An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation.

BACKGROUND: When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. OBJECTIVE: This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. METHODS: We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. RESULTS: ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). CONCLUSIONS: ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study.

Background: Young children living in urban slums are vulnerable to malnutrition and subsequently poor health outcomes, but data on the correlates of stunting, underweight, wasting, and anemia specifically among 10-18 month-old children in India remain limited. Objective: In this analysis, we sought to describe the prevalence of and examine correlates for different markers of undernutrition, including stunting, underweight, and anemia among 10-18 month-old children living in urban slums, an understudied vulnerable group. Methods: Children and their mothers (n = 323) were screened for anthropometry, demographics, and complete blood counts for hemoglobin concentration between March and November 2017 (Clinicaltrials.gov ID: NCT02233764). Correlates included child and mother's age, sex, birth order, birth weight, illness episodes, hemoglobin concentration, family income, maternal height, and maternal education level. Risk ratios (RR, 95% CI) for binary outcomes (stunting, underweight, wasting and anemia) and mean differences (ß, 95% CI) for continuous outcomes (anthropometric Z-scores, hemoglobin concentration) were calculated using multivariate binomial and linear regression (SAS 9.4). Results: The prevalence of stunting was 31.2%, underweight 25.1%, wasting (9.0%), and anemia (76%) among all children. Male children had a higher prevalence of poor growth indices and lower anthropometric Z-scores than females. Male sex, low birthweight, shorter maternal height, report of ≥1 episodes of illness within the past month, older maternal age, and birth order ≥2 were also associated with poor growth and anemia in multivariate models. Correlates of undernutrition were different among females and males. Female children had a 40% (20, 60%) higher risk of anemia associated with diarrhea, and male children who were firstborn had a 20% (0, 70%) lower risk of anemia. Conclusions: These results show that poor growth and anemia among young children is prevalent in urban slums of Mumbai, and that sex of the child may play an important role in informing interventions to address undernutrition.

Corrigendum: Acceptability of Iron- and Zinc-Biofortified Pearl Millet (ICTP-8203)-Based Complementary Foods among Children in an Urban Slum of Mumbai, India.

[This corrects the article DOI: 10.3389/fnut.2017.00039.].

Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India.

Biofortification, a method for increasing micronutrient content of staple crops, is a promising strategy for combating major global health problems, such as iron and zinc deficiency. We examined the acceptability of recipes prepared using iron- and zinc-biofortified pearl millet (FeZnPM) (~80 ppm Fe, ~34 ppm Zn, varietal Dhanashakti), [corrected] compared to conventional pearl millet (CPM) (~20 ppm Fe, ~19 ppm Zn) in preparation for an efficacy trial. Our objective was to examine the acceptability of FeZnPM compared to CPM among young children and mothers living in the urban slums of Mumbai. Standardized traditional feeding program recipes (n = 18) were prepared with either FeZnPM or CPM flour. The weight (g) of each food product was measured before and after consumption by children (n = 125) and the average grams consumed over a 3-day period were recorded. Mothers (n = 60) rated recipes using a 9-point hedonic scale. Mean intakes and hedonic scores of each food product were compared using t-tests across the two types of pearl millet. There were no statistically significant differences in consumption by children (FeZnPM: 25.27 ± 13.0 g; CPM: 21.72 ± 6.90 g) across the food products (P = 0.28). Overall mean hedonic scores for all recipes were between 7 to 9 points. CPM products were rated higher overall (8.22 ± 0.28) compared to FeZnPM products (7.95 ± 0.35) (P = 0.01). FeZnPM and CPM were similarly consumed and had high hedonic scores, demonstrating high acceptability in this population. These results support using these varieties of pearl millet in a proposed trial [http://Clinicaltrials.gov ID: NCT02233764; Clinical Trials Registry of India (CTRI), reference number REF/2014/10/007731, CTRI number CTRI/2015/11/006376] testing the efficacy of FeZnPM for improving iron status and growth.