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Nursing Interventions for Symptoms of Perimenopause

$226,000R15FY2004NRNIH

University Of Arizona, Tucson AZ

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): Every woman who lives long enough will experience the perimenopausal transition, and most experience symptoms that require management, either through medical intervention or by self-initiated practices. Increasing numbers of women choose alternatives to HRT for symptom management, yet little is known about the effectiveness of these alternatives. The overall goal of this program of research is to test the effectiveness of commonly available and frequently promoted strategies to reduce symptom-associated distress and to promote health during the perimenopausal transition. This pilot study serves priorities established for the 21st century by the NIH, which include perimenopausal research on behavioral interventions and dietary supplements. Utilizing a longitudinal, repeated measures three-group design, a multimodal (MMTP) treatment package (high fiber, low-fat diet; moderate exercise; stress reducing techniques) and soy isoflavone capsules will be tested for their effectiveness at managing severe perimenopausal symptoms. Specific aims include: To describe the immediate (1 month) and long-term (3 months) effectiveness of a MMTP (aim #1) and soy isoflavone capsules (aim #2) compared to the control group and explore the relative effectiveness of the two (aim #3) at reducing symptom perception, symptom severity, and symptom distress for women experiencing severe symptoms and menstrual dysregulation associated with the perimenopausal transition. Approximately 162 Anglo American women recruited from community sources will be screened to obtain a sample of 81 women age 45-55 years. Participants will be randomly assigned to one of the three treatment conditions (MMTP, Soy capsules, control). Data will be collected at baseline, PT1, and PT3.The longitudinal outcomes data will be analyzed using the Generalized Estimation Equation (GEE) to determine temporal differences within treatment groups and to test for differences between the treatment groups. The information gained from this pilot study will provide the basis for a larger, more inclusive study, and will assist clinicians to develop perimenopausal symptom treatment plans that include advice to perimenopausal women about their choices for symptom management. [unreadable] [unreadable] [unreadable]

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