scholarly journals Effect of low-dose versus higher-dose antenatal iron supplementation on child health outcomes at 36 months of age in Viet Nam: longitudinal follow-up of a cluster randomised controlled trial

2017 ◽  
Vol 2 (3) ◽  
pp. e000368 ◽  
Author(s):  
Sarah Hanieh ◽  
Tran T Ha ◽  
Julie A Simpson ◽  
Sabine Braat ◽  
Tran T Thuy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Iron Supplementation ◽  
Low Dose ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Viet Nam ◽  
Child Health Outcomes ◽  
Cluster Randomised ◽  
Randomised Controlled

scholarly journals Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045444
Author(s):  
Sophie Ansems ◽  
Marjolein Berger ◽  
Patrick van Rheenen ◽  
Karin Vermeulen ◽  
Gina Beugel ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Cluster Randomised Controlled Trial ◽  
Referral Rate ◽  
Faecal Calprotectin ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

scholarly journals Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034507 ◽  
Author(s):  
Sofa D Alfian ◽  
Rizky Abdulah ◽  
Petra Denig ◽  
Job F M van Boven ◽  
Eelko Hak
Keyword(s):  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Intervention Programme ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionCurrent intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.Methods and analysisA cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients’ blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.Ethics and disseminationEthical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.Trial registration numberNCT04023734.

scholarly journals Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047067
Author(s):  
Pushpanjali Shakya ◽  
Archana Shrestha ◽  
Biraj Man Karmacharya ◽  
Abha Shrestha ◽  
Bård Eirik Kulseng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetes Prevention ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Community Based ◽  
Prevention Education ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionEvidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.Methods and analysesThis is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18–64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140–250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data.Ethics and disseminationRegional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes.Trial registration numberNCT04074148, 2019/783.

Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care

2014 ◽  
Vol 204 (6) ◽  
pp. 471-479 ◽  
Author(s):  
Caterina Vicens ◽  
Ferran Bejarano ◽  
Ermengol Sempere ◽  
Catalina Mateu ◽  
Francisca Fiol ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Benzodiazepine Use ◽  
Structured Intervention ◽  
Randomised Controlled

BackgroundBenzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence.AimsTo analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use.MethodA multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months.ResultsAt 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03–4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04–4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability.ConclusionsBoth interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.

scholarly journals Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

2010 ◽  
Vol 14 (2) ◽  
pp. 219-226 ◽  
Author(s):  
Simon Murphy ◽  
GF Moore ◽  
K Tapper ◽  
R Lynch ◽  
R Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Breakfast Skipping ◽  
Cluster Randomised ◽  
Positive Attitudes ◽  
Randomised Controlled ◽  
At Home

AbstractObjectiveThe present study evaluated the impact of a national school programme of universal free healthy breakfast provision in Wales, UK.DesignA cluster randomised controlled trial with repeated cross-sectional design and a 12-month follow-up. Primary outcomes were breakfast skipping, breakfast diet and episodic memory. Secondary outcomes were frequency of eating breakfast at home and at school, breakfast attitudes, rest-of-day diet and class behaviour.SettingPrimary schools in nine local education authority areas.SubjectsA total of 4350 students (aged 9–11 years) at baseline and 4472 at follow-up in 111 schools.ResultsStudents in intervention schools reported significantly higher numbers of healthy food items consumed at breakfast and more positive attitudes towards breakfast eating at 12 months. Parents in intervention schools reported significantly higher rates of consumption of breakfast at school and correspondingly lower rates of breakfast consumption at home. No other significant differences were found.ConclusionsThe intervention did not reduce breakfast skipping; rather, pupils substituted breakfast at home for breakfast at school. However, there were improvements in children’s nutritional intake at breakfast time, if not the rest of the day, and more positive attitudes to breakfast, which may have implications for life-course dietary behaviours. There was no impact on episodic memory or classroom behaviour, which may require targeting breakfast skippers.

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