A behavioral weight-loss intervention for persons with serious mental illness in psychiatric rehabilitation centers.

OBJECTIVE: Overweight and obesity are epidemic in populations with serious mental illnesses. We developed and pilot-tested a behavioral weight-loss intervention appropriately tailored for persons with serious mental disorders. METHODS: We conducted a single-arm pilot study in two psychiatric rehabilitation day programs in Maryland, and enrolled 63 overweight or obese adults. The 6-month intervention provided group and individual weight management and group physical activity classes. The primary outcome was weight change from baseline to 6 months. RESULTS: A total of 64% of those potentially eligible enrolled at the centers. The mean age was 43.7 years; 56% were women; 49% were white; and over half had schizophrenia or a schizoaffective disorder. One-third had hypertension and one-fifth had diabetes. In total, 52 (82%) completed the study; others were discharged from psychiatric centers before completion of the study. Average attendance across all weight management sessions was 70% (87% on days participants attended the center) and 59% for physical activity classes (74% on days participants attended the center). From a baseline mean of 210.9 lbs (s.d. 43.9), average weight loss for 52 participants was 4.5 lb (s.d. 12.8) (P<0.014). On average, participants lost 1.9% of body weight. Mean waist circumference change was 3.1 cm (s.d. 5.6). Participants on average increased the distance on the 6-minute walk test by 8%. CONCLUSION: This pilot study documents the feasibility and preliminary efficacy of a behavioral weight-loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers. The results may have implications for developing weight-loss interventions in other institutional settings such as schools or nursing homes.

Effects of environmental enrichment on the amyotrophic lateral sclerosis mouse model.

The manner in which an animal's environment is furnished may have significant implications for animal welfare as well as research outcomes. We evaluated four different housing conditions to determine the effects of what has been considered standard rodent enrichment and the exercise opportunities those environments allow on disease progression in the amyotrophic lateral sclerosis mouse model. Forty-eight copper/zinc superoxide dismutase mice (strain: B6SJL-TgN [SOD1-G931]1Gur) (SOD1) and 48 control (C) (strain: B6SJL-TgN[SOD1]2Gur) male mice were randomly assigned to four different conditions where 12 SOD1 and 12 C animals were allotted to each condition (n = 96). Conditions tested the effects of standard housing, a forced exercise regime, access to a mouse house and opportunity for ad libitum exercise on a running wheel. In addition to the daily all-occurrence behavioural sampling, mice were weighed and tested twice per week on gait and Rotor-Rod performance until the mice reached the age of 150 days (C) or met the criteria for our humane endpoint (SOD1). The SOD1 mice exposed to the forced exercise regime and wheel access did better in average lifespan and Rotor-Rod performance, than SOD1 mice exposed to the standard cage and mouse house conditions. In SOD1 mice, stride length remained longest throughout the progression of the disease in mice exposed to the forced exercise regime compared with other SOD1 conditions. Within the control group, mice in the standard cage and forced exercise regime conditions performed significantly less than the mice with the mouse house and wheels on the Rotor-Rod. Alpha motor neuron counts were highest in mice with wheels and in mice exposed to forced exercise regime in both mouse strains. All SOD1 mice had significantly lower alpha neuron counts than controls (P < 0.05). These data show that different enrichment strategies affect behaviour and disease progression in a transgenic mouse model, and may have implications for the effects of these strategies on experimental outcomes.

Effect of methylmercury on midbrain cell proliferation during organogenesis: potential cross-species differences and implications for risk assessment.

5'-bromodeoxyuridine (BrdU) labeling was employed to explore the effects of methylmercury (MeHg) on cell cycle kinetics in the developing rat midbrain during gestational days (GDs) 11 to 14. Contrary to what has been previously reported in mice, no effects of MeHg on cell cycle kinetics were observed up to embryonic brain concentrations of 3-4 microg/g. The absence of an effect was confirmed using stereology and counts of midbrain cell number. Treatment with colchicine, the positive control, resulted in significant effects on cell cycle kinetics in the developing rat midbrain. The parallelogram method, borrowed from genetic toxicology, was subsequently used to place the data obtained in the present study in the context of previously collected in vitroand in vivo data on MeHg developmental neurotoxicity. This required developing a common dose metric (microg Hg/g cellular material) to allow in vitro and in vivo study comparisons. Evaluation suggested that MeHg's effects on neuronal cell proliferation show a reasonable degree of concordance across mice, rats, and humans, spanning approximately an order of magnitude. Comparisons among the in vivo data suggest that humans are at least or more sensitive than the rodent and that mice may be a slightly better model for MeHg human developmental neurotoxicity than the rat. Such comparisons can provide both a quantitative and a qualitative framework for utilizing both in vivo and in vitro data in human health risk assessment.

Motivations for exercise and weight loss among African-American women: focus group results and their contribution towards program development.

OBJECTIVE: African-American women are more likely to be sedentary and maintain higher body weights compared with Caucasian women, although some are physically active and able to maintain weight loss. To develop effective intervention strategies, we need to understand why some women are successful. DESIGN: We conducted focus groups on four distinct groups of African-American women (currently physically active; currently sedentary; successful weight loss for > or = 1 year; unsuccessful weight loss) to explore motivations and intervention strategies. Open-ended questions, probes, and visual aids were used to stimulate discussions. Transcripts of sessions were read to highlight themes and concepts. RESULTS: Results indicated that motivators for the exercisers to start exercising were health concerns, weight control, stress reduction, and the influence of others. Motivators to continue exercising were feeling good and having energy. In contrast, the sedentary women reported that social support and enjoyment would be motivating. Both groups reported that physically active women conveyed the image of high energy and self-esteem. The successful weight loss women employed strategies that allowed them to eat a variety of foods and were less likely to 'diet'. The unsuccessful women referred to 'going on a diet' and were more likely to label foods as 'good' or 'bad'. They reported feeling tired and thought that losing weight would give them more energy. CONCLUSION: This information was used to develop two culturally appropriate interventions for African-American women, which is presented. Conducting formative research in study design protocols can provide an important role in intervention development.

Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial.

CONTEXT: Incidence of end-stage renal disease due to hypertension has increased in recent decades, but the optimal strategy for treatment of hypertension to prevent renal failure is unknown, especially among African Americans. OBJECTIVE: To compare the effects of an angiotensin-converting enzyme (ACE) inhibitor (ramipril), a dihydropyridine calcium channel blocker (amlodipine), and a beta-blocker (metoprolol) on hypertensive renal disease progression. DESIGN, SETTING, AND PARTICIPANTS: Interim analysis of a randomized, double-blind, 3 x 2 factorial trial conducted in 1094 African Americans aged 18 to 70 years with hypertensive renal disease (glomerular filtration rate [GFR] of 20-65 mL/min per 1.73 m(2)) enrolled between February 1995 and September 1998. This report compares the ramipril and amlodipine groups following discontinuation of the amlodipine intervention in September 2000. INTERVENTIONS: Participants were randomly assigned to receive amlodipine, 5 to 10 mg/d (n = 217), ramipril, 2.5 to 10 mg/d (n = 436), or metoprolol, 50 to 200 mg/d (n = 441), with other agents added to achieve 1 of 2 blood pressure goals. MAIN OUTCOME MEASURES: The primary outcome measure was the rate of change in GFR; the main secondary outcome was a composite index of the clinical end points of reduction in GFR of more than 50% or 25 mL/min per 1.73 m(2), end-stage renal disease, or death. RESULTS: Among participants with a urinary protein to creatinine ratio of >0.22 (corresponding approximately to proteinuria of more than 300 mg/d), the ramipril group had a 36% (2.02 [SE, 0.74] mL/min per 1.73 m(2)/y) slower mean decline in GFR over 3 years (P =.006) and a 48% reduced risk of the clinical end points vs the amlodipine group (95% confidence interval [CI], 20%-66%). In the entire cohort, there was no significant difference in mean GFR decline from baseline to 3 years between treatment groups (P =.38). However, compared with the amlodipine group, after adjustment for baseline covariates the ramipril group had a 38% reduced risk of clinical end points (95% CI, 13%-56%), a 36% slower mean decline in GFR after 3 months (P =.002), and less proteinuria (P<.001). CONCLUSION: Ramipril, compared with amlodipine, retards renal disease progression in patients with hypertensive renal disease and proteinuria and may offer benefit to patients without proteinuria.

Estimating cell number in the central nervous system by stereological methods: the optical disector and fractionator.

This unit describes techniques, based on recent advances in stereological methods, to obtain unbiased estimates of total cell or synapse number in discrete structures of the central nervous system. They combine unbiased counting frames, unbiased systematic random sampling, and unbiased estimates of the structure volume to produce the final estimate of number.

Long-term effects of weight loss and dietary sodium reduction on incidence of hypertension.

To examine the long-term effects of weight loss and dietary sodium reduction on the incidence of hypertension, we studied 181 men and women who participated in the Trials of Hypertension Prevention, phase 1, in Baltimore, Md. At baseline (1987 to 1988), subjects were 30 to 54 years old and had a diastolic blood pressure (BP) of 80 to 89 mm Hg and systolic BP <160 mm Hg. They were randomly assigned to one of two 18-month lifestyle modification interventions aimed at either weight loss or dietary sodium reduction or to a usual care control group. At the posttrial follow-up (1994 to 1995), BP was measured by blinded observers who used a random-zero sphygmomanometer. Incident hypertension was defined as systolic BP > or =160 mm Hg and/or diastolic BP > or =90 mm Hg and/or treatment with antihypertensive medication during follow-up. Body weight and urinary sodium were not significantly different among the groups at the posttrial follow-up. After 7 years of follow-up, the incidence of hypertension was 18.9% in the weight loss group and 40.5% in its control group and 22.4% in the sodium reduction group and 32.9% in its control group. In logistic regression analysis adjusted for baseline age, gender, race, physical activity, alcohol consumption, education, body weight, systolic BP, and urinary sodium excretion, the odds of hypertension was reduced by 77% (odds ratio 0.23; 95% confidence interval 0.07 to 0.76; P=0.02) in the weight loss group and by 35% (odds ratio 0.65; 95% confidence interval 0.25 to 1.69; P=0.37) in the sodium reduction group compared with their control groups. These results indicate that lifestyle modification such as weight loss may be effective in long-term primary prevention of hypertension.

Recruitment and baseline characteristics of participants in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group.

Dietary Approaches to Stop Hypertension (DASH) was a randomized, multicenter feeding study designed to assess the effects of modifying dietary patterns on blood pressure. Among the most challenging aspects of conducting the DASH trial was the recruitment of participants at the 4 clinical centers. As part of the recruitment drive, 347,500 brochures were mailed, 250,500 coupons were distributed in coupon packs, 114 advertisements were published in newspapers or bulletins, 140 radio and 74 television advertisements were broadcast, and 68 screening events and presentations were conducted. These efforts yielded a total of 459 enrolled participants, ahead of schedule. The most common source of participants was mass mailing of individual brochures (n = 194, 42.3%), followed by word-of-mouth (n = 82, 17.8%), and then other types of mass mailing (n = 44, 9.6%). Recruitment of minority participants followed a similar pattern. Among the 3,192 persons attending the first in-person screening visit, the major reason for nonenrollment was low blood pressure (56%) rather than a diet-related factor. The study population was demographically heterogeneous (49% women, 60% African American, 48% married, and 77% employed full-time). On average, the diet of participants before the DASH feeding study was more similar to the trial control diet than to the combination diet, which reduced blood pressure more effectively. In summary, recruitment of a heterogeneous study population that includes a substantial number of minority participants is a feasible undertaking. However, the effort is considerable and requires a major commitment of resources.

Morphometric analysis of primordial follicle number in pigtailed monkey ovaries: symmetry and relationship with age.

We previously described a modern, three-dimensional counting method for determining primordial follicle (PF) numbers in primate ovaries using a combination of fractionator and physical dissector techniques. The purposes of our current study were 1) to apply our method to describe intraindividual differences in PF numbers between ovaries and 2) perform a linear regression analysis of age versus mean PF number per ovary. Ovaries from 16 pigtailed monkeys (Macaca nemestrina) age 0.85-12.5 yr were examined. Both ovaries were available from 11 subjects. The difference between ovaries ranged from 2% to 22% (mean +/- SD, 10 +/- 7%) and was not statistically significant. Regression analysis of data from all 16 subjects displayed a log-linear relationship according to the equation log N(a) = 4.8542 - 0.0714(age) where N(a) is the number of PF at a given chronological age. The fit for this model was highly significant (r(2) = 0.73, p

The renin-angiotensin system and blood pressure: differences between blacks and whites.

Although blacks have lower plasma renin activity compared to whites, the corresponding differences in serum angiotensin converting enzyme (ACE) levels have not been well studied. Furthermore, few studies have examined the relationship of renin activity and ACE levels to blood pressure (BP) in blacks. We addressed these questions in a cross-sectional study conducted in 110 blacks and 183 whites who were not on antihypertensive medications. Three BP readings were obtained during a clinic visit. Plasma renin activity was assayed by radioimmunoassay and serum ACE levels were measured by spectrophotometry. Mean systolic and diastolic BP were 122.6 and 77.9 mm Hg in the blacks, and 123.4 and 77.9 mm Hg in the whites, respectively. Plasma renin activity was significantly lower in the blacks compared to the whites (0.92 v 1.26 ng/mL/h, respectively, P < .05), but ACE levels were similar in both groups (28.8 v 29.6 U/L, respectively). Renin activity was significantly and inversely associated with systolic and diastolic BP in both the blacks and the whites. ACE levels, however, were inversely associated with BP in the blacks but positively associated with BP in the whites (P = .02 for interaction on diastolic BP), even after adjustment for age, gender, body mass index (BMI), alcohol consumption, and heart rate. The corresponding interaction between ACE level and race on systolic BP was of borderline significance (P = .06). These results suggest that levels of ACE are similar in blacks and whites but their association with BP is possibly reflecting underlying ethnic differences in regulation of BP.

Plasma insulin levels and incidence of hypertension in African Americans and whites.

BACKGROUND: Hyperinsulinemia may play an important role in the pathogenesis of hypertension in whites but the role of hyperinsulinemia in hypertension in African Americans is controversial. SUBJECTS AND METHODS: We studied the relationship between insulin levels and subsequent incidence of hypertension in 140 African Americans and 237 whites who were initially screened for possible participation in the Trials of Hypertension Prevention, phase 1. Plasma insulin and serum glucose were measured at baseline and at a follow-up examination 7 years later. Blood pressure was measured by trained observers using a random-zero sphygmomanometer. Incident hypertension was defined as an average systolic pressure of 160 mm Hg or higher and/or diastolic pressure of 95 mm Hg or higher at a single visit and/or use of antihypertensive medication during follow-up. RESULTS: Over the 7 years of follow-up, the incidence of hypertension was 25.7% in the African Americans and 25.3% in the whites. Baseline plasma insulin and insulin-to-glucose ratio were associated with an increased risk of hypertension in both the African Americans and the whites. After adjustment for age, sex, race, body mass, heart rate, and alcohol consumption at baseline as well as intervention assignment in the Trials of Hypertension Prevention, phase 1, a 1-SD (21 pmol/mmol) difference in baseline insulin-to-glucose ratio was associated with a 2.77 (95% confidence interval, 1.48-5.19) odds ratio of hypertension in the African Americans and a 1.69 (95% confidence interval, 1.08-2.64) odds ratio in the whites. CONCLUSION: These results suggest that higher plasma insulin levels are associated with an increased risk of hypertension in both African Americans and whites.

The relationship between health status and blood pressure in urban African Americans.

African Americans have higher rates of hypertension and poorer health status than their white counterparts. This study assessed the relationship between health status, cardiovascular risk factors, and measured blood pressure. Free blood pressure screenings were performed at businesses and organizations located in west Baltimore. All individuals with cardiovascular risk factors were offered health education. Also, participants with a measured blood pressure of > or = 140/90 mm Hg were referred for free medical treatment. Participants completed a questionnaire that included demographics, cardiovascular risk factors, the Medical Outcomes Study SF 36, and two tests on cholesterol and heart disease knowledge. A total of 1389 African-American men and women were screened; 20% were found to have high normal blood pressure and 31% had stage 1 hypertension or higher. Those with hypertension reported lower physical functioning and poorer general health than those without high blood pressure. When compared with US normative data, participants reported higher levels in vitality and physical and emotional role functioning, more bodily pain, and poorer general health, but they were similar in physical functioning, social functioning, and mental health. Preliminary data suggest that hypertension does have an effect on health function.

Recruitment and retention of minority participants in the DASH controlled feeding trial. DASH Collaborative Research Group. Dietary Approaches to Stop Hypertension.

The Dietary Approaches to Stop Hypertension (DASH) study was a National Heart, Lung, and Blood Institute multicenter trial that compared the impact of three dietary patterns on blood pressure (BP) among adults with high normal blood pressure or mild (Stage I) hypertension. DASH's high minority representation (two-thirds of the 459 randomized participants came from minority populations, and 60% of the cohort were African American) offered a valuable opportunity to assess factors affecting minority enrollment and retention in clinical trials of lifestyle modification. Recruitment strategies included targeted mailings to specific groups, mass mailings, community and worksite screenings, and mass media advertising; the four DASH clinical centers also reimbursed participants from $150 to $160. The most productive recruitment strategies tended to be mass mailings directed at a broad audience that was weighted toward, but not limited to, minority participants. DASH's African-American participants overwhelmingly (89%) cited health and dietary factors, such as learning more about blood pressure and healthy eating habits, as their primary reason for participating, while only six percent listed the financial incentives as their primary reason for participating. Eighty-eight percent of African-American respondents reported they would participate again in a similar study. The insights from DASH should help inform future efforts to recruit minority participants.

Seven-year incidence of hypertension in a cohort of middle-aged African Americans and whites.

Many studies have suggested that African Americans have a higher prevalence of hypertension than whites. The authors conducted a prospective study of hypertension incidence from 1987-1988 to 1994-1995 in 140 African American and 237 white adults aged 30 to 54 years at baseline. The study participants were screened for participation in the Trials of Hypertension Prevention, phase 1, an 18-month lifestyle modification intervention trial aimed at lowering blood pressure, at the Baltimore Clinical Center. Baseline age, blood pressure, body mass index, and heart rate were similar in the two groups. Compared with whites, however, African Americans had a lower percentage of men, college graduates, and households with an income > or = $40,000 per year. African Americans also had lower mean urinary sodium to creatinine ratio and potassium to creatinine ratio, but a similar sodium to potassium ratio. The incidence of hypertension (blood pressure > or = 160/95 mm Hg and/or taking antihypertensive medication) over 7 years of follow-up was nearly identical: 25.7% in African Americans and 25.3% in whites. Baseline age, gender, blood pressure, and heart rate were all associated with the incidence of hypertension. Even after adjustment for these covariables, the risk of hypertension was not higher in African Americans compared with whites. These results indicate that middle-aged African Americans and whites have a similar risk of developing hypertension given the same age, initial blood pressure, and body mass index at baseline.

Spontaneous exfoliation of teeth following severe elemental mercury poisoning: case report and histological investigation for mechanism.

BACKGROUND: Although the spontaneous exfoliation of teeth and breakdown of oral tissues from severe mercury intoxication have been noted for over a century, there are no published reports investigating the mechanisms of these phenomena. Severe mercury poisoning is rare in modern times, but it does occur. We present a case report and a histopathologic investigation into the mechanism of the associated tooth loss. METHODS: An exfoliated tooth and periodontal and gingival tissues were obtained from a 15-month-old patient who had been severely intoxicated with elemental mercury over a period of months and hospitalized for severe neurologic and renal effects. The tissues were examined both by routine hematoxylin and eosin stain and by autometallography specific for mercury. For comparison, control tissue from an age-matched subject was examined with the autometallography technique. RESULTS: Under light microscopy, the gingival tissue showed evidence of moderate to severe acute and chronic inflammation. The tooth pulp tissue showed evidence of moderate vascular dilatation and congestion, and it was infiltrated by many neutrophils. The autometallographic sections showed intense accumulations of mercury in the soft tissues of the mercury-exposed subject, but not in the tissues of the control subject. The deposits were primarily found in fibroblasts, which are essential to maintaining the integrity of the oral tissues. CONCLUSIONS: Histopathologic and autometallographic examination of the affected tissue indicates that the primary mechanism of the spontaneous sloughing of tissue and loss of teeth may be the cytotoxic effects of the accumulation of mercury in fibroblasts. Studies of additional cases would be valuable to confirm this hypothesis.

An accurate, simple method for unbiased determination of primordial follicle number in the primate ovary.

Previous investigations of primordial follicle (PF) number in primate ovaries have used biased, model-based techniques that require correction factors based on assumptions regarding cell size, orientation, and shape. We sought to apply several techniques from the "new stereology" to obtain unbiased number estimates. This method involves a hierarchy of systematic random sampling combined with the physical disector and fractionator techniques. The method readily allows the estimation of the coefficient of error (CE) of each sampling level as it contributes to the observed variance of the overall number estimate. We examined one ovary from each of five pigtailed monkeys (Macaca nemestrina). The mean number of PF was 15,735 +/- 6214 (mean +/- SD). The mean CE for the individual number estimates was 0.085, contributing minimally to the inter-individual coefficient of variation (CV) of the primordial follicle numbers (CV = 0.395). The correlation between age and PF number was not significant (r = -0.74, p > 0.1). The total time taken to count the 100-200 PF necessary per ovary was 4-5 h. We conclude that this method produces reliable, unbiased estimates with measurable and acceptable accuracy in a robust, efficient manner.

Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE).

OBJECTIVE: To compare the effectiveness of different approaches to participant enrollment in a behavior modification trial. DESIGN: Concurrent, prospective evaluation performed in context of recruitment for a randomized, controlled trial. SETTING: Four study centers located in Baltimore, Maryland, Memphis, Tennessee New Brunswick, New Jersey, and Winston-Salem, North Carolina. PARTICIPANTS: Men and women aged 60 to 80 years who were being treated with a prescription medication for control of hypertension. MAIN OUTCOME MEASURES: Visit counts and percent yields were assessed at each stage of the screening and randomization process. Logistic regression was used to contrast the randomization yields for different recruitment strategies and to explore the impact of sociodemographic characteristics and geographic location on recruitment yields. RESULTS: The overall randomization yields from a prescreen contact and a first screening visit to enrollment in the trial were 11% and 31%, respectively. Randomization yields varied significantly by participant age, education, and marital status. CONCLUSIONS: Our results demonstrate the feasibility of recruitment for trials of nonpharmacologic interventions in older people and suggest that mass mailing and mass media advertising campaigns provide an effective means of enrolling in such studies participants with a broad range of personal characteristics.

Recruitment experience in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

Several approaches for recruitment of African American adults with renal insufficiency due to hypertension (glomerular filtration rate between 25 and 70 ml/min/1.73 m2) were explored in the Pilot Study for the African American Study of Kidney Disease and Hypertension (AASK). Over a period of 42 weeks, prescreening information was obtained on 2880 individuals, of whom 498 (17%) were evaluated at a screening visit. Two hundred and twenty-five (8%) had an 125I-iothalamate assessment of glomerular filtration rate. Ninety-four of 97 participants who met all the study eligibility criteria were enrolled in the trial. The most common reasons for ineligibility during screening were absence of renal insufficiency or hypertension, presence of diabetes mellitus, and a body mass index above the acceptable level. Overall, an average of 31 prescreen contacts and 8 screening visits were conducted for every randomization (3.3% yield from prescreening to randomization). Screening in clinical practice was the most efficient method for recruitment (12.6% yield from prescreen contact to randomization compared to 1.1% from mass mailing campaigns, 1.3% from mass media campaigns, and 1.7% from referrals by patients with end-stage renal disease). Randomization yields increased with progressively higher age ranges (2.4%, 3.3%, and 6.0% prescreen to randomization yields for those aged < or = 50, 51-60, and 61-70, respectively). A slight majority (51%) of the prescreen contacts were women, but 75% of the randomized participants were men. Our results suggest that clinic-based screening is an effective approach for recruitment of African Americans with hypertension and renal insufficiency into clinical trials. They also suggest that enrollment of African American women in such studies is a special challenge.

Participant satisfaction in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

Seventy-one of the 94 eligible participants of the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study completed a self-administered questionnaire at the end of the study to determine their satisfaction with the study, difficulties encountered during participation, and willingness to join a similar study in the future. Nearly all of the participants (97%) believed that they would directly benefit from the study; treatment and information from physicians (94%), and more knowledge (92%) and closer monitoring (90%) of their physical condition were often cited as the ways in which the AASK Pilot Study helped. The two most commonly reported problems in the study were side effects from antihypertensive drugs (27%) and travel to and from the clinic (25%). Eighty-two percent of those who completed the survey indicated that they would volunteer for a similar study in the future. We conclude that AASK Pilot Study participants believed that they would benefit directly from the trial and that medical aspects of the trial were of major importance. Side effects from antihypertensive drugs and difficulties in travel to and from the clinic were commonly encountered problems and may hinder long-term participation in the AASK Full-Scale Trial.