Background Public health and clinical recommendations are established from systematic reviews and retrospective meta-analyses combining effect sizes, traditionally, from aggregate data and more recently, using individual participant data (IPD) of published studies. However, trials often have outcomes and other meta-data that are not defined and collected in a standardized way, making meta-analysis problematic. IPD meta-analysis can only partially fix the limitations of traditional, retrospective, aggregate meta-analysis; prospective meta-analysis further reduces the problems. Methods We developed an initiative including seven clinical intervention studies of balanced energy-protein (BEP) supplementation during pregnancy and/or lactation that are being conducted (or recently concluded) in Burkina Faso, Ethiopia, India, Nepal, and Pakistan to test the effect of BEP on infant and maternal outcomes. These studies were commissioned after an expert consultation that designed recommendations for a BEP product for use among pregnant and lactating women in low- and middle-income countries. The initiative goal is to harmonize variables across studies to facilitate IPD meta-analyses on closely aligned data, commonly called prospective meta-analysis. Our objective here is to describe the process of harmonizing variable definitions and prioritizing research questions. A two-day workshop of investigators, content experts, and advisors was held in February 2020 and harmonization activities continued thereafter. Efforts included a range of activities from examining protocols and data collection plans to discussing best practices within field constraints. Prior to harmonization, there were many similar outcomes and variables across studies, such as newborn anthropometry, gestational age, and stillbirth, however, definitions and protocols differed. As well, some measurements were being conducted in several but not all studies, such as food insecurity. Through the harmonization process, we came to consensus on important shared variables, particularly outcomes, added new measurements, and improved protocols across studies. Discussion We have fostered extensive communication between investigators from different studies, and importantly, created a large set of harmonized variable definitions within a prospective meta-analysis framework. We expect this initiative will improve reporting within each study in addition to providing opportunities for a series of IPD meta-analyses.
Objectives Malnutrition affects 25% of women in Ethiopia. We are conducting a study to determine the impact of a prenatal nutrition intervention on maternal and infant health in Ethiopia. The objective of this formative study was to better describe dietary practices among pregnant women and community members in rural Ethiopia prior to initiation the parent study. Methods This formative study was conducted from October-November 2018 among pregnant women and community members in the rural Amhara region of Ethiopia, prior to the “Enhancing Nutrition and Antenatal Infection Treatment (ENAT)” study [ISRCTN15116516]. 28 in-depth interviews (IDIs) were conducted among 16 pregnant women and 12 community members. IDIs were recorded, transcribed, and translated. We used a grounded theory approach and inductive reasoning for content analysis of interview transcripts. Results Fasting norms in the Ethiopian Orthodox religion had a significant impact on dietary behaviors which occurs for more than 200 days annually. Community members indicated that fasting during pregnancy is common and is also supported and encouraged by religious leaders and community members. Accordingly, women adhered to fasting restrictions during pregnancy, and many women maintained a vegan diet under direction of local religious leaders. Furthermore, many women reported restricting dietary intake in pregnancy to prevent growth of the fetus because of the concern for obstructed labor. A women's diet depended on her husbands’/family earnings and household food preferences. Sharing of meals is a cultural norm; the husband is served first, with the remaining portions to the pregnant women/children. Pregnant women in the area also reported regular consumption of a locally brewed alcohol (“tella”), as it is believed to have lower alcohol levels. These findings demonstrate the impact of traditional and cultural beliefs on dietary decisions amongst pregnant women in this population. Conclusions Reduced food intake in pregnancy is common in this population, due to fasting, reduced appetite, and food restriction to avoid pregnancy complications. Context-specific interventions are needed, and this formative work will inform the future delivery and education regarding nutrition interventions in rural Ethiopia. Funding Sources Bill & Melinda Gates Foundation (OPP1184363).
IntroductionThe WHO Nutrition Target aims to reduce the global prevalence of low birth weight by 30% by the year 2025. The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study will test the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management on birth outcomes in rural Ethiopia.Methods and analysisENAT is a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. Eligible pregnant women presenting at antenatal care (ANC) visits at <24 weeks gestation are enrolled (n=2400). ANC quality is strengthened across all centres. Health centres are randomised to receive an enhanced nutrition package (ENP) or standard nutrition care, and within each health centre, individual women are randomised to receive an enhanced infection management package (EIMP) or standard infection care. At ENP centres, women receive a regular supply of adequately iodised salt and iron–folate (IFA), enhanced nutrition counselling and those with mid-upper arm circumference of <23 cm receive a micronutrient fortified balanced energy protein supplement (corn soya blend) until delivery. In standard nutrition centres, women receive routine counselling and IFA. EIMP women have additional screening/treatment for urinary and sexual/reproductive tract infections and intensive deworming. Non-EIMP women are managed syndromically per Ministry of Health Guidelines. Participants are followed until 1-month post partum, and a subset until 6 months. The primary study outcomes are newborn weight and length measured at <72 hours of age. Secondary outcomes include preterm birth, low birth weight and stillbirth rates; newborn head circumference; infant weight and length for age z-scores at birth; maternal anaemia; and weight gain during pregnancy.Ethics and disseminationENAT is approved by the Institutional Review Boards of Addis Continental Institute of Public Health (001-A1-2019) and Mass General Brigham (2018P002479). Results will be disseminated to local and international stakeholders.Registration numberISRCTN15116516.
Objectives Providing balanced protein energy (BEP) supplementation to pregnant women in low-and-middle income countries has been shown to improve pregnancy outcomes. The objective of this study was to assess the feasibility, acceptability, and adherence of a proposed BEP product among pregnant women in rural Ethiopia prior to initiation of a clinical effectiveness study. Methods This formative study was conducted from October-November 2018 among pregnant women in the rural Amhara region of Ethiopia, prior to the “Enhancing Nutrition and Antenatal Infection Treatment (ENAT)” study [ISRCTN15116516]. Questionnaires to assess acceptability of a micronutrient fortified corn soy blend (CSB) BEP supplement were administered using a 7-point Likert scale (0 = strongly disagree, to 7 = strongly agree) after 2 and 4 weeks of utilization. Acceptability domains included: color, taste, texture, odor, portion size, ease of use, and adult favorability. Women were also given weekly provisions of daily sachets of the supplement and monitored weekly for adherence over one month. Results 39 women participated in the study and 33 completed the study at 4 weeks. Quantitative results demonstrated high acceptability (mean Likert score >6 of 7) for the following domains: color, odor and perceived adult favorability at mid and end point. Scores on acceptability and perception of the product remained generally stable through the duration of use. The average number of sachets consumed was 6.4 in week 1, 6.6 in week 2, 7 in week 3, and 6.9 in week 4. 43% of women consumed the portion in one sitting, whereas 57% of women split up the portion to consume throughout the day. The majority (66%) of women reported consuming the full daily serving. 26% of respondents reported sharing the supplement with family members. Conclusions These findings show that most women in rural Amhara, Ethiopia, found the BEP supplement acceptable and had positive perceptions of the product. Sharing of the product and completion of the full daily serving were important considerations. Overall, the BEP supplement demonstrated good feasibility of implementation in our study population. Future studies should consider utilizing such strategies to understand factors that may affect uptake and adherence of nutritional supplements. Funding Sources Bill & Melinda Gates Foundation.
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