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

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.

Download Full-text

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.

Download Full-text

Effect of childhood nutrition counselling on intelligence in adolescence: a 15-year follow-up of a cluster-randomised trial

Public Health Nutrition ◽

10.1017/s1368980017000751 ◽

2017 ◽

Vol 20 (11) ◽

pp. 2034-2041

Author(s):

Tiago N Munhoz ◽

Iná S Santos ◽

Simone de M. Karam ◽

Jose Martines ◽

Gretel Pelto ◽

...

Keyword(s):

Early Childhood ◽

Randomised Trial ◽

School Failure ◽

Cluster Randomised Trial ◽

Control Group ◽

Childhood Nutrition ◽

Nutrition Counselling ◽

Cluster Randomised ◽

Counselling Intervention

AbstractObjectiveThe present study aimed to assess the effects of an early childhood nutrition counselling intervention on intelligence (as measured by the intelligence quotient (IQ)) at age 15–16 years.DesignA single-blind, cluster-randomised trial.SettingIn 1998, in Southern Brazil, mothers of children aged 18 months or younger were enrolled in a nutrition counselling intervention (n 424). Counselling included encouragement and promotion of exclusive breast-feeding until 6 months of age and continued breast-feeding supplemented by protein-, lipid- and carbohydrate-rich foods after age 6 months up to age 2 years. The control group received routine feeding advice. In 2013, the fourth round of follow-up of these individuals, at the age of 15–16 years, was undertaken. IQ was assessed using the short form of the Wechsler Adult Intelligence Scale (WAIS-III). Mental disorders (evaluated using the Development and Well-Being Assessment (DAWBA)) and self-reported school failure, smoking and alcohol use were also investigated. Adjusted analyses were conducted using a multilevel model in accordance with the sampling process.SubjectsAdolescents, mean (sd) age of 15·4 (0·5) years (n 339).ResultsMean (sd) total IQ score was lower in the intervention group than the control group (93·4 (11·4) and 95·8 (11·2), respectively) but the association did not persist after adjustment. The prevalence of any mental disorders was similar between intervention and control groups (23·1 and 23·5 %, respectively). There were no differences between groups regarding school failure, smoking and alcohol use.ConclusionsNutrition counselling intervention in early childhood had no effect on intelligence measured during adolescence.

Download Full-text

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.

Download Full-text

‘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.

Download Full-text

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.

Download Full-text

Active Play in After-school Programmes: development of an intervention and description of a matched-pair cluster-randomised trial assessing physical activity play in after-school programmes

BMJ Open ◽

10.1136/bmjopen-2017-016585 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016585 ◽

Cited By ~ 4

Author(s):

Kirsti Riiser ◽

Sølvi Helseth ◽

Hanna Ellingsen ◽

Bjørg Fallang ◽

Knut Løndal

Keyword(s):

Physical Activity ◽

First Graders ◽

Randomised Trial ◽

Matched Pair ◽

After School ◽

Cluster Randomised Trial ◽

Small Scale ◽

Control Group ◽

Active Play ◽

Cluster Randomised

IntroductionInterventions delivered in after-school programmes (ASPs) have the potential to become a means of ensuring adequate physical activity among schoolchildren. This requires a motivational climate, allowing for self-determined play. If trained, ASP staff may represent a valuable resource for supporting such play. Increasing knowledge and supportive skills among ASP staff may also potentially increase their motivation for work. The purpose of this article is to describe the development of the ‘Active Play in ASP’ intervention, which aims to promote physical activity among first graders attending ASP, and to present a protocol for a matched-pair cluster-randomised trial to evaluate the intervention.Methods and analysisInformed by experiences from practice, evidence-based knowledge and theory, the intervention was developed in a stepwise process including focus group meetings and a small-scale pilot test. The intervention contains a course programme for ASP staff to increase their skills in how to support physical activity through play. In a cluster randomised controlled trial, the ASPs will be matched and randomly allocated to receive the 7-month intervention or to a control group. Outcomes will be assessed at baseline, after 7 and 19 months. First graders attending the ASPs included are eligible. The primary outcome will be accelerometer-determined minutes in moderate to vigorous physical activity in the ASP. The study uses a mixed methods approach including observations and interviews to provide rich descriptions of the concept of children's physical activity in ASP. Moreover, the trial will assess whether the ASP staff benefits from participation in the intervention in terms of increased work motivation. Lastly, process evaluations of programme fidelity, satisfaction and suggestions on improvement will be performed.Ethics and disseminationThe study is approved by the Data Protection Official for Research (reference no 46008). Results will be presented in conferences and peer-reviewed journals.Trial registration numberClinical Trials (NCT02954614), pre-results.

Download Full-text

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, one-year follow-up: a cluster-randomised trial

10.21203/rs.2.12516/v1 ◽

2019 ◽

Cited By ~ 1

Author(s):

Allen Nsangi ◽

Daniel Semakula ◽

Andrew David Oxman ◽

Astrid Austvoll- Dalghren ◽

Matt Oxman ◽

...

Keyword(s):

Primary School ◽

Primary Schools ◽

Randomised Trial ◽

Multiple Choice ◽

Cluster Randomised Trial ◽

Control Group ◽

Cluster Randomised ◽

Health Choices ◽

The Mean ◽

One Year

Abstract Introduction We evaluated an intervention designed to teach 10 to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report here on outcomes measured one year after the intervention. Methods In this cluster-randomised trial, we included primary schools in the central region of Uganda that taught year-five children (aged 10 to 12 years). We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books, and a teachers’ guide). The primary outcome, measured at the end of the school term and again after one year, was the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores. Results We assessed 2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n=60, 76 teachers and 6383 children) or control group (n=60, 67 teachers and 4430 children). After one year, the mean score in the multiple-choice test for the intervention schools was 68.7% compared to 53.0% for the control schools (adjusted mean difference 16.7%, 95% CI 13.9 to 19.5; p<0·00001). In the intervention schools, 3160 (80.1%) of 3943 children that completed the test after one year achieved a predetermined passing score (≥13 of 24 correct answers) compared with 1464 (51.5%) of 2844 children in the control schools (adjusted difference 39.5%, 95% CI 29.9 to 47.5). Conclusion Use of the learning-resources led to a large improvement in the ability of children to assess claims, which was sustained for at least one year.

Download Full-text

Feasibility of alcohol screening and brief intervention in primary health care in Kazakhstan: study protocol of a pilot cluster randomised trial

Pilot and Feasibility Studies ◽

10.1186/s40814-019-0547-x ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Bernd Schulte ◽

Amy O’Donnell ◽

Harald Lahusen ◽

Christina Lindemann ◽

Mariya Prilutskaya ◽

...

Keyword(s):

Health Care ◽

Primary Health Care ◽

Brief Intervention ◽

Randomised Trial ◽

Alcohol Screening ◽

Cluster Randomised Trial ◽

Control Group ◽

Screening And Brief Intervention ◽

Primary Health ◽

Cluster Randomised

Abstract Background Identifying and addressing heavy drinking represents a major public health priority worldwide. Whilst the majority of alcohol screening and brief intervention (ASBI) research has been conducted in western, high-income countries, evidence is growing that ASBI can also impact positively on heavy drinkers in low- and middle-income country populations. This mixed methods study aims to assess the feasibility of conducting a fully randomised controlled trial of the effectiveness of ASBI in primary care in Kazakhstan and explore the feasibility and acceptability of implementing ASBI in this setting from patients’ and physicians’ perspectives. Methods Six primary health care units in the region of Pavlodar will be cluster randomised to either an intervention (WHO manualised 5 min alcohol brief intervention plus alcohol leaflet) or control group (simple feedback plus alcohol leaflet). Primary feasibility measures will be rates of participation at baseline and retention of eligible patients at the 3-month follow-up point. Patient/physician questionnaires and physician focus groups will assess additional dimensions of feasibility, as well as acceptability, according to the RE-AIM framework: Reach (rates of eligible patients screened/received advice); Effectiveness (change in AUDIT-C score); Adoption (rate/representativeness of participating physicians); Implementation (quality of ASBI/barriers and facilitators to delivery); and Maintenance (potential sustainability of intervention). Discussion This is the first trial of the feasibility and acceptability of ASBI in Kazakhstan. As the planning and assessment of implementation determinants is based on the RE-AIM framework, the project outcomes will be relevant for the future development, tailoring and implementation of ASBI in Kazakhstan. Trial registration DRKS, DRKS00015882, Registered 17 December 2018.

Download Full-text

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

Nutrients ◽

10.3390/nu12113387 ◽

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.

Download Full-text