The authors analyzed data from the Women's Health Initiative (WHI) Calcium and Vitamin D Supplementation Trial (CaD) to learn more about factors affecting adherence to clinical trial study pills (both active and placebo). Most participants (36,282 postmenopausal women aged 50-79 years) enrolled in CaD 1 year after joining either a hormone trial or the dietary modification trial of WHI. The WHI researchers measured adherence to study pills by weighing the amount of remaining pills at an annual study visit; adherence was primarily defined as taking ≥ 80% of the pills. The authors in this study examined a number of behavioral, demographic, procedural, and treatment variables for association with study pill adherence. They found that relatively simple procedures (ie, phone contact early in the study [4 weeks post randomization] and direct social contact) later in the trial may improve adherence. Also, at baseline, past pill-use experiences, personal supplement use, and relevant symptoms may be predictive of adherence in a supplement trial.

Background: Dietary behavior, specifically a low-fat, high-fiber diet, plays a role in the primary prevention of chronic diseases including cancer.Design: A community-based randomized trial to assess the impact of a low-intensity, physician-endorsed, self-help dietary intervention that provided tailored dietary feedback, and was designed to promote improved fat and fiber behavior in a rural, low-education/low-literacy, partly minority population. The data were collected from 1999 to 2003.Setting/Participants: A total of 754 patients from three physician practices in rural Virginia completed a baseline telephone survey assessing dietary and psychosccial information, and were then randomly assigned to the intervention or control condition. Follow-up telephone evaluation was based on 522 participants at 1 month, 470 at 6 months, and 516 participants at 12 months.Intervention: A series of tailored feedback, followed by brief telephone counseling and theory-based nutritional education booklets, provided by staggered delivery to the home.Main Outcome Measures: Dietary fat and fiber behavior, dietary intentions to change, self-efficacy for dietary change, and fat and fiber knowledge.Results: The intervention group demonstrated significant improvement in dietary fat and fiber behaviors and intentions to change fat and fiber intake (p <0.05) at 1, 6, and 12 months.Conclusions: The Rural Physician Cancer Prevention Project provides an effective model for achieving public health-level dietary health behavior changes among a rural, minority, and low-literacy/low-education population. (C) 2005 American journal of Preventive Medicine.

ABSTRACT Inhibition of emotional expression has been associated with the incidence and progression of breast cancer and other chronic illnesses. Others have theorized that it may not be repression itself, but rather ambivalence over the expression of emotions that is the important health-related factor. The Women's Health Initiative (WHI), a long-term, national study focusing on disease prevention among postmenopausal women, is unique in its assessment of expression and ambivalence of negative emotion in a large study sample of multiethnic, older women. Psychological factors such as expression of negative emotion and ambivalence about expression of emotion are also determined by social patterning. The current study examined the psychometric properties of the instruments used to measure each construct and variation across race/ethnicity and age. The analysis suggests that the scales can be used with confidence in diverse ethnic and age groups. Examining ambivalence about expression of negative emotion in future longitudinal research will further elucidate its role in predicting disease incidence and recovery, both important in reducing the public health burden of chronic disease.

Objective: This study examined the effects of exercise on metabolic risk variables insulin, leptin, glucose, and triglycerides in overweight/obese postmenopausal women.Research Methods and Procedures: Sedentary women (n = 173) who were overweight or obese (BMI >= 25 kg/m(2) or >= 24 kg/m(2) With >= 33% body fat), 50 to 75 years of age, were randomized to 12 months of exercise ( :45 minutes of moderate-intensity aerobic activity 5 d/wk) or to a stretching control group. Body composition (DXA) and visceral adiposity (computed tomography) were measured at baseline and 12 months. Insulin, glucose, triglycerides, and leptin were measured at baseline and 3 and 12 months. Insulin resistance was evaluated by the homeostasis model assessment formula. Differences from baseline to follow-up were calculated and compared across groups.Results: Exercisers had a 4% decrease and controls had a 12% increase in insulin concentrations from baseline to 12 months (p = 0.0002). Over the same 12-month period, leptin concentrations decreased by 7% among exercisers compared with remaining constant among controls (p = 0.03). Homeostasis model assessment scores decreased by 2% among exercisers and increased 14% among controls from baseline to 12 months (p = 0.0005). The exercise effect on insulin was modified by changes in total fat mass (trend, p = 0.03), such that the exercise intervention abolished increases in insulin concentrations associated with gains in total fat mass.Discussion: Regular moderate-intensity exercise can be used to improve metabolic risk variables such as insulin and leptin in overweight/obese postmenopausal women. These results are promising for health care providers providing advice to postmenopausal women for lifestyle changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.

Postmenopausal women with elevated circulating androgen concentrations have an increased risk of developing breast cancer, yet interventions to reduce androgen levels have not been identified. We examined the effects of a 12-month moderate intensity exercise intervention on serum androgens. The study was a randomized clinical trial in 173 sedentary, overweight (body mass index > or = 24.0 kg/m(2), body fat > 33%), postmenopausal women, ages 50 to 75 years, not using hormone therapy and living in the Seattle, WA area. The exercise intervention included facility-based and home-based exercise (45 minutes, 5 days per week of moderate intensity sports/recreational exercise). A total of 170 (98.3%) women completed the study, with exercisers averaging 171 minutes per week of exercise. Women in the exercise and control groups experienced similar, nonsignificant declines in most androgens. Among women who lost >2% body fat, testosterone and free testosterone concentrations fell by 10.1% and 12.2% between baseline and 12 months in exercisers compared with a decrease of 1.6% and 8.0% in controls (P = 0.02 and 0.03 compared with exercisers, respectively). Concentrations of testosterone and free testosterone among exercisers who lost between 0.5% and 2% body fat declined by 4.7% and 10.4%. In controls who lost this amount of body fat, concentrations of testosterone and free testosterone declined by only 2.8% and 4.3% (P = 0.03 and 0.01 compared with exercisers, respectively). In summary, given similar levels of body fat loss, women randomized to a 12-month exercise intervention had greater declines in testosterone and free testosterone compared with controls. The association between exercise and breast cancer risk may be partly explained by the effects of exercise on these hormones.

BACKGROUND:Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI).METHODS:The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned to receive conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The primary efficacy outcome of the trial was CHD (nonfatal myocardial infarction or death due to CHD).RESULTS:After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits. Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 (nominal 95 percent confidence interval, 1.00 to 1.54; 95 percent confidence interval after adjustment for sequential monitoring, 0.97 to 1.60). The elevation in risk was most apparent at one year (hazard ratio, 1.81 [95 percent confidence interval, 1.09 to 3.01]). Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy, higher base-line levels of C-reactive protein, other biomarkers, and other clinical characteristics did not significantly modify the treatment-related risk of CHD.CONCLUSIONS:Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women, especially during the first year after the initiation of hormone use. This treatment should not be prescribed for the prevention of cardiovascular disease.

Objective: To evaluate the effect of moderate-intensity exercise on the occurrence and severity of menopause symptoms.Design: A yearlong, randomized, clinical trial, conducted in Seattle, WA, with 173 overweight, postmenopausal women not taking hormone therapy in the previous 6 months. The intervention was a moderate-intensity exercise intervention (n = 87) versus stretching control group (n = 86). Using logistic regression, odds ratios comparing exercise with controls were calculated at 3, 6, 9, and 12 months for menopause symptoms and their severity.Results: There was a significant increase in hot flash severity and decreased risk of memory problems in exercisers versus controls over 12 months, although the numbers affected were small. No other significant changes in symptoms were observed.Conclusions: Exercise does not seem to decrease the risk of having menopause symptoms in overweight, postmenopausal women not taking hormone therapy and may increase the severity of some symptoms in a small number of women.

Background. Few studies have examined the long-term adherence to a yearlong exercise intervention among postmenopausal women. We examined the patterns of adherence to a yearlong exercise intervention and the influence of demographic, physiologic, and psychosocial variables on patterns of adherence among 173 sedentary, overweight, postmenopausal women.Methods. We collected demographic, physical activity (PA), physiologic, psychosocial, and medical history information at baseline and 12 months. The exercise prescription consisted of at least 45 min of moderate-intensity exercise 5 days/week for 12 months. We calculated several adherence variables. Associations between baseline variables and adherence levels were assessed in bivariate analyses and in multiple regression models.Results. Women randomized to the exercise group (N = 87) participated in moderate-intensity sports or recreational PA on 3.7 1.4 days/week (79% of the prescribed 5 days/week) for 171 + 88 min/week (87% of the prescribed 225 min/week) over the yearlong trial period. Sixty-eight percent of the exercisers had a yearlong average PA level exceeding the national recommendation of 150 min/week. Being in the preparation stage vs. the contemplation stage of the transtheoretical model and a history of participating in any sports or recreational PA were significant predictors of adherence.Conclusions. Our findings provide important information for the design of future PA interventions and health promotion programs. (C) 2004 The Institute for Cancer Prevention and Elsevier Inc. All rights reserved.

Elevated circulating estrogens and a sedentary lifestyle increase risk for breast cancer. The effect of exercise on circulating estrogens in sedentary postmenopausal women is unknown. The objective of this study was to examine the effects of a 12-month moderate-intensity exercise intervention on serum estrogens. We randomly assigned 173 sedentary, overweight (body mass index > 24.0 kg/m(2), body fat > 33%), postmenopausal women, ages 50-75 years, not using hormone therapy, living in the Seattle, Washington, area for the next year, and willing to be randomly assigned to an exercise intervention or stretching control group. The exercise intervention included facility and home-based exercise (45 min, 5 days/week moderate intensity sports/recreational exercise). A total of 170 (98.3%) women completed the study with exercisers averaging 171 min/week of exercise. After 3 months, exercisers experienced declines in estrone, estradiol, and free estradiol of 3.8, 7.7, and 8.2%, respectively, versus no change or increased concentrations in controls (P = 0.03, 0.07, and 0.02, respectively). At 12 months, the direction of effect remained the same, although the differences were no longer statistically significant. The effect was limited to women who lost body fat: women whose percentage of body fat [by dual energy x-ray absortiometry (DEXA)] decreased by >/==" BORDER="0">2% had statistically significant (comparing exercisers versus controls) decreases at 12 months of 11.9, 13.7, and 16.7% for serum estrone, estradiol, and free estradiol, respectively. We concluded that a 12-month moderate-intensity exercise intervention in postmenopausal women resulted in significant decreases in serum estrogens. The association between increased physical activity and reduced risk for postmenopausal breast cancer may be partly explained by effects on serum estrogens.

Although recruitment of ethnic and racial minorities in medical research has been evaluated in several studies, much less is known about the methods used to recruit these populations to participate in cancer genetics research. This report reviews the resources that have been used to identify and recruit ethnic and racial minorities to participate in hereditary breast cancer research. Overall, hospital-based resources were used most often to identify potential subjects, and active recruitment methods were used most frequently to enroll eligible subjects. This review suggests that there appears to be a finite number of resources and strategies to identify and recruit potential subjects to participate in cancer genetics research; however, options for improving awareness about cancer genetics research among ethnic and racial minorities have not been extensively evaluated. To study ethnic and racial minority participation in cancer genetics research, stronger evaluation components will need to be integrated into research methods. Both observational and experimental studies are needed to determine resources that are most effective for identifying potential subjects who are ethnic and racial minorities and to evaluate the effects of different recruitment strategies on enrollment decisions among these populations.

Understanding and perhaps overriding preferences for fat is important, given the relationship between higher dietary fat consumption and poorer health. We have examined the roles of potential mechanisms for differences in fat preference: actual fat content and expected fat content. The subjects were women (n=192, ages=50–69) recruited to a study of low-fat dietary change. Subjects were randomized to one of the four cells: participants received either a high- or low-fat milkshake at baseline, and half of each group was told that their milkshake was low in fat and the other half high in fat. Women who received a high-fat milkshake consumed more grams than women who received a low-fat milkshake. Women who expected low-fat shakes reported liking them more than those who expected high-fat milkshakes. These data indicate that both physiology and cognition play a role in determining consumption of high- and low-fat foods.

CONTEXT:The increasing prevalence of obesity is a major public health concern. Physical activity may promote weight and body fat loss.OBJECTIVE:To examine the effects of exercise on total and intra-abdominal body fat overall and by level of exercise.DESIGN:Randomized controlled trial conducted from 1997 to 2001.SETTING AND PARTICIPANTS:A total of 173 sedentary, overweight (body mass index > or =24.0 and >33% body fat), postmenopausal women aged 50 to 75 years who were living in the Seattle, Wash, area.INTERVENTION:Participants were randomly assigned to an intervention consisting of exercise facility and home-based moderate-intensity exercise (n = 87) or a stretching control group (n = 86).MAIN OUTCOME MEASURE:Changes in body weight and waist and hip circumferences at 3 and 12 months; total body, intra-abdominal, and subcutaneous abdominal fat at 12 months.RESULTS:Twelve-month data were available for 168 women. Women in the exercise group participated in moderate-intensity sports/recreational activity for a mean (SD) of 3.5 (1.2) d/wk for 176 (91) min/wk. Walking was the most frequently reported activity. Exercisers showed statistically significant differences from controls in baseline to 12-month changes in body weight (-1.4 kg; 95% confidence interval [CI], -2.5 to -0.3 kg), total body fat (-1.0%; 95% CI, -1.6% to -0.4%), intra-abdominal fat (-8.6 g/cm2; 95% CI, -17.8 to 0.9 g/cm2), and subcutaneous abdominal fat (-28.8 g/cm2); 95% CI, -47.5 to -10.0 g/cm2). A significant dose response for greater body fat loss was observed with increasing duration of exercise.CONCLUSIONS:Regular exercise such as brisk walking results in reduced body weight and body fat among overweight and obese postmenopausal women.

CONTEXTObservational studies have suggested that postmenopausal hormone treatment may improve cognitive function, but data from randomized clinical trials have been sparse and inconclusive. The Women's Health Initiative Memory Study (WHIMS) is an ancillary study of the Women's Health Initiative (WHI) hormone therapy trials. On July 8, 2002, the estrogen plus progestin therapy in the WHI trial was discontinued because of certain increased health risks for women.OBJECTIVETo determine whether estrogen plus progestin therapy protects global cognitive function in older postmenopausal women.DESIGN, SETTING, AND PARTICIPANTSA randomized, double-blind, placebo-controlled clinical trial, WHIMS is an ancillary study of geographically diverse, community-dwelling women aged 65 years or older from 39 of 40 clinical centers within the WHI estrogen plus progestin trial that started in June 1995. Of 4894 eligible postmenopausal women aged 65 years or older and free of probable dementia at baseline, 4532 (92.6%) were enrolled in the estrogen plus progestin component of WHIMS. A total of 4381 participants (96.7%) provided at least 1 valid cognitive function score between June 1995 and July 8, 2002.INTERVENTIONSParticipants received either 1 daily tablet containing 0.625 mg of conjugated equine estrogen with 2.5 mg of medroxyprogesterone acetate (n = 2145) or matching placebo (n = 2236).MAIN OUTCOME MEASUREGlobal cognitive function measured annually with the Modified Mini-Mental State Examination.RESULTSThe Modified Mini-Mental State Examination mean total scores in both groups increased slightly over time (mean follow-up of 4.2 years). Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo (P =.03), but these differences were not clinically important. Removing women by censoring them after adjudicated dementia, mild cognitive impairment, or stroke, and nonadherence to study protocol, did not alter the findings. Prior hormone therapy use and duration of prior use did not affect the interpretation of the results, nor did timing of prior hormone therapy initiation with respect to the final menstrual period. More women in the estrogen plus progestin group had a substantial and clinically important decline (> or =2 SDs) in Modified Mini-Mental State Examination total score (6.7%) compared with the placebo group (4.8%) (P =.008).CONCLUSIONSAmong postmenopausal women aged 65 years or older, estrogen plus progestin did not improve cognitive function when compared with placebo. While most women receiving estrogen plus progestin did not experience clinically relevant adverse effects on cognition compared with placebo, a small increased risk of clinically meaningful cognitive decline occurred in the estrogen plus progestin group.

STUDY OBJECTIVES:To examine the effects of a moderate-intensity exercise or stretching intervention and changes in fitness, body mass index, or time spent outdoors on self-reported sleep quality and to examine the relationship between the amount and timing of exercise and sleep quality.DESIGN:A randomized intervention trial.SETTING:A cancer research center in Seattle, Washington.PARTICIPANTS:Postmenopausal, overweight or obese, sedentary women not taking hormone replacement therapy, aged 50 to 75 years, and recruited from the Seattle metropolitan area.INTERVENTIONS:A yearlong moderate-intensity exercise (n=87) and a low-intensity stretching (n=86) program.MEASUREMENTS AND RESULTS:Among morning exercisers, those who exercised at least 225 minutes per week had less trouble falling asleep (odds ratio [OR]: 0.3, P < or = .05) compared with those who exercised less than 180 minutes per week. However, among evening exercisers, those who exercised at least 225 minutes per week had more trouble falling asleep (OR: 3.3, P < or = .05) compared to those who exercised less than 180 minutes per week. Stretchers were less likely to use sleep medication (OR = 0.4, P < or = .05) and have trouble falling asleep (OR: 0.7, P < or = .10) during the intervention period compared with baseline. A greater than 10% versus a 1% or less increase in maximum O2 consumption over the year was associated with longer sleep duration (P < or = .05), less frequently falling asleep during quiet activities (P < or = .05), and less use of sleep medication (P < or = .05). Reductions in body mass index and increases in time spent outdoors had inconsistent effects on sleep quality.CONCLUSIONS:Both stretching and exercise interventions may improve sleep quality in sedentary, overweight, postmenopausal women. Increased fitness was associated with improvements in sleep. However, the effect of moderate-intensity exercise may depend on the amount of exercise and time of day it is performed.

OBJECTIVE:The purpose of this study was to develop, implement, and evaluate the efficacy of an intensive intervention program (IIP) based on motivational interviewing to motivate participants within the dietary study of the Women's Health Initiative (WHI) to meet the study's nutritional goals. SUBJECTS/DESIGN:WHI dietary intervention participants (n=175) from 3 clinical centers were randomly assigned to either intervention or control status. Participants assigned to IIP intervention received 3 individual motivational interviewing contacts from a dietitian, plus the usual WHI Dietary Intervention. Participants randomly assigned to IIP control received the usual WHI dietary modification (DM) Intervention. Percent of energy from fat was estimated at study baseline and at follow-up (1 year later) using the WHI Food Frequency Questionnaire. RESULTS:The change in percent energy from fat between IIP baseline and IIP 1-year follow-up was -1.2% for IIP intervention participants and +1.4% for IIP control participants, giving an overall difference of 2.6% (P<.001). Participants having the highest IIP baseline fat intake (>30% energy) showed the largest overall change in percent energy from fat between IIP baseline and IIP follow-up. CONCLUSIONS:The results of this study indicate that a protocol based on motivational interviewing and delivered through contacts with trained dietitians is an efficacious way to further lower dietary fat intake among participants exposed to ongoing intervention. These data will be useful in future intervention situations when there is a need to increase motivation to change.

The purpose of this study was to relate women's awareness of breast cancer risk genetic testing to the sources of information used by women for obtaining information about breast health. A sample of 354 women with a family history of breast or ovarian cancer was interviewed. Study variables included women's information sources for breast health, personal risk perceptions, family history of breast cancer, personal experience (i.e., having had a biopsy), awareness of genetic testing, and demographic variables. Regression analyses were conducted to assess the relationships among the variables. Only approximately one-third of the study participants were moderately aware of genetic testing for breast cancer risk. The Internet Web was the only information source significantly related to awareness of genetic testing. Having had a biopsy, being more highly educated, and being married also were significant predictors of awareness of genetic testing. Study participants were not uniformly aware of genetic testing. If the diffusion of Web technology continues, the Web may be a promising source for increasing awareness on genetic testing for breast cancer risk.

There is an increasing need for accurate prediction methods of assessing individual risk for breast cancer for both clinical and research purposes. The purpose of this study is to compare the Gail and Claus model risk estimates of breast cancer among women with a family history of breast cancer. This study presents risk estimates from two models of breast cancer risk in 491 women 18 to 74 years of age with a family history of breast cancer who were recruited to risk counseling clinical trials in Seattle, Washington between 1996 and 1997. These trials included women from the general population and additional samples of Ashkenazi Jewish, African-American, and lesbian women. We estimated and compared lifetime (to age 79) and 5-year risk for developing breast cancer using the National Surgical Adjuvant Breast and Bowel Project adaptation of the Gail model and the Claus model. About one-quarter of participants fell into the Gail "high" risk category (> or =1.7% risk of developing breast cancer in the next 5 years). The average lifetime risk was estimated at 13.2% by the Gail model and 11.2% by the Claus model. Estimates from the two models were moderately and positively correlated (r = 0.55) with the Gail model yielding a higher estimate than the Claus model for most participants. If women with a family history of breast cancer are being counseled regarding decisions on genetic testing, tamoxifen use, or other preventive measures, presenting both Claus and Gail estimates may be the best option.