Background: Intention-to-treat analyses do not address adherence. Per protocol analyses treat non-adherence as a protocol deviation and assess if the intervention is effective if followed. Objective: To determine the rate of early preterm birth (EPTB, < 34 weeks gestation) and preterm birth (PTB, < 37 weeks gestation) in participants who adhered to a randomly assigned docosahexaenoic acid (DHA) dose of 1000 mg/day.Study design: Eleven hundred women with a singleton pregnancy were enrolled before 20-weeks' gestation, provided a capsule with 200 mg/day DHA and randomly assigned to two additional capsules containing a placebo or 800 mg of DHA. In the Bayesian Adaptive Design, new randomization schedules were determined at prespecified intervals. In each randomization, the group with the most EPTB was assigned fewer participants than the other group. Adherence was defined a priori as a postpartum red blood cell phospholipid DHA (RBC-PL-DHA) >= 5.5%.and post hoc as >= 8.0% RBC-PL-DHA, the latter after examination of postpartum RBC-PL-DHA. Bayesian mixture models were fitted for gestational age and dichotomized for EPTB and PTB as a function of baseline RBC-PL-DHA and dose-adherence. Bayesian hierarchical models were also fitted for EPTB by dose adherence and quartiles of baseline RBC-PL-DHA.Results: Adherence to the high dose using both RBC-PL-DHA cut points resulted in less EPTB compared to 200 mg [Bayesian posterior probability (pp) = 0.93 and 0.92, respectively]. For participants in the two lowest quartiles of baseline DHA status, adherence to the higher dose resulted in lower EPTB (>= 5.5% RBC-PL-DHA, quartiles 1 and 2, pp = 0.95 and 0.96; >= 8% RBC-PL-DHA, quartiles 1 and 2, pp = 0.94 and 0.95). Using the Bayesian model, EPTB was reduced by 65%, from 3.45% to 1.2%, using both cut points. Adherence also reduced PTB before 35, 36 and 37 weeks using both cut points (pp >= 0.95). In general, performance of the nonadherent subgroup mirrored that of participants assigned to 200 mg.Conclusion: Adherence to high dose DHA reduced EPTB and PTB. The largest effect of adherence on reducing EPTB was observed in women with low baseline DHA levels.(c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Background: Two randomized trials found women with low blood docosahexaenoic acid (DHA; an omega 3 fatty acid) had fewer early preterm births (<34 weeks gestation) if they were assigned to high dose DHA supplementation, however, there is currently no capacity for clinicians who care for preg-nancies to obtain a blood assessment of DHA. Determining a way to identify women with low DHA intake whose risk could be lowered by high dose DHA supplementation is desired. Objective: To determine if assessing DHA intake can identify pregnancies that benefit from high dose DHA supplementation. Study design: This secondary analysis used birth data from 1310 pregnant women who completed a 7 -question food frequency questionnaire (DHA-FFQ) at 16.8 ?? 2.5 weeks gestation that is validated to assess DHA status. They were then randomly assigned to a standard (200 mg/day) or high dose (800 or 1000 mg/day) DHA supplement for the remainder of pregnancy. Bayesian logistic regressions were fitted for early preterm birth and preterm birth as a function of DHA intake and assigned DHA dose. Results: Participants who consumed less than 150 mg/day DHA prior to 20 weeks??? gestation (n = 810/ 1310, 58.1%) had a lower Bayesian posterior probability (pp) of early preterm birth if they were assigned to high dose DHA supplementation (1.4% vs 3.9%, pp = 0.99). The effect on preterm birth (<37 weeks) was also significant (11.3% vs 14.8%, pp = 0.97). Conclusion: The DHA-FFQ can identify pregnancies that will benefit most from high dose DHA supple-mentation and reduce the risk of preterm birth. The DHA-FFQ is low burden to providers and patients and could be easily implemented in obstetrical practice. ?? 2022 The Author(s). Published by Elsevier Ltd on behalf of European Society for Clinical Nutrition and Metabolism. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).

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. 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. This study used a mixed-method approach based on the Theoretical Domains Framework. Nine semi-structured interviews were conducted with healthcare professionals that worked in birth centers, clinics, or hospitals that provided prenatal care (PNC) services for Latina women. Eight focus groups and quantitative surveys were conducted with Latina women and their supporters in Kansas City metropolitan area. FTPNC was challenged by women’s immigrant status, lack of healthcare coverage due to immigrant status, and complexity of Medicaid application. PNCU was challenged by the cost of PNC when diagnosed with gestational diabetes, lack of healthcare coverage, PNC literacy, late access to gynecologists/obstetricians, inadequate interpretation services, transportation, and mental health distress. Meanwhile, FTPNC was facilitated by social support and connectedness. PNCU was facilitated by Spanish-proficient providers and interpreters, effective nonverbal communication and education techniques, and pregnancy prevention access and education. Results from this study highlight important targets to improve PNC for Latina women. Participants called for various types of support to address identified challenges, ranging from information on social media about PNC services to broader efforts such as building trust from the community toward PNC providers and making PNC services affordable for women with gestational diabetes. Minoritized communities have historically low FTPNC and PNCU. However, access and use of PNC may be affected and improved by specific communities’ cultural, social, and patient-provider interactions within specific geographical areas. For a primarily immigrant Latino community living in a midwestern metropolitan area, FTPNC and PNCU were challenged by immigration status, lack of healthcare coverage, difficulty completing public healthcare coverage application, cost of PNC when diagnosed with gestational diabetes, PNC literacy, limited access to women’s health providers, inadequate interpretation services, transportation, and mental health distress. However, social support, connectedness, appropriate interpretation services, bilingual providers, empathetic nonverbal communication, spoken communication strategies delivered at the provider’s office, access to PNC, and pregnancy prevention education were considered facilitators to FTPNC and PNCU.

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 (n = 843) or multiple 24 h recalls (n = 178) at baseline and their intake of nutritional supplements at baseline through 30 days postpartum. Participants/Setting: 1021 participants from the parent trial who had reliable data for dietary intake, supplement intake, or both. Main outcome measures: Micronutrient intake from dietary and supplement sources and percentage of intakes meeting the DRIs for pregnancy. Statistical analyses performed: Percent of participants whose intake was below the estimated average requirement (EAR) or adequate intake (AI) and above the tolerable upper limit (UL). Results: Dietary intakes of choline, folate, iron, vitamin D, zinc, vitamin E, magnesium, and potassium, were below the AI or EAR for 30–91% of the participants; thiamin and vitamin B6 were also below the AI or EAR for non-Hispanic/Latina women. Supplement intake improved the intake for most; however, 80% of the group remained below the AI for choline and 52.5% for potassium while 30% remained below the EAR for magnesium. Folate and iron intakes were above the UL for 80% and 19%, respectively. Conclusions: Dietary supplements, despite their variability, allowed the majority of this cohort of pregnant women to achieve adequate intakes for most micronutrients. Choline, magnesium, and potassium were exceptions. Of interest, folate intake was above the tolerable UL for the majority and iron for 16.8% of the participants. Clinicians have the opportunity to address the most common nutrient deficits and limits with advice on food sources that provide choline, magnesium, and potassium and to ensure folate is not overabundant. More research is needed to determine if these findings are similar in a cross-sectional population.

Abstract Objectives Examine the associations between added sugars and fructose intake during the first 2 years of life and body composition in middle childhood. Our hypothesis is that infants and toddlers with higher added sugars and fructose intake will have greater percentage fat mass later in life compared to those with lower intakes. Methods 24-hour dietary recalls were collected in children (n varied with age from 101 to 208) born to mothers who participated in the KUDOS study, a randomized control trial that evaluated the effect of prenatal DHA supplementation on offspring cognitive outcomes. Dietary data were reported from 6 weeks to 2y. Percentage fat mass (%fat) was measured by air displacement plethysmography (Bod Pod®) at 5, 7, 8, and 9y. Principal component analysis determined qualitative transitions of sugars intake across early childhood. Hierarchical linear regression models assessed the relationship between early added sugars and fructose intake and %fat later in life. Results Clinical trial assignment did not affect outcomes. Added sugars and fructose intake increased over infancy and early childhood, starting at 31.5 and 0.04 grams/day at 6 weeks up to 44.8 and 17.9 grams/day by 2y for added sugars and fructose, respectively. Principal component analyses revealed two distinct phases of intake, with transitions at the end of the 1st year, for both forms of sugar intake. Regressions were conducted for outcomes at each age, controlling for SES and average kcal intake during infancy. Added sugars intake during the 2nd year had an unexpectedly negative association with %fat at 5y (b = −0.359, P < 0.01), while fructose intake during the 1st year had a positive association with %fat at 8y (b = 0.361, P < 0.05). No other significant associations were observed at the other ages. Conclusions Intake of added sugars and fructose increased precipitously over the first 2 years of life and added sugars intake was well above the recommended 0 grams/day for children < 2 years of age. Analyses suggested a qualitative transition in intake occurring for both forms of sugars toward the end of the first year. Timing of intake in the first 1,000 days of life, along with the form of sugar consumed, may impact child body composition differently. Funding Sources The KUDOS study was supported by US NIH grants R01HD047315 and U54 HD090216.

Docosahexaenoic acid (DHA) intake was estimated in pregnant women between 12- and 20-weeks' gestation using the National Cancer Institute's (NCI) Diet History Questionnaire-II (DHQ-II) and a 7-question screener designed to capture DHA intake (DHA Food Frequency Questionnaire, DHA-FFQ). Results from both methods were compared to red blood cell phospholipid DHA (RBC-DHA) weight percent of total fatty acids. DHA intake from the DHA-FFQ was more highly correlated with RBC-DHA (rs=0.528) than the DHQ-II (rs=0.352). Moreover, the DHA-FFQ allowed us to obtain reliable intake data from 1355 of 1400 participants. The DHQ-II provided reliable intake for only 847 of 1400, because many participants only partially completed it and it was not validated for Hispanic participants. Maternal age, parity, and socioeconomic status (SES) were also significant predictors of RBC-DHA. When included with estimated intake from the DHA-FFQ, the model accounted for 36% of the variation in RBC-DHA.

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. We decided to stop the study. This paper describes how the RAR was used to execute the study. The value of RAR in two-armed studies is quite high and their use in the future is promising.

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. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. Objective The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. Methods A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. Results Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. Conclusions The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. Trial Registration ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj

Background: Several meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (<34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.Methods: This randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres. Women with singleton pregnancies and 12 to 20 weeks gestation were eligible. Randomisation was generated in SAS® by site in blocks of 4. The planned adaptive design periodically generated allocation ratios favoring the better performing dose. Managing study personnel were blind to treatment until 30 days after the last birth. The primary outcome was early preterm birth by dose and by enrollment DHA status (low/high). Bayesian posterior probabilities (pp) were determined for planned efficacy and safety outcomes using intention-to-treat. Findings: Eleven hundred participants (1000 mg, n=576; 200 mg, n=524) were enrolled between June 8, 2016 and March 13, 2020. 1032 (n=540 and n=492) were included in the primary analyses. The higher dose was superior for prevention of early preterm birth [1.7% (9/540) vs 2.4% (12/492), pp=0.81]. Participants with low enrollment DHA status had half the rate of early preterm birth with 1000 compared to 200 mg [2.0% (5/249) vs 4.1%, (9/219), pp=0.93]. Participants with high enrollment DHA status did not realize a dose effect [1000 mg: 1.4% (4/289); 200 mg: 1.1% (3/271), pp=0.57]. The higher dose was associated with fewer serious adverse events (maternal: chorioamnionitis, premature rupture of membranes and pyelonephritis; neonatal: feeding, genitourinary and neurologic problems, all pp>0.90).Interpretation: Physicians should consider prescribing 1000 mg DHA daily during pregnancy to reduce early preterm birth, particularly in women entering pregnancy with low DHA status.Trial Registration: The study is registered with ClinicalTrials.gov (NCT02626299) and closed to enrollment.Funding Statement: National Institutes of Health Child Health and Human Development (NICHD) R01HD083292.Declaration of Interests: SEC has received honorariums for presentations about DHA in infancy and pregnancy. CJV is an employee of RB Nutrition, which produces infant formulas and supplements, however, RB had no involvement in the study execution or analysis. She conducted this study through her role as an Adjunct Professor at The University of Cincinnati. The other authors have no competing interests.Ethics Approval Statement: The University of Kansas Medical Center granted approval under a central IRB with reliance by the other institutions (STUDY00003455). All participants gave written consent.

Introduction: Offsprings from a prenatal docosahexaenoic acid (DHA) supplementation trial, in which pregnant women were assigned to placebo or 600mg DHA/day, were followed to determine the effect of prenatal DHA supplementation on the behavior and brain function at 5.5 years (n=81 placebo, n=86 supplemented).Methods: Event-related potentials (ERP) were recorded during a visual task requiring a button press (Go) to frequent target stimuli and response inhibition to the rare stimuli (No-Go). Univariate ANOVAs were used to test differences between group and sex for behavioral measures. ERP differences were tested using a three-way mixed-design multivariate analysis of variance (MANOVA).Results: There was a significant sex × group interaction for hit rate and errors of omission; there was no difference between males and females in the placebo group, but DHA males outperformed DHA females. Males overall and the placebo group made more errors requiring response inhibition; DHA females were significantly better than placebo females and DHA males. ERP P2 amplitude was larger in the DHA group. A significant N2 amplitude condition effect was observed in females and DHA group males, but not in placebo group males.Discussion: Prenatal DHA supplementation improved inhibitory performance overall, especially for females in the DHA group, possibly accounting for their conservative behavior during Go trials. Development of brain regions responsible for visual processing may be sensitive to maternal DHA status, evidenced by greater P2 amplitude. Males may benefit more from maternal DHA supplementation, indicated by the N2 condition effect seen only in males in the DHA group.

IMPORTANCE The blood pressure-lowering property of docosahexaenoic acid (DHA) in children and adults is known, and an observational study from the Netherlands has linked higher intrauterine DHA exposure to lower childhood blood pressure. However, the association of prenatal intake of DHA supplement with childhood blood pressure has not been evaluated in randomized clinical trials. OBJECTIVE To determine the effect of DHA supplementation during pregnancy on childhood blood pressure. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis of the Kansas University DHA Outcome Study (KUDOS), a phase 3, double-blind, randomized, placebo-controlled clinical trial was conducted at several local hospitals in the Kansas City, Kansas, metropolitan area. Pregnant women (n = 350) were enrolled in the KUDOS trial between January 10, 2006, and November 17, 2009, and were followed up until their children were 18 months of age. During pregnancy, the women received either 3 capsules per day of placebo or 600mg per day of DHA from a mean (SD) of 14.5 (3.7) weeks' (all before 20 weeks) gestation until birth. The parents of 190 children consented to additional follow-up of their children until 6 years, which ended April 29, 2016. Study personnel involved in testing were blind to the randomization until all children had completed the trial. Data analysis was performed from May 23, 2017, to July 10, 2018. INTERVENTIONS Pregnant women were assigned to either 600 mg per day of DHA or a placebo that was half soy and half corn oil. Both placebo and DHA were provided in 3 capsules per day. MAIN OUTCOMES AND MEASURES Childhood blood pressure was a planned secondary outcome of a study powered to measure cognitive development. The hypothesis was that DHA would lower blood pressure prior to data analysis. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at 4, 4.5, 5, 5.5, and 6 years and were analyzed for possible covariates using mixed models to generate a final model. RESULTS In total, 171 children (88 [51.5%] female) were included in this analysis. Of these children, 89 (52.0%) were randomized to the DHA group and 82 (47.9%) to the placebo group. A statistically significant interaction was found between treatment (placebo or DHA) and child weight status (5-year body mass index <= 85th or >85th percentile) for both SBP and DBP. Children who were overweight or obese whose mothers received placebo during pregnancy had higher SBP and DBP compared with children who were overweight or obese whose mothers received DHA (mean [SE] SBP, 104.28 [1.37] mmHg vs 100.34 [1.02] mmHg; DBP, 64.7 [1.23] mmHg vs 59.76 [0.91] mmHg). No differences in the SBP and DBP were found between children who were overweight or obese whose mothers received DHA and children who were not overweight or obese. In the mixed model analysis, the child's age at blood pressure measurement and the maternal prepregnancy body mass index were the only other statistically significant variables (child age, SBP: F = 7.385; P =.001; DBP: F = 7.39; P =.001; prepregnancy BMI, SBP: r = 0.284; P =.001; DBP: r = 0.216; P =.01). CONCLUSIONS AND RELEVANCE Maternal docosahexaenoic acid intake during pregnancy appeared to mitigate the association between childhood overweight condition or obesity and blood pressure.

BACKGROUND Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. OBJECTIVE Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. METHODS In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. RESULTS Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. CONCLUSIONS Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

Maternal vitamin D status during pregnancy may modulate fetal immune system development and infant susceptibility to infections. Vitamin D deficiency is common during pregnancy, particularly among African American (AA) women. Our objective was to compare maternal vitamin D status (plasma 25(OH)D concentration) during pregnancy and first-year infections in the offspring of African American (AA) and non-AA women. We used medical records to record frequency and type of infections during the first year of life of 220 term infants (69 AA, 151 non-AA) whose mothers participated in the Kansas University DHA Outcomes Study. AA and non-AA groups were compared for maternal 25(OH)D by Mann–Whitney U-test. Compared to non-AA women, AA women were more likely to be vitamin D deficient (<50 nmol/L; 84 vs. 37%, p < 0.001), and more of their infants had at least one infection in the first 6 months (78.3% and 59.6% of infants, respectively, p = 0.022). We next explored the relationship between maternal plasma 25(OH)D concentration and infant infections using Spearman correlations. Maternal 25(OH)D concentration was inversely correlated with the number of all infections (p = 0.033), eye, ear, nose, and throat (EENT) infections (p = 0.043), and skin infection (p = 0.021) in the first 6 months. A model that included maternal education, income, and 25(OH)D identified maternal education as the only significant predictor of infection risk in the first 6 months (p = 0.045); however, maternal education, income, and 25(OH)D were all significantly lower in AA women compared to non-AA women . The high degree of correlation between these variables does not allow determination of which factor is driving the risk of infection; however, the one that is most easily remediated is vitamin D status. It would be of value to learn if vitamin D supplementation in this at-risk group could ameliorate at least part of the increased infection risk.

As previously reported, intention-to-treat findings from our phase III randomized clinical trial found that a supplement of 600 mg docosahexaenoic acid (DHA)/day during the last half of pregnancy reduced the incidence of early preterm birth (ePTB, <34 weeks gestation) and very low birth weight (VLBW < 1500 g) offspring. Given the potentially immense clinical significance of these findings, the goal of this secondary analysis was to (1) identify maternal characteristics related with capsule intake (i.e. DHA dose exposure) and (2) determine if DHA dose was associated with low (<2500 g) and very low birth weight after controlling for any relevant maternal characteristics. Three hundred forty-five pregnant mothers were recruited from hospitals in the Kansas City metropolitan area between 2006 and 2011. Most participants (n = 299) were from the phase III trial mentioned above, but we also included 46 participants from a second smaller, randomized trial that utilized an identical intervention design and was conducted concurrent to the larger trial. Both trials assigned participants to either 3 daily capsules of vegetable oil without DHA (n = 169) or 3 daily capsules of 200 mg DHA each (n = 176). Total capsules consumed was recorded by pharmacy supervised capsule count or participant self-report when needed. Maternal age, education, race and gestational age at delivery as well as infant birth weight were available for both trials. A Bayesian linear model indicated capsule intake increased with maternal age (p = 0.0100) and years of education (p = 0.0002). A Bayesian bivariate mixture-model associated capsule intake with simultaneous lower probability of ePTB, low birth weight (LBW, <2500 g) and VLBW (p = 0.0327). This, in conjunction with the positive findings in the clinical trial, support the need for future research to examine intervention methods to improve capsule compliance strategies in younger and less educated mothers.

Background:Observational studies find associations between maternal docosahexaenoic acid (DHA) and greater fat-free mass and lower percentage of body fat, but randomized trials of prenatal DHA supplementation have not found significant intent-to-treat effects on childhood body composition.Objective:This study sought to explore associations between intrauterine DHA exposure and body composition and size at 5 y in the offspring of women who participated in a randomized trial of prenatal DHA supplementation (corn and soybean oil placebo or 600 mg/d).Design:At 5 y, body composition was measured by air displacement plethysmography in 154 offspring of women who had participated in the Kansas University DHA Outcomes Study and who had red blood cell (RBC) phospholipid (PL) fatty acids assessed at enrollment and delivery. We used linear regression models to analyze the relation among 3 indicators of intrauterine DHA exposure-1) intent-to-treat (placebo or DHA), 2) maternal RBC PL DHA status at delivery, and 3) change in maternal DHA (delivery minus enrollment)-and 6 outcomes of interest: 5-y fat mass, fat-free mass, percentage of body fat, height, weight, and body mass index z score.Results:Change in maternal RBC PL DHA correlated with higher fat-free mass (r = 0.21, P = 0.0088); the association was unchanged after adjustment for maternal, perinatal, and childhood dietary factors. Intent-to-treat and DHA status at delivery showed positive trends with fat-free mass that were not statistically significant. There was no evidence relating intrauterine DHA exposure to any other body composition measure.Conclusions:Change in maternal DHA status during pregnancy was related to higher offspring 5-y fat-free mass. The other 2 indicators of intrauterine exposure to DHA suggested a trend for higher offspring 5-y fat-free mass. Our findings agree with an earlier observational study from the United Kingdom. This trial was registered at clinicaltrials.gov as NCT00266825.

The DHA Intake and Measurement of Neural Development (DIAMOND) trial represents one of only a few studies of the long-term dose-response effects of LCPUFA-supplemented formula feeding during infancy. The trial contrasted the effects of four formulations: 0.00% docosahexaenoic acid (DHA)/0.00% arachidonic acid (ARA), 0.32% DHA/0.64% ARA, 0.64% DHA/0.64% ARA, and 0.96% DHA/0.64% ARA against a control condition (0.00% DHA/0.00% ARA). The results of this trial have been published elsewhere, and show improved cognitive outcomes for infants fed supplemented formulas, but a common finding among many of the outcomes show a reduction of benefit for the highest DHA dose (i.e., 0.96%DHA/0.64% ARA, that is, a DHA:ARA ratio 1.5:1.0). The current paper gathers and summarizes the evidence for the reduction of benefit at this dose, and in an attempt to account for this reduced benefit,  Mead Johnson Nutrition provided support for the parent DIAMOND study and for investigators at both Dallas and Kansas City sites to follow the long term development of these children, results of which are reviewed here. 2 presents for the first time data from infants’ red blood cell (RBC) assays taken at 4 and 12 months of age. Those assays indicate that blood DHA levels generally rose with increased DHA supplementation, although those levels tended to plateau as the DHA-supplemented level exceeded 0.64%. Perhaps more importantly, ARA levels showed a strong inverted-U function in response to increased DHA supplementation; indeed, infants assigned to the formula with the highest dose of DHA (and highest DHA/ARA ratio) showed a reduction in blood ARA relative to more intermediate DHA doses. This finding raises the possibility that reduced ARA may be responsible for the reduction in benefit on cognitive outcomes seen at this dose. The findings implicate the DHA/ARA balance as an important variable in the contribution of LCPUFAs to cognitive and behavioral development in infancy. Abbreviations: ARA, arachidonic acid; DHA, docosahexaenoic acid; DIAMOND, DHA intake and measurement of neural development.

The DHA Intake and Measurement of Neural Development (DIAMOND) trial represents one of only a few studies of the long-term dose-response effects of LCPUFA-supplemented formula feeding during infancy. The trial contrasted the effects of four formulations: 0.00% docosahexaenoic acid (DHA)/0.00% arachidonic acid (ARA), 0.32% DHA/0.64% ARA, 0.64% DHA/0.64% ARA, and 0.96% DHA/0.64% ARA against a control condition (0.00% DHA/0.00% ARA). The results of this trial have been published elsewhere, and show improved cognitive outcomes for infants fed supplemented formulas, but a common finding among many of the outcomes show a reduction of benefit for the highest DHA dose (i.e., 0.96%DHA/0.64% ARA, that is, a DHA: ARA ratio 1.5:1.0). The current paper gathers and summarizes the evidence for the reduction of benefit at this dose, and in an attempt to account for this reduced benefit, presents for the first time data from infants' red blood cell (RBC) assays taken at 4 and 12 months of age. Those assays indicate that blood DHA levels generally rose with increased DHA supplementation, although those levels tended to plateau as the DHA-supplemented level exceeded 0.64%. Perhaps more importantly, ARA levels showed a strong inverted-U function in response to increased DHA supplementation; indeed, infants assigned to the formula with the highest dose of DHA (and highest DHA/ARA ratio) showed a reduction in blood ARA relative to more intermediate DHA doses. This finding raises the possibility that reduced ARA may be responsible for the reduction in benefit on cognitive outcomes seen at this dose. The findings implicate the DHA/ARA balance as an important variable in the contribution of LCPUFAs to cognitive and behavioral development in infancy.

In an interesting study published in the Journal, Gibbs et al 1 Gibbs H.D. Kennett A.R. Kerling E.H. et al. Assessing the nutrition literacy of parents and its relationship with child diet quality. J Nutr Educ Behav. 2016; 48: 505-509 Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar aimed to investigate the reliability and validity of the Nutrition Literacy Assessment Instrument for Parents (NLit-P) and its relationship to the child Healthy Eating Index. They found that the NLit-P is a reliable tool that can predict the child Healthy Eating Index. Assessing the Nutrition Literacy of Parents and Its Relationship With Child Diet QualityJournal of Nutrition Education and BehaviorVol. 48Issue 7PreviewTo estimate the reliability and validity of the Nutrition Literacy Assessment Instrument for Parents (NLit-P) and to investigate relationships among parental nutrition literacy, parental and child body mass index, and child diet quality (Healthy Eating Index). Full-Text PDF Response to Letter to the EditorJournal of Nutrition Education and BehaviorVol. 48Issue 8PreviewWe appreciate the comments provided to us in the letter from Dr Ayubi, and we thank the editors for the opportunity to respond to the criticisms offered and to expand discussion of our work. Full-Text PDF

Dietary habits established in early childhood and maternal socioeconomic status (SES) are important, complex, interrelated factors that influence a child’s growth and development. The aim of this study was to define the major dietary patterns in a cohort of young US children, construct a maternal SES index, and evaluate their associations.