Cluster-randomized Intervention Trial Research Articles

Faith-based intervention to increase fruit and vegetable intake among Koreans in the USA: a feasibility pilot.

In the USA, adults of Korean descent tend to eat fewer vegetables than adults in South Korea. The present pilot study examined the feasibility of developing and implementing a faith-based intervention to improve knowledge, attitudes and intake of fruit and vegetables (F&V) for Koreans in the USA. Feasibility pilot using a cluster-randomized intervention trial design. The multicomponent intervention included motivational interviewing sessions by telephone and church-based group activities. Eleven of the largest Korean churches in Southern California. Adults (n 71) from the eleven Korean churches. Feasibility was demonstrated for the study procedures, including recruitment of churches and individual participants. Allocating time throughout the study for church collaboration and having a study church coordinator to coordinate multiple churches were crucial. Participants' attendance at church activities (89 %) and participation by pastors and fellow churchgoers exceeded expectations. Participants' use of intervention materials was high (94 % or above) and satisfaction with coaching sessions was also high (75 % or above). Having a centralized coach trained in motivational interviewing, instead of one at each church, proved practical. Pilot results are promising for F&V knowledge, attitudes and behaviours. The intervention group improved knowledge and intake of the recommended amounts of F&V, above that of the control group. This pilot suggests that Koreans in the USA can be reached through their church and that a faith-based intervention study can be implemented to increase F&V intake. Preliminary results for the intervention appear promising but further research is needed to properly evaluate its efficacy.

Qualitative Data from a Trial of Home Blood Pressure Telemonitoring and Pharmacist Management (Hyperlink)

Background/Aims: Hyperlink was a cluster-randomized intervention trial in HealthPartners clinics from 2009 to 2013 with nonintervention follow-up through 2015 (60 months). Participants had uncontrolled hypertension. Telemonitoring intervention patients had improved blood pressure control at 6 months compared with usual care patients (72% vs. 45%, P < 0.001). Intervention effects narrowed at 12 (72% vs. 53%, P = 0.005) and 18 months (72% vs. 57%, P = 0.003); 60-month blood pressure data will be complete in October 2015. We conducted a mixed-methods analysis combining our quantitative results with patient, clinical and other organizational stakeholder perspectives to learn how to optimize the intervention for the most patients and implement this intervention in our care setting.

Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial.

BackgroundUptake of couples’ HIV counseling and testing (couples’ HCT) services remains largely low in most settings. We report the effect of a demand-creation intervention trial on couples’ HCT uptake among married or cohabiting individuals who had never received couples’ HCT.MethodsThis was a cluster-randomized intervention trial implemented in three study regions with differing HIV prevalence levels (range: 9–43 %) in Rakai district, southwestern Uganda, between February and September 2014. We randomly assigned six clusters (1:1) to receive the intervention or serve as the comparison arm using computer-generated random numbers. In the intervention clusters, individuals attended small group, couple and male-focused interactive sessions, reinforced with testimonies from ‘expert couples’, and received invitation coupons to test together with their partners at designated health facilities. In the comparison clusters, participants attended general adult health education sessions but received no invitation coupons. The primary outcome was couples’ HCT uptake, measured 12 months post-baseline. Baseline data were collected between November 2013 and February 2014 while follow-up data were collected between March and April 2015. We conducted intention-to-treat analysis using a mixed effects Poisson regression model to assess for differences in couples’ HCT uptake between the intervention and comparison clusters. Data analysis was conducted using STATA statistical software, version 14.1.ResultsOf 2135 married or cohabiting individuals interviewed at baseline, 42 % (n = 846) had ever received couples’ HCT. Of those who had never received couples’ HCT (n = 1,174), 697 were interviewed in the intervention clusters while 477 were interviewed in the comparison clusters. 73.6 % (n = 513) of those interviewed in the intervention and 82.6 % (n = 394) of those interviewed in the comparison cluster were interviewed at follow-up. Of those interviewed, 72.3 % (n = 371) in the intervention and 65.2 % (n = 257) in the comparison clusters received HCT. Couples’ HCT uptake was higher in the intervention than in the comparison clusters (20.3 % versus 13.7 %; adjusted prevalence ratio (aPR) = 1.43, 95 % CI: 1.02, 2.01, P = 0.04).ConclusionOur findings show that a small group, couple and male-focused, demand-creation intervention reinforced with testimonies from ‘expert couples’, improved uptake of couples’ HCT in this rural setting.Trial registrationClinicalTrials.gov, NCT02492061. Date of registration: June 14, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-1720-y) contains supplementary material, which is available to authorized users.

A holistic school-based nutrition program fails to improve teachers’ nutrition-related knowledge, attitudes and behaviour in rural China

Purpose– The purpose of this paper is to examine the effectiveness of a holistic school-based nutrition programme using the health-promoting school (HPS) approach, on teachers’ knowledge, attitudes and behaviour in relation to nutrition in rural China.Design/methodology/approach– A cluster-randomised intervention trial design was employed. Two middle schools were randomly selected and assigned to either the intervention school using the HPS framework (HPS School), or to the Control School, in Miyun County, Beijing. From each school 20 teachers were randomly selected to complete the survey. Nutrition-related knowledge, attitudes and behaviour were measured at pre- and post-intervention surveys with the same instrument. The nutrition intervention last for six months.Findings– The holistic school-based nutrition programme using the HPS framework had no statistical impact on improving teacher’s knowledge, attitudes and behaviour in relation to nutrition (p&gt; 0.05).Practical implications– Future holistic school-based nutrition programmes targeting adolescents should also design and implement longer and more intensive interventions for teachers focusing on how to equip them with the awareness and ability to disseminate their knowledge, positive attitudes and role model behaviours to students, rather than on how to teach them basic knowledge and skills.Originality/value– Although teachers play a critical role in the HPS framework, there is very limited published research investigating the change in teachers’ nutrition-related knowledge, attitudes and behaviour as a result of a nutrition promotion programme.

School-based intervention for nutrition promotion in Mi Yun County, Beijing, China

Purpose – The purpose of this paper is to assess whether the school-based nutrition programme using the health-promoting school (HPS) framework was effective to improve parents’ knowledge, attitudes and behaviour (KAB) in relation to nutrition in rural Mi Yun County, Beijing. Design/methodology/approach – A cluster-randomised intervention trial design was employed. Two middle schools were randomly selected and assigned to either the intervention school using the HPS framework (HPS School), or to the Control School, in Mi Yun County, Beijing. From each school 65 parents of seventh-grade students were randomly selected to participate in the study. Nutrition-related KAB were measured at pre- and post-intervention surveys with the same instrument. The nutrition intervention last for six months. Findings – The school-based nutrition intervention using the HPS framework was effective in increasing parents’ nutrition knowledge; however, it had no statistical significant impact on improving parents’ attitudes towards nutrition and their eating behaviours. Research limitations/implications – The intervention appeared to be inadequate from the point of view of its impact on parents in terms of content, form and frequency. Practical implications – Future school-based nutrition promotion programmes using the HPS framework should focus more on parents, providing them with a more informative, participative and interactive, and frequent intervention. Originality/value – There is very limited published research focusing on the effect of the school-based nutrition promotion programmes using an HPS framework on parents’ nutrition-related KAB. Although, the improved KAB in relation to nutrition among parents is essential to promote young people’s nutrition and healthy eating behaviours.

Unmet Needs of Community-Dwelling Primary Care Patients with Dementia in Germany: Prevalence and Correlates.

To provide an optimal care for persons with dementia (PWD), their individual unmet needs have to be identified and comprehensively addressed. Present analyses aim to describe the number and types of unmet needs of German primary care patients screened positive for dementia and factors associated with the number of unmet needs. DelpHi-MV (Dementia: life- and person-centered help in Mecklenburg-Western Pomerania) is a general practitioner-based, cluster-randomized controlled intervention trial. Analyses are based on the baseline data of 227 PWD (≥70 years, living at home) of the intervention group who had screened positive for dementia (DemTect<9) and received a standardized computer-assisted needs assessment. PWD had on average 8.77±5.04 unmet needs (Range = 0-31). More than 90% of the PWD had three or more unmet needs. Unmet needs were identified across all predefined 26 subcategories. The majority of unmet needs occurred in the domains "nursing treatment and care" (38%), "social counseling and legal support" (20%), and "pharmacological treatment and care" (15%). More impairment in the activities of daily living was the only factor that was significantly associated with a higher number of unmet needs, independent of age, gender, living situation, presence of an informal caregiver, cognitive impairment, and depression. Present results demonstrate that community-dwelling PWD had a broad range of varying unmet needs. These findings emphasize the importance of a comprehensive needs assessment that allows the identification of individual needs as the basis for a tailored intervention- such as Dementia Care Management- that can address these needs.

Effect of Facilitation of Local Stakeholder Groups on Equity in Neonatal Survival; Results from the NeoKIP Trial in Northern Vietnam.

BackgroundTo operationalize the post-MDG agenda, there is a need to evaluate the effects of health interventions on equity. The aim of this study is to evaluate the effect on equity in neonatal survival of the NeoKIP trial (ISRCTN44599712), a population-based, cluster-randomized intervention trial with facilitated local stakeholder groups for improved neonatal survival in Quang Ninh province in northern Vietnam.MethodsSemi-structured interviews were conducted with all mothers experiencing neonatal mortality and a random sample of 6% of all mothers with a live birth in the study area during the study period (July 2008-June 2011). Multilevel regression analyses were performed, stratifying mothers according to household wealth, maternal education and mother’s ethnicity in order to assess impact on equity in neonatal survival.FindingsIn the last year of study the risk of neonatal death was reduced by 69% among poor mothers in the intervention area as compared to poor mothers in the control area (OR 0.31, 95% CI 0.15–0.66). This pattern was not evident among mothers from non-poor households. Mothers with higher education had a 50% lower risk of neonatal mortality if living in the intervention area during the same time period (OR 0.50, 95% CI 0.28–0.90), whereas no significant effect was detected among mothers with low education.InterpretationThe NeoKIP intervention promoted equity in neonatal survival based on wealth but increased inequity based on maternal education.

Improving antibiotic prescribing quality by an intervention embedded in the primary care practice accreditation: the ARTI4 randomized trial.

Antibiotic overprescribing is a significant problem. Multifaceted interventions improved antibiotic prescribing quality; their implementation and sustainability, however, have proved difficult. We analysed the effectiveness of an intervention embedded in the quality cycle of primary care practice accreditation on quantity and quality of antibiotic prescribing for respiratory tract and ear infections (RTIs). This was a pragmatic, cluster-randomized intervention trial in 88 Dutch primary care practices. The intervention (physician education and audit/feedback on antibiotic prescribing quantity and quality) was integrated in practice accreditation by defining an improvement plan with respect to antibiotic prescribing for RTIs. Numbers and types of dispensed antibiotics were analysed from 1 year prior to the intervention to 2 years after the intervention (pharmacy data). Overprescribing, underprescribing and non-first-choice prescribing for RTIs were analysed at baseline and 1 year later (self-registration). There were significant differences between intervention and control practices in the changes in dispensed antibiotics/1000 registered patients (first year: -7.6% versus -0.4%, P = 0.002; second year: -4.3% versus +2%, P = 0.015), which was more pronounced for macrolides and amoxicillin/clavulanate (first year: -12.7% versus +2.9%, P = 0.001; second year: -7.8% versus +6.7%, P = 0.005). Overprescribing for RTIs decreased from 44% of prescriptions to 28% (P < 0.001). Most general practitioners (GPs) envisaged practice accreditation as a tool for guideline implementation. GP education and an audited improvement plan around antibiotics for RTIs as part of primary care practice accreditation sustainably improved antibiotic prescribing. Tools should be sought to further integrate and facilitate education and audit/feedback in practice accreditation.

Lifestyle intervention to prevent excessive maternal weight gain: mother and infant follow-up at 12 months postpartum.

BackgroundExcessive gestational weight gain (GWG) is associated with elevated weight retention in mothers and might be related to adiposity of their offspring. Little is known if lifestyle intervention during pregnancy has beneficial effects for mothers and children beyond gestation.MethodsA cluster-randomized controlled intervention trial was performed with 250 pregnant women in 8 gynaecological practices. Lifestyle intervention was carried out twice with individual counselling sessions on nutrition, physical activity and weight monitoring. Participants in the control group received routine prenatal care and an information leaflet. Follow-up data of women and their offspring were collected one year postpartum (pp) by phone call and/or via e-mail using a structured questionnaire. Maternal weight retention at 12 months pp and weight development of the children in their first year of life was compared between groups using linear regression. The association between energy and macronutrient intake during pregnancy with maternal weight retention and children weight development was also assessed.ResultsThe intervention resulted in a trend towards lower mean weight retention 12 months pp (0.2 vs. 0.8 kg), but was not statistically significant (p = 0.321). Among women receiving lifestyle counselling, only 8 % retained more than 5 kg weight while 17 % in the control group retained >5 kg (OR: 0.40 (95 % CI: 0.16, 0.97)). For the whole study cohort, an association between higher GWG and increased 12 month weight retention was found (0.4 kg weight retention per 1 kg increase in GWG, p < 0.001). Weight development of the infants did not differ between groups in the first months after birth. At the 10th–12th month weight measurement, infants born to mothers in the intervention group tended towards lower body weights. Both energy intake and macronutrient composition of the diet during pregnancy did not affect maternal weight retention and weight development of the infants.ConclusionsLifestyle counselling during pregnancy to avoid GWG had a rather modest effect on maternal pp weight retention and weight development of the infants. However, larger intervention studies and longer follow-up are required to be able to draw definite conclusions.Trial registrationGerman Clinical Trials Register DRKS00003801.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-015-0701-2) contains supplementary material, which is available to authorized users.

The SI! Program for Cardiovascular Health Promotion in Early Childhood: A Cluster-Randomized Trial

BackgroundThe preschool years offer a unique window of opportunity to instill healthy life-style behaviors and promote cardiovascular health. ObjectivesThis study sought to evaluate the effect of a 3-year multidimensional school-based intervention to improve life-style–related behaviors. MethodsWe performed a cluster-randomized controlled intervention trial involving 24 public schools in Madrid, Spain, that were assigned to either the SI! Program intervention or the usual curriculum and followed for 3 years. The SI! Program aimed to instill and develop healthy behaviors in relation to diet, physical activity, and understanding how the human body and heart work. The primary outcome was change in the overall knowledge, attitudes, and habits (KAH) score (range 0 to 80). The intervention’s effect on adiposity markers was also evaluated. ResultsA total of 2,062 children from 3 to 5 years of age were randomized. After 3 years of follow-up, the overall KAH score was 4.9% higher in children in the intervention group compared with the control group (21.7 vs. 16.4; p < 0.001). A peak effect was observed at the second year (improvement 7.1% higher than in the control group; p < 0.001). Physical activity was the main driver of the change in KAH at all evaluation times. Children in the intervention group for 2 years and 1 year showed greater improvement than control subjects (5.9%; p < 0.001 and 2.9%; p = 0.002, respectively). After 3 years, the intervention group showed a higher probability than the control group of reducing the triceps skinfold z-score by at least 0.1 (hazard ratio: 1.40, 95% confidence interval: 1.04 to 1.89; p = 0.027). ConclusionsThe SI! Program is an effective strategy for instilling healthy habits among preschoolers, translating into a beneficial effect on adiposity, with maximal effect when started at the earliest age and maintained over 3 years. Wider adoption may have a meaningful effect on cardiovascular health promotion. (Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial [Preschool_PSI!]; NCT01579708)

The MAM'Out project: a randomized controlled trial to assess multiannual and seasonal cash transfers for the prevention of acute malnutrition in children under 36 months in Burkina Faso.

BackgroundWasting is a public health issue but evidence gaps remain concerning preventive strategies not primarily based on food products. Cash transfers, as part of safety net approach, have potential to prevent under-nutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to a lack of evidence regarding their nutritional benefits.Methods/DesignThe MAM’Out research project aims at evaluating a seasonal and multiannual cash transfer program to prevent acute malnutrition in children under 36 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (Eastern region of Burkina Faso, Africa). The program is targeted to economically vulnerable households with children less than 1 year old at the time of inclusion. Cash is distributed to mothers and the transfers are unconditional, leading to beneficiaries’ self-determination on the use of cash. The study is designed as a two-arm cluster randomized intervention trial, based on the randomization of rural villages. One group receives cash transfers via mobile phones and one is a control group. The main outcomes are the cumulative incidence of acute malnutrition and the cost-effectiveness. Child anthropometry (height, weight and MUAC) is followed, as well as indicators related to dietary diversity, food security, health center utilization, families’ expenses, women empowerment and morbidities. 24 h-food recalls are also carried out. Individual interviews and focus group discussions allow collecting qualitative data. Finally, based on a theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.DiscussionThe design chosen will lead to a robust assessment of the effectiveness of the proposed intervention. Several challenges appeared while implementing the study and discrepancies with the research protocol, mainly due to unforeseen events, can be highlighted, such as delay in project implementation, switch to e-data collection and implementation of a supervision process.Trial registrationClinicalTrials.gov, identifier: NCT01866124, registered May 7, 2013.

Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial.

BackgroundBangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation.MethodsThis cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model.ResultsNone of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001) higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model.ConclusionsThese results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic.

Improving Oral Hygiene in Institutionalised Elderly by Educating Their Caretakers in Bangalore City, India: a Randomised Control Trial.

BackgroundThe population of older people, as well as the number of dependent older people, is steadily increasing; those unable to live independently at home are being cared for in a range of settings. Practical training for nurses and auxiliary care staff has frequently been recommended as a way of improving oral health care for functionally dependent elderly. The aim was improve oral hygiene in institutionalized elderly in Bangalore city by educating their caregivers.MethodsThe study is a cluster randomized intervention trial with an elderly home as unit of randomization in which 7 out of 65 elderly homes were selected. Oral health knowledge of caregivers was assessed using a pre-tested pro forma and later oral-health education was provided to the caregivers of the study group. Oral hygiene status of elderly residents was assessed by levels of debris, plaque of dentate and denture plaque, and denture stomatitis of denture wearing residents, respectively. Oral-health education to the caregivers of control group was given at the end of six monthsResultsThere was significant improvement in oral-health knowledge of caregivers from the baseline and also a significant reduction of plaque score from baseline score of 3.17 ± 0.40 to 1.57 ± 0.35 post-intervention (p < .001), debris score 2.87 ± 0.22 to 1.49 ± 0.34 (p < .001), denture plaque score 3.15 ± 0.47 to 1.21 ± 0.27 (p < .001), and denture stomatitis score 1.43 ± 0.68 to 0.29 ± 0.53 (p < .001).ConclusionsThe result of the present study showed that there was a significant improvement in the oral-health knowledge among the caregivers and oral-hygiene status of the elderly residents.

Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE–Acute Ischemic Stroke

Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke (AIS) in China. This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention. This is a multicenter, 2-arm, open-label, cluster-randomized trial involving 40 clusters (hospitals) from China National Network of Stroke Research. Hospitals are randomized to receive a targeted multifaceted quality improvement intervention (experimental group) or routine standard of care (control group). The multifaceted intervention includes an evidence-based clinical pathway, written care protocols, a quality coordinator, and a monitoring and feedback system of performance measures. The number of enrolled patients in the trial will be 4,800. Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure (defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients) and the all-or-none measure (defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible). Secondary patient outcomes include inhospital death; a new vascular event; disability; and all-cause death at 3, 6, and 12 months after initial symptom onset. All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations. If proven effective, this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China.

Effect of a school-based nutrition education program on adolescents' nutrition-related knowledge, attitudes and behaviour in rural areas of China.

This study aimed at examining the effect of the nutrition education program on adolescents' knowledge, attitudes and behaviour in relation to nutrition in rural China. A cluster-randomised intervention trial design was employed. Two middle schools were randomly selected and assigned to the school conducting nutrition education (NE school), or to the Control school, in Mi Yun County, Beijing. From each school 65 seventh-grade students were randomly selected to participate in the study. Nutrition-related knowledge, attitudes and behaviour were measured at pre- and post-intervention surveys with the same instrument. The nutrition education lasted for 6 months. After the intervention, more students in NE school knew the main function of dairy products and vegetables, which micronutrient is rich in dairy products and beans, and in meat, and the symptom of food poisoning, than those in Control school. The rate of students who thought nutrition is very important to health, and foods with an expired date should be thrown away in NE school was higher than that in Control school (93.8 vs. 80.3 and 92.3 vs. 78.7%, respectively). The rate of students who ate vegetables and breakfast everyday in NE school was higher than that in Control school (96.9 vs. 80.3, and 89.2 vs. 75.4%, respectively). (p < 0.05). This nutrition education programme is effective in improving adolescents' knowledge, attitudes, and behaviour in relation to nutrition; therefore, the nutrition education with interactive and innovative intervention components is strongly recommended for future nutrition promotion programmes for adolescents.

Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control

BackgroundFour million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves).ObjectiveThe trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program.MethodsUltrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed.ResultsPublication of trial results is anticipated in late 2016.ConclusionsUse of ultrasound should be strongly considered in field-based trials involving pregnant women to accurately establish gestational age, as menstrual dates may be incorrect or unknown. The inclusion of ultrasound in areas where ultrasound capacity does not previously exist requires a significant investment of time and resources. Such investment ensures appropriate training, high quality images, and accurate dating pregnancies. We outline our ultrasound training, image acquisition, quality control, and dating protocols in detail.Trial RegistrationClinicaltrials.gov NCT01335490; http://clinicaltrials.gov/ct2/show/NCT01335490 (Archived by WebCite at http://www.webcitation.org/6UbERJNO6).

Association Between Anthropometry and High Blood Pressure in a Representative Sample of Preschoolers in Madrid

Introduction and objectivesProgram SI! is a multi-level, school-based intervention for the promotion of cardiovascular health from early childhood. The aim of this paper is to characterize the prevalence of obesity and high blood pressure in the preschoolers enrolled in the study, and to compare various criteria for classifying obesity. MethodsThe study was a cluster-randomized controlled intervention trial including 24 state schools in Madrid (Spain). Weight, height, triceps and subscapular skinfold thicknesses, waist circumference, and systolic and diastolic blood pressure were measured in 2011 children (1009 boys and 1002 girls) aged 3 to 5 years (3.7 [0.9]). Body mass index and blood pressure were classified by corresponding task force criteria. Obesity was studied by 6 different criteria. Associations of body mass index, body weight, body fat, and waist circumference on blood pressure were examined, and the risk of high blood pressure in relation to tertiles of body mass index was calculated. ResultsThe prevalence of obesity according to the International Obesity Task Force varied from 2% at age 3 to 8% at age 5, and the overall prevalence of high blood pressure (≥ 90th percentile) was 20%. Sex- and age-specific criteria for obesity showed better agreement with the reference than a single generalized cutoff. The risk of high blood pressure was higher for the highest tertile of body mass index distribution. ConclusionsThe highest prevalence of obesity and high blood pressure was found among older children. The classification of obesity in children was more accurate using sex- and age-specific cutoffs.

Asociación entre antropometría y presión arterial alta en una muestra representativa de preescolares de Madrid

Introduction and objectivesProgram SI! is a multi-level, school-based intervention for the promotion of cardiovascular health from early childhood. The aim of this paper is to characterize the prevalence of obesity and high blood pressure in the preschoolers enrolled in the study, and to compare various criteria for classifying obesity. MethodsThe study was a cluster-randomized controlled intervention trial including 24 state schools in Madrid (Spain). Weight, height, triceps and subscapular skinfold thicknesses, waist circumference, and systolic and diastolic blood pressure were measured in 2011 children (1009 boys and 1002 girls) aged 3 to 5 years (3.7 [0.9]). Body mass index and blood pressure were classified by corresponding task force criteria. Obesity was studied by 6 different criteria. Associations of body mass index, body weight, body fat, and waist circumference on blood pressure were examined, and the risk of high blood pressure in relation to tertiles of body mass index was calculated. ResultsThe prevalence of obesity according to the International Obesity Task Force varied from 2% at age 3 to 8% at age 5, and the overall prevalence of high blood pressure (≥ 90th percentile) was 20%. Sex- and age-specific criteria for obesity showed better agreement with the reference than a single generalized cutoff. The risk of high blood pressure was higher for the highest tertile of body mass index distribution. ConclusionsThe highest prevalence of obesity and high blood pressure was found among older children. The classification of obesity in children was more accurate using sex- and age-specific cutoffs.Full English text available from: www.revespcardiol.org/en

Early infant feeding practices in three African countries: the PROMISE-EBF trial promoting exclusive breastfeeding by peer counsellors.

BackgroundImmediate and exclusive initiation of breastfeeding after delivery has been associated with better neonatal survival and child health and are recommended by the WHO. We report its impact on early infant feeding practices from the PROMISE-EBF trial.MethodsPROMISE-EBF was a cluster randomised behaviour change intervention trial of exclusive breastfeeding (EBF) promotion by peer counsellors in Burkina Faso, Uganda and South Africa implemented during 2006-2008 among 2579 mother-infant pairs. Counselling started in the last pregnancy trimester and mothers were offered at least five postnatal visits. Early infant feeding practices: use of prelacteal feeds (any foods or drinks other than breast milk given within the first 3 days), expressing and discarding colostrum, and timing of initiation of breastfeeding are presented by trial arm in each country. Prevalence ratios (PR) with 95% confidence intervals (95%CI) are given.ResultsThe proportion of women who gave prelacteal feeds in the intervention and control arms were, respectively: 11% and 36%, PR 0.3 (95% CI 0.2, 0.6) in Burkina Faso, 13% and 44%, PR 0.3 (95% CI 0.2, 0.5) in Uganda and 30% and 33%, PR 0.9 (95% CI 0.6, 1.3) in South Africa. While the majority gave colostrum, the proportion of those who expressed and discarded it in the intervention and control arms were: 8% and 12%, PR 0.7 (95% CI 0.3, 1.6) in Burkina Faso, 3% and 10%, PR 0.3 (95% CI 0.1, 0.6) in Uganda and 17% and 16%, PR 1.1 (95% CI 0.6, 2.1) in South Africa. Only a minority in Burkina Faso (<4%) and roughly half in South Africa initiated breastfeeding within the first hour with no large or statistically significant differences between the trial arms, whilst in Uganda the proportion of early initiation of breastfeeding in the intervention and control arms were: 55% and 41%, PR 0.8 (95% CI 0.7, 0.9).ConclusionsThe PROMISE-EBF trial showed that the intervention led to less prelacteal feeding in Burkina Faso and Uganda. More children received colostrum and started breastfeeding early in the intervention arm in Uganda. Late breastfeeding initiation continues to be a challenge. No clear behaviour change was seen in South Africa.Trial registrationNCT00397150.Electronic supplementary materialThe online version of this article (doi:10.1186/1746-4358-9-19) contains supplementary material, which is available to authorized users.

Effects of social activation and physical mobilization on sleep in nursing home residents

Age-related changes in sleep physiology, frequent occurrence of health impairments, and a sedentary lifestyle make nursing home residents particularly vulnerable to sleep disturbances. Despite the high prevalence of sleep disturbances in nursing homes, there is a lack of research concerning the use of non-pharmacological approaches for improving residents' sleep. This study aimed to promote residents' sleep by improving their social activation and physical mobilization. An experimental group of residents attending an activation program four times a week during an eight-week study course was compared to a non-treated control group in a cluster-randomized intervention trial among 85 residents of 20 nursing homes. Sleep was assessed by the Insomnia Severity Index (ISI), nurses' ratings of residents' sleep disturbances and actigraphy-based sleep parameters. Although no changes in actigraphy-based sleep parameters were observed, the subjective sleep quality ratings of the intervention participants significantly improved compared to the control group members (p = 0.004). This study suggests that physical mobilization and social activation may improve residents' subjective sleep quality. Further efforts to improve residents' sleep by increasing their physical and social activity should consider existing obstacles to encourage participation and adherence to the program.