Impact of Protein Supplementation and Presumptive Treatment for Enteric Pathogens on Infant Growth from 6–12 Months of Age: Results of a Cluster-Randomized Controlled Trial

Abstract Objectives Intake of high-quality protein may be insufficient to support growth in the context of high enteric pathogen carriage and environmental enteric dysfunction. Our objective was to test whether supplemental protein, with or without presumptive treatment for enteric pathogens, would improve infant growth from 6–12 months of age. Methods We conducted a 2 × 4 factorial cluster-randomized trial in rural Bangladesh. The first factor was azithromycin treatment (10 mg/kg * 3 days) or placebo at 6 & 9 months of age. The second factor, delivered from 6–12 months of age, consisted of: supplemental protein as daily porridge (125 kcal/d, with 10 g protein/day as egg white powder) or a daily egg; an isocaloric daily porridge; or nutrition education alone. The present aim tested the impact of the protein-rich porridge, with or without azithromycin treatment. All infants born in the study area over a 9-mo period were eligible and consented at ∼3 mo of age. Trained field workers measured infant size at 6, 9, and 12 mo of age using standardized protocols. We used linear regression with generalized estimating equations to test the interventions’ impact on anthropometric indices, respectively, at 12 mo of age, controlling for baseline measures. Analysis was intention-to-treat. Results Overall, 2205 infants were enrolled from 282 clusters and exposed to both nutrition (1074 in protein arm from 140 clusters; 1074 in the isocaloric arm from 142 clusters) and presumptive treatment interventions. At baseline, 18.7%, 16.9%, and 6.4% of infants were stunted, underweight, and wasted, respectively. There was no statistical interaction between protein supplementation and azithromycin treatment for any of the anthropometric indices, so groups were combined. In the analysis of main effects, added protein had no impact on mean length-for-age (β = 0.01; 95% CI: −0.06, 0.08), weight-for-age (β = −0.002; 95% CI: −0.06, 0.05), or weight-for-length (β = −0.04; 95% CI: −0.12, 0.05) Z-scores at 12 mo of age. Conclusions Supplemental protein from 6–12 mo of age had no effect on mean linear or ponderal growth measured at 12 mo of age, irrespective of presumptive treatment for enteric pathogens with azithromycin. Funding Sources The Bill and Melinda Gates Foundation.

Download Full-text

Effects of Different Allotments of Avocados on the Nutritional Status of Families: A Cluster Randomized Controlled Trial

Nutrients ◽

10.3390/nu13114021 ◽

2021 ◽

Vol 13 (11) ◽

pp. 4021

Author(s):

Lorena S. Pacheco ◽

Ryan D. Bradley ◽

Julie O. Denenberg ◽

Cheryl A. M. Anderson ◽

Matthew A. Allison

Keyword(s):

Nutritional Status ◽

Nutrition Education ◽

Energy Intake ◽

Controlled Trial ◽

Plant Food ◽

Primary Analysis ◽

Intention To Treat ◽

Calcium Magnesium ◽

Cluster Randomized ◽

The Impact

Avocados are a nutrient-dense plant-food, but limited trial-derived evidence exists about the effects of avocado intake on family nutritional status. We investigated the impact of two levels of avocado allotment, plus a standard nutrition education intervention on the nutritional status of Hispanic/Latino families. Seventy-two families consisting of at least three members of ≥5 years of age and residing in the same home, free of severe chronic disease, not on specific diets, and self-identified of Hispanic heritage, were randomized to one of two levels of avocado allotment (low = 3/week/family or high = 14/week/family) for 6 months plus 12 bi-weekly nutrition education sessions. The primary outcomes included change in a family’s total energy and macro- and micronutrient intakes. Primary analysis was intention-to-treat with unpaired, two-sided t-tests to assess mean changes between groups at 6 months. At 6 months, the high avocado allotment group had a significant reduction in energy intake, carbohydrate, animal and vegetable protein, saturated and polyunsaturated fat, calcium, magnesium, sodium, potassium, iron, and vitamin D intakes (all p < 0.05). A high allotment of avocados significantly reduced self-reported energy intake by 29% kcal/family/day, compared to a 3% kcal/family/day reduction in families who received a low allotment. Culturally-appropriate plant-food interventions may alter the nutritional status of at-risk families.

Download Full-text

Protocol: Impact of nutrition education on nutrition capacity of caregivers and nutrition outcomes of indigenous Mbororo children in the West Region of Cameroon: cluster randomized controlled trial (Preprint)

10.2196/preprints.23115 ◽

2020 ◽

Author(s):

Florence Titu Manjong ◽

Vincent Siysi Verla ◽

Thomas Obinchemti Egbe ◽

Dickson Nsagha

Keyword(s):

Nutrition Education ◽

Health Workers ◽

Controlled Trial ◽

Child Growth ◽

Community Based ◽

Cluster Randomized ◽

And Control ◽

The Impact ◽

Knowledge Attitude And Practice ◽

Child Caregiver

BACKGROUND Inadequate diets and life-threatening infections have profound adverse implications for child growth, development and survival, particularly among indigenous peoples. Evidence of the effectiveness of community-based nutrition education interventions in improving child feeding and nutrition outcomes among indigenous Mbororo population in Cameroon is scare. OBJECTIVE This study aims at investigating the impact of culturally-tailored community-based nutrition education intervention (Nu-WASHE) on caregivers’ knowledge, attitude and practice regarding complementary feeding, and nutrition outcomes of indigenous Mbororo children (3-59 months) in the Foumban and Galim health districts of the West region of Cameroon. METHODS A two-arm cluster randomized controlled trial will be conducted in the Foumban Health District and Galim Health District. The intervention and control arms will each comprise of 5 clusters with 121 child-caregiver pairs. Participants in the intervention arm will be organized into 5 caregivers’ peer-support platforms. A total of 12 educational sessions will be delivered to the intervention group by trained female Mbororo nutrition volunteers (6), and community health workers (6). The control arm will receive routine facility-based nutrition education. Data will be collected at 3 months and 6 months follow-up. Both descriptive statistics and multivariate logistic models will be used to estimate the effect of Nu-WASHE (independent variable) on outcome variables (caregivers’ knowledge, attitude and practice); child growth (weight, height/length, weight-for-age); and morbidity status (diarrhea, cough and fever) between both arms. Data assessors will be blinded to the group allocation. An approval (ref: 2019/1002-07/UB/SG/IRB/FHS) was obtained from the Faculty of Health Sciences-Institutional Review Board of the University of Buea. RESULTS Baseline data was collected in September 2019. In February 2020, 10 Mbororo communities (clusters) with 242 child-caregiver pairs were selected and allocated to the experimental and control arm in a 1:1 ratio. Community nutrition volunteers (6) and community health workers (6) were selected and trained. Data collection and analysis are ongoing, and statistical results will be available by the end of December 2020. CONCLUSIONS The findings of this study will provide evidence on the impact of culturally-tailored and Health belief model-based nutrition education for behavior change as a complementary strategy for strengthening health facility-based approaches to the reduction of malnutrition burden among the study population. CLINICALTRIAL The protocol was submitted to the Wealth Health Organization Pan Africa Clinical Trial Registry in South Africa for review. Feedback is still being awaited. The last correspondence was on July 4, 2020.

Download Full-text

Impact of an Amaranth-Sorghum Grains Product on Nutrient Intake of Children Aged 6-23 Months in Kiandutu Slums, Thika, Kenya

10.37512/700 ◽

2020 ◽

Keyword(s):

Nutrition Education ◽

Nutrient Intake ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Composite Flour ◽

Monthly Basis ◽

Sorghum Flour ◽

Baseline Characteristics ◽

The Impact

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.

Download Full-text

Reduced exposure to malaria vectors following indoor residual spraying of pirimiphos-methyl in a high-burden district of rural Mozambique with high ownership of long-lasting insecticidal nets: entomological surveillance results from a cluster-randomized trial

Malaria Journal ◽

10.1186/s12936-021-03583-8 ◽

2021 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Joseph M. Wagman ◽

Kenyssony Varela ◽

Rose Zulliger ◽

Abuchahama Saifodine ◽

Rodaly Muthoni ◽

...

Keyword(s):

Controlled Trial ◽

Indoor Residual Spraying ◽

Malaria Vectors ◽

Light Traps ◽

High Burden ◽

Randomized Controlled ◽

Pirimiphos Methyl ◽

Cluster Randomized ◽

The Impact ◽

Long Lasting Insecticidal Nets

Abstract Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p < 0.001) in indoor light traps and by 74% (CI95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. < 0.001) and outdoors (68% reduction: CI95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.

Download Full-text

Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

Download Full-text

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Trials ◽

10.1186/s13063-021-05124-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Anca Vasiliu ◽

Sabrina Eymard-Duvernay ◽

Boris Tchounga ◽

Daniel Atwine ◽

Elisabete de Carvalho ◽

...

Keyword(s):

Controlled Trial ◽

Standard Of Care ◽

Preventive Therapy ◽

Community Based ◽

Randomized Controlled ◽

Eligible Child ◽

Contact Investigation ◽

Cluster Randomized ◽

The Impact ◽

Index Cases

Abstract Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 2019

Download Full-text

Exploring alternative insecticide delivery options in a “Lethal House Lure” for malaria vector control

10.21203/rs.3.rs-1107058/v1 ◽

2021 ◽

Author(s):

Welbeck A. Oumbouke ◽

Antoine M.G. Barreaux ◽

Innocent T. Zran ◽

Alphonsine A. Koffi ◽

Yao N’Guessan ◽

...

Keyword(s):

Controlled Trial ◽

Residual Activity ◽

Alternative Methods ◽

Malaria Vector Control ◽

Rapid Decline ◽

Mosquito Mortality ◽

Delivery Options ◽

Control Technologies ◽

Cluster Randomized ◽

The Impact

Abstract The In2Care® EaveTube is a house modification designed to block and kill malaria mosquitoes using an electrostatic netting treated with insecticide powder. A previous study demonstrated prolonged duration of effective action of insecticide-treated electrostatic netting in a semi-field setting. As part of a cluster randomized controlled trial (CRT) of the EaveTube intervention in Cote d’Ivoire, we investigated the residual efficacy of a pyrethroid insecticide deployed in Eave Tubes under village condition of use. We also explored the scope of using existing malaria control technologies including LLINs and IRS as alternative methods to deliver insecticides in the lethal house lure. The efficacy of beta-cyfluthrin was evaluated using the “eave tube bioassay” and was found to be relatively short-lived in the field during the CRT, with mortality of pyrethroid resistant Anopheles gambiae mosquitoes declining below 80% after 4 months. The impact (mosquito mortality) of PVC tubes coated with pirimiphos methyl was similar to that of beta-cyfluthrin treated insert (66.8 vs 62.8%) in release-recapture experiments in experimental huts. Efficacy was significantly lower with all the LLINs tested; however, the roof of PermaNet 3.0 induced significantly higher mosquito mortality (50.4%) compared to Olyset Plus (25.9%) and Interceptor G2 (21.6%) LLINs. The new delivery methods showed a rapid decline in efficacy over time with mortality decreasing below 50% within 2 months in residual activity bioassays. None of the current products appeared superior to the powder treatments but as with the powders, further research and development on formulations and doses are required.

Download Full-text

Seeing is believing: the impact of body-worn cameras on court outcomes, a cluster-randomized controlled trial in Miami Beach

Journal of Experimental Criminology ◽

10.1007/s11292-021-09479-6 ◽

2021 ◽

Author(s):

Kevin Petersen ◽

Alejandro Mouro ◽

Donald Papy ◽

Noel Castillo ◽

Barak Ariel

Keyword(s):

Domestic Violence ◽

Randomized Controlled Trial ◽

Police Officers ◽

Negative Binomial ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Randomized Controlled ◽

Early Results ◽

Cluster Randomized ◽

The Impact

Abstract Objectives To assess the effects of BWCs on prosecutorial and court-related charge outcomes across multiple crime types, including domestic violence charges, crimes committed against police officers, and drug/alcohol charges. Methods A cluster-randomized controlled trial with 22 spatiotemporal police units assigned to BWCs and 17 assigned to control conditions. Data from the State Attorney’s Office were used to track convictions, adjudication withheld dispositions, and declined prosecutions for both experimental and control charges. A series of multilevel logistic and negative binomial regression models were used to estimate the effect of BWC footage on charge outcomes. Outcomes BWCs led to a significantly higher proportion of crimes against police officers resulting in convictions or adjudication withheld outcomes, and a significantly higher proportion of domestic violence charges resulting in convictions alone, compared to control charges. However, after the clustering effect was taken into account, only the effect of BWCs on crimes against police officers remained statistically significant. Conclusion These early results suggest that BWCs have significant evidentiary value that varies by crime type. BWCs may be best suited to capture evidence of crimes committed against police officers and potentially in domestic violence offenses as well.

Download Full-text

Putting PjBL to the Test: The Impact of Project-Based Learning on Second Graders’ Social Studies and Literacy Learning and Motivation in Low-SES School Settings

American Educational Research Journal ◽

10.3102/0002831220929638 ◽

2020 ◽

pp. 000283122092963

Author(s):

Nell K. Duke ◽

Anne-Lise Halvorsen ◽

Stephanie L. Strachan ◽

Jihyun Kim ◽

Spyros Konstantopoulos

Keyword(s):

Social Studies ◽

Low Socioeconomic Status ◽

Comparison Group ◽

Controlled Trial ◽

Project Based Learning ◽

Learning Session ◽

Target Number ◽

Cluster Randomized ◽

The Impact ◽

Experimental Group

This cluster randomized controlled trial investigated the impact of project-based learning with professional development supports on social studies and literacy achievement and motivation of second-grade students from low–socioeconomic status school districts. At random in within-school pairs, 48 teachers were assigned to the experimental or comparison group. Experimental group teachers were asked to teach four project-based learning units designed to address nearly all social studies and some literacy standards. Comparison group teachers were asked to teach social studies as they normally would except to teach a target number of lessons. The experimental group showed higher growth in social studies and informational reading but not writing or motivation. Greater consistency with project-based learning session plans was associated with higher growth in writing, motivation, and reading.

Download Full-text

A Nutrition Education Intervention Using NOVA Is More Effective Than MyPlate Alone: A Proof-of-Concept Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122965 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2965

Author(s):

Aydin Nazmi ◽

Marilyn Tseng ◽

Derrick Robinson ◽

Dawn Neill ◽

John Walker

Keyword(s):

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Education Intervention ◽

Proof Of Concept ◽

Food Groups ◽

Randomized Controlled ◽

The Impact ◽

Level Of Processing

The ability to classify foods based on level of processing, not only conventional MyPlate food groups, might be a useful tool for consumers faced with a wide array of highly processed food products of varying nutritional value. The objective of this study was to assess the impact of a proof-of-concept nutrition education intervention on nutrition knowledge, assessed by correct classification of foods according to MyPlate food groups, MyPlate ‘limit’ status (for fat, sugar, sodium), and level of processing (NOVA categories). We utilized a randomized, controlled design to examine the impact of a MyPlate vs. combined MyPlate + NOVA intervention vs. control group. Intervention groups received educational flyers via email and participants were assessed using electronic baseline and follow-up surveys. The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and ‘limit’ status. Moreover, the MyPlate + NOVA group far outperformed the other groups on classifying NOVA categories. Longer-term trials are needed, but our results suggest that NOVA principles may be more easily understood and applied than those of MyPlate. Education strategies focusing on level of food processing may be effective in the context of the modern food environment.

Download Full-text