Cluster Randomized Community Trial Research Articles

The Effect of Iron-Fortified Lentils on Blood and Cognitive Status among Adolescent Girls in Bangladesh

Background: Iron deficiency is highly prevalent in South Asia, especially among women and children in Bangladesh. Declines in cognitive performance are among the many functional consequences of iron deficiency. Objective: We tested the hypothesis that, over the course of a 4-month iron fortification trial, cognitive performance would improve, and that improvement would be related to improvements in iron status. Methods: Participants included 359 adolescent girls attending Bangladesh Rural Advancement Committee (BRAC) clubs as a subsample of a larger double-blind, cluster-randomized community trial in which participants were assigned to one of three conditions: a condition in which no lentils were supplied (NL, n = 118, but which had the usual intake of lentils), a control (non-fortified) lentil condition (CL, n = 124), and an iron-fortified lentil condition (FL, n = 117). In the FL and CL conditions, approximately 200 g of cooked lentils were served five days per week for a total of 85 feeding days. In addition to biomarkers of iron status, five cognitive tasks were measured at baseline (BL) and endline (EL): simple reaction time task (SRT), go/no-go task (GNG), attentional network task (ANT), the Sternberg memory search Task (SMS), and a cued recognition task (CRT). Results: Cognitive performance at EL was significantly better for those in the FL relative to the CL and NL conditions, with this being true for at least one variable in each task, except for the GNG. In addition, there were consistent improvements in cognitive performance for those participants whose iron status improved. Although there were overall declines in iron status from BL to EL, the declines were smallest for those in the FL condition, and iron status was significantly better for those in FL condition at EL, relative to those in the CL and NL conditions. Conclusions: the provision of iron-fortified lentils provided a protective effect on iron status in the context of declines in iron status and supported higher levels of cognitive performance for adolescent girls at-risk of developing iron deficiency.

Effect of household couple counselling for male involvement on the utilization of postnatal services at 1 week in Ibanda district, Uganda; A cluster randomized community trial

Introduction: Prompt and Skilled postnatal care attendance coupled with skilled Antenatal and delivery care can drastically reduce maternal morbidity and mortality and also improve newborn outcomes. Research shows that men are decision makers in the home but they may also restrict resources, hence preventing women and children from health care seeking. But however if involved men may lead to better health care seeking behavior and better utilization of Antenatal care, delivery and postnatal care services. The postnatal care attendance at 1 week is low in Uganda, Ibanda district reported 4% in 2018. The aim of this study was to innovate, implement and document an intervention of house hold couple counseling for male involvement and compare the intervention and control clusters on the utilization of postnatal care services at 1 week. Methods: This was a two arm cluster randomized Community trial with a parallel design with the aim of comparing utilization of postnatal care services. It was carried out in two intervention parishes and two control parishes and was a superiority trial to test if the intervention of household couple counseling would improve utilization of postnatal care services. Results: The intervention arm had 200 respondents while the control had 213. The mean age was 27.3years (SD 6.8). Ninety one point five percent of mother had used skilled delivery services in the intervention compared to 78.4% in the control. Seventy Five percent attended postnatal care at 1week in the intervention as compared to 21.1% in the control (OR 11.2, P<0.001). The activity that are statistically significantly associated with utilization of postnatal services utilization is providing transport to the postnatal clinic (AOR 30.8, P<0.001) comparing the intervention and control clusters. The others included; accompanying to antenatal clinic, partner attending antenatal clinic, providing transport for delivery, escorting partner for delivery, providing psychological support during delivery and providing necessary drugs during delivery and PNC period but these were not statistically significant. Conclusion: The study demonstrated that the intervention of household couple counseling for increased male partner involvement improved significantly utilization of postnatal care services. Interventions to improve utilization of postnatal care services should focus on involving male partners to do the supportive activities which help their partners utilize the health care services.

Iodine Concentration Effects on Linear Growth of Children after Nutrition Behavior intervention, Central Highland of Ethiopia: A Cluster Randomized Community Trial

Background: To improve the iodine status and growth of children was not documented in Ethiopia. This study aimed to determine the effects of nutrition behavior communication change (BCC) on improving iodine status and growth of children 6 to 59 months.
 Methods: A community cluster randomized trial with a single treatment arm was conducted from February 2018 to April 2020. “Kebeles” [lower administrative units] were randomly assigned to either the intervention or the control cluster. Mothers and their paired children were randomly selected from kebeles. Anthropometry data and urine samples were collected at baseline and end-line surveys. Percentile rank and Independent t-test were used to determine the difference between arms. Finally, Generalized Estimating Equation (GEE) is used to isolate independent predictors.
 Results: At baseline, 97.83 % (n = 812) mothers/ caregivers and paired children were enrolled for the trial study, but at the end-line, 88.05% (n =715) of children completed the intervention. Iodine deficiency prevalence was higher (11.82%, n = 96) at baseline and reduced to 6.15 % (n =44) at the end-line. The growth defect among children was 41 %( n = 332) at the baseline and declined to 28.67 %( n=205) at the end-line, while among interventions reduced by more than two times (39% to 12.81%). At the baseline, the median UIC among the intervention group was 106.0µg/L and increased to 207.190µg/L. The prevalence of iodine deficiency among intervention was 14.29% (n = 58) at the baseline and lowered to 3.45% (n=14) at the end-line, but a slight increment observed among control from 9.36% to 9.71% at end-line. The end-line median UIC was very high (210.56µg/L ± 150 compared to the baseline median UIC (107µg/L ± 8.66). Most (43.6%) of the intervention group found in the 4th and 5th percentile ranks factions of UIC by Height (Ht) mean differences. Being an intervention group increased Ht by 10.85cm (β =10.85, Std. E = 0.33). Likewise, for 1µg/l UIC change a 1cm (β = 1.0, p = <0.05) Ht change predicted at the end-line.
 Conclusions: Findings from this trial enhance nutrition behavior communication to improve the iodine status and growth of young children in the community. Longitudinal studies are needed to determine the level of iodine deficiency disorders in the community.

Small-quantity lipid-based nutrient supplements, with or without added zinc, do not cause excessive fat deposition in Burkinabe children: results from a cluster-randomized community trial

PurposePublic health interventions to address stunting and wasting should be evaluated for possibly contributing to obesity risk. The present study tested the hypothesis that small-quantity lipid-based nutrient supplements (SQ-LNS) might increase fat deposition, and that additional zinc provided via SQ-LNS or in the form of dispersible tablets would increase fat-free mass (FFM) accretion.MethodsUsing a two-stage, cluster-randomized trial design, 34 communities were randomly assigned to the intervention cohort (IC) or non-intervention cohort (NIC), and family compounds within the IC were randomly assigned to receive different amounts of zinc (0, 5 or 10 mg zinc) incorporated in SQ-LNS or 5 mg zinc in the form of dispersible tablets along with treatment for diarrhea, malaria and fever. Body composition was assessed in a subset of IC (n = 201) and NIC (n = 74) children at 9 and 18 months using the deuterium dilution method. A mixed linear model was used to examine average change in FFM and % fat mass (%FM) among intervention groups and by cohort.ResultsChildren in the IC had significantly greater change in FFM (Mean (95% Confidence Interval)) (1.57 (1.49, 1.64) kg) compared to the NIC (1.35 (1.23, 1.46) kg; p = 0.005). There were no significant differences in the change in %FM between the NIC and IC or among the intervention groups.ConclusionSQ-LNS, along with morbidity treatment increased weight gain and FFM in young children from 9 to 18 months of age without increasing FM deposition. Additional zinc supplementation did not affect changes in FFM or %FM.Trial registrationThe study was registered as a clinical trial with the US National Institute of Health (www.ClinicalTrials.gov; NCT00944281).

Safety of mass drug coadministration with ivermectin, diethylcarbamazine, albendazole, and azithromycin for the integrated treatment of neglected tropical diseases: a cluster randomized community trial

Neglected tropical diseases control programmes run separately. For settings with more than one endemic disease, combined mass drug administration (MDA) has potential practical advantages compared with separate programmes but needs confirmation of safety. We assessed the safety of combined MDA for multiple neglected tropical diseases using ivermectin, diethylcarbamazine, albendazole (IDA) and azithromycin (AZI). We conducted an open-label, cluster-randomized trial involving individuals living in 34 wards (smaller administrative division) in two study sites, Namatanai District and Lihir Island, Papua New Guinea. We randomly assigned wards to the combined treatment arm (which received a single dose of the triple combination IDA and a single dose of AZI at the same visit) or the control arm (which received IDA separately followed by AZI separately one week after). All participants underwent safety assessments one day after drug administration. Methodology for collecting the adverse events (AEs) was a general question (in Namatanai) and individual questions about specific AEs (in Lihir). The primary endpoint was the prevalence of AEs. Safety of combined treatment was taken to be non-inferior to that of IDA if the upper limit of the two-sided CI for the difference in rates was equal or lower than 5%. The study enrolled 15,656 participants. Of those enrolled, 7,281 (46.3%) received the combined regimen and 8,375 (53.3%) received standard treatment with IDA for lymphatic filariasis between Nov 1, 2018, and Apr 15, 2019. Of the individuals in the control group, 4,228 (50.5%) attended a second visit one week apart to receive AZI for yaws. In Namatanai, the proportion of AEs was similar in the combined group (0.8%) compared to the IDA group (1.3%, difference 0.5% [95CI -2.5% to 1.4%]) or the AZI group (3.6%, d -2.8% [95CI -8.6% to 2.8%]). In Lihir, the proportion of AEs was higher in the combined group (23.0%) compared to the IDA group (12.2%, d 10.8% [95% CI 1.5% to 20.2%]) or the AZI group (11.1%, d 11.9% [95% CI 2.7% to 21.1%]).We observed 21 (0.3%) grade-2 AEs in the combined treatment group, 33 (0.4%) in the IDA separately group, and 18 (0.2%) in the AZI separately group. No participants required treatment for any AE. We observed no deaths, serious AEs, or AEs of special interest. In the largest trial so far involving coadministration of regimens based on IDA and AZI, the combination was safe and feasible in a population of more than 15,000 people. Combined MDA based on these two regimens opens up new potential for the control of neglected tropical diseases in the Western Pacific region.

Effectiveness of mobile short message service intervention to increase parental socio-demographic knowledge of drowning prevention in Bangladesh

Background: Drowning is the third leading cause of death for children aged 0–4 years in many Asian countries, and is a serious but neglected health problem in low and middle-income countries (LMICs) like Bangladesh. In Bangladesh, drowning rates are 10 to 20 times more than those in other developed countries. The aim of this study is the efficiency of mobile SMS intervention for increasing parental socio-demographic knowledge of drowning prevention in Bangladesh.Methods: A cluster randomized community trial with 788 parents of children aged under five in a rural community of Bangladesh. The intervention was the mobile short message service (SMS) for parents of children under five years concerning the prevention of drowning. The main outcome of this study was the differences in knowledge of parents with socio-demographic factors concerning the prevention of drowning between the baseline and immediate follow-up after the intervention, and after three months.Results: There was a significant improvement in knowledge in the intervention group compared to the control group at different time points. There is a significant association with parental age, education, gender, and income and to improve childhood drowning prevention knowledge of parents to compare control group of parents.Conclusions: Special programmes and training could be increase knowledge about childhood drowning prevention in Bangladesh and should be broadcast on the radio and television networks.

Eye Care Utilization in A Community-oriented Mobile Screening Programme for Improving Eye Health in Iran: A Cluster Randomized Trial

ABSTRACT Purpose To evaluate the effect of a mobile-based screening programme on eye care utilization in Iran. Method In this cluster randomized community trial, a representative sample of residents aged≥50 years from urban and rural areas in four districts in Tehran province were enrolled. The clusters were randomly assigned to one of the three parallel arms; the mHealth arm with digital data collection, vision screening test and retina evaluation using an integrated mobile application, the conventional arm with manual data collection and screening tests using Snellen chart and Fundus photography at the local primary healthcare facility, and the control arm with manual data collection without screening tests. The main outcome measure was eye care utilization which was defined as at least one visit to an optometrist or ophthalmologist. Results Of 3312 eligible individuals, 2520 (76.1%) participated. In the first 3 months after the screening programme, eye care utilization was higher among those who were referred by the mHealth method (35.6% 95%CI: 31.1–40.4%) compared to those referred by the conventional method (32.7%, 95%CI: 27.5–38.2%) and to those observed in the control arm (4.5%, 95%CI: 3.2–6.0). Eye care utilization improved (OR = 1.5, 95%CI: 1.2–1.9) among the referred people after the screening programme compared to the utilization before this programme; however, this improvement was significantly higher in the mHealth method (OR: 1.7, 95%CI: 1.2–2.4) compared to the conventional method (OR: 1.2, 95%CI: 0.8–1.8). Conclusion and relevance The mobile-based screening programme can significantly improve eye care utilization at the community level.

Integrated and simplified approaches to community management of acute malnutrition in rural Kenya: a cluster randomized trial protocol

BackgroundIn many low income countries, the majority of acutely malnourished children are either brought to the health facility late or never at all due to reasons related to distance and associated costs. Integrated community case management (iCCM) is an integrated approach addressing disease and malnutrition through use of community health volunteers (CHVs) in children under-5 years. Evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. In this study, we aim to investigate the effectiveness and cost effectiveness of integrating management of acute malnutrition into iCCM.MethodsThis is a two arm parallel groups, non-inferiority cluster randomized community trial (CRT) employing mixed methods approach (both qualitative and quantitative approaches). Baseline and end line data will be collected from eligible (malnourished) mother/caregiver-child dyads. Ten community units (CUs) with a cluster size of 24 study subjects will be randomized to either an intervention (5 CUs) and a control arm (5 CUs). CHV in the control arm, will only screening and refer MAM/SAM cases to the nearby health facility for treatment by healthcare professionals. In the intervention arm, however; CHVs will be trained both to screen/diagnose and also treat moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication. A paired-matching design where each control group will be matched with intervention group with similar characteristics will be matched to ensure balance between the two groups with respect to baseline characteristics. Qualitative data will be collected using key informant and in-depth interviews (KIIs) and focused group discussions (FGDs) to capture the views and experiences of stakeholders.DiscussionOur proposed intervention is based on an innovative approach of integrating and simplifying SAM and MAM management through CHWs bring the services closer to the community. The trial has received ethical approval from the Ethics Committee of AMREF Health Africa - Ethical and Scientific Review Committee (AMREF- ESRC), Nairobi, Kenya. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, and presented to local and international conferences.Trial registrationPACTR201811870943127; Pre-results. 26 November 2018.

Is deployment of trained nurses to rural villages a remedy for the low skilled birth attendance in Ethiopia? A cluster randomized-controlled community trial

BackgroundLow coverage of Skilled Birth Attendance (SBA) is one of the major drivers of maternal mortality in many low- and middle-income countries (LMICs) including Ethiopia. We conducted a cluster-randomized controlled community trial to assess the effect of deploying trained community based nurses to rural communities on the uptake levels of SBA in Ethiopia.MethodsA three-arm, parallel groups, cluster-randomized community trial was conducted to assess the effect of deploying trained community based reproductive health nurses (CORN) on the uptake of SBA services. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where these new service providers were deployed, a health post (HP) or health center (HC). Baseline and end line surveys were conducted to document and measure the effects of the intervention. Program impacts on SBA coverage were calculated using difference‐in‐difference (DID) analysis.ResultsAfter nine months of intervention, the coverage of SBA services increased significantly by 81.1% (from 24.61 to 44.59) in the HP based intervention arm, and by 122.9% (from 16.41 to 36.59) in the HC arm, respectively (p <0.01). Conversely, a small and non-significant (2%) decline in SBA coverage were observed in the control arm (P >0.05). The DID estimate indicated a net increase in SBA coverage of 21.32 and 20.52 percentage points (PP) across the HP and HC based intervention arms, respectively (p < 0.001).ConclusionsDeployment of trained reproductive health nurses to rural communities in Ethiopia significantly improved utilization of SBA services. Therefore; in similar low income settings where coverage of SBA services is very low, deployment of trained community based nurses to grassroots level could potentiate rapid service uptake. Additional cost-effectiveness and validation studies at various setups are required, before scale-up of the innovation, however.Trial registrationclinicaltrails.gov NCT02501252.

Integrating use of point-of-care circulating cathodic antigen rapid diagnostic tests by community health workers during mass drug administration campaigns to improve uptake of praziquantel treatment among the adult population at Kome Island, North-Western Tanzania: a cluster randomized community trial

BackgroundThe major drawback of the community-based mass drug administration (MDA) approach against schistosomiasis is that treatment is offered blindly without testing for the targeted infection. This partly contributes to the low treatment coverage. One approach to overcome this limitation is to introduce a diagnostic component in the treatment approach. This will improve drug uptake and compliance to treatment. This study is conducted to assess the feasibility and acceptability of integrating point-of-care Circulating Cathodic Antigen (POC-CCA) test to community-based directed MDA in improving treatment coverage and compliance with treatment among adults.MethodsThis is a randomized control community trial in which 30 clusters were randomly assigned to either an intervention or control arm to evaluate two interventions on treatment coverage and compliance with treatment. In each cluster, 150 adult participants were enrolled. Community Health Workers (CHW) in both arms were trained on all aspects of praziquantel (PZQ) distribution and management of mild side effects. In the intervention arm, CHWs had additional training on how to use POC-CCA to diagnose intestinal schistosomiasis. In the intervention arm, participants were tested using POC-CCA test for presence of intestinal schistosomiasis and treated based on test results, while in the control arm, participants were treated with PZQ without testing. The primary outcome measure was the proportion of participants provided with PZQ between the two arms and geographical clusters. Secondary outcomes were prevalence of S. mansoni infection based on the POC-CCA test conducted by CHWs, ability of CHWs to use the POC-CCA test accurately and safely and community acceptability of the POC-CCA test results from CHWs. Both quantitative and qualitative techniques have been used to collect data at study endpoint.DiscussionThe study will generate evidence on the importance of integrating a diagnostic component into the community directed MDA conducted by CHWs. Findings will generate discussion on the current MDA policy and practice in Tanzania.Trial registrationPACTR201804003343404 (25/4/2018).

Diagnosing Cervical Neoplasia in Rural Brazil Using a Mobile Van Equipped with In Vivo Microscopy: A Cluster-Randomized Community Trial.

Cervical cancer is a leading cause of death in underserved areas of Brazil. This prospective randomized trial involved 200 women in southern/central Brazil with abnormal Papanicolaou tests. Participants were randomized by geographic cluster and referred for diagnostic evaluation either at a mobile van upon its scheduled visit to their local community, or at a central hospital. Participants in both arms underwent colposcopy, in vivo microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of in vivo microscopy compared with colposcopy. There was a 23% absolute and 37% relative increase in diagnostic follow-up completion rates for patients referred to the mobile van (102/117, 87%) compared with the central hospital (53/83, 64%; P = 0.0001; risk ratio = 1.37, 95% CI, 1.14-1.63). In 229 cervical sites in 144 patients, colposcopic examination identified sites diagnosed as cervical intraepithelial neoplasia grade 2 or more severe (CIN2+; 85 sites) with a sensitivity of 94% (95% CI, 87%-98%) and specificity of 50% (95% CI, 42%-58%). In vivo microscopy with real-time automated image analysis identified CIN2+ with a sensitivity of 92% (95% CI, 84%-97%) and specificity of 48% (95% CI, 40%-56%). Women referred to the mobile van were more likely to complete their diagnostic follow-up compared with those referred to a central hospital, without compromise in clinical care. In vivo microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy. Cancer Prev Res; 11(6); 359-70. ©2018 AACR.

Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long‐Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial

To investigate the effect of innovative means to distribute LARC on contraceptive use, we implemented a three arm, parallel groups, cluster randomized community trial design. The intervention consisted of placing trained community-based reproductive health nurses (CORN) within health centers or health posts. The nurses provided counseling to encourage women to use LARC and distributed all contraceptive methods. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where the new service providers were deployed, health post or health center. We calculated difference-in-difference (DID) estimates to assess program impacts on LARC use. After nine months of intervention, the use of LARC methods increased significantly by 72.3 percent, while the use of short acting methods declined by 19.6 percent. The proportion of women using LARC methods increased by 45.9 percent and 45.7 percent in the health post and health center based intervention arms, respectively. Compared to the control group, the DID estimates indicate that the use of LARC methods increased by 11.3 and 12.3 percentage points in the health post and health center based intervention arms. Given the low use of LARC methods in similar settings, deployment of contextually trained nurses at the grassroots level could substantially increase utilization of these methods.

Effectiveness of a cluster-randomized controlled trial community-based lifestyle intervention program to control prehypertension and/or prediabetes in Thailand

Lifestyle intervention is recommended as the primary management for prehypertension and prediabetes. The aim of the study was to examine the effect of a community-based lifestyle intervention on glucose and blood pressure levels in Nakhon Pathom Province, Thailand. We conducted a cluster-randomized community trial in 12 Buddhist temples, enrolling 443 members, aged 35–65 years, with prediabetes and/or prehypertension. The temple (and their members) was randomized to six 2-h group session of lifestyle intervention (physical activity and nutrition) over 6 months guided by the Health Action Process Approach model or receiving a healthy lifestyle pamphlet. Physical outcomes (glucose, blood pressure, lipid profiles, and anthropometric measures) were assessed at 6 and/or 12 months following baseline assessments. The effects of the lifestyle intervention were assessed with generalized linear mixed models. The study recruited 443 participants in 12 temples (220 in the intervention and 223 in the control group), and 89% completed the 12-month evaluation. At 12-month follow-up, mixed modeling found significant interaction effects on fasting plasma glucose (p = 0.017) and diastolic blood pressure (p = 0.002). Improvements were found for systolic blood pressure, but no significant interaction effect was detected. In conclusion, the lifestyle intervention was only partially effective. More research is needed to investigate lifestyle interventions in this community-based setting. Trial registration number: TCTR20170721001

School-Based Nutrition Education Intervention Using Social Cognitive Theory for Overweight and Obese Iranian Adolescent Girls: A Cluster Randomized Controlled Trial.

Background Nowadays childhood obesity has become one the most challenging issue which is considered as a principle public health problem all around the world. This study was conducted with the aim of evaluating the impact of a 7-month school-based nutrition education intervention using social cognitive theory (SCT) to prevent obesity among overweight and obese adolescent girls. Method In this cluster randomized community trial after choosing schools, a total of 172 overweight and obese girl students participated in the study (87 in the intervention and 85 in the control group). A 7-month intervention based on SCT for students, their parents, and teachers was conducted. At baseline and end of the study, body mass index (BMI), waist circumstances (WCs), dietary intake, and psychological questionnaires regarding the SCT constructs were obtained. Results After 7 months, the mean of BMI and WCs reduced in the intervention group from 29.47 (4.05) to 28.5 (4.35) and from 89.65 (8.15) to 86.54 (9.76), respectively, but in comparison to the control group, they were not statistically significant ( p values .127 and .504, respectively). In the intervention group, nutritional behaviors and most of the psychological variables (self-efficacy, social support, intention, and situation) were improved in favor of the study and they were significant in comparison to the control group ( p < .05). Conclusion Although school-based nutrition education intervention using SCT did not change significantly BMI and WCs among the targeted population in this study, dietary habits as well as psychological factors improved significantly in the intervention group. This trial was registered in Iranian Registry of Clinical Trials, www.irct.ir (IRCT2013103115211N1).

Percent weight reduction required to achieve minimal clinically important improvements in health-related quality of life among African Americans: A secondary analysis of the fit body and soul study

ObjectiveTo calculate the percent weight reduction required to achieve minimal clinically important improvement (MCII) in health-related quality of life (HRQOL). DesignSecondary data analysis from the longitudinal cohort of a single-blinded, cluster-randomized community trial to test the efficacy of the faith-based adaptation of the Diabetes Prevention Program. SettingAfrican-American churches. ParticipantsThis study included 472 congregants with a body mass index of ≥25 and fasting plasma glucose<126mg/dl. Main outcome measurePercent weight reduction required to achieve the MCII in HRQOL measured by two instruments, SF-12 and EQ-5D, one year following baseline. AnalysisThe percent weight reduction required to achieve established MCII in SF-12 Physical Component Summary (PCS), SF-12 Mental Component Summary (MCS), and EQ-5D Health Status (HS) at one-year follow-up were calculated using fitted linear regression models. In addition to models for the total sample, we generated models, stratified by baseline BMI, PCS, and HS, to calculate the percent weight reduction required to achieve MCII in HRQOL for those most in need of weight reduction and those in need of improved HRQOL. ResultsThe percent weight reduction was a significant predictor of improvement in the SF-12PCS and the EQ-5DHS but not SF-12MCS. To achieve a MCII in SF-12PCS and EQ-5DHS, 18% and 30% weight reductions were required, respectively. A smaller percent weight reduction was required when the baseline BMI was ≥40. Conclusions and implicationsImprovements in HRQOL among African-American congregants seeking weight reduction required more than the 3–5% weight reduction associated with improvements in physical health.

Efecto de una intervención basada en guarderías para reducir conductas de riesgo de obesidad en niños preescolares

BackgroundPreschool age is a critical stage for health promotion and prevention of obesity, which is an emerging public health problem in children. The aim of this study was to design and evaluate the effect of a multifaceted intervention based on child-care centers to reduce risk behaviors for obesity among preschool children. MethodsA 12-month cluster-randomized community trial was conducted in 16 Mexican Institute of Social Security child-care centers in Mexico City. Children between 2 and 4 years of age enrolled in the selected child-care centers participated in the study. Intervention comprised 12 weekly curriculum sessions for the children, and six family workshops. Changes in children's dietary and physical activity, food availability at home, and maternal feeding styles were determined after 6 and 12 months. Changes within groups among stages, and between groups by stage were analyzed through χ2 test. ResultsThe intervention showed decrease of home availability for some non-recommended foods and increase in physical activity in the intervention group compared to the usual care group. ConclusionsImprovement in physical activity can be effective in the long term; innovative strategies aimed to modify family dietary risk behaviors are required.

Effect of an intervention based on child-care centers to reduce risk behaviors for obesity in preschool children

Abstract Background Preschool age is a critical stage for health promotion and prevention of obesity, which is an emerging public health problem in children. The aim of this study was to design and evaluate the effect of a multifaceted intervention based on child-care centers to reduce risk behaviors for obesity among preschool children. Methods A 12-month cluster-randomized community trial was conducted in 16 Mexican Institute of Social Security child-care centers in Mexico City. Children between 2 and 4 years of age enrolled in the selected child-care centers participated in the study. Intervention comprised 12 weekly curriculum sessions for the children, and six family workshops. Changes in children’s dietary and physical activity, food availability at home, and maternal feeding styles were determined after 6 and 12 months. Changes within groups among stages, and between groups by stage were analyzed through X2 test. Results The intervention showed a decrease of home availability for some non-recommended foods and an increase in physical activity in the intervention group compared to the control group. Conclusions Improvement in physical activity can be effective in the long term; innovative strategies aimed to modify family dietary risk behaviors are required.

Randomized controlled trial on drowning prevention for parents with children aged below five years in Bangladesh: a study protocol.

BackgroundDrowning is the third leading cause of death for children aged 0–4 years in many Asian countries, and is a serious but neglected health problem in low and middle-income countries like Bangladesh. The aim of the study is to outline the study protocol of a trial to test the efficacy of a mobile coach based intervention for the prevention of childhood drowning.Method/designA two-arm cluster randomized community trial will be conducted to test the efficacy of the mobile coach intervention for childhood drowning on parents with children below five years of age and compared to an assessment only control group. A total of 1680 parents in the villages with children aged below five years of age will participate. The village will be used as a randomized unit, randomly assigned to an intervention group (N = 840) receiving the mobile coach based intervention or an assessment only control group (N = 840). An individualized mobile coach intervention based on the demographic data and the individual will be developed, and SMSs, audio messages, videos and images about childhood drowning will be sent to the participants of the intervention group over a period of six months. The participants will receive per week one text message (SMS) and image and one video and audio text per month. The primary outcome measure will be increased knowledge and safety awareness, and behaviour practice about childhood drowning assessed at the six-month follow-up, and the secondary outcome measure will be the reduced incidence of childhood drowning in Bangladesh. The study assistants conducting the baseline and the follow-up assessments will be blinded regarding the group assignment.DiscussionThis is the first study testing a fully mobile coach intervention for childhood drowning prevention in Bangladesh. It is hoped that the programme will offer an effective and inexpensive way to prevent childhood drowning among children aged below five years and also increase the awareness of parents concerning the risks to their children from drowning.Trial registrationISRCTN13774693, 08/03/2015.

Household Water Chlorination Reduces Incidence of Diarrhea among Under-Five Children in Rural Ethiopia: A Cluster Randomized Controlled Trial

BackgroundHousehold water treatment has been advocated as a means of decreasing the burden of diarrheal diseases among young children in areas where piped and treated water is not available. However, its effect size, the target population that benefit from the intervention, and its acceptability especially in rural population is yet to be determined. The objective of the study was to assess the effectiveness of household water chlorination in reducing incidence of diarrhea among children under-five years of age.MethodA cluster randomized community trial was conducted in 36 rural neighborhoods of Eastern Ethiopia. Households with at least one child under-five years of age were included in the study. The study compared diarrhea incidence among children who received sodium hypochlorite (liquid bleach) for household water treatment and children who did not receive the water treatment. Generalized Estimation Equation model was used to compute adjusted incidence rate ratio and the corresponding 95% confidence interval.ResultIn this study, the incidence of diarrhea was 4.5 episodes/100 person week observations in the intervention arm compared to 10.4 episodes/100 person week observations in the control arm. A statistically significant reduction in incidence of diarrhea was observed in the intervention group compared to the control (Adjusted IRR = 0.42, 95% CI 0.36–0.48).ConclusionExpanding access to household water chlorination can help to substantially reduce child morbidity and achieve millennium development goal until reliable access to safe water is achieved.Trial RegistrationClinicalTrials.gov NCT01376440

Dengue vector management using insecticide treated materials and targeted interventions on productive breeding-sites in Guatemala

BackgroundIn view of the epidemiological expansion of dengue worldwide and the availability of new tools and strategies particularly for controlling the primary dengue vector Aedes aegypti, an intervention study was set up to test the efficacy, cost and feasibility of a combined approach of insecticide treated materials (ITMs) alone and in combination with appropriate targeted interventions of the most productive vector breeding-sites.MethodsThe study was conducted as a cluster randomized community trial using “reduction of the vector population” as the main outcome variable. The trial had two arms: 10 intervention clusters (neighborhoods) and 10 control clusters in the town of Poptun Guatemala. Activities included entomological assessments (characteristics of breeding-sites, pupal productivity, Stegomyia indices) at baseline, 6 weeks after the first intervention (coverage of window and exterior doorways made of PermaNet 2.0 netting, factory treated with deltamethrin at 55 mg/m2, and of 200 L drums with similar treated material) and 6 weeks after the second intervention (combination of treated materials and other suitable interventions targeting productive breeding-sites i.e larviciding with Temephos, elimination etc.). The second intervention took place 17 months after the first intervention. The insecticide residual activity and the insecticidal content were also studied at different intervals. Additionally, information about demographic characteristics, cost of the intervention, coverage of houses protected and satisfaction in the population with the interventions was collected.ResultsAt baseline (during the dry season) a variety of productive container types for Aedes pupae were identified: various container types holding >20 L, 200 L drums, washbasins and buckets (producing 83.7% of all pupae). After covering 100% of windows and exterior doorways and a small number of drums (where the commercial cover could be fixed) in 970 study households, tropical rains occurred in the area and lead to an increase of the vector population, more pronounced (but statistically not significant) in the control arm than in the intervention arm. In the second intervention (17 months later and six weeks after implementing the second intervention) the combined approach of ITMs and a combination of appropriate interventions against productive containers (Temephos in >200 L water drums, elimination of small discarded tins and bottles) lead to significant differences on reductions of the total number of pupae (P = 0.04) and the House index (P = 0.01) between intervention and control clusters, and to borderline differences on reductions of the Pupae per Person and Breteau indices (P = 0.05). The insecticide residual activity on treated curtains was high until month 18 but the chemical concentration showed a high variability. The cost per house protected with treated curtains and drum covers and targeting productive breeding-sites of the dengue vector was $ 5.31 USD. The acceptance of the measure was generally high, particularly in families who had experienced dengue.ConclusionEven under difficult environmental conditions (open houses, tropical rainfall, challenging container types mainly in the peridomestic environment) the combination of insecticide treated curtains and to a less extent drum covers and interventions targeting the productive container types can reduce the dengue vector population significantly.