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Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE Phase 2) screening and recruitment: methods and results.
Stewart, TM, Bhapkar, M, Das, S, Galan, K, Martin, CK, McAdams, L, Pieper, C, Redman, L, Roberts, S, Stein, RI, et al
Contemporary clinical trials. 2013;(1):10-20
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Abstract
The Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study is a systematic investigation of sustained 25% calorie restriction (CR) in non-obese humans. CALERIE is a multicenter (3 clinical sites, one coordinating center), parallel group, randomized controlled trial. Participants were recruited, screened, and randomized to the CR or control group with a 2:1 allocation. Inclusion criteria included ages 21-50 years for men and 21-47 years for women, and a body mass index (BMI) of 22.0 ≤ BMI < 28.0 kg/m(2). Exclusion criteria included abnormal laboratory markers, significant medical conditions, psychiatric/behavioral problems, and an inability to adhere to the rigors of the evaluation/intervention schedule. A multi-stage screening process (telephone screen and 3 in-clinic visits) was applied to identify eligible participants. Recruitment was effective and enrollment targets were met on time. 10,856 individuals contacted the clinical sites, of whom 9787 (90%) failed one or more eligibility criteria. Of the 1069 volunteers who started the in-clinic screening, 831 (78%) were either ineligible or dropped. 238 volunteers were enrolled (i.e., initiated the baseline evaluations), 220 were randomized, and 218 started the assigned intervention (2% from the first screening step). This study offered lessons for future multi-center trials engaging non-disease populations. Recruitment strategies must be tailored to specific sites. A multi-disciplinary screening process should be applied to address medical, physical, and psychological/behavioral suitability of participants. Finally, a multi-step screening process with simple criteria first, followed by more elaborate procedures has the potential to reduce the use of study resources.
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Methods and issues in conducting a community-based environmental randomized trial.
Swartz, LJ, Callahan, KA, Butz, AM, Rand, CS, Kanchanaraksa, S, Diette, GB, Krishnan, JA, Breysse, PN, Buckley, TJ, Mosley, AM, et al
Environmental research. 2004;(2):156-65
Abstract
The environment is suspected to play an important role in the prevalence and severity of asthma in inner-city children. This paper describes the implementation and baseline data of an inner-city community-based participatory research clinical trial designed to test the effectiveness of a pollutant and allergen control strategy on children's asthma morbidity. Participants were 100 elementary-school-aged children with asthma, graduates of a school-based asthma education program in East Baltimore. The intervention for half of the randomly assigned families consisted of environmental control education, allergen-proof encasements, pest extermination, and a HEPA air cleaner at the beginning of the study. Controls received the same at the end of the study. Participants visited a clinic for questionnaires, allergy skin testing, spirometry, and blood sample at baseline and 12 months. Home environments, NO(2), O(3), airborne particulates, and allergens were evaluated at baseline and at 6 and 12 months. Asthma morbidity and adherence was assessed quarterly. Collaboration with the community proved very beneficial in creating a study design and procedures acceptable to an inner-city community.
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Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial.
Carmack Taylor, CL, Smith, MA, de Moor, C, Dunn, AL, Pettaway, C, Sellin, R, Charnsangavej, C, Hansen, MC, Gritz, ER
Controlled clinical trials. 2004;(3):265-85
Abstract
Prostate cancer patients receiving androgen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment. Because physical activity improves physical and psychological well-being, a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life (QOL). No studies have evaluated an intervention to improve multiple QOL domains in patients receiving androgen ablation therapy. Active for Life After Cancer is a three-group randomized controlled trial designed to evaluate the effectiveness of a lifestyle physical activity intervention (Lifestyle Program) in improving QOL. The Lifestyle Program, a 6-month behavioral skills training group, is compared to an Educational Support Program and Standard Care. The purpose of this paper is to describe the design of the randomized trial and present baseline data that will characterize the QOL of the sample. Challenges to recruitment for the trial also will be presented and discussed.
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Is there really a power shortage in clinical trials testing the "homocysteine hypothesis?".
Hankey, GJ, Eikelboom, JW, Loh, K, Yi, Q, Pizzi, J, Tang, M, Hickling, S, Le, M, Klijn, CJ, Dusitanond, P, et al
Arteriosclerosis, thrombosis, and vascular biology. 2004;(8):e147
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YOUTH: decisions and challenges in designing an osteoporosis prevention intervention for teen girls.
DeBar, LL, Ritenbaugh, C, Vuckovic, N, Stevens, VJ, Aickin, M, Elliot, D, Moe, E, Orwoll, E, Ernst, D, Irving, LM
Preventive medicine. 2004;(5):1047-55
Abstract
BACKGROUND This paper describes decisions about the experimental design for the Youth, Osteoporosis, and Understanding Total Health Project (YOUTH), a trial designed to test the efficacy of a health plan-based lifestyle intervention for increasing bone mineral density among adolescent women 14 to 16 years of age. METHODS This randomized controlled trial recruited adolescent women who were at higher risk for developing osteoporosis (body mass index 16-23) from a large HMO in the Pacific Northwest. The intervention focused on improving diet (high calcium foods, fruits, and vegetables) and increasing physical activity (high impact and spinal motion). The intervention included both group and individual activities. The primary endpoint in the study was total bone mineral density as measured by dual-energy X-ray absorptiometry (DEXA). RESULTS Baseline data were collected on the trial cohort of 228 adolescent women and their families. This paper discusses how researchers met the following challenges in designing and implementing the trial: determining appropriate dietary and exercise targets to affect bone mineral density in adolescents; choosing suitable assessments; and developing an intervention well suited for implementation in a non-school (health plan) setting. We also discuss the rationale for the specific study population chosen (females, younger adolescents). CONCLUSIONS The YOUTH project is one of very few preventive research interventions with adolescents conducted in a health plan setting. Many of the recruitment and intervention strategies used in this trial may be appropriate for adoption in other health plan-based prevention studies.
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The second progress report on the Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study.
Saito, S, Asayama, K, Ohkubo, T, Kikuya, M, Metoki, H, Obara, T, Hashimoto, J, Totsune, K, Miura, Y, Imai, Y, et al
Blood pressure monitoring. 2004;(5):243-7
Abstract
BACKGROUND The Hypertension Objective treatment based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study is a large-scale intervention trial to determine both optimal target blood pressure (BP) on the basis of self-measured BP at home, and optimal initial antihypertensive medication. OBJECTIVE To investigate the quality of randomization at the end of March 2003, and BP-controlled conditions during initial 6 months. METHODS We evaluated the number of patients randomized by the end of March 2003, and BP changes during the initial 6 months based on intention-to-treat analysis. RESULTS By the end of March 2003, a total of 1086 patients (12% of a planned randomization of 9000 patients) had been randomized. Among 653 patients who had been followed for > or =6 months after randomization, mean systolic/diastolic BPs at randomization in the calcium antagonist, angiotensin-converting enzyme and angiotensin II receptor blocker groups were 149/89, 150/89 and 149/88 mmHg, respectively. Blood pressures were reduced after 3 months (137/83, 139/82 and 136/82 mmHg, respectively), and further reduced after 6 months (134/81, 135/80 and 133/80 mmHg, respectively), with no significant differences identified between groups. In more- and less-intensive BP-lowering groups, mean systolic/diastolic BPs at randomization were 149/88 and 150/89 mmHg, respectively. Although BPs were reduced after treatment for 3 months (137/83 and 137/82 mmHg, respectively) and 6 months (134/80 and 135/80 mmHg, respectively) in each target group, significant differences were still not observed between groups. CONCLUSIONS Good quality of randomization was observed at the end of March 2003, but rate of achievement for target BPs was insufficient.
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BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991].
Nau, B, Schmitt, CP, Almeida, M, Arbeiter, K, Ardissino, G, Bonzel, KE, Edefonti, A, Fischbach, M, Haluany, K, Misselwitz, J, et al
BMC nephrology. 2004;:14
Abstract
BACKGROUND Peritoneal dialysis (PD) is the preferred dialysis modality in children. Its major drawback is the limited technique survival due to infections and progressive ultrafiltration failure. Conventional PD solutions exert marked acute and chronic toxicity to local tissues. Prolonged exposure is associated with severe histopathological alterations including vasculopathy, neoangiogenesis, submesothelial fibrosis and a gradual loss of the mesothelial cell layer. Recently, more biocompatible PD solutions containing reduced amounts of toxic glucose degradation products (GDPs) and buffered at neutral pH have been introduced into clinical practice. These solutions contain lactate, bicarbonate or a combination of both as buffer substance. Increasing evidence from clinical trials in adults and children suggests that the new PD fluids may allow for better long-term preservation of peritoneal morphology and function. However, the relative importance of the buffer in neutral-pH, low-GDP fluids is still unclear. In vitro, lactate is cytotoxic and vasoactive at the concentrations used in PD fluids. The BIOKID trial is designed to clarify the clinical significance of the buffer choice in biocompatible PD fluids. METHODS/DESIGN The objective of the study is to test the hypothesis that bicarbonate based PD solutions may allow for a better preservation of peritoneal transport characteristics in children than solutions containing lactate buffer. Secondary objectives are to assess any impact of the buffer system on acid-base status, peritoneal tissue integrity and the incidence and severity of peritonitis. After a run-in period of 2 months during which a targeted cohort of 60 patients is treated with a conventional, lactate buffered, acidic, GDP containing PD fluid, patients will be stratified according to residual renal function and type of phosphate binding medication and randomized to receive either the lactate-containing Balance solution or the bicarbonate-buffered Bicavera solution for a period of 10 months. Patients will be monitored by monthly physical and laboratory examinations. Peritoneal equilibration tests, 24-h dialysate and urine collections will be performed 4 times. Peritoneal biopsies will be obtained on occasion of intraabdominal surgery. Changes in small solute transport rates, markers of peritoneal tissue turnover in the effluent, acid-base status and peritonitis rates and severity will be analyzed.
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Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--.
Igarashi, K, Fujita, K, Yamase, T, Morita, N, Okita, K, Satake, K, Kanazawa, N, Nishijima, H
Circulation journal : official journal of the Japanese Circulation Society. 2004;(12):1199-204
Abstract
BACKGROUND The annual health check followed by lifestyle recommendations has long been the standard national strategy to improve cardiovascular disease (CVD) risk factors in Japan. Exercise at fitness clubs, now widely accessible in major cities, has a novel appeal as a strategy with the additive effect of CVD risk reduction. The Sapporo Fitness Club Trial (SFCT) is a randomized controlled trial to compare the efficacy of the national standard alone (control) with the standard plus exercise at a fitness club (intervention) for the reduction of CVD risk factors. METHODS The SFCT has recruited and randomized 561 relatively inactive overweight men and women, aged 40-85 years, with elevated levels of 2 or more of the following: systolic blood pressure, fasting blood glucose, and low-density lipoprotein cholesterol. The intervention group was required to exercise at a fitness club 2-4 times per week. At the end of 6 months, risk factors, aerobic capacity, health-related quality of life measures, and adverse effects are to be compared. CONCLUSION The SFCT is expected to have a major impact in Japan on public health recommendations on exercise for the reduction of lifestyle-related disease.
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Dose Response to Exercise in Women aged 45-75 yr (DREW): design and rationale.
Morss, GM, Jordan, AN, Skinner, JS, Dunn, AL, Church, TS, Earnest, CP, Kampert, JB, Jurca, R, Blair, SN
Medicine and science in sports and exercise. 2004;(2):336-44
Abstract
INTRODUCTION AND PURPOSE Physical inactivity in postmenopausal women contributes to a rise in atherogenic risk factors associated with the metabolic syndrome. Although regular physical activity positively contributes to health, inactivity progressively increases with age. The Dose Response to Exercise in Women aged 45-75 yr (DREW) study is designed to investigate the effect of different amounts of exercise training on cardiorespiratory fitness and risk factors for cardiovascular disease (CVD) in postmenopausal women at moderately increased risk of CVD. METHODS DREW will recruit 450 sedentary, healthy, postmenopausal women with a body mass index of 25-40 kg.m-2, resting systolic blood pressure (BP) of 120-159 mm Hg, and a resting diastolic BP of < or = 99 mm Hg. Laboratory and self-report measures completed at baseline and 6 months include maximal oxygen consumption (.VO2max), resting BP, anthropometry, dietary habits, physical activity history, medication use, menstrual history, personal and family medical history, and fasting HDL cholesterol, LDL cholesterol, triglycerides, and glucose. Eligible participants are randomly assigned to a nonexercise group or one of three exercise groups. Participants exercise 3 to 4x wk-1 at a heart rate equivalent to 50% of .VO2max expending 4, 8, or 12 kcal.kg-1.wk-1, depending on group assignment. This study will allow quantification of possible dose-response relations (50%, 100%, and 150% of the consensus physical activity recommendation) between exercise training and study outcomes. CONCLUSION DREW can make important contributions to our understanding of the effects of physical activity in postmenopausal women and help refine public health and clinical recommendations for this group.
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Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949].
Besselink, MG, Timmerman, HM, Buskens, E, Nieuwenhuijs, VB, Akkermans, LM, Gooszen, HG, ,
BMC surgery. 2004;:12
Abstract
BACKGROUND Infectious complications are the major cause of death in acute pancreatitis. Small bowel bacterial overgrowth and subsequent bacterial translocation are held responsible for the vast majority of these infections. Goal of this study is to determine whether selected probiotics are capable of preventing infectious complications without the disadvantages of antibiotic prophylaxis; antibiotic resistance and fungal overgrowth. METHODS/DESIGN PROPATRIA is a double-blind, placebo-controlled randomised multicenter trial in which 200 patients will be randomly allocated to a multispecies probiotic preparation (Ecologic 641) or placebo. The study is performed in all 8 Dutch University Hospitals and 7 non-University hospitals. The study-product is administered twice daily through a nasojejunal tube for 28 days or until discharge. Patients eligible for randomisation are adult patients with a first onset of predicted severe acute pancreatitis: Imrie criteria 3 or more, CRP 150 mg/L or more, APACHE II score 8 or more. Exclusion criteria are post-ERCP pancreatitis, malignancy, infection/sepsis caused by a second disease, intra-operative diagnosis of pancreatitis and use of probiotics during the study. Administration of the study product is started within 72 hours after onset of abdominal pain. The primary endpoint is the total number of infectious complications. Secondary endpoints are mortality, necrosectomy, antibiotic resistance, hospital stay and adverse events. To demonstrate that probiotic prophylaxis reduces the proportion of patients with infectious complications from 50% to 30%, with alpha 0,05 and power 80%, a total sample size of 200 patients was calculated. CONCLUSION The PROPATRIA study is aimed to show a reduction in infectious complications due to early enteral use of multispecies probiotics in severe acute pancreatitis.