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Results for “randomized controlled trial (RCT)”

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PubMed1997

Predictors of antipsychotic withdrawal or dose reduction in a randomized controlled trial of provider education.

OBJECTIVES: To evaluate the effects of an educational program to reduce antipsychotic use in nursing homes that had high use rates post-OBRA-87 and to identify factors that predicted antipsychotic withdrawal or 50% or greater dose reduction. DESIGN/SETTING: A randomized controlled trial (RCT) of the educational program (nursing home the unit of randomization and analysis) was conducted in 12 Tennessee nursing homes (6 education/6 control). Cohort analysis in baseline antipsychotic users identified factors predicting withdrawal or dose reduction. SUBJECTS: The RCT analysis included 1152 patients in the homes at baseline and 6 months. The cohort analysis included 133 baseline antipsychotic users in the five education homes able to implement the recommendations of the educational program. OUTCOME MEASURES: Change in days of antipsychotic use per 100 days of nursing home residence, withdrawal from antipsychotics, reduction in antipsychotic dose by 50% or more. RESULTS: Following the educational intervention, use of antipsychotics in the six education homes decreased from 25.3 days per 100 at baseline to 19.7 days per 100 by month 6, a 23% reduction relative to control homes (P = .014). In the withdrawal analysis, 44 (33%) of 133 baseline antipsychotic users were withdrawn. Factors at baseline predicting successful withdrawal were low antipsychotic dose, no use of benzodiazepines or antidepressants, and behavioral symptoms score below the median. However, although an additional 22 patients had dose reductions > or = 50%, none of the predictors of withdrawal were associated with dose reductions. CONCLUSIONS: Focused provider education programs may facilitate antipsychotic reduction above and beyond that attributable to regulatory changes. Patients who are poor candidates for total antipsychotic withdrawal may tolerate substantial dose reductions, which should reduce their risk of adverse antipsychotic effects.

Aged↗

PubMed2003

A randomized controlled trial evaluating the efficacy of tetracaine gel for pain relief from peripherally inserted central catheters in infants.

BACKGROUND: Insertion of peripherally inserted central catheters (PICC) is a commonly performed procedure in both preterm and term infants. Tetracaine 4% gel (Ametop; Smith & Nephew Inc, St. Laurent, Quebec), a topical anesthetic, although reported to be effective for reducing the pain of venipuncture in neonates, has not been investigated for the management of pain associated with the PICC procedure. PURPOSE: To determine the efficacy of tetracaine gel for managing the pain associated with the PICC procedure in preterm and term infants. METHODS: A double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. Infants undergoing nonurgent PICC insertion were randomized to receive either the treatment (1.0 g of tetracaine 4% gel) or placebo control (1.0 g of eucerin-plus cream) applied to the skin under occlusion for 30 minutes before the procedure. Data on the behavioral (facial expression) and physiologic (heart rate and oxygen saturation) indicators of pain were collected via videotaping and computer monitoring throughout the procedure. Data then were coded and measured by independent observers using the Premature Infant Pain Profile (PIPP; Stevens et al, 1996), and analyzed using descriptive statistics and repeated-measures analyses of variance. RESULTS: Forty-nine infants, gestational age 27 to 41 weeks (mean = 33; SD = 4.2) and age at time of insertion 2 to 85 days (mean = 18; SD = 22.5) participated. No differences were found between the groups at the time of randomization. There were no adverse cardiorespiratory events or local skin reactions in either group. There was a significant within-subjects main effect of time across the procedure (F[48,3] = 11.03; P < 0.0001). There was no significant between-subjects main effect of group (F[48,1] = 0.11; P = 0.74) and no (group x time) interaction (F[48,3] = 0.45; P = 0.72). CONCLUSION: Tetracaine gel was not effective for pain relief for PICC insertion in infants. Its use for pain relief cannot be recommended based on the results of this study. Other pharmacologic, behavioral, and physical interventions should be investigated for safety and relief of procedural pain in this population of infants.

Anesthetics, Local↗

PubMed2006

[Clincal observation of qingre yulin decoction in treatment of male infertility caused by accessory gland infection].

OBJECTIVE: To study the effect of Qingre Yulin Decoction (QYD) on male infertility caused by accessory gland infection (AGI) with randomized controlled trial (RCT). METHODS: Sixty infertility outpatients were equally divided into two groups randomly, the QYD group treated with modified QYD and the control group with antibiotic plus vitamin E, both for 3 months with another 6 months' follow-up. Pregnant rates, routine test of sperm and expressed prostatic secretion (EPS) were determined. RESULTS: The healed rate was 26.7% (8 cases), the markedly effective rate was 43.3% (13 cases), the effective rate was 16.7% (5 cases), and the total effective rate was 86.7% in the QYD group, while in the control group it was 6.7% (2), 30.0% (9), 40.0% (12) and 76.7% respectively, showing higher healed rate and total effective rate in the former than those in the latter. Sperm quality of infertility patients with AGI decreased obviously, manifesting short ened average liquefaction time, reduced concentration, survival rate and vitality of sperm. These abnormal changes were improved after treatment in both groups, and the efficacy was better in the QYD group than that in the control group. CONCLUSION: Infertility patients with AGI were manifested as oligospermatism and asthenospermia, which may not be the definite outcome of AGI. QYD is able to improve sperm quality, especially sperm vitality in infertility patients with AGI and therefore increase pregnant rate of their wives.

Adult↗

PubMed2005

"Unblinding" in randomized controlled drug trials for urinary incontinence: Implications for assessing outcomes when adverse effects are evident.

AIMS: To determine whether women with urinary incontinence (UI) can identify their allocation in a randomized controlled trial (RCT) of tolterodine (TOL), and whether correct identification is associated with outcomes and adverse effects (AEs). METHODS: Exploratory analysis of a randomized, double-blind, placebo (PLC)-controlled trial of TOL 4 mg daily for 8 weeks in 743 women with urge-predominant mixed UI. Patient perception of their randomization was assessed at trial end. Main outcome measures were 7-day bladder diaries, patient perception of improvement, and UI-specific quality of life (QoL). RESULTS: TOL produced a significant decrease in urge UI episodes compared to PLC (78% vs. 51%, P = 0.0001). Fifty-one percent of women correctly identified their randomization (58% on TOL vs. 37% on PLC, P < 0.001). Women who assumed they took TOL had better bladder diary outcomes than those who assumed they took PLC. Within each assumption group, patient perception outcomes were similar, regardless of actual randomization. QoL improved in all domains except general health for women on TOL. In women who assumed they took TOL, significant drug benefit was evident in three domains. Moderate-severe dry mouth was higher in those who assumed they took TOL (7.3% vs. 0%, P < 0.0001). CONCLUSIONS: Greater than fifty percent of women in this RCT of antimuscarinic treatment were "unblinded" to their randomization. Patient assumption of randomization was associated with bladder diary and perception outcomes, specific QoL domains, and dry mouth. Efficacy of urge incontinence drugs should be considered in the context of patient assumptions, expectations, and "unblinding" by easily evident side effects.

Aged↗

PubMedDate not supplied

Long-term outcome of cardiovascular prevention: a Nijmegen Academic Family Practices Network study.

CONTEXT: Cardiovascular disease is common and preventable. Primary care is the preferred setting for individual prevention and management. OBJECTIVE: This study analyzed the long-term outcome of cardiovascular risk in a family practice population. DESIGN: A longitudinal cohort analysis of cardiovascular outcome after 18 years, in participants of a randomized controlled trial (RCT) of cardiovascular prevention. In 1977, a RCT with cluster randomization at practice level assessed the effects of a 1-year preventive intervention in patients 20 to 50 years of age. Cardiovascular risk factors (smoking, body mass index, blood pressure, serum cholesterol, family history, and physical activity) were measured and intervention was a practice-nurse support for the follow-up of those at elevated risk. The control practices prescribed care as usual. Between 1994 and 1995, all participants were approached again, to analyze subsequent (cardiovascular) mortality and morbidity and their cardiovascular risk in a random sample. SETTING: The Nijmegen Academic Family Practices Network, The Netherlands. PARTICIPANTS: All participants (7092) of the 1977 screening for follow-up morbidity and mortality, 2600 for re-measurement risk factors. OUTCOME MEASURES: Cardiovascular risk factors; cardiovascular morbidity and mortality 1977-1995. RESULTS: Follow-up was achieved in 5945 participants (84%) and 2335 participated in the re-measurement (89%). No effects of the preventive intervention were found, but those initially at low risk profile were still so 18 years later. Risk of subsequent cardiovascular mortality and morbidity was related to baseline risk, but for women, the absolute risk was low in all risk strata and lower than predicted from international references. CONCLUSIONS: This study demonstrated the feasibility of family practice network research in pursuing longitudinal research. A single cardiovascular screening resulted in reliable risk assessment: those initially at low risk still were so after 18 years. Effects of a 1-year intensive intervention could no longer be demonstrated.

Adult↗

PubMed1996

Clinical studies of drug effects in humans.

Many important drug properties cannot be predicted from in vitro or animal studies but must be quantified from studies of clinically relevant endpoints in humans. Clinical study designs include the randomized controlled trial (RCT) and a variety of observational designs. In RCTs, randomization usually ensures treatment group comparability with respect to other factors, so outcome differences reflect treatment differences per se. Properly conducted RCTs thus are the strongest study design, the mainstay of mandatory premarketing studies, and essential for evaluation of therapeutic efficacy. RCT limitations include frequent use of surrogate endpoints, limited power, short-term follow-up, and cross-contamination of study groups. For ethical reasons, some questions cannot be studied with RCTs. The simplest observational design, the case series, has limited value because it lacks a denominator. Limitations of cohort and case-control studies include misclassification, selection bias, and confounding. Despite their limitations, properly conducted experimental and observational clinical studies provide essential data for clinical practice.

Aspirin↗

PubMed2005

[Design and application of single case randomized controlled trial].

The principle, method, procedure, indicated subject and feasibility of application of single case randomized controlled trial (SCRCT) were reviewed in the article. In randomized controlled trials (RCT), the allocation unit can be a single case (random therapy), multiple cases (random allocation) or group such as family, class or community. Traditional Chinese medicine is good at treatment of chronic disease, Syndrome differentiation, the traits of TCM, requires multiple research methods. SCRCT is suitable for symptomatic treatment of chronic discase due to its convenience in observation, reduce individual divergence and low research cost. SCRCGT is characterized by using randomized method to carry out multiple crossover follow-up, to assess the efficacy of treatment for two therapeutic schemes.

Chronic Disease↗

PubMed2004

[Evidence based surgery of cancer of head of pancreas].

Physicians and surgeons who treat patients with gastrointestinal or hepatic disease must prescribe the most appropriate diagnostic tests, together with an accurate prognosis and effective and safe therapy. This paper examines the best modalities of surgical treatment for cancer of the pancreas, in an evidence-based approach. Evidence was classified as follows: Grade A : evidence from large randomized controlled trials (RCT) or systematic reviews (including meta-analyses) of multiple randomized trials which collectively have at least as much data as one single well-defined trial. Grade B: evidence from at least one high-quality study of non-randomized cohorts or evidence from at least one high-quality case-control study or one high-quality case series. Grade C: opinions from experts without references or access to any of the foregoing The data were obtained from Medline and from controlled randomized trials listed in the Cochrane Library up to the end of 2003. Two series (grade B) showed the superiority of Whipple over total pancreatectomy, with respective median survival times of 12.6 months and 9.6 months. Extensive lymphadenectomy (grade A) in patients with positive lymph nodes gave significantly better survival than standard resection in one trial, but this was not confirmed in the other trial. Results of pylorus-preserving pancreaticoduodenectomy (PPPD) were not different from those of the Whipple procedure on postoperative mortality, morbidity or survival (grade A). Portal vein resection increased the resectability rate. Post-operative mortality was not increased: survival was not different in four studies and was shorter in another four studies (grade C). Low-dose postoperative erythromycin accelerates gastric emptying if the right gastric artery is preserved (grade A). One trial suggests that pancreaticogastrostomy reduces the risk of pancreatic fistula. The two other trials are controversial and showed no difference. One prospective non randomized study showed that stenting in pancreaticojejunostomy reduces the risk of pancreatic fistulae and intraabdominal abscess. To prevent this risk of pancreatic fistula, six controlled trials involving patients receiving octreotride were performed Three European trials showed a smaller volume of abdominal drainage fluid and an abnormal amylase concentration; however, two American trials failed to demonstrate a significant difference. Occlusion of the pancreatic duct with fibrin glue did not reduce the risk of pancreatic fistula, but increased the risk of developing diabetes. Intraabdominal drainage after pancreatic resection significantly increased post-operative complications (grade A). Surgical resection and reconstruction procedures for pancreatic cancer must be based on evidence-based studies. However, the most important prognostic factor is the surgeon's experience, not only with regard to the post-operative course, but also survival. Specific teaching and training is thus essential.

Evidence-Based Medicine↗

PubMed1999

Are randomized control trial outcomes influenced by the inclusion of a placebo group?: a systematic review of nonsteroidal antiinflammatory drug trials for arthritis treatment.

Placebo groups are often included in randomized control trials evaluating drug therapy, yet we know little about the placebo effect. The purpose of our study was to evaluate how the presence of a placebo group in a randomized control trial (RCT) influences the patients' ratings of the efficacy of an active drug therapy and their reporting of its adverse effects. We identified studies published between 1966 and 1994 using MEDLINE. Randomized control trials evaluating acetylsalicylic acid, diclofenac, or indomethacin for the treatment of osteo or rheumatoid arthritis were included in our sample. Two investigators independently extracted data. Fifty-eight treatment arms met our inclusion criteria and were available for analysis. Twenty-five treatment arms evaluated a nonsteroidal antiinflammatory drug (NSAID) in placebo control trials and 33 in comparative trials. Using a logistic regression model to adjust for the differences between the evaluated drugs and between the types of arthritis, we found that patients receiving an NSAID in a placebo control trial were more likely to withdraw due to inefficacy (OR=1.3; 95% CI, 1.0 to 1.6; P=0.04). Using a similar model, withdrawals due to adverse effects were found to be more common when the NSAID was given in trials that did not include a placebo group (OR=1.5; 95% CI, 1.1 to 1.9; P=0.002) as were reports of cutaneous (OR=4.2; 95% CI, 1.7 to 9.9), gastrointestinal (OR=1.6; 95% CI, 1.3 to 2.0), and other types (OR=5.3; 95% CI, 3.8 to 7.4) of adverse effects. Although reports of central nervous system adverse effects were more frequent in the comparative trials, this difference was not significant. Including a placebo group in a RCT changes how patients rate the efficacy and adverse effects of their therapy. Our results highlight the need to consider the placebo effect in the design and analyses of clinical trials.

Aged↗

PubMed2006

Physical activity measurements affected participants' behavior in a randomized controlled trial.

BACKGROUND AND OBJECTIVE: Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. METHODS: Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. RESULTS: Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. CONCLUSION: Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

Adult↗

PubMed2006

Metaanalyses of acustimulations: effects on nausea and vomiting in postoperative adult patients.

OBJECTIVE: Using metaanalysis to examine the effects of acustimulations on nausea and vomiting symptoms (NVS) in postoperative adult populations. METHODS: Metaanalyses of effects of various acupoints stimulations (AS) (including acupuncture, acupressure, and electrical stimulation) on NVS in postoperative adult populations were performed. Thirty-three quality randomized controlled trials (RCT) published over the past three decades were identified by evaluating the quality of randomization and treatment methods, and results were pooled using a fixed effects model. RESULTS: Twenty-four trials were pooled for nausea, 29 trials for vomiting, and 19 trials for rescue antiemetics, with AS compared with placebo or controls. Two additional trials did not have control groups but compared AS to medication groups. Compared with the controls, AS (all modalities) reduced nausea (relative risk [RR] = 0.60, 95% confidence interval [CI]: 0.54-0.67, P < .0001), vomiting (RR = 0.51, 95% CI: 0.45-0.57, P < .0001), and use of rescue antiemetics (RR = 0.63, 95% CI: 0.54-0.74, P < 0001). All AS modalities were effective in reducing NVS. Korean hand acupressure stimulations (two trials) had the best impact on reducing vomiting. There were no significant differences on pooled RRs for nausea (five trials) and vomiting (eight trials) between medication and AS groups, but medication groups had increased use of rescue antiemetics (two trials, RR = 2.27, 95% CI: 1.48-3.49, P = .0002). There was a placebo effect when compared with controls in reducing nausea (four trials, RR = 0.67, 95% CI: 0.50-0.90, P = .0069) and vomiting (three trials, RR = 0.39, 95% CI: 0.19-0.80, P = .0106). CONCLUSIONS: This metaanalysis demonstrated that AS is just as effective as medications in reducing NVS and that acupressure is just as effective as acupuncture or electrical stimulation in reducing NVS for postoperative adult populations.

Acupressure↗

PubMed1996

The efficacy of dexamethasone iontophoresis for the treatment of rheumatoid arthritic knees: a pilot study.

OBJECTIVE: To examine the efficacy of dexamethasone sodium phosphate (DEX) iontophoresis for the treatment of rheumatoid arthritis (RA) of the knee, and to obtain statistical information for a future randomized controlled trial (RCT). METHODS: Ten subjects with RA, ranging in age from 34-75, were randomly assigned to either the experimental or placebo group. Iontophoresis treatments were given to both groups on days 1, 3, and 5. Five subjects in the experimental group received a mixture of 1 ml of DEX (4 mg/ml) and 1 ml of injectable sterile water; those in the placebo group received 2 ml of saline solution. Pain on movement, at rest, and on pressure, active joint count, and active range of motion, were evaluated on days 1, 5, and 20. The patient's global assessment of treatment efficacy was also assessed on days 5 and 20. Mann-Whitney U tests and Friedman two-way analyses of variance were performed for statistical analyses. RESULTS: Pain at rest was found to be statistically different between the two groups (P = 0.0317). Statistical significance was also found over time for pain on movement within the experimental group (P = 0.0224). CONCLUSION: The results suggest that DEX iontophoresis is more effective than placebo in relieving pain at rest and on movement in the RA knee. Based on the study data, a total of 40 subjects will be required for an RCT of a similar nature.

Activities of Daily Living↗

PubMed2004

[Fecal and urinary incontinence after delivery: risk factors and prevention].

OBJECTIVE: This study was undertaken to review the available data on urinary and fecal incontinence and their association with maternal as well as fetal per partum characteristics. METHOD: A Pubmed (Medline search performed between 1999 and 2003 using "urinary incontinence and delivery" and "fecal incontinence and delivery" identified 501 relevant papers. Most of them are retrospective analyses whereas few are randomized controlled trials (RCT). RESULTS: Two studies performed with computer-stored databases analyzed the risk factors of incontinence among 2,886,126 deliveries. Primiparity, birthweight over 4000 g and all types of assisted vaginal deliveries significantly increased the risk of anal sphincter damage. Results concerning the effect of episiotomy are conflicting. Controlled randomized trials have shown that pelvic floor muscle training during pregnancy as well as planned cesarean section significantly and moderately decrease the risk of urinary incontinence. The only RCT available has shown that planned cesarean section did not reduce significantly incontinence of flatus. Finally the only trial that compare surgical techniques used to repair the anal sphincter did not show any significant difference. CONCLUSION: Risk factors for anal sphincter damage during delivery are well known. RCT focusing on how to prevent and how to cure fecal as well as urinary incontinence are urgently needed.

Anal Canal↗

PubMed2002

Issues in conducting randomized controlled trials of health services research interventions in nonacademic practice settings: the case of retail pharmacies.

OBJECTIVE: To describe unexpected challenges and strategies to overcome them when conducting randomized controlled trials (RCT) of health services research interventions in retail pharmacies. STUDY SETTING: Thirty-six retail drug stores in Indianapolis. STUDY DESIGN: We conducted an RCT to evaluate the effectiveness of an intervention to increase pharmacists' involvement in caring for customers. We describe: (1) our RCT as originally designed, (2) unexpected challenges we faced; and (3) how we resolved those challenges. DATA COLLECTION/EXTRACTION METHODS: Randomized controlled trial. PRINCIPAL FINDINGS: Major modifications in research design were necessitated by factors such as corporate restructuring, heightened sensitivity to patient confidentiality, and difficulties altering employees' behavior. We overcame these barriers by conducting research that is consistent with corporate goals, involving appropriate corporate administrators and technical personnel early in the process, and being flexible. CONCLUSIONS: Health services researchers should conduct RCTs in a variety of non-academic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.

Adolescent↗

PubMed2005

Cluster randomized controlled trials.

Cluster randomized controlled trial (RCT), in which groups or clusters of individuals rather than individuals themselves are randomized, are increasingly common. Indeed, for the evaluation of certain types of intervention (such as those used in health promotion and educational interventions) a cluster randomized trial is virtually the only valid approach. However, cluster trials are generally more difficult to design and execute than individually randomized studies, and some design features of a cluster trial may make it particularly vulnerable to a range of threats that can introduce bias. In this paper we discuss the issues that can lead to bias in cluster randomized trials and conclude with some suggestions for avoiding these problems.

Cluster Analysis↗

PubMed2002

Correlates of adherence and contamination in a randomized controlled trial of exercise in cancer survivors: an application of the theory of planned behavior and the five factor model of personality.

In this study, we examined correlates of adherence and contamination in a randomized controlled trial (RCT) of exercise in cancer survivors using the theory of planned behavior and the Five Factor Model of personality (FFM). We randomly assigned cancer survivors in group psychotherapy classes to either a waiting-list control group (n = 45) or a home-based, moderate intensity exercise program (n = 51). At baseline, participants completed measures of the theory of planned behavior, the FFM, past exercise, physical fitness, medical variables, and demographics. We then monitored exercise over a 10-week period by weekly self-reports. Hierarchical multiple regression analyses indicated that the independent predictors of overall RCT exercise across both conditions were past exercise (beta = .36, p < .001), assignment to experimental condition (beta = .34, p < .001), sex (beta = .30, p < .001), and intention (beta = .14, p < .10). For exercise adherence in the exercise condition, the independent predictors were sex (beta = .38, p < .01), extraversion (beta = .30, p < .05), normative beliefs (beta = -.27, p < .05), and perceived behavioral control (beta = .23, p < .10). Finally, the independent predictors of exercise contamination in the control condition were past exercise (beta = .70, p < .001), sex (beta = .20, p < .05), and intention (beta = .17, p < .10). We conclude that the correlates of exercise adherence and contamination differ in kind as well as in degree. Explanations for these findings and practical implications for conducting exercise RCTs in this population are offered.

Adult↗

PubMed2006

Testing effectiveness of a community-based aggression management program for children 7 to 11 years old and their families.

OBJECTIVE: There are few well-evaluated uncomplicated community-based interventions for childhood aggression. The authors assess the impact of a community-based anger management group on child aggressive behaviors, using a randomized, controlled trial (RCT). METHOD: Families with children 7 to 11 years old were recruited through advertisements and randomized (N = 123). Inclusion required parent concern about anger/aggressive behavior, RCT agreement, and a telephone behavior screen. Intervention participants were offered three parent education/skill-building group sessions, 10 weekly child group sessions, and three in-home family practice sessions. Nine groups ran from August 2002 to August 2004. Interviewers naïve to randomization collected data on all participants pre- and postgroup. Outcomes included child-rated anger and parent-rated child aggressive behavior, externalizing behavior and hostility, parent-child relationship, and parenting stress. Intent-to-treat analyses were done. RESULTS: Pre/postoutcome comparisons indicated no significant differences between intervention versus control, with small effect sizes for most outcomes (0.27-0.29). Although not significant, the magnitude of improvement favored intervention families on all parent-rated measures. CONCLUSIONS: Overall, there was no differential impact of participating in a community-based anger management group versus control on child aggressive behaviors and other associated measures. The impact of regression to the mean, effect, and sample size estimates; child comorbidity; and programmatic and methodological issues are discussed.

Aggression↗

PubMed2006

A school-based physical activity program to improve health and fitness in children aged 6-13 years ("Kinder-Sportstudie KISS"): study design of a randomized controlled trial [ISRCTN15360785].

BACKGROUND: Childhood obesity is the result of a long lasting imbalance between energy intake and energy expenditure. A major contributing factor is physical inactivity which is closely linked to bone health, cardiovascular disease risk, fitness and psychological factors. The school seems to provide an excellent setting to enhance levels of physical activity (PA). However, there is insufficient data from previous school-based intervention trials on how to enhance overall PA. It is also unknown whether an intervention aimed at increasing PA is effective in improving the children's health. The purpose of this paper is to outline the design of a school-based randomized, controlled trial (RCT) aiming to increase overall PA and to improve fitness and health in 6- to 13-year-old children. METHODS/DESIGN: 15 schools were randomized to the intervention (n = 9) or the control (n = 6) group, stratified by geographic region (urban vs. rural) and by age (1st and 5th grade). Participation was given for all children in the intervention group since in this group the intervention was part of the normal school curriculum. The intervention during one academic year consisted of: 1. two additional physical education classes per week given by trained physical education teachers adding up to a total of five PA classes per week, 2. short PA breaks (2-5 min each) during academic lessons, 3. PA home work, and 4. adaptation of recreational areas around the school. All children underwent anthropometric measurements, blood pressure assessment, fitness testing, measurement of PA and they filled out questionnaires. At least 70% of all children agreed to blood sampling and measurements of body composition and bone mineral measurements by dual energy x-ray absorptiometry. The primary endpoints of the study after one year were an increase in total PA by accelerometry, an increase in aerobic fitness measured by the 20 m shuttle run, a decrease in percent body fat derived from skinfold measurements and an increase in quality of life as assessed by the child health questionnaire in the intervention group compared to the control group. Secondary outcomes were overall fitness, differences in body composition including body fat distribution, cardiovascular risk factors, psychosocial health, bone mineral content and density of femur, lumbar spine and total body and food intake. DISCUSSION: Our preliminary data suggest that the children were representative of Swiss children with respect to sex, socio-demographic status, and body mass index. Short-term results can be expected by the beginning of 2007. We hypothesized that our intervention will lead to an increase in PA, fitness and overall health. Based on our data, we aim to provide important information regarding the influence of such an intervention on these outcome measures in school-aged children and to provide nationwide guidelines to improve PA in children.

Adolescent↗