999 resultados para Trial
Resumo:
We examined the combined effects of exercise and calcium on BMC accrual in pre- and early-pubertal boys. Exercise and calcium together resulted in a 2% greater increase in femur BMC than either factor alone and a 3% greater increase in BMC at the tibia–fibula compared with the placebo group. Increasing dietary calcium seems to be important for optimizing the osteogenic effects of exercise.
Introduction: Understanding the relationship between exercise and calcium during growth is important given that the greatest benefits derived from these factors are achieved during the first two decades of life. We conducted a blinded randomized-controlled exercise–calcium intervention in pre- and early-pubertal boys to test the following hypotheses. (1) At the loaded sites (femur and tibia–fibula), exercise and calcium will produce greater skeletal benefits than either exercise or calcium alone. (2) At nonloaded sites (humerus and radius–ulna), there will be an effect of calcium supplementation.
Materials and Methods: Eighty-eight pre- and early-pubertal boys were randomly assigned to one of four study groups: moderate impact exercise with or without calcium (Ca) (Ex + Ca and Ex + placebo, respectively) or low impact exercise with or without Ca (No-Ex + Ca and No-Ex + Placebo, respectively). The intervention involved 20 minutes of either moderate- or low-impact exercise performed three times a week and/or the addition of Ca-fortified foods using milk minerals (392 ± 29 mg/day) or nonfortified foods over 8.5 months. Analysis of covariance was used to determine the main and combined effects of exercise and calcium on BMC after adjusting for baseline BMC.
Results: At baseline, no differences were reported between the groups for height, weight, BMC, or bone length. The increase in femur BMC in the Ex + Ca group was 2% greater than the increase in the Ex + placebo, No-Ex + Ca, or No-Ex + Placebo groups (all p < 0.03). At the tibia–fibula, the increase in BMC in the Ex + Ca group was 3% greater than the No-Ex + placebo group (p < 0.02) and 2% greater than the Ex + Placebo and the No-Ex + Ca groups (not significant). No effect of any group was detected at the humerus, ulna–radius, or lumbar spine for BMC, height, bone area, or volume.
Conclusions: In this group of normally active boys with adequate calcium intakes, additional exercise and calcium supplementation resulted in a 2–3% greater increase in BMC than controls at the loaded sites. These findings strengthen the evidence base for public health campaigns to address both exercise and dietary changes in children for optimizing the attainment of peak BMC.
Resumo:
Background
The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice.
Methods/design
In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures.
Discussion
Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH study. This study explores the potential role for PNs to help reduce the treatment and outcomes gap in people with T2D by using telephone coaching. The intervention, if found to be effective, has potential to be sustained and embedded within real world General Practice.
Resumo:
Objectives: To determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system.
Design: Cluster randomised trial.
Setting: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
Participants: 328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.
Intervention: Behavioural strategies delivered over individual structured MCH consultations versus usual care.
Main outcome measures: Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.
Results: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference –1.4 (–2.3 to –0.4) and 12 months (–1.7 (–2.6 to –0.7)). SF-12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non-MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.
Conclusions: Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.
Resumo:
Background: Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT). The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU). The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability) associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial.
Methods/design: The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a) training and delivery of IPT, or (b) TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra-class correlation coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method.
Discussion: This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services.
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Aim: To determine whether buprenorphine is more effective than clondine and other symptomatic medications in managing ambulatory heroin withdrawal.
Design: Open label. prospective randomized controlled trial examining
withdrawal and 4-week postwithdrawal outcomes on intention-to-treat.
Setting: Two specialist, out-patient drug treatment centres in inner city
Melbourne and Sydney, Australia.
Participants: One hundred and fourteen dependent heroin users were recruited. Participants were 18 yea rs or over. and with no significant other drug dependence, medical or psychiatric conditions or recent methadone treatment. One hundred and one (89%) participants completed a day 8 research interview examining withdrawal outcomes, and 92 (81%) completed day 35 research interview examining postwithdrawal outcomes.
Interventions: Participants randomized to control (n = 56) (up to 8 days or
clonidine and other symptomatic medications) or experimental (n = 58) (up to 5 days of buprenorphine) withdrawal groups. Following the 8-day withdrawal episode, participants could self-select from range of postwithdrawal options (naltrexone, substitution maintenance or counselling).
Measurements: Retention in withdrawal: heroin use during withdrawl: and
retention in drug treatment 4 weeks after withdrawal.
Secondary outcomes: Withdrawal severity: adverse events, and heroin use in the postwithdrawal period.
Findings: The experimental group had better treatment retention at day 8 (86% versus 57%, P = 0.001, 95% CI for numbers needed to treat (NNT) = 3-8) and day 35 (62% versus 39%, P = 0.02, 95% CI for NNT = 4-18): used heroin on fewer days during the withdralwal programlme (2.6 ± 2.5 versus 4.5 ± 2. 3.
P < 0.001. 95% CI = 1- 2.5 days) and in the postwithdrawal period (9.0±8.2
versus 14.6± 10. P<O.Ol. 95% CI = I .8- 9.4): and reported less withdrawal
severity. No severe adverse events reported.
Conclusions: Buprenorphine is effective for short-term ambulatory heroin
withdrawaI, with greater retention, less heroin use and less withdrawal discomfort during withdrawal: and increased postwithdrawal treatment retention than symptomatic medications.
Resumo:
BACKGROUND: Intervention trials with self-selected participants have shown that mailed stage-targeted print materials can increase participation in physical activity in the short term. We examined the effects of a mailed stage-targeted print intervention designed to promote physical activity, in a random sample of adults living in a regional city.
METHOD: Participants (n = 462, 40-60 years of age) were randomly allocated to an intervention (n = 227) or control group (n = 235). Measures included validated 2-week physical activity recall and stage of motivational readiness for physical activity. The intervention consisted of a single mailing of a letter and full-color stage-targeted booklets (specific to precontemplation, contemplation, preparation, and action/maintenance) 1 week postbaseline. Follow-up interviews were conducted at 2 and 6 months postbaseline.
RESULTS: After 2 months, participants in the intervention group were significantly more likely to meet the current American College of Sports Medicine/Centers for Disease Control and Prevention recommendation for sufficient physical activity than those in the control group (adjusted odds ratio [OR] = 2.40; 95% confidence interval [CI] = 1.44-3.99). After 6 months, intervention participants who reported receiving and reading the intervention materials were significantly more likely to be meeting the sufficient physical activity criterion compared with the control group (adjusted OR = 2.03; 95% CI = 1.16-3.56).
CONCLUSIONS: The stage-targeted print intervention was effective in promoting short-term increases in physical activity and was most effective for participants who recognized and used the materials. This low-cost, generalizable intervention has demonstrated potential as a practical population-based physical activity promotion strategy. Further research is required before widespread dissemination would be justified, as additional strategies may be required to ensure sustained change.
Resumo:
The effects of a commercial sports drink on performance in high-intensity cycling was investigated. Nine well-trained subjects were asked to complete a set amount of work as fast as possible (time trial) following 24 h of dietary (subjects were provided with food, energy 57.4 ± 2.4 kcal/kg and carbohydrate 9.1 ± 0.4 g/kg) and exercise control. During exercise, subjects were provided with 14 mL/kg of either 6% carbohydrate-electrolyte (CHO-E) solution or carbohydrate-free placebo (P).
Resumo:
The blood-nourishing and hard-softening (BNHS) capsule is a traditional Chinese formula used in the symptomatic treatment of inflammation and pain. We conducted this randomized controlled trial to compare the efficacy of BNHS with other commonly prescribed drugs. We recruited 120 patients from two teaching hospitals; 30 patients in each hospital were randomly assigned to receive BNHS. In one hospital, the 30 controls were given another traditional Chinese drug; whereas a Western medicine (chondroprotection drug/Viartril-s) was used as the control in the other hospital. Intervention was carried out over a period of 4 weeks. Primary outcome measures included self-reported pain level, and changes in stiffness and functional ability as measured by the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index. Mixed models were used for statistical analysis. Substantial improvements in disease-specific symptoms were observed, after 4 weeks of treatment, in patients taking BNHS capsules. As assessed by the WOMAC index, pain level of the BNHS group decreased by 57% [95% confidence interval (CI) = 50, 63], stiffness by 63% (95% CI = 55, 71) and functional ability increased by 56% (95% CI = 50, 63). No significant differences were found in any of the outcome measures between the BNHS group and either of the comparison groups. No severe adverse effects were reported. However, this study lacked a placebo group; therefore, we conclude that BNHS appears to be as effective as commonly prescribed medicines for the relief of pain and dysfunction in knee osteoarthritis patients, but costs a lot less than other Western and herbal drugs in the study.
Resumo:
Largely unexplored, a free service trial may be defined as an offer to the consumer to experience, at no monetary cost, all or part of a core, augmented or facilitating service from a provider that the consumer does not currently use. Free service trials are worth studying for two reasons. First they are one of the important examples of inequitable exchange between supplier and purchaser – one that is likely to lead to a sense of obligation among those who adopt the trial offer. Second, they are a very common promotional device. This paper proposes that free service trials are more problematic than tangible product trials. The value of what is offered may be limited by time, the scope of trial, or because only a partial, facilitating or augmented service is offered. Judgments about the perceived value of the complete service in its paid form will also contribute to the evaluation of the trial offer. In deciding whether they accept the trial, the paper proposes that consumers make attributions about the motives of the service trial provider and the consumer’s consequent obligations if they accept it. Obligations are likely to be felt more acutely where the trial is interpersonal (e.g. a facial massage) rather than impersonal (e.g. anti-virus service). Such evaluations are also likely to be affected by past experience with the service category, consumer skepticism and personal norms of reciprocity. A program of research is proposed which would systematically examine the consumers’ evaluations of free trial offers.
Resumo:
Background: General practitioners (GPs) could make an important contribution to management of childhood overweight. However, there are no efficacy data to support this, and the feasibility of this approach is unknown.
Objectives: To determine if GPs and families can be recruited to a randomized controlled trial (RCT), and if GPs can successfully deliver an intervention to families with overweight/obese 5- to 9-year-old children.
Methods: A convenience sample of 34 GPs from 29 family medical practices attended training sessions on management of childhood overweight. Practice staff trained in child anthropometry conducted a cross-sectional body mass index (BMI) survey of 5- to 9-year-old children attending these practices. The intervention focused on achievable goals in nutrition, physical activity and sedentary behaviour, and was delivered in four solution-focused behaviour change consultations over 12 weeks.
Results: General practitioners were recruited from across the sociodemographic spectrum. All attended at least two of the three education sessions and were retained throughout the trial. Practice staff weighed and measured 2112 children in the BMI survey, of whom 28% were overweight/obese (17.5% overweight, 10.5% obese), with children drawn from all sociodemographic quintiles. Of the eligible overweight/obese children, 163 (40%) were recruited and retained in the LEAP RCT; 96% of intervention families attended at least their first consultation.
Conclusions: Many families are willing to tackle childhood overweight with their GP. In addition, GPs and families can participate successfully in the careful trials that are needed to determine whether an individualized, family-based primary care approach is beneficial, harmful or ineffective.
Resumo:
OBJECTIVES: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.
DESIGN: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.
SETTING: Twenty nine general practices, Melbourne, Australia.
PARTICIPANTS: (1) BMI survey: 2112 children visiting their general practitioner (GP) April-December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months-9 years 11 months (82 intervention, 81 control).
INTERVENTION: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.
MAIN OUTCOME MEASURES: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.
RESULTS: Attrition was 10%. The adjusted mean difference (intervention-control) in BMI was -0.2 kg/m(2) (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m(2) (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.
CONCLUSIONS: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.
Resumo:
Background: Mediated physical activity interventions can reach large numbers of people at low cost. Programs delivered through the mail that target the stage of motivational readiness have been shown to increase activity. Communication technology (websites and e-mail) might provide a means for delivering similar programs. Methods: Randomized trial conducted between August and October 2001. Participants included staff at an Australian university (n=655; mean AGE=43, standard deviation, 10 years). Participants were randomized to either an 8-week, stage-targeted print program (Print) or 8-week, stage-targeted website (Web) program. The main outcome was change in self-reported physical activity. Results: There was no significant increase in total reported physical activity within or between groups when analyzed by intention to treat (F [1,653]=0.41, p=0.52). There was a significant increase in total physical activity reported by the Print participants who were inactive at baseline (t [1,173]=−2.21, p=0.04), and a significant decrease in the average time spent sitting on a weekday in the Web group (t [1,326]=2.2, p=0.03). Conclusions: There were no differences between the Print and Web program effects on reported physical activity. The Print group demonstrated slightly larger effects and a higher level of recognition of program materials.
Resumo:
Background. Both self-help print materials and telephone-assisted counseling have generally proved useful strategies to increase physical activity. This study examined their effectiveness in an intervention aimed specifically at promoting walking for specific purposes.
Methods. Participants (n = 399) were randomly allocated to one of two 3-week intervention programs. The Print program comprised multiple mailing of brochures that emphasized walking within the local community environments. The Print plus Telephone program received the same brochures plus three telephone calls. Data collected via mailed self-completed surveys were analyzed by exploring outcomes related to walking for specific purposes.
Results. There were no significant differences between the two programs in any of the walking measures. Both groups significantly increased time reported walking for exercise per week [Print: t(1,277) = −3.50, P < 0.001; Print plus telephone: t(1,106) = −2.44, P < 0.016]. Significantly, more participants in the Print plus Telephone group reported receiving and reading the materials (χ2 = 20.11, P < 0.0001).
Conclusions. The intervention programs were more successful at increasing walking for exercise than for any other purpose. The addition of brief telephone support was successful in focusing participants' attention on the print materials, but did not result in any additional increase in walking.
Resumo:
Objectives To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery.
Design Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision).
Setting 20 orthopaedic surgery centres in Australia and New Zealand.
Participants 902 patients undergoing elective primary or revision total hip replacement surgery.
Intervention 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery.
Main outcome measures Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index).
Results There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39).
Conclusions These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery.
Trial registration NCT00145730.
