scholarly journals The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial

2020 ◽  
pp. 1-10
Author(s):  
Prudence Atukunda ◽  
Grace KM Muhoozi ◽  
Lien M Diep ◽  
Jens P Berg ◽  
Ane C Westerberg ◽  
...  
Keyword(s):  
Child Development ◽  
Randomised Trial ◽  
Intervention Group ◽  
Secondary Analysis ◽  
Positive Association ◽  
Study Groups ◽  
Iodine Intake ◽  
Cluster Randomised Trial ◽  
Cognitive Score ◽  
Ages And Stages Questionnaire

Abstract Objective: We examined associations of urine iodide excretion, proxy for iodine intake, with child development and growth. Design: This is a secondary analysis of a 1:1 cluster-randomised trial with a 6-month nutrition/stimulation/hygiene education intervention among mothers of children aged 6–8 months to improve child development and growth. Development was assessed using Bayley Scales of Infant and Toddler Development–III (BSID-III) and Ages and Stages Questionnaire (ASQ), whereas anthropometry was used to assess growth. Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR) were measured. Setting: The current study was conducted in southern Uganda. Participants: We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20–24 and 36 months. Results: Median UIC for both study groups at 20–24 and 36 months were similar (P > 0·05) and within the normal range of 100–199 µg/l (0·79–1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20–24 months. The BSID-III cognitive score was positively associated (P = 0·028) with ICR at 20–24 months in the intervention group. The ASQ gross motor score was negatively associated (P = 0·020) with ICR at 20–24 months among the controls. ICR was not significantly associated with anthropometry in the two study groups at either time-point. Conclusions: Following the intervention, a positive association was noted between ICR and child’s cognitive score at 20–24 months, whereas no positive association with ICR and growth was detected. Iodine sufficiency may be important for child’s cognitive development in this setting.

scholarly journals Effectiveness of a home fortification programme with multiple micronutrients on infant and young child development: a cluster-randomised trial in rural Bihar, India

2018 ◽  
Vol 120 (2) ◽  
pp. 176-187 ◽  
Author(s):  
Leila M. Larson ◽  
Melissa F. Young ◽  
Patricia J. Bauer ◽  
Rukshan Mehta ◽  
Amy Webb Girard ◽  
...  
Keyword(s):  
Executive Function ◽  
Child Development ◽  
Randomised Trial ◽  
Intervention Group ◽  
Mental Development ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Nutrition Counselling ◽  
Cluster Randomised ◽  
Home Fortification

AbstractResearch demonstrates the importance of nutrition for early brain development. Few studies have examined the effectiveness of multiple micronutrient powders (MNP) on child development. This study examined the impacts of home fortification with MNP on motor and mental development, executive function and memory of children living in Bihar. This two-arm cluster-randomised effectiveness trial selected seventy health sub-centres to receive either MNP and nutrition counselling (intervention) or nutrition counselling alone (control) for 12 months. Front-line health workers delivered the intervention to all households in study communities with a child aged 6–18 months. Data were collected using cross-sectional surveys at baseline and endline by selecting households from intervention (baseline,n2184; endline,n2170) and control (baseline,n2176; endline,n2122) communities using a two-stage cluster-randomised sampling strategy. Children in the intervention group had a significantly larger improvement from baseline to endline compared with those in the control group on scores for motor and mental development (Cohen’sd, motor=0·12; 95 % CI 0·03, 0·22; mental=0·15; 95 % CI 0·06, 0·25). Greater impacts of MNP on motor and mental development were observed in children from households with higher stimulation scores at baseline compared with those with lower stimulation (Cohen’sd, motor=0·20v. 0·09; mental=0·22v. 0·14;Pinteraction<0·05). No significant treatment differences were seen for executive function or memory. Home fortification with MNP through the existing health infrastructure in Bihar was effective in improving motor and mental development and should be considered in combination with other child development interventions such as stimulation.

scholarly journals Effects of the Preschool-Based Family-Involving DAGIS Intervention on Family Environment: A Cluster Randomised Trial

Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3387
Author(s):  
Carola Ray ◽  
Rejane Figueiredo ◽  
Riikka Pajulahti ◽  
Henna Vepsäläinen ◽  
Elviira Lehto ◽  
...  
Keyword(s):  
Family Environment ◽  
Interaction Effect ◽  
Repeated Measures ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Intervention Effects ◽  
Role Modelling ◽  
The Family

Interventions promoting young children’s healthy energy balance-related behaviours (EBRBs) should also examine changes in the family environment as this is an important determinant that may affect the effectiveness of the intervention. This study examines family environmental effects of the Increased Health and Wellbeing in Preschools (DAGIS) intervention study, and whether these effects differed when considering three parental educational level (PEL) groups. The DAGIS intervention was conducted in preschools and involving parents in Southern Finland from September 2017 to May 2018. It was designed as a randomised trial, clustered at preschool-level. Parents of 3–6-year-olds answered questionnaires recording PEL, parental role modelling for EBRBs, and the family environment measured as EBRBs availability and accessibility. Linear Mixed Models with Repeated Measures were used in order to detect intervention effects. Models included group by time interactions. When examining intervention effects separated by PEL groups, models with three-level interactions (group × time-points × PEL) were evaluated. There was an interaction effect for the availability of sugary everyday foods and drinks (p = 0.002). The analyses showed that the control group increased availability (p = 0.003), whereas in the intervention group no changes were detected (p = 0.150). In the analysis separated by PEL groups, changes were found only for the accessibility of sugary treats at home; the high PEL control group increased the accessibility of sugary treats (p = 0.022) (interaction effect: p = 0.027). Hence, results suggest that the DAGIS multicomponent intervention had a limited impact on determinants for children’s healthy EBRBs, and no impact was found in the low PEL group.

A multifaceted intervention to improve mental health literacy in employees of a multi-campus university: a cluster randomised trial

2014 ◽  
Vol 13 (1) ◽  
pp. 25-39 ◽  
Author(s):  
Nicola J. Reavley ◽  
Terence V. McCann ◽  
Stefan Cvetkovski ◽  
Anthony F. Jorm
Keyword(s):  
Mental Health ◽  
Health Literacy ◽  
Alcohol Use ◽  
Help Seeking ◽  
Mental Health Literacy ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Depression And Anxiety ◽  
Content Type

Purpose – The purpose of this study was to assess whether a multifaceted intervention could improve mental health literacy, facilitate help seeking and reduce psychological distress and alcohol misuse in staff of a multi-campus university in Australia. Design/methodology/approach – In this cluster randomised trial (ACTRN12610001027000), nine campuses were paired, with one of each pair randomly assigned to either intervention or control. Interventions (which were whole-of-campus) included e-mails, posters, campus events, factsheets/booklets and mental health first aid training courses. A monitoring sample of staff were recruited from each campus. Participants had a 20-minute computer-assisted telephone interview at baseline, and at the end of academic years 1 and 2. The interview assessed mental health literacy, help seeking for mental health problems, psychological distress and alcohol use. The primary outcomes were depression and anxiety levels and alcohol use and pertained to the individual level. Six campuses were randomised to intervention and three to control and all campuses were included in the analysis. Findings – There were no effects on depression and anxiety levels and alcohol use. Recall of intervention elements was greater in the intervention group at the end of the two-year assessment period. Staff in the intervention group showed better recognition of depression, greater knowledge of the National Health and Medical Research Council guidelines for safe levels of drinking and a greater intention to seek help for alcohol misuse from a general practitioner. Originality/value – Future interventions should involve more focused interventions that include consideration of working conditions and their influence on mental health, as well as addressing mental illness among employees, regardless of cause.

scholarly journals Sociological variety and the transmission efficiency of Mycobacterium tuberculosis: a secondary analysis of qualitative and quantitative data from 15 communities in Zambia

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e047136
Author(s):  
Emma J Murray ◽  
Peter J Dodd ◽  
Ben Marais ◽  
Helen Ayles ◽  
Kwame Shanaube ◽  
...  
Keyword(s):  
Mycobacterium Tuberculosis ◽  
Randomised Trial ◽  
Secondary Analysis ◽  
Transmission Efficiency ◽  
Cluster Randomised Trial ◽  
Data Sets ◽  
Wide Variability ◽  
Registration Number ◽  
Lower Transmission ◽  
Formed Part

ObjectivesSelected Zambian communities formed part of a cluster randomised trial: the Zambia and South Africa TB and AIDS Reduction study (ZAMSTAR). There was wide variability in the prevalence of Mycobacterium tuberculosis infection and tuberculosis (TB) disease across these communities. We sought to clarify whether specific communities could have been more/less vulnerable to M. tuberculosis transmission as a result of sociological variety relevant to transmission efficiency.DesignWe conducted a mixed methods secondary analysis using existing data sets. First, we analysed qualitative data to categorise and synthesise patterns of socio-spatial engagement across communities. Second, we compared emergent sociological variables with a measure of transmission efficiency: the ratio of the annual risk of infection to TB prevalence.SettingZAMSTAR communities in urban and peri-urban Zambia, spanning five provinces.ParticipantsFifteen communities, each served by a health facility offering TB treatment to a population of at least 25 000. TB notification rates were at least 400 per 100 000 per annum and HIV seroprevalence was estimated to be high.ResultsCrowding, movement, livelihoods and participation in recreational activity differed across communities. Based on 12 socio-spatial indicators, communities were qualitatively classified as more/less spatially crowded and as more/less socially ‘open’ to contact with others, with implications for the presumptive risk of M. tuberculosis transmission. For example, watching video shows in poorly ventilated structures posed a presumptive risk in more socially open communities, while outdoor farming and/or fishing were particularly widespread in communities with lower transmission measures.ConclusionsA dual dynamic of ‘social permeability’ and crowding appeared relevant to disparities in M. tuberculosis transmission efficiency. To reduce transmission, certain socio-spatial aspects could be adjusted (eg, increasing ventilation on transport), while more structural aspects are less malleable (eg, reliance on public transport). We recommend integrating community level typologies with genome sequencing techniques to further explore the significance of ‘social permeability’.Trial registration numberISRCTN36729271.

scholarly journals Promoting parent-child relationships and preventing violence via home-visiting:  A pre-post cluster randomised trial among Rwandan families linked to social protection programmes

2020 ◽  
Author(s):  
Theresa S. Betancourt ◽  
Sarah K.G. Jensen ◽  
Dale A. Barnhart ◽  
Robert T. Brennan ◽  
Shauna M. Murray ◽  
...  
Keyword(s):  
Child Development ◽  
Home Visiting ◽  
Social Protection ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Care Seeking ◽  
Cohen’S D ◽  
Cluster Randomised ◽  
Cohen's D ◽  
Parent Child Relationships

Abstract Background: Sugira Muryango ​ is a father-engaged early child development and violence-prevention home-visiting programme delivered by trained lay workers. This cluster-randomised trial evaluates whether families living in extreme poverty ( Ubudehe 1, the poorest category in the Government of Rwanda’s wealth ranking) who receive Sugira Muryango in combination with a government-provided social protection programme demonstrate greater responsive, positive caregiving, nutrition, care seeking, hygiene, and father involvement compared with control families receiving usual care (UC). Methods: Using detailed maps, we grouped closely spaced villages into 284 geographic clusters stratified by the type of social protection programs operating in the village clusters; 198 clusters met all enrolment criteria. Sugira Muryango was delivered to n=541 families in 100 treatment clusters with children aged 6–36 months living in extreme poverty. We assessed changes in outcomes in intervention and 508 UC control families using structured surveys and observation. Analyses were intent to treat using mixed models to accommodate the clustering. Results: Families receiving Sugira Muryango improved on core outcomes of parent-child relationships assessed using the Home Observation for Measurement of the Environment (Cohen’s d =0.87, 95% CI: 0.74, 0.99) and the Observation of Mother-Child Interaction (Cohen’s d =0.29, 95% CI: 0.17, 0.41). We also saw reductions in harsh discipline on items from the UNICEF MICS (OR=0.30: 95% CI: 0.22, 0.51) and violent victimization of female caregivers by their partners (OR=0.49, 95% CI: 0.24, 1.00) compared with UC. Moreover, children in families receiving SM had a 0.45 higher increase in food groups consumed in the past 24 hours (Cohen’s d =0.35, 95% CI: 0.22, 0.47), increased care seeking for diarrhoea (OR=4.43, 95% CI: 1.95, 10.10) and fever (OR=3.28, 95% CI: 1.82, 5.89), and improved hygiene behaviours such as proper treatment of water (OR=3.39, 95% CI: 2.16, 3.69) compared with UC. Finally, Sugira Muryango was associated with decreased caregiver depression and anxiety (OR=0.58, 95% CI: 0.38, 0.88). Conclusions: Sugira Muryango led to improvements in caregiver behaviours linked to child development and health as well as reductions in violence. Trial registration: ClinicalTrials.gov number NCT02510313.

scholarly journals Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036416
Author(s):  
Laura Green ◽  
Jahnavi Daru ◽  
Julie Dodds ◽  
Francisco Jose Gonzalez Carreras ◽  
Doris Lanz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Postpartum Haemorrhage ◽  
Randomised Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Primary Objective ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Advisory Group ◽  
Cluster Randomised

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.

scholarly journals Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Samantha Keogh ◽  
Caroline Shelverton ◽  
Julie Flynn ◽  
Gabor Mihala ◽  
Saira Mathew ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Control Period ◽  
Randomised Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

scholarly journals Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032616 ◽  
Author(s):  
Yvonne L Luigjes-Huizer ◽  
Marije L van der Lee ◽  
Niek J de Wit ◽  
Charles W Helsper
Keyword(s):  
Primary Care ◽  
The Netherlands ◽  
Medical Research ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Fear Of Cancer

IntroductionMany successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated.Methods and analysisA two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive–behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group.Ethics and disseminationThe Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations.Trial registration numberNL7573 in the Netherlands Trial Register on 25-02-2019.

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