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1.  Examining the Behavioral Processes through which Lifestyle Interventions Promote Weight Loss: Results from the PREMIER Trial 
Obesity (Silver Spring, Md.)  2013;22(4):1002-1007.
To examine the behavioral processes through which lifestyle interventions impacted weight loss.
Design and Methods
We limited our analyses to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and six month weight change.
Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with six-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change.
Our findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss.
PMCID: PMC3968223  PMID: 24124061
Lifestyle modification; weight loss; behavior change; self-monitoring
2.  Longitudinal Accuracy of Web-Based Self-Reported Weights: Results From the Hopkins POWER Trial 
Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain.
Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights.
This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight – clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy.
Underestimation of self-reported weights increased significantly from 6 months (mean -0.5kg, SD 1.0kg) to 24 months (mean -1.1kg, SD 2.0kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7kg, SD 0.8kg) to 24 months (mean 1.3, SD 1.8kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001).
Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting.
Trial Registration NCT00783315; (Archived by WebCite at
PMCID: PMC4129117  PMID: 25042773
self-report; weight loss; obesity; Internet
3.  Baseline Predictors of Missed Visits in the Look AHEAD Study 
Obesity (Silver Spring, Md.)  2014;22(1):131-140.
To identify baseline attributes associated with consecutively missed data collection visits during the first 48 months of Look AHEAD—a randomized, controlled trial in 5145 overweight/obese adults with type 2 diabetes designed to determine the long-term health benefits of weight loss achieved by lifestyle change.
Design and Methods
The analyzed sample consisted of 5016 participants who were alive at month 48 and enrolled at Look AHEAD sites. Demographic, baseline behavior, psychosocial factors, and treatment randomization were included as predictors of missed consecutive visits in proportional hazard models.
In multivariate Cox proportional hazard models, baseline attributes of participants who missed consecutive visits (n=222) included: younger age ( Hazard Ratio [HR] 1.18 per 5 years younger; 95% Confidence Interval 1.05, 1.30), higher depression score (HR 1.04; 1.01, 1.06), non-married status (HR 1.37; 1.04, 1.82), never self-weighing prior to enrollment (HR 2.01; 1.25, 3.23), and randomization to minimal vs. intensive lifestyle intervention (HR 1.46; 1.11, 1.91).
Younger age, symptoms of depression, non-married status, never self-weighing, and randomization to minimal intervention were associated with a higher likelihood of missing consecutive data collection visits, even in a high-retention trial like Look AHEAD. Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.
PMCID: PMC3943994  PMID: 23996977
randomized clinical trials; behavioral trial; retention; obesity
4.  Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice 
The New England journal of medicine  2011;365(21):1959-1968.
Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse.
We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely — through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months.
At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was −0.8 kg in the control group, −4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and −5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups.
In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; number, NCT00783315.)
PMCID: PMC4074540  PMID: 22085317
5.  The Effects of n-3 Long-Chain Polyunsaturated Fatty Acid Supplementation on Biomarkers of Kidney Injury in Adults With Diabetes 
Diabetes Care  2013;36(6):1462-1469.
Long-chain n-3 polyunsaturated fatty acid (n-3 PUFA) supplements may have renoprotective effects in patients with diabetes, but previous trials have been inconsistent. We performed a randomized controlled trial of n-3 PUFA supplementation on urine albumin excretion and markers of kidney injury in adults with type 2 diabetes.
We conducted a randomized, placebo-controlled, two-period crossover trial to test the effects of 4 g/day of n-3 PUFA supplementation on markers of glomerular filtration and kidney injury in adults with adult-onset diabetes and greater than or equal to trace amounts of proteinuria. Each period lasted 6 weeks and was separated by a 2-week washout. The main outcome was urine albumin excretion and, secondarily, markers of kidney injury (kidney injury molecule-1, N-acetyl β-d-glucosaminidase [NAG], neutrophil gelatinase-associated lipocalin [NGAL], and liver fatty acid–binding protein [LFABP]), serum markers of kidney function (cystatin C, β2-microglobulin, and creatinine), and estimated glomerular filtration rate (eGFR).
Of the 31 participants, 29 finished both periods. A total of 55% were male, and 61% were African American; mean age was 67 years. At baseline, mean BMI was 31.6 kg/m2, median eGFR was 76.9 mL/min/1.73 m2, and median 24-h urine albumin excretion was 161 mg/day. Compared with placebo, n-3 PUFA had nonsignificant effects on urine albumin excretion (−7.2%; 95% CI −20.6 to 8.5; P = 0.35) and significant effects on urine NGAL excretion (−16% [−29.1 to −0.5%]; P = 0.04). There was no effect on serum markers of kidney function or eGFR. In subgroup analyses, there were significant decreases in 24-h urinary excretion of albumin, NGAL, LFABP, and NAG among participants taking medications that block the renin-angiotensin-aldosterone system (RAAS).
These results suggest a potential effect of n-3 PUFA supplementation on markers of kidney injury in patients with diabetes and early evidence of kidney disease. In the context of prior studies, these results provide a strong rationale for long-term trials of n-3 PUFA on chronic kidney disease progression.
PMCID: PMC3661851  PMID: 23275364
Hypertension  2012;61(1):82-88.
The objective of our study was to determine the effects of two antihypertensive drug dose schedules (‘PM dose’ and ‘Add on dose’) on nocturnal blood pressure (BP) in comparison to usual therapy (‘AM dose’) in African Americans with hypertensive chronic kidney disease (CKD) and controlled office BP. In a three period, cross-over trial, former participants of the African American Study of Kidney Disease were assigned to receive the following three regimens, each lasting 6 weeks, presented in random order: AM dose (once daily antihypertensive medications taken in the morning), PM dose (once daily antihypertensives taken at bedtime) and ‘Add on dose’ (once daily antihypertensives taken in the morning and an additional antihypertensive medication before bedtime [diltiazem 60–120 mg, hydralazine 25 mg, or additional ramipril 5 mg]). Ambulatory BP monitoring was performed at the end of each period. The primary outcome was nocturnal systolic BP. Mean age of the study population (n=147) was 65.4 years, 64% were male, mean estimated GFR was 44.9 ml/min/1.73 m2. At the end of each period, mean (SE) nocturnal systolic BP was 125.6 (1.2) mm Hg in the AM dose, 123.9 (1.2) mm Hg in the PM dose, and 123.5(1.2) mm Hg in the Add-on dose. None of the pairwise differences in nocturnal, 24-hour and daytime systolic BP were statistically significant. Among African Americans with hypertensive CKD, neither PM (bedtime) dosing of once daily antihypertensive nor the addition of drugs taken at bedtime significantly reduced nocturnal BP compared to morning dosing of anti-hypertensive medications.
PMCID: PMC3523681  PMID: 23172931
Nocturnal blood pressure; chronic kidney disease; hypertension
7.  Cigarette Smoking and Health Characteristics in Individuals With Serious Mental Illness Enrolled in a Behavioral Weight Loss Trial 
Journal of dual diagnosis  2013;9(1):39-46.
Objective: Cigarette smoking is the most preventable cause of disease and death in the US. We examined the prevalence of smoking and the association between smoking status and health characteristics in persons with serious mental illness. Methods: A total of 291 overweight or obese adults with serious mental illness were enrolled in a behavioral weight loss trial. Cigarette smoking, co-occurring medical diagnoses, dietary intake, blood pressure, cardiovascular fitness, body mass index, quality of life, and psychiatric symptoms were assessed at baseline in 2008–2011. Fasting glucose and lipid markers were measured from blood samples. Cardiovascular risk profile was calculated based on the global Framingham Health Study Risk Equation. Results: A total of 128 (44%) of participants were current smokers or had smoked in the previous one year. The smokers had significantly higher diastolic blood pressure and blood triglyceride levels, and lower HDL cholesterol than the nonsmokers, adjusted for age, sex, education, and diagnosis. They were more likely to have a history of emphysema, and had a 10-year cardiovascular disease risk of 13.2%, significantly higher than the 7.4% in the nonsmokers. The smokers also had elevated ratings of psychopathology on the BASIS-24 scale. Smokers did not differ from nonsmokers in cardiovascular fitness, body mass index, depression, quality of life, or other comorbid medical diagnoses. There was no characteristic in which smokers appeared healthier than nonsmokers. Conclusions: The prevalence of smoking in this contemporary cohort of individuals with serious mental illness who were motivated to lose weight was more than twice that in the overall population. Smokers had more indicators of cardiovascular disease and poorer mental health than did nonsmokers. The high burden of comorbidity in smokers with serious mental illness indicates a need for broad health interventions.
PMCID: PMC3780421  PMID: 24072987
smoking; health; cardiovascular; serious mental illness; weight loss
8.  Long-term Effects of Renin-Angiotensin System–Blocking Therapy and a Low Blood Pressure Goal on Progression of Hypertensive Chronic Kidney Disease in African Americans 
Archives of internal medicine  2008;168(8):10.1001/archinte.168.8.832.
Antihypertensive drugs that block the renin-angiotensin system (angiotensin-converting enzyme inhibitors [ACEIs] or angiotensin receptor blockers) are recommended for patients with chronic kidney disease (CKD). A low blood pressure (BP) goal (BP, <130/80 mm Hg) is also recommended. The objective of this study was to determine the long-term effects of currently recommended BP therapy in 1094 African Americans with hypertensive CKD.
Multicenter cohort study following a randomized trial. Participants were 1094 African Americans with hypertensive renal disease (glomerular filtration rate, 20–65 mL/min/1.73 m2). Following a 3×2-factorial trial (1995–2001) that tested 3 drugs used as initial antihypertensive therapy (ACEIs, calcium channel blockers, and β-blockers) and 2 levels of BP control (usual and low), we conducted a cohort study (2002–2007) in which participants were treated with ACEIs to a BP lower than 130/80 mm Hg. The outcome measures were a composite of doubling of the serum creatinine level, end-stage renal disease, or death.
During each year of the cohort study, the annual use of an ACEI or an angiotensin receptor blocker ranged from 83.7% to 89.0% (vs 38.5% to 49.8% during the trial). The mean BP in the cohort study was 133/78 mm Hg (vs 136/82 mm Hg in the trial). Overall, 567 participants experienced the primary outcome; the 10-year cumulative incidence rate was 53.9%. Of 576 participants with at least 7 years of follow-up, 33.5% experienced a slow decline in kidney function (mean annual decline in the estimated glomerular filtration rate, <1 mL/min/1.73 m2).
Despite the benefits of renin-angiotensin system–blocking therapy on CKD progression, most African Americans with hypertensive CKD who are treated with currently recommended BP therapy continue to progress during the long term.
PMCID: PMC3870204  PMID: 18443258
9.  Rationale, design and baseline data for the Activating Consumers to Exercise through Peer Support (ACE trial): A randomized controlled trial to increase fitness among adults with mental illness 
The benefits of regular physical activity are particularly salient to persons with serious mental illness (SMI) who have increased prevalence of obesity, diabetes, and earlier mortality from cardiovascular disease.
The Activating Consumers to Exercise through Peer Support (ACE) trial will examine the effectiveness of peer support on adherence to a 4-month pilot exercise program for adults with SMI. Design, rationale and baseline data are reported. Baseline measures included: graded treadmill test; six-minute walk; height, weight and blood pressure; body composition; fasting blood; and self-reported psychiatric symptoms. Fitness levels were compared with national data and relationships among fitness parameters, psychological factors and cardiovascular disease risk factors were examined.
There were 93 participants and 18 peer leaders recruited from community psychiatry programs with an average age of 47 years (SD 10). There were no differences in demographics (76% female, 72% African American) or mental health symptoms between participants and peer leaders. Ninety-five percent of the sample had below average fitness levels for their age and sex with average MET levels of 5.9(SD 2.2) for participants and 6.2(SD 2.3) for peer leaders. Fitness evaluated during the treadmill test and the six-minute-walk were associated (rs = 0.36, p<.001). Lower MET levels were associated with a higher BMI (rs = −0.35, p<.001) and percent body fat (rs = −0.36, p <.001).
The uniformly low baseline cardiovascular fitness and the association of fitness with BMI and adiposity underscore the importance of suitably tailored programs to increase physical activity among adults with SMI.
PMCID: PMC3587110  PMID: 23471190
physical fitness; exercise; mental illness; cardiovascular risk
10.  A Behavioral Weight-Loss Intervention in Persons with Serious Mental Illness 
The New England journal of medicine  2013;368(17):1594-1602.
Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness.
We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months.
Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was −3.2 kg (−7.0 lb, P = 0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P = 0.009). There were no significant between-group differences in adverse events.
A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population.
PMCID: PMC3743095  PMID: 23517118
11.  A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol 
Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care.
Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions.
As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have incorporated stakeholder input and tailored components of the interventions to meet the specific needs of the involved clinics and communities. Results from this study will provide knowledge about how integrated multi-level interventions can improve hypertension care and reduce disparities.
Trial Registration NCT01566864
PMCID: PMC3680084  PMID: 23734703
Quality improvement; Hypertension; Health disparities; Pragmatic trial; Organizational culture; Community-based participatory research; Study design
12.  Intensive Blood-Pressure Control in Hypertensive Chronic Kidney Disease 
The New England journal of medicine  2010;363(10):918-929.
In observational studies, the relationship between blood pressure and end-stage renal disease (ESRD) is direct and progressive. The burden of hypertension-related chronic kidney disease and ESRD is especially high among black patients. Yet few trials have tested whether intensive blood-pressure control retards the progression of chronic kidney disease among black patients.
We randomly assigned 1094 black patients with hypertensive chronic kidney disease to receive either intensive or standard blood-pressure control. After completing the trial phase, patients were invited to enroll in a cohort phase in which the blood-pressure target was less than 130/80 mm Hg. The primary clinical outcome in the cohort phase was the progression of chronic kidney disease, which was defined as a doubling of the serum creatinine level, a diagnosis of ESRD, or death. Follow-up ranged from 8.8 to 12.2 years.
During the trial phase, the mean blood pressure was 130/78 mm Hg in the intensive-control group and 141/86 mm Hg in the standard-control group. During the cohort phase, corresponding mean blood pressures were 131/78 mm Hg and 134/78 mm Hg. In both phases, there was no significant between-group difference in the risk of the primary outcome (hazard ratio in the intensive-control group, 0.91; P = 0.27). However, the effects differed according to the baseline level of proteinuria (P = 0.02 for interaction), with a potential benefit in patients with a protein-to-creatinine ratio of more than 0.22 (hazard ratio, 0.73; P = 0.01).
In overall analyses, intensive blood-pressure control had no effect on kidney disease progression. However, there may be differential effects of intensive blood-pressure control in patients with and those without baseline proteinuria. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center on Minority Health and Health Disparities, and others.)
PMCID: PMC3662974  PMID: 20818902
13.  Reliability of resting blood pressure measurement and classification using an oscillometric device in children with chronic kidney disease 
The Journal of Pediatrics  2011;160(3):434-440.e1.
To compare the reliability of blood pressure (BP) readings obtained by an oscillometric device to those obtained by auscultation and assess for differences in BP status classification based upon the two techniques.
Study design
Resting BP was measured by auscultation and with an oscillometric device at the same encounter in 235 subjects enrolled in the Chronic Kidney Disease in Children study. Resting auscultatory BP’s were averaged and compared with averaged oscillometric readings. BP agreement by the two methods was assessed using Bland-Altman plots, and BP status classification agreement was assessed by calculation of Kappa statistics.
Oscillometric BP readings were higher than auscultatory readings, with a median paired difference of 9 mmHg for systolic BP (SBP) and 6 mmHg for diastolic BP (DBP). Correlation for mean SBP was 0.624 and for mean DBP was 0.491. The bias for oscillometric BP measurement was 8.7 mmHg for SBP (P<0.01) and 5.7 mmHg for DBP (P<0.01). BP status classification agreement was 61% for SBP and 63% for DBP, with Kappas of 0.31 for SBP and 0.20 for DBP.
Compared with auscultation, the oscillometric device significantly overestimated both systolic and diastolic BP, leading to frequent misclassification of BP status.
PMCID: PMC3274610  PMID: 22048052
14.  Quality of Life and Psychosocial Factors in African Americans with Hypertensive Chronic Kidney Disease 
Health-related quality of life (HRQOL) is poorly understood in patients with chronic kidney disease (CKD) prior to end-stage renal disease. The association between psychosocial measures and HRQOL has not been fully explored in CKD, especially in African Americans. We performed a cross-sectional analysis of HRQOL and its association with sociodemographic and psychosocial factors in African Americans with hypertensive CKD.
There were 639 participants in the African American Study of Kidney Disease and Hypertension Cohort Study. The Short Form-36 was used to measure HRQOL. The Diener Satisfaction with Life Scale measured life satisfaction, the Beck Depression Inventory-II assessed depression, the Coping Skills Inventory-Short Form measured coping, and the Interpersonal Support Evaluation List-16 was used to measure social support.
Mean participant age was 60 years at enrollment, and 61% were male. Forty-two percent reported a household income below $15,000/year. Higher levels of social support, coping skills, and life satisfaction were associated with higher HRQOL, while unemployment and depression were associated with lower HRQOL (p<0.05). There was a significant positive association between higher estimated glomerular filtration rate (eGFR) with the Physical Health Composite (PHC) score (p=0.004) but not the Mental Health Composite (MHC) score (p=0.24).
Unemployment was associated with lower HRQOL, and lower eGFR was associated with lower PHC. African Americans with hypertensive CKD with better social support and coping skills had higher HRQOL. This study demonstrates an association between CKD and low HRQOL and highlights the need for longitudinal studies to further examine this association.
PMCID: PMC3240805  PMID: 22153804
15.  Elevated depressive affect is associated with adverse cardiovascular outcomes among African Americans with chronic kidney disease 
Kidney international  2011;80(6):670-678.
This study was designed to examine the impact of elevated depressive affect on health outcomes among participants with hypertensive chronic kidney disease in the African-American Study of Kidney Disease and Hypertension (AASK) Cohort Study. Elevated depressive affect was defined by Beck Depression Inventory II (BDI-II) thresholds of 11 or more, above 14, and by 5-Unit increments in the score. Cox regression analyses were used to relate cardiovascular death/hospitalization, doubling of serum creatinine/end-stage renal disease, overall hospitalization, and all-cause death to depressive affect evaluated at baseline, the most recent annual visit (time-varying), or average from baseline to the most recent visit (cumulative). Among 628 participants at baseline, 42% had BDI-II scores of 11 or more and 26% had a score above 14. During a 5-year follow-up, the cumulative incidence of cardiovascular death/hospitalization was significantly greater for participants with baseline BDI-II scores of 11 or more compared with those with scores <11. The baseline, time-varying, and cumulative elevated depressive affect were each associated with a significant higher risk of cardiovascular death/hospitalization, especially with a time-varying BDI-II score over 14 (adjusted HR 1.63) but not with the other outcomes. Thus, elevated depressive affect is associated with unfavorable cardiovascular outcomes in African Americans with hypertensive chronic kidney disease.
PMCID: PMC3237701  PMID: 21633409
AASK (African American Study of Kidney Disease and Hypertension); cardiovascular events; chronic kidney disease; depression
16.  Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine Concentrations in Older Adults: A Dose-Response Trial 
American Journal of Epidemiology  2010;172(8):932-941.
The authors’ objective in this study was to estimate the changes in serum folate and homocysteine concentration that resulted from 6 weeks of supplementation with folic acid. A randomized, double-blind, placebo-controlled, dose-response trial with a parallel-group design was conducted. A total of 133 participants aged 60–90 years (70% female, 19% nonwhite) were assigned to receive 0, 100, 400, 1,000, or 2,000 μg/day of folic acid for 6 weeks. Data were collected in the United States between June and September 1996. At baseline, median serum folate and plasma homocysteine concentrations were 5.7 ng/mL (interquartile range (25th–75th percentiles), 4.1–7.8) and 8.3 μmol/L (interquartile range, 7.1–10.0), respectively. As the folic acid dose increased, serum folate levels increased (P-trend < 0.001). There was no dose-response relation with homocysteine level among all participants. In analyses restricted to persons with the lowest serum folate concentration (<4.5 ng/mL) at baseline, there was a trend (P = 0.06) toward decreased homocysteine levels with increasing folic acid dose. In healthy, older adults with adequate folate status, folic acid supplementation is not beneficial for homocysteine reduction. However, for older adults with low serum folate levels, supplementation will improve folate status and may be beneficial for lowering homocysteine concentrations.
PMCID: PMC2984248  PMID: 20847105
adult; dietary supplements; folic acid; homocysteine
17.  Sociodemographic factors contribute to the depressive affect among African Americans with chronic kidney disease 
Kidney international  2010;77(11):1010-1019.
Depression is common in end-stage renal disease and is associated with poor quality of life and higher mortality; however, little is known about depressive affect in earlier stages of chronic kidney disease. To measure this in a risk group burdened with hypertension and kidney disease, we conducted a cross-sectional analysis of individuals at enrollment in the African American Study of Kidney Disease and Hypertension Cohort Study. Depressive affect was assessed by the Beck Depression Inventory II and quality of life by the Medical Outcomes Study-Short Form and the Satisfaction with Life Scale. Beck Depression scores over 14 were deemed consistent with an increased depressive affect and linear regression analysis was used to identify factors associated with these scores. Among 628 subjects, 166 had scores over 14 but only 34 were prescribed antidepressants. The mean Beck Depression score of 11.0 varied with the estimated glomerular filtration rate (eGFR) from 10.7 (eGFR 50–60) to 16.0 (eGFR stage 5); however, there was no significant independent association between these. Unemployment, low income, and lower quality and satisfaction with life scale scores were independently and significantly associated with a higher Beck Depression score. Thus, our study shows that an increased depressive affect is highly prevalent in African Americans with chronic kidney disease, is infrequently treated with antidepressants, and is associated with poorer quality of life. Sociodemographic factors have especially strong associations with this increased depressive affect. Because this study was conducted in an African-American cohort, its findings may not be generalized to other ethnic groups.
PMCID: PMC3114445  PMID: 20200503
AASK (African American Study of Kidney Disease and Hypertension); chronic kidney disease; clinical epidemiology; depression; quality of life
18.  Hypertension Awareness, Treatment, and Control in Adults With CKD: Results From the Chronic Renal Insufficiency Cohort (CRIC) Study 
A low rate of blood pressure control has been reported among patients with chronic kidney disease (CKD). These data were derived from population-based samples with a low rate of CKD awareness.
Study Design
Setting & Participants
Data from the baseline visit of the Chronic Renal Insufficiency Cohort (CRIC) study (n=3612) were analyzed. Participants with an estimated glomerular filtration rate of 20 to 70 ml/min/1.73m2 were identified from physician offices and review of laboratory databases.
Prevalence and awareness of hypertension, treatment patterns, control rates and factors associated with hypertension control.
Following a standardized protocol, blood pressure was measured three times by trained staff and hypertension was defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg and/or self-reported antihypertensive medication use. Patients’ awareness and treatment of hypertension were defined using self-report and two levels of hypertension control were evaluated: systolic/diastolic blood pressure <140/90 mmHg and <130/80 mmHg.
The prevalence of hypertension was 85.7%, and 98.9% of CRIC participants were aware of this diagnosis, 98.3% were treated with medications while 67.1% and 46.1% had their hypertension controlled to <140/90 mmHg and <130/80 mmHg, respectively. Of CRIC participants with hypertension, 15%, 25%, 26% and 32% were taking one, two, three and four or more antihypertensive medications, respectively. After multivariable adjustment, older patients, blacks, those with higher urinary albumin excretion were less likely while participants taking ACE-inhibitors and angiotensin receptor blockers were more likely to have controlled their hypertension to <140/90 mmHg and <130/80 mmHg.
Data were derived from a single study visit.
Despite almost universal hypertension awareness and treatment in this cohort of patients with CKD, rates of hypertension control were sub-optimal.
PMCID: PMC2866514  PMID: 19962808
19.  Overall and Minority-Focused Recruitment Strategies in the PREMIER Multicenter Trial of Lifestyle Interventions for Blood Pressure Control 
Recruitment strategies employed by four clinical centers across the US and a coordinating center were examined to identify successful overall and minority-focused recruitment strategies for the PREMIER multicenter trial of lifestyle changes for blood pressure control. The goal was to recruit 800 adults (40% African Americans) with systolic blood pressure of 120-159 mmHg and diastolic of 80-95 mmHg, not taking antihypertensive medication. Clinical centers used combinations of mass distribution of brochures, mass media, email distribution lists, screening events, and a national website. Culturally appropriate strategies for African Americans were designed by a Minority Implementation (MI) committee. Diversity training was provided for study staff, and African Americans were included in the study design process. Main recruitment outcomes were number overall and number of African Americans recruited by each strategy. Of the 810 randomized PREMIER participants, 279 (34%) were African American with site specific percentages of 56%, 46%, 27%, and 8%. Of African Americans recruited, 151 (54%) were from mass distribution of brochures (mailed letter, flyer included in Val-Pak coupons, or other), 66 (24%) from mass media (printed article, radio, TV story or ads, 52 (19%) from word of mouth, and 10 (3%) from email/website and screening events combined. Yields for Non-Hispanic Whites were 364 (69%) from brochures, 71 (13%) from mass media, 49 (9%) from word of mouth and 47 (9%) from email/website and screening events. Mass distribution of brochures was relatively more effective with Non-Hispanic Whites, while African Americans responded relatively better to other recruitment strategies.
PMCID: PMC2818364  PMID: 19879377
Cultural Appropriateness; Mass Distribution; Minority Participants
20.  Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial 
BMC Psychiatry  2010;10:108.
Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group.
A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months.
Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.
Trial Registration
Clinical NCT00902694
PMCID: PMC3016313  PMID: 21144025
21.  Physical activity levels of persons with mental illness attending psychiatric rehabilitation programs 
Schizophrenia research  2009;108(1-3):252-257.
This study objectively measured physical activity levels in overweight and obese adults with severe mental illness and examined relationships among psychiatric symptoms, cognitive functioning and physical activity. A diverse sample (50% female, 50% African American) of overweight and obese adults (n=55) with mental illness were asked to wear accelerometers for 4 days. Study participants averaged 120 minutes/week of moderate to vigorous physical activity (MVPA); 35% had ≥ 150 minutes/week of MVPA. Only 4% accumulated ≥ 150 minutes/week of MVPA in bouts ≥ 10 minutes as per public health recommendations. Depressive symptoms, psychological distress and cognitive functioning were not associated with physical activity (p > .05). Although participants appeared to have substantial minutes of MVPA, increased physical activity bouts, or sessions, may be necessary for increased health and weight management benefits for persons with severe mental illness. Efforts are needed to increase physical activity sessions in this vulnerable population.
PMCID: PMC2679956  PMID: 19157787
Severe Mental Illness; Physical Activity; Exercise; Accelerometers; Obesity

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