Maternal Characteristics Affect Fetal Growth Response to Maternal Supplements in the Women First Preconception Trial (WF) (P10-017-19)

Abstract Objectives Determine if maternal characteristics modified newborn anthropometric outcomes in the WF trial (ClinicalTrials.gov NCT01883193). Methods Secondary analysis included combined data for all 1465 maternal infant dyads in WF sites in Guatemala, India, and Pakistan who had 1st trimester ultrasounds and newborn anthropometry with the three WF arms maintained: Arm 1 commenced a comprehensive nutrition supplement ≥3 months prior to conception; Arm 2 commenced the same supplement in the 1st trimester, and Arm 3 received no trial supplements. Maternal characteristics included were: baseline, BMI, hemoglobin, age, education, SES, and parity plus newborn sex. Newborn outcomes were Z-scores for length (LAZ), weight (WAZ), and weight-to-length ratio (WLRZ). Mixed effect regression models were fit for each outcome, including treatment arm, effect modifier, and treatment arm x effect modifier interaction as predictors and controlling for study site, maternal characteristics, and newborn sex. Results Parity, anemia and newborn sex were significant effect modifiers favoring para 0 vs para ≥1, anemia vs non anemia, and newborn male vs female. Effect of Arm 1 vs 3 was significantly larger for para 0 vs ≥1 women on length and weight (Table). Arm 2 vs 3 was not associated with improvements for para 0 in weight (P = 0.273) or WLRZ (P = 0.710). Arms 1 and 2 (vs 3) were associated with significantly higher length, weight, and WLRZ for anemic women. For parity and anemia, effect sizes for Arm 1 were greater than for Arm 2 for WAZ and WLZ (P < 0.05), but not LAZ. Arm 1 and 2 were associated with significantly higher weight and WLRZ for male vs female newborn. Conclusions In diverse low resource populations, impaired fetal growth (weight and length) is substantially improved in nulliparous and in anemic women but minimally or not at all in parous and in non-anemic women. Correction of weight decrements is most pronounced with improvement in maternal nutrition commencing prior to conception. Funding Sources Bill & Melinda Gates Foundation; NIH, NICHD and ODS. Supporting Tables, Images and/or Graphs

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Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial

Nutrients ◽

10.3390/nu11102534 ◽

2019 ◽

Vol 11 (10) ◽

pp. 2534 ◽

Cited By ~ 2

Author(s):

K Michael Hambidge ◽

Carla M. Bann ◽

Elizabeth M. McClure ◽

Jamie E. Westcott ◽

Ana Garcés ◽

...

Keyword(s):

Fetal Growth ◽

Economic Status ◽

Secondary Analysis ◽

Nutrition Intervention ◽

Effect Modifier ◽

Mixed Effect ◽

Maternal Characteristics ◽

Effect Regression ◽

Z Scores ◽

Newborn Size

The objective of this secondary analysis was to identify maternal characteristics that modified the effect of maternal supplements on newborn size. Participants included 1465 maternal–newborn dyads in Guatemala, India, and Pakistan. Supplementation commenced before conception (Arm 1) or late 1st trimester (Arm 2); Arm 3 received usual care. Characteristics included body mass index (BMI), stature, anemia, age, education, socio-economic status (SES), parity, and newborn sex. Newborn outcomes were z-scores for length (LAZ), weight (WAZ), and weight to length ratio-for-age (WLRAZ). Mixed-effect regression models included treatment arm, effect modifier, and arm * effect modifier interaction as predictors, controlling for site, characteristics, and sex. Parity (para-0 vs. para ≥1), anemia (anemia/no anemia), and sex were significant effect modifiers. Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. ≥1 for all outcomes (LAZ 0.56 (0.28, 0.84, p < 0.001); WAZ 0.45 (0.20, 0.07, p < 0.001); WLRAZ 0.52 (0.17, 0.88, p < 0.01) but only length for Arm 2 vs. 3. Corresponding effects for para ≥1 were >0.02. Arm 3 z-scores were all very low for para-0, but not para ≥1. Para-0 and anemia effect sizes for Arm 1 were > Arm 2 for WAZ and WLRAZ, but not LAZ. Arm 1 and 2 had higher WAZ for newborn boys vs. girls. Maternal nulliparity and anemia were associated with impaired fetal growth that was substantially improved by nutrition intervention, especially when commenced prior to conception.

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Harmonization of Maternal Nutrition Trials – Finding and Creating Similarities in Protocols and Outcomes

Current Developments in Nutrition ◽

10.1093/cdn/nzaa065_003 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 1738-1738

Author(s):

Alison Gernand ◽

Yemane Berhane ◽

Nita Bhandari ◽

Ranadip Chowdhury ◽

Fyezah Jehan ◽

...

Keyword(s):

Data Analysis ◽

Gestational Age ◽

Maternal Nutrition ◽

Time Frame ◽

Protein Supplementation ◽

Fetal Biometry ◽

Funding Sources ◽

Biospecimen Collection ◽

Gates Foundation ◽

Meta Analyses

Abstract Objectives Public health and clinical recommendations should be based on results from multiple studies, however trials often have outcomes that are not defined in the same way. This project aims to harmonize selected protocols, outcome definitions, and data analysis across five randomized trials of antenatal balanced energy-protein supplementation being conducted in Burkina Faso, Ethiopia, India, Nepal, and Pakistan. Methods Harmonization efforts include a range of activities from reviewing detailed protocols, biospecimen collection plans, data dictionaries, and data analysis plans to proposing best practices and acceptable practices based on field limitations. Most studies have not begun or are early in enrollment, an ideal time frame to make changes. A two-day workshop of lead investigators, content experts and advisors will be held in late February, and harmonization activities will continue thereafter. Results All studies are examining anthropometry at birth as a primary outcome, however the timing of birth measurements (hours since birth) and types of measurements taken differ across trials. All studies are estimating gestational age by ultrasound measurements, but the gestational age at ultrasound differs (in part due to differences in timing of antenatal care by country) as well as the number of fetal biometry measures. Finally, stillbirth is a key outcome across trials, but initial definitions had slight differences that will now be harmonized. We are also able to add new, important maternal and child health outcomes to each trial that will have the same protocols from inception (e.g., microbiome). Conclusions Efforts thus far have resulted in communication between study investigators, consideration of improved protocols, and addition of new outcomes to collect across all sites. Further results are forthcoming after the February workshop, which will include documentation of how much definitions vary across studies and the challenges of standardization. We expect the harmonization process to improve overall reporting within each study and provide opportunities for better meta-analyses. Funding Sources The Bill and Melinda Gates Foundation.

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The Effect of a Preconception Nutrition Supplement on One Carbon Metabolites (P24-028-19)

Current Developments in Nutrition ◽

10.1093/cdn/nzz044.p24-028-19 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

Author(s):

Stephanie Gilley ◽

Evan Sticca ◽

Mattie Kerns ◽

Alexandra Palacios ◽

Purevsuren Jambal ◽

...

Keyword(s):

Multiple Testing ◽

Longitudinal Research ◽

Controlled Trial ◽

Secondary Analysis ◽

Methyl Donors ◽

Funding Sources ◽

Nutrition Supplement ◽

Metabolite Concentrations ◽

Liquid Chromatography Tandem Mass ◽

Gates Foundation

Abstract Objectives Studies in both animals and humans have shown that maternal dietary restriction and supplementation of one carbon (1C) metabolites (methyl donors), such as methionine and choline, can impact offspring growth, insulin resistance, and DNA methylation. However, there has been limited longitudinal research of 1C metabolite concentrations over the reproduction cycle of human pregnancy. The purpose of this study was to investigate if 1C metabolite concentrations change prior to and during pregnancy and if a preconception lipid-based nutrition supplement (LNS) influences such changes. Methods This study was a secondary analysis as part of the Women First study (clinicaltrials.gov, NCT01883193), a large, randomized controlled trial investigating whether the timing of maternal LNS initiation would impact fetal growth and development. The study arms were supplementation at least 3 months prior to conception (Arm 1), supplementation at ∼12 weeks of gestation (Arm 2), or no supplementation (Arm 3). Dried blood spot (DBS) cards were collected at study enrollment prior to conception, and at 12 and 34 weeks gestation. A targeted 1C metabolite assay (27 metabolites) was performed on a subset of DBS samples from Guatemalan women (n = 134) at each time point using liquid chromatography/tandem mass spectrometry. Longitudinal analyses were performed using linear mixed modeling to investigate the influence of time and LNS on these metabolites. Results The concentrations of two metabolites were changed by intervention status: asymmetric dimethylarginine (ADMA) and symmetric dimethylarginine (SDMA). Twenty-one of 27 metabolites significantly changed from preconception and across gestation after correcting for multiple testing using the Bonferroni correction (P < 0.00185). Conclusions Preconception LNS significantly decreased the level of ADMA, a metabolite which has been implicated in intrauterine growth restriction and preeclampsia. More work is needed to determine whether this intervention could influence development of these conditions. Funding Sources Bill & Melinda Gates Foundation, National Institutes of Health.

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Modeling the Effect of Mother's Characteristics on the Weight of a Newborn

International Journal of Childbirth ◽

10.1891/ijcbirth-d-20-00024 ◽

2020 ◽

Vol 10 (4) ◽

pp. 206-216

Author(s):

Oluwafemi Samson Balogun ◽

Donald Douglas Atsa'am ◽

Toluwalase Janet Akingbade ◽

Emmanuel Awuni Kolog ◽

Richard O. Agjei ◽

...

Keyword(s):

Birth Weight ◽

Fetal Growth ◽

Secondary Analysis ◽

Policy Issue ◽

Multiple Linear Regression Model ◽

Maternal Weight ◽

Maternal Characteristics ◽

Public Policy Issue ◽

Neonatal Birth Weight ◽

Antenatal Visits

BACKGROUNDNeonatal mortality related to fetal growth is a public policy issue in Nigeria.METHODTo determine maternal characteristics associated with fetal growth and neonatal birth weight, a secondary analysis of data collected from 701 mothers using a multiple linear regression model was undertaken.FINDINGSMaternal age, parity, and weight were found to be significantly associated with neonatal birth weight. The number of antenatal visits and maternal level of education were not found to be associated with neonatal birth weight.CONCLUSIONSTo the extent that providers might influence maternal weight, education and counselling during pregnancy may impact fetal growth and neonatal birth weight.

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Potential of community-based risk estimates for improving hospital performance measures and discharge planning

BMJ Open Quality ◽

10.1136/bmjoq-2020-001230 ◽

2021 ◽

Vol 10 (2) ◽

pp. e001230

Author(s):

Michael Reid ◽

George Kephart ◽

Pantelis Andreou ◽

Alysia Robinson

Keyword(s):

Discharge Planning ◽

Care Transitions ◽

Hospital Setting ◽

Hospital Performance ◽

Case Mix ◽

Readmission Rates ◽

Mixed Effect ◽

Adjusted Risk ◽

Community Risk ◽

Effect Regression

BackgroundRisk-adjusted rates of hospital readmission are a common indicator of hospital performance. There are concerns that current risk-adjustment methods do not account for the many factors outside the hospital setting that can affect readmission rates. Not accounting for these external factors could result in hospitals being unfairly penalized when they discharge patients to communities that are less able to support care transitions and disease management. While incorporating adjustments for the myriad of social and economic factors outside of the hospital setting could improve the accuracy of readmission rates as a performance measure, doing so has limited feasibility due to the number of potential variables and the paucity of data to measure them. This paper assesses a practical approach to addressing this problem: using mixed-effect regression models to estimate case-mix adjusted risk of readmission by community of patients’ residence (community risk of readmission) as a complementary performance indicator to hospital readmission rates.MethodsUsing hospital discharge data and mixed-effect regression models with a random intercept for community, we assess if case-mix adjusted community risk of readmission can be useful as a quality indicator for community-based care. Our outcome of interest was an unplanned repeat hospitalisation. Our primary exposure was community of residence.ResultsCommunity of residence is associated with case-mix adjusted risk of unplanned repeat hospitalisation. Community risk of readmission can be estimated and mapped as indicators of the ability of communities to support both care transitions and long-term disease management.ConclusionContextualising readmission rates through a community lens has the potential to help hospitals and policymakers improve discharge planning, reduce penalties to hospitals, and most importantly, provide higher quality care to the people that they serve.

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Maternal nutrition and fetal growth

The Indian Journal of Pediatrics ◽

10.1007/bf02776432 ◽

1984 ◽

Vol 51 (4) ◽

pp. 443-449

Author(s):

R. R. Devi ◽

K. N. Agarwal

Keyword(s):

Fetal Growth ◽

Maternal Nutrition

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Limited not lazy: a quasi-experimental secondary analysis of evidence quality evaluations by those who hold implausible beliefs

Cognitive Research Principles and Implications ◽

10.1186/s41235-020-00264-z ◽

2020 ◽

Vol 5 (1) ◽

Author(s):

Kristy A. Martire ◽

Bethany Growns ◽

Agnes S. Bali ◽

Bronte Montgomery-Farrer ◽

Stephanie Summersby ◽

...

Keyword(s):

Secondary Analysis ◽

Past Research ◽

Linear Mixed Effect Model ◽

High Quality ◽

Mixed Effect ◽

High Quality Evidence ◽

Effect Model ◽

Evidence Quality ◽

Quasi Experimental ◽

Quality Evidence

AbstractPast research suggests that an uncritical or ‘lazy’ style of evaluating evidence may play a role in the development and maintenance of implausible beliefs. We examine this possibility by using a quasi-experimental design to compare how low- and high-quality evidence is evaluated by those who do and do not endorse implausible claims. Seven studies conducted during 2019–2020 provided the data for this analysis (N = 746). Each of the seven primary studies presented participants with high- and/or low-quality evidence and measured implausible claim endorsement and evaluations of evidence persuasiveness (via credibility, value, and/or weight). A linear mixed-effect model was used to predict persuasiveness from the interaction between implausible claim endorsement and evidence quality. Our results showed that endorsers were significantly more persuaded by the evidence than non-endorsers, but both groups were significantly more persuaded by high-quality than low-quality evidence. The interaction between endorsement and evidence quality was not significant. These results suggest that the formation and maintenance of implausible beliefs by endorsers may result from less critical evidence evaluations rather than a failure to analyse. This is consistent with a limited rather than a lazy approach and suggests that interventions to develop analytical skill may be useful for minimising the effects of implausible claims.

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