating a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials. The MSI-FLASH Data Coordinating Center (DCC) will be jointly led by Andrea LaCroix and Garnet Anderson who have served together as Co-Prinicpal Investigators of the Women's Health Initiative, Clinical Coordinating Center (Seattle) for more than a decade. The five clinical field sites participating in the MSI-FLASH network are located in Boston (Drs. Lee Cohen and Hadine Joffe, PIs),Indianapolis, IN (Dr. Janet Carpenter, PI),Oakland, CA (Drs. Barbara Sternfeld and Bette Caan, PIs), Philadelphia, PN (Dr. Ellen Freeman, PI) and Seattle, WA (Drs. Katherine Newton and Susan Reed, PIs). This multidisciplinary investigator group is proposing five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG032669-05
Application #
8312530
Study Section
Special Emphasis Panel (ZAG1-ZIJ-5 (M2))
Program Officer
Hannah, Judy S
Project Start
2008-09-15
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2012
Total Cost
$282,951
Indirect Cost
$112,679
Name
Kaiser Foundation Research Institute
Department
Type
DUNS #
150829349
City
Oakland
State
CA
Country
United States
Zip Code
94612
Diem, Susan J; Joffe, Hadine; Larson, Joseph C et al. (2014) Effects of escitalopram on markers of bone turnover: a randomized clinical trial. J Clin Endocrinol Metab 99:E1732-7
Joffe, Hadine; Guthrie, Katherine A; LaCroix, Andrea Z et al. (2014) Low-dose estradiol and the serotonin-norepinephrine reuptake inhibitor venlafaxine for vasomotor symptoms: a randomized clinical trial. JAMA Intern Med 174:1058-66
Reed, Susan D; Mitchell, Caroline M; Joffe, Hadine et al. (2014) Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. Obstet Gynecol 124:233-41
Reed, Susan D; Guthrie, Katherine A; Newton, Katherine M et al. (2014) Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements. Am J Obstet Gynecol 210:244.e1-11
Sternfeld, Barbara; LaCroix, Andrea; Caan, Bette J et al. (2013) Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience. Contemp Clin Trials 35:25-34
Carpenter, Janet S; Newton, Katherine M; Sternfeld, Barbara et al. (2012) Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network. Menopause 19:664-71
Reed, Susan D; Guthrie, Katherine A; Joffe, Hadine et al. (2012) Sexual function in nondepressed women using escitalopram for vasomotor symptoms: a randomized controlled trial. Obstet Gynecol 119:527-38
Carpenter, Janet S; Guthrie, Katherine A; Larson, Joseph C et al. (2012) Effect of escitalopram on hot flash interference: a randomized, controlled trial. Fertil Steril 97:1399-404.e1
Freeman, Ellen W; Guthrie, Katherine A; Caan, Bette et al. (2011) Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA 305:267-74