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

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.

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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 ◽

10.1136/bmjopen-2019-036416 ◽

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.

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

British Journal Of Nutrition ◽

10.1017/s000711451800140x ◽

2018 ◽

Vol 120 (2) ◽

pp. 176-187 ◽

Cited By ~ 6

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.

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Paediatric oncology simulation training for resident education

BMJ Simulation and Technology Enhanced Learning ◽

10.1136/bmjstel-2018-000347 ◽

2018 ◽

Vol 5 (3) ◽

pp. 155-160 ◽

Cited By ~ 1

Author(s):

Gayle M Smink ◽

Donna B Jeffe ◽

Robert J Hayashi ◽

Noor Al-Hammadi ◽

James J Fehr

Keyword(s):

End Of Life ◽

Repeated Measures ◽

Simulation Training ◽

Intraclass Correlation ◽

Randomised Trial ◽

Intervention Group ◽

Paediatric Oncology ◽

Control Group ◽

Emotional Appraisal ◽

Perceived Challenge

IntroductionWe sought to evaluate paediatric oncology simulations intended to improve paediatric residents’ skills and comfort in caring for children with cancer.MethodIn a non-randomised trial, controls (the first three rotations) received a standard set of lectures, and the intervention arm received these lectures plus five simulation training scenarios—fever/neutropaenia, a new leukaemia diagnosis, end-of-life care discussion, tumour lysis syndrome and a mediastinal mass. All residents were tested after the rotation on the first three scenarios; management skills were evaluated independently by two raters. Before and after training, all residents completed an emotional-appraisal questionnaire evaluating each scenario as a perceived challenge or threat. Analysis of variance (ANOVA) measured differences by study arm in skills checklist assessments and appraisals; repeated measures ANOVA measured changes in emotional-appraisal scores.ResultsForty-two residents (9 controls, 33 interventions) participated. Inter-rater agreement for skills checklist scores using average-measures intraclass correlation was high (0.847), and overall mean scores were significantly higher for the intervention than control group across both raters (p=0.005). For all residents, perceived challenge increased in the end-of-life simulation, and perceived threat decreased in all three test scenarios. The intervention group, regardless of training year, evaluated the teaching scenarios favourably and felt that challenging oncology situations were addressed, skills were enhanced and the simulations should be offered to other residents.ConclusionsIt was feasible to introduce residents to difficult paediatric oncology scenarios using simulation. The intervention group performed more skills than controls when tested and perceive threat declined in all residents after their paediatric oncology rotation.

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Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial

Occupational and Environmental Medicine ◽

10.1136/oemed-2020-106794 ◽

2021 ◽

pp. oemed-2020-106794

Author(s):

Luise Moelenberg Begtrup ◽

Per Malmros ◽

Charlotte Brauer ◽

Sandra Soegaard Toettenborg ◽

Esben Meulengracht Flachs ◽

...

Keyword(s):

Educational Intervention ◽

Randomised Trial ◽

Intervention Group ◽

Cluster Randomised Trial ◽

Control Group ◽

Term Pregnancy ◽

Intention To Treat ◽

Cluster Randomised ◽

Work Units

ObjectiveThe aim was to test if targeting managers with an educational intervention reduces absence among pregnant employees.MethodsThe study was a non-blinded cluster randomised trial conducted in hospitals and daycare institutions from two administrative Danish Regions and two Danish municipalities. Clusters (work units) were assigned randomly and non-blinded to either (1) intervention, where all managers were invited to participate in a 3-hour seminar addressing needs and options for adjustment of work in pregnancy, or (2) control, with practice as usual. The primary outcome based on payroll data was long-term pregnancy-related absence, defined as ≥12.5% cumulated absence during pregnancy weeks 1–32. Intention-to-treat analysis was applied using mixed logistic regression.ResultsNinety work units were included (56 hospital departments and 34 daycare units) with 451 pregnant employees in the intervention group and 464 in the control group. Work units had on average 11 pregnant employees with no difference between the groups. 103 of the 216 invited managers (48%) participated in a the 3-hour seminar. In the intervention group, 154 (34%) had long-term pregnancy-related absence during pregnancy weeks 1–32 vs 166 (36%) in the control group. Relative odds of having long-term pregnancy-related absence, when being in the intervention group, was 1.06 (95% CI 0.71 to 1.58), with an interclass correlation coefficient of 0.07.ConclusionAn educational intervention targeting managers did not reduce pregnancy-related absence among pregnant employees.Trial registration numberNCT03002987.

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‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India

BMJ Open ◽

10.1136/bmjopen-2021-052238 ◽

2021 ◽

Vol 11 (12) ◽

pp. e052238

Author(s):

Bharati Kulkarni ◽

Little Flower Augustine ◽

Raghu Pullakhandam ◽

Anju Sinha Pradhan ◽

Teena Dasi ◽

...

Keyword(s):

Rural Areas ◽

Randomised Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Cluster Randomised Trial ◽

Control Group ◽

Population Mean ◽

Cluster Randomised ◽

The Difference ◽

The Impact

IntroductionCurrent anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population.Methods and analysisAn open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering.Ethics and disseminationThe study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders.Trial registration numberCTRI/2019/01/016918.

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Effectiveness of a kindergarten-based intervention to increase vegetable intake and reduce food neophobia amongst 1-year-old children: a cluster randomised controlled trial

Food & Nutrition Research ◽

10.29219/fnr.v65.7679 ◽

2021 ◽

Author(s):

Eli Anne Myrvoll Blomkvist ◽

Andrew K. Wills ◽

Sissel Heidi Helland ◽

Elisabet Rudjord Hillesund ◽

Nina Cecilie Øverby

Keyword(s):

Vegetable Intake ◽

Controlled Trial ◽

Randomised Trial ◽

Intervention Group ◽

Cluster Randomised Trial ◽

Control Group ◽

Post Intervention ◽

Food Neophobia ◽

Cluster Randomised ◽

Group 2

Background: Children’s first years of life are crucial to their future health. Studies show that a varied diet with a high intake of vegetables is positive in several domains of health. The present low vegetable intake amongst children is, therefore, a concern. Food neophobia is a common barrier to vegetable intake in children. As most Norwegian children attend kindergarten from an early age, kindergartens could contribute to the prevention of food neophobia and the promotion of vegetable intake. Objective: The aim of this study was to assess the effect of a cluster randomised trial amongst 1-year-old children in kindergarten to reduce food neophobia and promote healthy eating. Methods: Kindergartens were randomly allocated to either a control group or one of two intervention groups. Both intervention groups (diet and diet + Sapere-method) were served a warm lunch meal including three alternating intervention vegetables, whilst the intervention group 2 (diet + Sapere) in addition received tools for weekly sensory lessons. The intervention was digitally administered via information and recipes on a study website. The control group did not receive any information. Parents completed digitally distributed questionnaires addressing food neophobia and food habits at baseline and post-intervention. Results: The parents of 144 1-year-old children in 46 kindergartens completed the questionnaires, which were included in the main analysis. The results suggested a higher intake of the intervention vegetables in group 2 (diet + Sapere) compared to the control group. The effect on total vegetable intake was inconclusive. No effect was observed on the level of food neophobia in either of the intervention group. Conclusion: This digitally delivered dietary and sensory intervention promoted the intake of intervention-targeted vegetables with inconclusive effect on total vegetable intake due to large loss to follow-up. No effect on the level of food neophobia was detected.

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Promoting Media Literacy Online: An Intervention on Performance and Appearance Enhancement Substances with Sport High School Students

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115596 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5596

Author(s):

Federica Galli ◽

Tommaso Palombi ◽

Luca Mallia ◽

Andrea Chirico ◽

Thomas Zandonai ◽

...

Keyword(s):

High School ◽

High School Students ◽

Media Literacy ◽

Repeated Measures ◽

Intervention Group ◽

Literacy Intervention ◽

Media Influence ◽

Control Group ◽

School Students ◽

Health Promoting Behaviors

The outbreak of coronavirus required adjustment regarding the delivery of interventions. Media literacy interventions are necessary to help people acquire relevant skills to navigate the complexities of media communications, and to encourage health-promoting behaviors. The present study aimed to promote a media literacy intervention regarding performance and appearance enhancement substances use in sports high school students. The COVID-19 contingency allowed us to evaluate whether online sessions can effectively promote greater awareness of media influence, a stronger sense of confidence in persuading others to deal with media messages, and healthier attitudes about PAES use among high school students. The study relied on an “intervention group” comprising 162 students (31.5% female) and a “control group” comprising 158 students (42% female). Data were analyzed through repeated measures of Group X Time MANOVA and ANOVA, demonstrating some degree of efficacy of the media literacy intervention. The “intervention group” reported higher awareness of potential newspapers’ influence and a significant increase in their sense of confidence in dealing with media influence compared to the “control group”. Findings support the efficacy of online media literacy programs to prevent doping consumption in adolescents.

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Effectiveness of a Primary Care Program to Increase Physical Activity in People With Dementia and Their Family Caregivers (AFISDEMYF Study).

10.21203/rs.3.rs-1058583/v1 ◽

2021 ◽

Author(s):

Elena DE DIOS-RODRIGUEZ ◽

María C PATINO-ALONSO ◽

Susana GONZÁLEZ-SÁNCHEZ ◽

Joana RIPOLL ◽

Olaya TAMAYO-MORALES ◽

...

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Primary Care ◽

Systolic Blood Pressure ◽

Family Caregivers ◽

Intervention Group ◽

Care Program ◽

Control Group ◽

People With Dementia ◽

The Family

Abstract Aim: To evaluate the effectiveness of an intervention in primary health care designed to increase physical activity in people with dementia and their family caregivers.Methods: A cluster-randomized multicentre clinical trial was carried out.Participants: 140 people with dementia (median age 82 years;63.6% women) and 176 caregivers (median age 62 years ;72.7% women). Seventy patients and 80 caregivers were assigned to the Control Group (CG) and 70 patients and 96 caregivers to the Intervention Group (IG). The physical activity was measured with the pedometer and with the IPAQ-SF questionnaire. The intervention consisted of applying in primary care the program promoting physical activity (PEPAF) for 3 months. The changes observed at 6 months were analyzed. Results:In people with dementia, in the pedometer assessment a decrease was observed in both groups, but it was larger in the CG both in the total number step/day lower in the IG than in the CG and in the aerobic steps / day (52.89 vs -615.93). The activity reported with the IPAQ-SF decreased more in IG, both in the MET/min/week (-258.470 vs -148.23) and in the MVPA min/week. In caregivers the pedometer assessment showed that total steps/day increased more in the IG, as did aerobic steps/day (356.91 vs -12.95). The IPAQ-SF a smaller increase in global activity was declared in the IG than in the CG (545.25 MET/min/week vs 609.55), but the increase in vigorous activity was greater. No differences were found in changes in the functional status and the cognitive performances of people with dementia nor in the mental health in the caregivers, but systolic blood pressure, the Family APGAR and overload in the IG did improve.Conclusions: The results suggest that the intervention carried out may be effective on physical activity in both patients and caregivers. It can also improve systolic blood pressure, the Family APGAR and overload in caregivers. This is the first study to implement a primary care intervention aimed at simultaneously increasing physical activity in people with dementia and their relatives. These results reinforce the importance of using objective measures in clinical trials in people with dementia.Trial registration number: NCT 02044887.

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Comparison of Statistical Models For Estimating Intervention Effects Based On Time-To-Recurrent-Event In Stepped Wedge Cluster Randomized Trial Using Open Cohort Design

10.21203/rs.3.rs-999906/v1 ◽

2021 ◽

Author(s):

Shunsuke Oyamada ◽

Shih-Wei Chiu ◽

Takuhiro Yamaguchi

Keyword(s):

Monte Carlo ◽

Monte Carlo Simulations ◽

Statistical Models ◽

Randomised Trial ◽

Recurrent Event ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Intervention Effects ◽

Cohort Design

Abstract Background: There are currently no methodological studies on the performance of the statistical models for estimating intervention effects based on the time-to-recurrent-event (TTRE) in stepped wedge cluster randomised trial (SWCRT) using an open cohort design. This study aims to address this by evaluating the performance of these statistical models using an open cohort design with the Monte Carlo simulation in various settings and their application using an actual example.Methods: Using Monte Carlo simulations, we evaluated the performance of the existing extended Cox proportional hazard models, i.e., the Andersen-Gill (AG), Prentice-Williams-Peterson Total-Time (PWP-TT), and Prentice-Williams-Peterson Gap-time (PWP-GT) models, using the settings of several event generation models and true intervention effects, with and without stratification by clusters. Unidirectional switching in SWCRT was represented using time-dependent covariates.Results: Using Monte Carlo simulations with the various described settings, the PWP-GT model with stratification by clusters showed the best performance in most settings and reasonable performance in the others. The only situation in which the performance of the PWP-TT model with stratification by clusters was not inferior to that of the PWP-GT model with stratification by clusters was when there was a certain amount of follow-up period, and the timing of the trial entry was random within the trial period, including the follow-up period. The AG model performed well only in a specific setting. By analysing actual examples, it was found that almost all the statistical models suggested that the risk of events during the intervention condition may be somewhat higher than in the control, although the difference was not statistically significant.Conclusions: The PWP-GT model with stratification by clusters had the most reasonable performance when estimating intervention effects based on the TTRE in SWCRT in various settings using an open cohort design.

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Negative Air Pressure on Wet Cupping in Decreasing Blood Pressures in Hypertensive Patients

Nurse Media Journal of Nursing ◽

10.14710/nmjn.v7i2.15177 ◽

2018 ◽

Vol 7 (2) ◽

pp. 116

Author(s):

Budi Darmawan ◽

Diyah Fatmasari ◽

Rr. Sri Endang Pujiast

Keyword(s):

Blood Pressure ◽

Repeated Measures ◽

Community Health Centers ◽

Intervention Group ◽

Air Pressure ◽

Control Group ◽

P Value ◽

Decrease Blood Pressure ◽

Blood Pressures ◽

The Mean

Background: Wet cupping, furthermore mentioned cupping, decreases blood pressures through the level of negative air pressures added by hydrostatics filtration pressure to reinforce the power of fluids filtration in capillaries. However, an appropriate negative air pressure to decrease blood pressure remains an uncertainty.Purpose: This study aimed to analyze negative air pressure differences on cupping in decreasing blood pressures in hypertensive patients.Methods: This is a quasi-experimental design conducted in three Community Health Centers in Langsa City, Aceh, Indonesia. The samples were 36 hypertensive males with age from 45 to 55, who were randomly stratified into two groups with cupping pressures 400 mbar (n=18) as the control group; and 540 mbar (n=18) as the intervention group. The cupping session was performed to each group on T1 (alkahil) point and in the middle line of both shoulders blade points. The systolic blood pressure (SBP) and diastolic blood pressures (DBP) were measured by validated automatic sphygmomanometer. The follow-up periods were one week and two weeks. The data were then analyzed by repeated measures ANOVA.Results: Cupping pressure of 400 mbar decreased the mean of SBP and DPB with a p-value of 0.450 and 0.026, respectively after two weeks of intervention. Meanwhile, cupping pressure of 540 mbar decreased the mean of SBP and DBP with a p-value of 0.006 and 0.057, respectively. Tests of within-subjects resulted in the p-value of 0.250 (SBP) and 0.176 (DBP) after two weeks of intervention. There were no significant differences in SBP and DBP between the intervention group and the control group.Conclusion: The cupping pressure between 400 mbar and 540 mbar could reduce blood pressure; however, the cupping pressure of 540 mbar yielded greater effect in decreasing blood pressure than the 400 mbar. Negative air vacuum pressure loads on cupping to decrease blood pressure should be considered between 400 to 540 mbar, and further studies are needed.

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