Search

ImportanceEffective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings.ObjectiveTo evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC).Design, setting, and participantsA single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted.InterventionsSix CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health.Main outcomes and measuresPrimary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference.ResultsAt 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P

Purpose of the studyA comparison of longitudinal global cognitive functioning in women Veteran and non-Veteran participants in the Women's Health Initiative (WHI).Design and methodsWe studied 7,330 women aged 65-79 at baseline who participated in the WHI Hormone Therapy Trial and its ancillary Memory Study (WHIMS). Global cognitive functioning (Modified Mini-Mental State Examination [3MSE]) in Veterans (n = 279) and non-Veterans (n = 7,051) was compared at baseline and annually for 8 years using generalized linear modeling methods.ResultsCompared with non-Veterans, Veteran women were older, more likely to be Caucasian, unmarried, and had higher rates of educational and occupational attainment. Results of unadjusted baseline analyses suggest 3MSE scores were similar between groups. Longitudinal analyses, adjusted for age, education, ethnicity, and WHI trial assignment revealed differences in the rate of cognitive decline between groups over time, such that scores decreased more in Veterans relative to non-Veterans. This relative difference was more pronounced among Veterans who were older, had higher educational/occupational attainment and greater baseline prevalence of cardiovascular risk factors (e.g., smoking) and cardiovascular disease (e.g., angina, stroke).ImplicationsVeteran status was associated with higher prevalence of protective factors that may have helped initially preserve cognitive functioning. However, findings ultimately revealed more pronounced cognitive decline among Veteran relative to non-Veteran participants, likely suggesting the presence of risks that may impact neuropathology and the effects of which were initially masked by Veterans' greater cognitive reserve.

ObjectiveThis study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother.MethodsThis study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks.ResultsAmong 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007).ConclusionsAmong healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

ObjectiveThis study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother.MethodsThis study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks.ResultsAmong 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007).ConclusionsAmong healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

ObjectiveThe purpose of this study was to determine the efficacy of 3 nonhormonal therapies for the improvement of menopause-related quality of life in women with vasomotor symptoms.Study designWe conducted a 12-week 3 × 2 randomized, controlled, factorial design trial. Peri- and postmenopausal women, 40-62 years old, were assigned randomly to yoga (n = 107), exercise (n = 106), or usual activity (n = 142) and also assigned randomly to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules. We performed the following interventions: (1) weekly 90-minute yoga classes with daily at-home practice, (2) individualized facility-based aerobic exercise training 3 times/week, and (3) 0.615 g omega-3 supplement, 3 times/day. The outcomes were assessed with the following scores: Menopausal Quality of Life Questionnaire (MENQOL) total and domain (vasomotor symptoms, psychosocial, physical and sexual).ResultsAmong 355 randomly assigned women who average age was 54.7 years, 338 women (95%) completed 12-week assessments. Mean baseline vasomotor symptoms frequency was 7.6/day, and the mean baseline total MENQOL score was 3.8 (range, 1-8 from better to worse) with no between-group differences. For yoga compared to usual activity, baseline to 12-week improvements were seen for MENQOL total -0.3 (95% confidence interval, -0.6 to 0; P = .02), vasomotor symptom domain (P = .02), and sexuality domain (P = .03) scores. For women who underwent exercise and omega-3 therapy compared with control subjects, improvements in baseline to 12-week total MENQOL scores were not observed. Exercise showed benefit in the MENQOL physical domain score at 12 weeks (P = .02).ConclusionAll women become menopausal, and many of them seek medical advice on ways to improve quality of life; little evidence-based information exists. We found that, among healthy sedentary menopausal women, yoga appears to improve menopausal quality of life; the clinical significance of our finding is uncertain because of the modest effect.

BackgroundBehavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy.PurposeDescribe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids.MethodsWomen from three geographic areas with a weekly average of ≥14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12weeks 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.ResultsOf 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%ConclusionsConducting 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.

A random clinical study aimed to ascertain the relation between estrogen therapy and calcification in the coronary artery, and the results are documented.

Studies collectively named the Women's Health Initiative (WHI) are currently enrolling 164,500 postmenopausal women in several overlapping clinical trials and an observational study. The overall goals of WHI are to understand the determinants of postmenopausal women's health and to evaluate the efficacy of practical interventions in preventing the major causes of morbidity and mortality in older women. This article reviews the research leading to the WHI studies; describes the study designs and protocols, with an emphasis on what's new about WHI from a psychological perspective; and outlines the major psychosocial hypotheses under investigation and the major challenges WHI presents to psychological science.

Objectives. This study examined whether foods in household pantries are an indicator of household members' diet. Methods. In a random-digit-dial survey, the presence in the house of 15 high-fat foods was assessed with whoever answered the phone. A randomly selected household member was surveyed about diet-related behaviors (n = 1002). Results. Individuals in the precontemplation stage of dietary change had more high-fat foods in their pantry than those in maintenance (means of 7.4 and 5.8, respectively). Individuals with low-fat pantries had an intake of 32% energy from fat vs 37% for those with high-fat pantries. Conclusions. Household food inventories are a practical and valid approach to monitoring dietary behaviors in community-based studies. (Am J Public Health. 1997;87:272-275)

A random-digit-dialing survey to examine the prevalence, content, and impact of physician dietary recommendations in a representative population-based sample of Washington State residents was administered to 1972 persons aged 18 years and older. Twenty percent of those surveyed received a physician's recommendation for dietary change in the previous year. The most common recommendations were to decrease intake of cholesterol, calories, and red meat and to increase intake of vegetables and fiber. Respondents receiving recommendations were more likely to report decreased use of high-fat foods and increased use of high-fiber foods and to be in the maintenance stage of dietary change. Results suggest that physicians can play a limited role in promoting dietary change. (Am J Public Health. 1995;85:722-726), Physicians can have a limited effect on the diet of their patients, according to a survey of Washington State residents. Of 1,967 randomly selected adults in a telephone survey, 20% said their physicians had recommended a change of diet in the previous year. Physicians had most commonly suggested a reduction of red meat, cholesterol, and calories, and an increase of bran/fiber, fruits, and vegetables. Among those who had received dietary recommendations, the greatest percentage claimed to have reduced their intake of eggs and butter, and increased their intake of fruits, vegetables, and whole wheat. Among men, 67% who had received recommendation and 46% who had not were maintaining some dietary change. Among women, 63% who had received recommendations and 58% who had not were maintaining a dietary change.

In a laboratory experiment, undergraduate subjects tested positive for an enzyme deficiency they believed to be a risk factor for pancreatic disorders. All Ss were tested with a confederate who received a positive or negative test result. For half the Ss, the confederate expressed a minimizing appraisal of the deficiency's seriousness. Although Ss' concern about the test result was significantly reduced by what the confederate said, behavioral intentions were determined by the confederate's diagnostic status. The effect of the confederate's diagnostic status on intentions was mediated by Ss' perceptions of the deficiency's prevalence. The results support Leventhal's self-regulation theory and demonstrate that the opinions and health characteristics of comparison others have differential effects on cognitive, emotional, and behavioral aspects of coping with a health threat.

Background: The Women's Health Initiative has collected data on the aging process of postmenopausal women for over two decades, including data on many women who have achieved age 80 years and older. However, there has not been any previous effort to characterize the 80+ cohort and to identify associated retention factors.Methods: We include all women at baseline of the Women's Health Initiative who would be at least 80 years of age as of September 17, 2012. We summarize retention rates during the study and across two re-enrollment campaigns as well as the demographic and health-related characteristics that predicted retention. Further, we describe the longitudinal change from baseline in the women identified as members of the 80+ cohort.Results: Retention rates were lower during each of two re-enrollment periods (74% and 83% retained during re-enrollment periods 1 and 2, respectively) than during the first and second data collection periods (90% each). Women who were retained were more likely to be white, educated, and healthier at baseline. Women age 80 and older saw modest changes in body mass index and depression burden, despite lower physical activity and increased cardiovascular disease.Conclusions: The characteristics of women who were retained in the 80+ cohort differ in significant ways compared with their peers at baseline. Identifying the characteristics associated with attrition in older cohorts is important because aging and worsening health has a negative impact on study attrition. Strategies should be implemented to improve retention rates among less healthy older adults. [ABSTRACT FROM AUTHOR]

Introduction: Vasomotor symptoms (VMS), including hot flashes and night sweats, are common among postmenopausal women and are associated with reduced health related quality of life (HRQOL). Purpose of the Study: To determine whether Veterans are more likely to report VMS than non-Veterans, and whether the association of VMS with HRQOL varies by Veteran status. Design and Methods: We used data from the Women's Health Initiative Observational Study, including self-reported baseline VMS presence and severity, and HRQOL at follow-up Year 3 (RAND Short Form 36-Item Health Survey). Employing generalized linear models we estimated whether Veteran status was associated with any VMS. We estimated the association between any VMS and HRQOL using linear regression, stratified by Veteran status. Interaction terms were added separately to determine whether the association varied by baseline depression, obesity, or smoking status. Results: The final analyses included 77,153 postmenopausal women (2,004 Veterans). After adjustment, Veterans were no more likely than non-Veterans to report any VMS at baseline (relative risk [RR] 0.97, 95% confidence interval [CI] 0.90-1.04) or moderate to severe VMS (RR 1.03, 95% CI 0.89-1.18). Any VMS was associated with decreased HRQOL at Year 3, particularly among Veterans (mean difference range: Veterans -2.7 to -4.6, p-values < .001; non-Veterans -2.2 to -2.6, 95% CI -0.13 to -0.09, p values < .001). Baseline depression and obesity, but not smoking, amplified the negative association between VMS and HRQOL. Implications: Multicondition care models for postmenopausal Veteran and non-Veteran women are needed that incorporate management strategies for VMS, weight, and depression [ABSTRACT FROM AUTHOR]