Enhancing DHA supplementation adherence: A Bayesian approach with finite mixture models and irregular interim schedules in adaptive trial designs.

Docosahexaenoic acid (DHA) supplementation has proven beneficial in reducing preterm births. However, the challenge lies in addressing nonadherence to prescribed supplementation regimens-a hurdle that significantly impacts clinical trial outcomes. Conventional methods of adherence estimation, such as pill counts and questionnaires, usually fall short when estimating adherence within a specific dosage group.

The Effect of Prenatal Docosahexaenoic Acid Supplementation on Offspring Fat Mass and Distribution at 24 Months Old.

Background: Excessive gestational weight gain (GWG) is related to increased offspring fat accrual, and increased fat mass (FM) is related to obesity development. Prenatal DHA supplementation has been linked to lower levels of offspring FM; however, conflicting data exist.

Objectives: This study aimed to determine if there is a protective effect of prenatal DHA supplementation on offspring fat accrual and adipose tissue deposition at 24 mo in offspring born to females who gain excessive weight compared with nonexcessive weight during pregnancy.

The Role of Fresh Beef Intake and Mediterranean Diet Adherence during Pregnancy in Maternal and Infant Health Outcomes.

Beef is an excellent source of nutrients important for maternal health and fetal development. It is also true that the Mediterranean diet is beneficial for the health of both the mother and offspring; however, the relative value of fresh beef intake within Mediterranean diet patterns during pregnancy is unknown. The objective of this project was two-fold: (1) assess the relationship between beef intake and nutrient intake in a pregnant population; (2) assess the relationship between maternal beef consumption among varying degrees of Mediterranean diet adherence with maternal risk of anemia and infant health outcomes.

Is choline deficiency an unrecognized factor in necrotizing enterocolitis of preterm infants?

We undertook this review to determine if it is plausible that choline or phosphatidylcholine (PC) deficiency is a factor in necrotizing enterocolitis (NEC) after two clinical trials found a dramatic and unexpected reduction in NEC in an experimental group provided higher PC compared to a control group. Sources and amounts of choline/PC for preterm infants are compared to the choline status of preterm infants at birth and following conventional nutritional management. The roles of choline/PC in intestinal structure, mucus, mesenteric blood flow, and the cholinergic anti-inflammatory system are summarized.

Treatment of functional bowel disorders in an integrative medicine clinic resulting in improved digestive tract symptoms.

Background And Aim: Functional bowel disorders (FBDs), including irritable bowel syndrome (IBS) and others, are conditions without a physically identifiable etiology that, as a result, are difficult to treat. Alternatives to traditional medical interventions are needed because IBS patients require more of physician time and higher healthcare spending. The goal of this study was to determine the efficacy of alternative lifestyle interventions for patients with FBDs seen in an integrative medicine (IM) clinic at an academic medical center.

DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation.

Purpose: To investigate the relationships among docosahexaenoic acid (DHA) intake, nutrient intake, and maternal characteristics on pregnancy outcomes in a phase III randomised clinical trial designed to determine the effect of a DHA dose of 1000 mg/day compared to 200 mg/day on early preterm birth (<34 weeks gestation).

Methods: A secondary aim of the phase III randomised trial was to explore the relationships among pregnancy outcomes (maternal red blood cell phospholipid (RBC-PL) DHA at delivery, preterm birth, gestational age at delivery, labor type, birth anthropometric measures, low birth weight, gestational diabetes, pre-eclampsia, and admission to a neonatal intensive care unit) in participants (n = 1100). We used Bayesian multiple imputation and linear and logistic regression models to conduct an analysis of five general classes of predictor variables collected during the trial: a) DHA intake, b) nutrient intake from food and supplements, c) environmental exposure to tobacco and alcohol, d) maternal demographics, and e) maternal medical history.

Micronutrient Gaps and Supplement Use in a Diverse Cohort of Pregnant Women.

Background: Micronutrition in pregnancy is critical to impact not only fetal growth and development but also long-term physical and psychiatric health outcomes.

Objective: Estimate micronutrient intake from food and dietary supplements in a diverse cohort of pregnant women and compare intake to the Dietary Reference Intakes (DRIs).

Design: Secondary analysis of women enrolled in a multi-site clinical trial of docosahexaenoic acid (DHA) supplementation who provided their dietary intake using the diet history questionnaire-II ( = 843) or multiple 24 h recalls ( = 178) at baseline and their intake of nutritional supplements at baseline through 30 days postpartum.

Iodine Intake From Diet and Supplements and Urinary Iodine Concentration in a Cohort of Pregnant Women in the United States.

Background: The DRI Estimated Average Requirement (EAR) in pregnancy for Iodine (I), an essential nutrient for fetal neurodevelopment, is 160 μg/d. Supplementation with 150 μg/d I/day is recommended during pregnancy, however, neither dietary intake or the combination of diet and supplement intake has been reported in US pregnant women.

Objective: Determine iodine intake from diet and supplements and iodine status in pregnancy by urinary iodine concentration in a large cohort of pregnant women.

Prenatal Care Utilization Challenges and Facilitators for a Growing Latino Community in the Midwest.

Background: Latina women are less likely to start prenatal care in the first trimester and to attend the recommended amount of prenatal visits compared to their non-Latina white counterparts.

Objectives: This study aimed to assess challenges and facilitators to first-trimester prenatal care (FTPNC) and prenatal care utilization (PNCU) in a Midwestern urban area with a growing immigrant Latino community.

Methods: This study used a mixed-method approach based on the Theoretical Domains Framework.

Evidence for human milk as a biological system and recommendations for study design-a report from "Breastmilk Ecology: Genesis of Infant Nutrition (BEGIN)" Working Group 4.

Human milk contains all of the essential nutrients required by the infant within a complex matrix that enhances the bioavailability of many of those nutrients. In addition, human milk is a source of bioactive components, living cells and microbes that facilitate the transition to life outside the womb. Our ability to fully appreciate the importance of this matrix relies on the recognition of short- and long-term health benefits and, as highlighted in previous sections of this supplement, its ecology (i.

A Scoping Review of Iodine and Fluoride in Pregnancy in Relation to Maternal Thyroid Function and Offspring Neurodevelopment.

Iodine (I), an essential nutrient, is important for thyroid function and therefore growth and development. Fluoride (F), also an essential nutrient, strengthens bones and teeth, and prevents childhood dental caries. Both severe and mild-to-moderate I deficiency and high F exposure during development are associated to decreased intelligence quotient with recent reports associating high levels of F exposure during pregnancy and infancy to low intelligence quotient.

The value of a two-armed Bayesian response adaptive randomization trial.

We investigate the value of a two-armed Bayesian response adaptive randomization (RAR) design to investigate early preterm birth rates of high versus low dose of docosahexaenoic acid during pregnancy. Unexpectedly, the COVID-19 pandemic forced recruitment to pause at 1100 participants rather than the planned 1355. The difference in power between number of participants at the pause and planned was 87% and 90% respectively.

Higher Diet Quality in Latina Women during Pregnancy May Be Associated with Sociodemographic Factors.

Acculturation contributes to low diet quality and can foster health inequities for Latina women during pregnancy. Conversely, nutrition literacy (NL) increases diet quality and could promote health equity. This study assessed the associations between the diet quality, acculturation, and NL of Latina women (n = 99) participating in the Assessment of Docosahexaenoic Acid On Reducing Early Preterm Birth (ADORE) study.

DHA Supplementation During Pregnancy Enhances Maternal Vagally Mediated Cardiac Autonomic Control in Humans.

Background: DHA is an essential omega-3 (ω-3; n-3) fatty acid that has well-established benefits for the fetus. DHA also has the potential to influence the health of the mother, but this area is understudied.

Objectives: The objective of this secondary analysis was to determine if DHA was related to maternal heart rate (HR) and heart rate variability (HRV) metrics in a large cohort of pregnant women.

Nutrition Literacy Among Latina/x People During Pregnancy Is Associated With Socioeconomic Position.

Background: During pregnancy, Latina/x people experience nutrition and nutrition-related health inequities. Nutrition literacy is a potential factor impacted by these inequities. However, the nutrition literacy level of Latina/x people during pregnancy is not well investigated.

A Preliminary Study of Clinical Practice and Prenatal Nutrition in Rural Kansas.

Introduction: The primary purpose of this study was to determine if new recommendations for prenatal supplements of docosahexaenoic acid (DHA) and choline have been implemented into care by physicians who care for pregnant women in rural Kansas communities. Both nutrients are inadequate in the diet of most pregnant women in the U.S.

Higher-Dose DHA Supplementation Modulates Immune Responses in Pregnancy and Is Associated with Decreased Preterm Birth.

Pregnancy and parturition involve extensive changes in the maternal immune system. In our randomized, multi-site, double-blind superiority trial using a Bayesian adaptive design, we demonstrated that 1000 mg/day of docosahexaenoic acid (DHA) was superior to 200 mg/day in preventing both early preterm birth (less than 34 weeks' gestation) and preterm birth (less than 37 weeks' gestation). The goal of this secondary study is to compare the effects of 1000 mg/day versus 200 mg/day on maternal inflammation, a possible mechanism by which DHA may prevent preterm birth.

The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study.

Background: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses.

Prenatal docosahexaenoic acid effect on maternal-infant DHA-equilibrium and fetal neurodevelopment: a randomized clinical trial.

Introduction: Maternal-infant equilibrium occurs when cord blood docosahexaenoic acid (DHA) is less than or equal to maternal DHA at delivery. Equilibrium may be an indicator of sufficient DHA for optimal fetal and infant neurodevelopment. The purpose of this study was to test the effect of maternal DHA supplementation on equilibrium status and fetal neurodevelopment.