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

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.

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 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 ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016585 ◽  
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.

scholarly journals 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

2019 ◽  
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.

scholarly journals Secular trend, seasonality and effects of a community-based intervention on neonatal mortality: follow-up of a cluster-randomised trial in Quang Ninh province, Vietnam

2018 ◽  
Vol 72 (9) ◽  
pp. 776-782
Author(s):  
Leif Eriksson ◽  
Nguyen T Nga ◽  
Dinh T Phuong Hoa ◽  
Duong M Duc ◽  
Anna Bergström ◽  
...  
Keyword(s):  
Time Series ◽  
Neonatal Mortality ◽  
Secular Trend ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Neonatal Deaths ◽  
Live Births ◽  
Cluster Randomised ◽  
Quang Ninh

BackgroundLittle is know about whether the effects of community engagement interventions for child survival in low-income and middle-income settings are sustained. Seasonal variation and secular trend may blur the data. Neonatal mortality was reduced in a cluster-randomised trial in Vietnam where laywomen facilitated groups composed of local stakeholders employing a problem-solving approach for 3 years. In this analysis, we aim at disentangling the secular trend, the seasonal variation and the effect of the intervention on neonatal mortality during and after the trial.MethodsIn Quang Ninh province, 44 communes were allocated to intervention and 46 to control. Births and neonatal deaths were assessed in a baseline survey in 2005, monitored during the trial in 2008–2011 and followed up by a survey in 2014. Time series analyses were performed on monthly neonatal mortality data.ResultsThere were 30 187 live births and 480 neonatal deaths. The intervention reduced the neonatal mortality from 19.1 to 11.6 per 1000 live births. The reduction was sustained 3 years after the trial. The control areas reached a similar level at the time of follow-up. Time series decomposition analysis revealed a downward trend in the intervention areas during the trial that was not found in the control areas. Neonatal mortality peaked in the hot and wet summers.ConclusionsA community engagement intervention resulted in a lower neonatal mortality rate that was sustained but not further reduced after the end of the trial. When decomposing time series of neonatal mortality, a clear downward trend was demonstrated in intervention but not in control areas.Trial registration numberISRCTN44599712, Post-results.

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

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.

Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial

2017 ◽  
Vol 27 (5) ◽  
pp. 355-364 ◽  
Author(s):  
Jeffrey Todd Kullgren ◽  
Erin Krupka ◽  
Abigail Schachter ◽  
Ariel Linden ◽  
Jacquelyn Miller ◽  
...  
Keyword(s):  
Primary Care ◽  
Low Back Pain ◽  
Randomised Trial ◽  
Choosing Wisely ◽  
Cluster Randomised Trial ◽  
Low Back ◽  
Stepped Wedge ◽  
Intervention Period ◽  
Cluster Randomised

BackgroundLittle is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders.MethodsWe conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1–6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders.ResultsThe intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up.ConclusionClinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and may have increased alternate orders.Trial registration numberNCT02247050; Pre-results.

scholarly journals Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101634
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Muhammad Ahmar Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Public Health ◽  
Primary Outcome ◽  
Clinical Care ◽  
Randomised Trial ◽  
Health Facilities ◽  
Cluster Randomised Trial ◽  
Public Healthcare ◽  
Public Health Facilities ◽  
Cluster Randomised

BackgroundIn Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice.AimTo assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation.Design & settingA two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014–December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up.MethodFacilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded.ResultsSix-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention–control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001).ConclusionThe findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.

scholarly journals 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

2019 ◽  
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.

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.

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