Design Cluster (design + cluster)

Distribution by Scientific Domains


Selected Abstracts


A computerized harm minimization prevention program for alcohol misuse and related harms: randomized controlled trial

ADDICTION, Issue 4 2009
Laura Vogl
ABSTRACT Aims Hazardous alcohol use is a leading cause of death among adolescents and young adults world-wide, yet few effective prevention interventions exist. This study was the first to examine a computerized harm minimization intervention to reduce alcohol misuse and related harms in adolescents. Design Cluster randomized controlled trial of a six-session curriculum-integrated harm minimization prevention program. The intervention was delivered by computer in the form of a teenage drama, which provided education through alcohol-related scenarios to which young people could relate. Setting Schools in Australia. Participants A total of 1466 year 8 students (13 years) from 16 high schools in Australia were allocated randomly to a computerized prevention program (n = 611, eight schools) or usual classes (n = 855, eight schools). Measurements Change in knowledge, alcohol use, alcohol-related harms and alcohol expectancies. Findings A computerized prevention program was more effective than usual classes in increasing alcohol-related knowledge of facts that would inform safer drinking choices and decreasing the positive social expectations which students believed alcohol may afford. For females it was effective in decreasing average alcohol consumption, alcohol-related harms and the frequency of drinking to excess (more than four standard drinks; 10 g ethanol). For males the behavioural effects were not significant. Conclusions A harm minimization approach is effective in educating young people about alcohol-related risks and is effective in reducing risky drinking and harms among girls. Reduction of problems among boys remains a challenge. [source]


Does stage-based smoking cessation advice in pregnancy result in long-term quitters?

ADDICTION, Issue 1 2005
18-month postpartum follow-up of a randomized controlled trial
ABSTRACT Aims To evaluate the effect on quitting smoking at 18 months postpartum of smoking cessation interventions based on the Transtheoretical Model (TTM) delivered in pregnancy compared to current standard care. It has been claimed that TTM-based interventions will continue to create quitters after the end of the intervention period. Design Cluster randomized trial. Setting Antenatal clinics in general practices in the West Midlands, UK. Participants A total of 918 pregnant smokers originally enrolled in the trial, of which 393 women were followed-up at 18 months postpartum. Interventions One hundred general practices were randomized into the three trial arms. Midwives in these practices delivered three interventions: A (standard care), B (TTM-based self-help manuals) and C (TTM-based self-help manuals plus sessions with an interactive computer program giving individualized smoking cessation advice). Measurements Self-reported continuous and point prevalence abstinence since pregnancy. Findings When combined together, there was a slight and not significant benefit for both TTM arms compared to the control, with an odds ratio (OR) 95% confidence interval (CI) of 1.20 (0.29,4.88) for continuous abstinence. For point prevalence abstinence, the OR (95%CI) was 1.15 (0.66,2.03). Seven of the 54 (13%) women who had quit at the end of pregnancy were still quit 18 months later, and there was no evidence that the TTM-based interventions were superior in preventing relapse. Conclusions The TTM-based interventions may have shown some evidence of a short-term benefit for quitting in pregnancy but no benefit relative to standard care when followed-up in the longer-term. [source]


Breastfeeding expectations versus reality: a clusterrandomised controlled trial

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 8 2005
Tina Lavender
Objective To evaluate the affect of an antenatal educational breastfeeding intervention on women's breastfeeding duration. Design Cluster randomised controlled trial. Unit of randomisation: electoral ward. The primary outcome was the proportion that fulfilled their antenatal breastfeeding expectation. Secondary outcomes were the number of women breastfeeding on discharge and at four months. Data were collected using a series of questionnaires and diaries. Setting Teaching hospital in North West of England. Participants Women who expressed a desire to breastfeed at the start of their pregnancy. Methods Women were allocated to either routine antenatal education or an additional single educational group session supervised by a lactation specialist and attended by midwives from their locality. Main outcome measure The proportion of women who fulfilled their expectation of breastfeeding. Result One thousand three hundred and twelve women were randomised, with 1249 (95%) women available for analysis. There was no difference between the groups in the proportion of women who attained their expected duration of breastfeeding (OR 1.2; 95% CI 0.89,1.6; ,2= 1.4, df= 1, P= 0.2; mean cluster size 156, design effect 1.6). There were no differences between the groups in the uptake of breastfeeding on discharge (OR = 1.2; 95% CI 0.8,1.7; ,2= 1.1, df= 1, P= 0.3; mean cluster size 163, design effect = 2.0) or exclusively at four months (OR = 1.1; 95% CI 0.6,1.8; ,2= 0.07, df= 1, P= 0.8; mean cluster size 156, design effect 1.6). Conclusion The provision of a single educational group session supervised by a lactation specialist, and attended by midwives and women, failed to promote the uptake of breastfeeding. Public health interventions, which encourage positive attitudes to breastfeeding within the family and wider community, should be developed and evaluated. [source]


A randomised controlled trial of a tailored multifaceted strategy to promote implementation of a clinical guideline on induced abortion care

BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 7 2004
R. Foy
Objective To evaluate the effectiveness and efficiency of a tailored multifaceted strategy, delivered by a national clinical effectiveness programme, to implement a guideline on induced abortion. Design Cluster randomised controlled trial. Setting and participants All 26 hospital gynaecology units in Scotland providing induced abortion care. Intervention Following the identification of barriers to guideline implementation, intervention units received a package comprising audit and feedback, unit educational meetings, dissemination of structured case records and promotion of a patient information booklet. Control units received printed guideline summaries alone. Main outcome measures Compliance with five key guideline recommendations (primary outcomes) and compliance with other recommendations, patient satisfaction and costs of the implementation strategy (secondary outcomes). Results No effect was observed for any key recommendation: appointment with a gynaecologist within five days of referral (odds ratio 0.89; 95% confidence interval 0.50 to 1.58); ascertainment of cervical cytology history (0.93; 0.36 to 2.40); antibiotic prophylaxis or screening for lower genital tract infection (1.70; 0.71 to 5.99); use of misoprostol as an alternative to gemeprost (1.00; 0.27 to 1.77); and offer of contraceptive supplies at discharge (1.11; 0.48 to 2.53). Median pre-intervention compliance was near optimal for antibiotic prophylaxis and misoprostol use. No intervention benefit was observed for any secondary outcome. The intervention costs an average of £2607 per gynaecology unit. Conclusions The tailored multifaceted strategy was ineffective. This was possibly attributable to high pre-intervention compliance and the limited impact of the strategy on factors outside the perceived control of clinical staff. [source]


Effects of a booster seat education and distribution program in child care centers on child restraint use among children aged 4 to 8 years

CHILD: CARE, HEALTH AND DEVELOPMENT, Issue 4 2009
Richard ReadingArticle first published online: 5 JUN 200
Effects of a booster seat education and distribution program in child care centers on child restraint use among children aged 4 to 8 years . ThoresonS., MyersL., GossC. & DiGuiseppiC. ( 2009 ) Archives of Pediatrics & Adolescent Medicine , 163 , 261 , 267 . Objective To compare child care centre-based booster seat education and distribution with no intervention when implemented immediately after booster seat legislation. Design Cluster randomized controlled trial. Setting Thirty-nine urban child care centres. Participants A total of 854 parents and 1010 children aged 4 to 8 years in vehicles leaving centres. Intervention We trained 168 staff members at 20 centres to give parents and children messages promoting booster seats and supplied lesson plans, children's activities, and free booster seats. Main outcome measures Observed booster seat use, ,good practice' restraint use and legal restraint use. Results Parents at intervention centres were more likely to report receiving restraint information from the centre [adjusted odds ratio (AOR), 4.06; 95% confidence interval (CI), 2.48,6.67], speaking with staff about booster seats (AOR, 3.95; 95% CI, 2.26,6.88) and using fit to decide when to move children into seat belts (AOR, 3.39; 95% CI, 1.91,5.99). Groups did not differ in proportions using booster seats (44% vs. 43%; AOR, 1.03; 95% CI, 0.62,1.73), good practice (42% vs. 41%; AOR, 1.11; 95% CI, 0.70,1.74) or legal restraints (65% vs. 65%; AOR, 0.79; 95% CI, 0.48,1.31). Results were similar for children aged 4 to 5 and 6 to 8 years. All outcomes were significantly less likely among children riding in pickup trucks or with Hispanic or black drivers. Conclusions The intervention increased parents' receipt of information from centre staff and knowledge about booster seats but not booster seat use. Research is needed to identify methods and messages that will empower centre providers to promote booster seats effectively and reach high-risk populations. [source]


Physical activity to prevent obesity in young children: cluster randomised controlled trial

CHILD: CARE, HEALTH AND DEVELOPMENT, Issue 3 2007
Richard Reading
Physical activity to prevent obesity in young children: cluster randomised controlled trial . Reilly, J. J., Kelly, L., Montgomery, C., Williamson, A., Fisher, A., McColl, J. H., Lo Conte, R., Paton, J. Y. & Grant, S. ( 2006 ) British Medical Journal , 333 , 1041 DOI: 10.1136/bmj.38979.623773.55. Objective To assess whether a physical activity intervention reduces body mass index in young children. Design Cluster randomized controlled single blinded trial over 12 months. Setting Thirty-six nurseries in Glasgow, Scotland. Participants In total, 545 children in their pre-school year, mean age 4.2 years (SD 0.2) at baseline. Intervention Enhanced physical activity programme in nursery (three 30-minute sessions a week over 24 weeks) plus home-based health education aimed at increasing physical activity through play and reducing sedentary behaviour. Main outcome measure Body mass index, expressed as a standard deviation score relative to UK 1990 reference data. Secondary measures were objectively measured physical activity and sedentary behaviour; fundamental movement skills; and evaluation of the process. Results Group allocation had no significant effect on the primary outcome measure at 6 and 12 months or on measures of physical activity and sedentary behaviour by accelerometry. Children in the intervention group had significantly higher performance in movement skills tests than control children at 6-month follow-up (P = 0.0027; 95% CI 0.3,1.3) after adjustment for sex and baseline performance. Conclusions Physical activity can significantly improve motor skills but did not reduce body mass index in young children in this trial. [source]