Acceptability of a text message-based intervention for obesity prevention in infants from Hawai'i and Puerto Rico WIC.

BACKGROUND: Low-income and minority children are at increased risk for obesity. Text messaging offers advantages for delivering education, but few studies have assessed the acceptability of text messaging in interventions aimed at preventing excessive weight gain in infants. This study investigated the acceptability of a text message-based intervention for prevention of excessive weight gain in infants from Hawai'i and Puerto Rico WIC clinics. METHODS: The four-month text message based intervention designed to improve infant feeding practices and reduce excessive weight gain was a randomized controlled trial that included mothers with infants ages 0-2 months at baseline. Participants in the intervention arm received 18 text messages (1/week) promoting breastfeeding and appropriate complementary feeding. Acceptability of the intervention was assessed from participant retention, satisfaction, and evidence of behavior change in a sequential multimethod approach, quantitatively from questions sent via text and qualitatively during the in-person exit interview. The final analysis included 80 mother-infant pairs from the intervention arm. RESULTS: When asked about messages liked and disliked the most, the majority of responses via text indicated that they liked all messages. From the qualitative analyses, most participants reported that all messages were useful and that the messages led them to make changes in the way they fed their infants. Participant retention was good at 78.4%. CONCLUSIONS: The intervention was acceptable to participants based upon participant retention, measures of satisfaction, and reports of behavior change. Results may inform development of mobile health programs for minority childhood obesity prevention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier; NCT02903186; September 16, 2016.

Breastfeeding Discontinuation Not Associated with Maternal Pregravid BMI But Associated with Native Hawaiian or Other Pacific Islander Race in Hawaii and Puerto Rico WIC Participants.

Objectives This study investigated the association between maternal pregravid body mass index (BMI) and breastfeeding discontinuation at 4-6 months postpartum in Hawaii and Puerto Rico participants from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Methods A secondary data analysis was conducted from a text message-based intervention in WIC participants in Hawaii and Puerto Rico. The analysis included 87 women from the control group who initiated breastfeeding and whose breastfeeding status was known at the end of the study when infants were 4-6 months old. Pregravid BMI and breastfeeding discontinuation were assessed using questionnaires. Results The association between pregravid BMI and breastfeeding discontinuation was not significant in the unadjusted model or in the adjusted model. Native Hawaiian or Other Pacific Islander (NHOPI) participants showed significantly increased odds of discontinuing breastfeeding (adjusted odds ratio [AOR] 7.12; 95% CI 1.34, 37.97; p = .02) compared to all the other racial/ethnic participants, as did older women ages 32-39 years versus women who were 25-31 years old (AOR 4.21; 95% CI 1.13, 15.72; p = .03). Women who took vitamins while breastfeeding had decreased odds of discontinuing breastfeeding (AOR 0.15; 95% CI 0.05, 0.46; p = .0009). Conclusions for Practice Pregravid BMI was not significantly associated with breastfeeding discontinuation at 4-6 months postpartum in women from Hawaii and Puerto Rico WIC, but NHOPIs and women who were older had higher odds of discontinuing breastfeeding. The results of this study may inform strategies for breastfeeding promotion and childhood obesity prevention but should be further investigated in larger studies. ClinicalTrials.gov Identifier: NCT02903186.

Effect of a Multi-Site Trial using Short Message Service (SMS) on Infant Feeding Practices and Weight Gain in Low-Income Minorities.

OBJECTIVE: To test the effects of weekly SMS for improving infant feeding practices and infant weight. METHODS: This was a multi-site randomized clinical trial in a convenience sample of 202 caregivers of healthy term infants 0-2 months participating in the WIC program in Puerto Rico and Hawaii. Participants were randomized to receive SMS about infant's general health issues (control) or SMS for improving feeding practices (intervention) for four months. Weight, length and infant feeding practices were assessed at baseline and four months later. RESULTS: A total of 170 participants completed the study (n = 86 control and n = 84 intervention). Baseline characteristics were similar between groups. At the end, exclusive breastfeeding rates were similar between groups (67.4% control and 59.1% intervention). Introduction of other foods and beverages, addition of foods to the bottle, placing infants to sleep with milk bottles, caregiver's method and response to feeding infants and distractions while feeding infants were similar between groups. Also, weight status or rate of weight gain was similar between groups. CONCLUSION: There were no significant improvements in feeding practices or in weight with the intervention. The timeline of the messages in relation to the targeted behavior may have affected the effectiveness of the intervention. Earlier dissemination of messages, higher level of intensity, longer intervention, additional contacts and inclusion of other caregivers may be needed to achieve the desired effects.

Cross-sectional associations of impaired glucose metabolism measures with bleeding on probing and periodontitis.

AIM: This study assessed the associations of pre-diabetes and insulin resistance with bleeding on probing (BOP) and periodontitis among adults. MATERIALS AND METHODS: We included 1191 Hispanic adults aged 40-65 years, free of diabetes, enrolled in San Juan Overweight Adults Longitudinal Study. Pre-diabetes was defined as impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or impaired glycated haemoglobin. Impaired one-hour plasma glucose (1hPG) was defined as levels >155 mg/dl. Insulin resistance was defined using the study population-specific 75th percentile (HOMA-IR ≥ 3.13). High BOP was defined as percentage of teeth with bleeding ≥30%. Periodontitis was defined according to the CDC/AAP definition. RESULTS: After multivariable adjustment for age, gender, education, smoking status, alcohol consumption, physical activity, obesity, HDL-C, and plaque index, pre-diabetes with and without 1hPG, IFG, impaired 1hPG, IGT, and HOMA-IR were significantly associated with high BOP; pre-diabetes, IFG, and impaired 1hPG were significantly associated with severe periodontitis. Most of these associations remained significant when the analyses were restricted to non-smokers. CONCLUSIONS: This study suggests associations between pre-diabetes and insulin resistance with BOP and periodontitis. Given the high prevalence of impaired glucose metabolism and periodontitis, the assessment of the temporal sequence of these associations is of utmost importance.

Building a growing genomic data repository for maternal and fetal health through the PING Consortium.

Background: Prenatally transmitted viruses can cause severe damage to the developing brain. There is unexplained variability in prenatal brain injury and postnatal neurodevelopmental outcomes, suggesting disease modifiers. Discordant outcomes among dizygotic twins could be explained by genetic susceptibly or protection. Among several well-recognized threats to the developing brain, Zika is a mosquito-borne, positive-stranded RNA virus that was originally isolated in Uganda and spread to cause epidemics in Africa, Asia, and the Americas. In the Americas, the virus caused congenital Zika syndrome and a multitude of neurodevelopmental disorders. As of now, there is no preventative treatment or cure for the adverse outcomes caused by prenatal Zika infection. The Prenatal Infection and Neurodevelopmental Genetics (PING) Consortium was initiated in 2016 to identify factors modulating prenatal brain injury and postnatal neurodevelopmental outcomes for Zika and other prenatal viral infections. Methods: The Consortium has pooled information from eight multi-site studies conducted at 23 research centers in six countries to build a growing clinical and genomic data repository. This repository is being mined to search for modifiers of virally induced brain injury and developmental outcomes. Multilateral partnerships include commitments with Children's National Hospital (USA), Instituto Nacional de Salud (Colombia), the Natural History of Zika Virus Infection in Gestation program (Brazil), and Zika Instituto Fernandes Figueira (Brazil), in addition to the Centers for Disease Control and Prevention and the National Institutes of Health. Discussion: Our goal in bringing together these sets of patient data was to test the hypothesis that personal and populational genetic differences affect the severity of brain injury after a prenatal viral infection and modify neurodevelopmental outcomes. We have enrolled 4,102 mothers and 3,877 infants with 3,063 biological samples and clinical data covering over 80 phenotypic fields and 5,000 variables. There were several notable challenges in bringing together cohorts enrolled in different studies, including variability in the timepoints evaluated and the collected clinical data and biospecimens. Thus far, we have performed whole exome sequencing on 1,226 participants. Here, we present the Consortium's formation and the overarching study design. We began our investigation with prenatal Zika infection with the goal of applying this knowledge to other prenatal infections and exposures that can affect brain development.

Acceptability and Ease of Use of an Educational Website among Women, Infants, and Children Program Participants in Puerto Rico: A Pilot Study.

OBJECTIVE: To evaluate a website for an educational intervention among participants of the Baby-Act Trial. Baby-Act is a community-based intervention to prevent infant obesity by promoting physical activity, sleep, and healthy eating behaviors in Women, Infants, and Children (WIC) program participants in Puerto Rico. The intervention was designed to be delivered through a mobile application, but after the study was launched, participants reported many difficulties, and an alternative educational platform was developed. METHODS: Participants of the WIC program completed a face-to-face structured interview consisting of several open-ended questions. After completing the interview, they were instructed on how to access the newly developed webpage and completed the lessons found therein. Then followed a survey that explored the overall experience. RESULTS: Nine participants were interviewed; they all agreed that the website was easy to access, registration was simple, and the webpage was clear; 8 were able to complete at least 1 lesson (1 participant had a very poor signal), and all 9 reported being confident in using the webpage and stated they would use it again. CONCLUSION: The study participants found this website to be user-friendly and a viable alternative for future educational intervention delivery to WIC participants.

Effect of a Short Messaging Service (SMS) intervention delivered to caregivers on energy, nutrients, and food groups intake in infant participants of the WIC program.

Objectives: To test the effect of a weekly test message (SMS) intervention for improving feeding practices on infant intake of energy, nutrients, and specific food groups. Methods: This study was a multi-site, randomized clinical trial, in 202 caregivers of healthy term infants participating in either the Puerto Rico or Hawaii WIC program. Participants were randomized to receive weekly SMS about either infant's general health issues (control) or SMS for improving feeding practices (intervention) to complement WIC messages for 4 months. Anthropometrics and demographics were assessed at baseline. A validated infant food frequency questionnaire was assessed at the four-month visit to assess intake of general food groups. Data was summarized as median (25th and 75th percentiles) or percentage and differences between study arms was compared using Mann Whitney or chi-square. Results: A total of 163 participants completed the study (n = 84 control and n = 79 intervention). Baseline characteristics were similar between both groups. At 4-6 months of age, compared to the control group, the intervention group had a significantly higher intake of total grains (0.28 oz; 0.00, 0.60; P = 0.033), protein (13.5 g, 10.5, 18.3; P = 0.022), calcium (472 mg; 418, 667; P = 0.012), and zinc (4.39 mg; 2.61, 6.51; P = 0.028). No differences were seen in the other food groups, including breastmilk. Conclusions for practice: Feeding SMS to complement WIC messages led to higher intakes of some key nutrients but did not have an overall improvement in the intake of food groups. Messaging also did not delay the introduction of complimentary foods or improve breastfeeding rates. Future studies should evaluate the use of more intensive SMS interventions for continued care between WIC visits.

Associations between vitamin D levels and glucose metabolism markers among pregnant women and their infants in Puerto Rico.

INTRODUCTION: Objectives: low vitamin D during pregnancy is common and could adversely affect health outcomes. This study evaluated vitamin D status during pregnancy and early in life, and its association with glucose metabolism. Methods: maternal serum 25(OH)D, glucose, and insulin levels were measured longitudinally during pregnancy in Hispanic women with overweight/obesity (n = 31) and their infants at birth and 4 months. Results: insulin and HOMA-IR levels were higher among women with vitamin D below adequate levels compared to those with adequate levels in pregnancy (p < 0.05). Late in pregnancy, as vitamin D increased by one unit (ng/mL), insulin decreased by 0.44 units and HOMA-IR by 0.09 units. Maternal vitamin D late in pregnancy was correlated with infant vitamin D levels at birth (r = 0.89; p < 0.01) and 4 months (r = 0.9; p = 0.04), and with glucose (r = 0.79; p = 0.03) and insulin (r = 0.83; p = 0.04) at 4 months. Conclusion: maternal vitamin D status was associated with maternal and infant glucose metabolism in this sample.

INTRODUCCIÓN: Objetivos: un bajo nivel de vitamina D durante el embarazo es común y puede tener consecuencias adversas en la salud. Este estudio evaluó el nivel de vitamina D en mujeres embarazadas y sus bebés, así como su asociación con los marcadores de glucosa. Métodos: los niveles séricos de 25(OH)D, glucosa e insulina se midieron longitudinalmente en mujeres embarazadas hispanoamericanas con sobrepeso/obesidad (n = 31) y en sus bebés, desde el nacimiento hasta los 4 meses de edad, en Puerto Rico. Resultados: los niveles maternos de insulina y HOMA-IR eran mayores en las mujeres con niveles de vitamina D por debajo de lo considerado adecuado, comparado con aquellas con niveles adecuados durante todo el embarazo (p < 0,05). Al final del embarazo, a medida que los niveles de vitamina D aumentaron, por cada unidad (ng/mL) de aumento, la insulina disminuyo en 0,44 unidades y el HOMA-IR en 0,09 unidades. El nivel de vitamina D al final del embarazo se correlacionó con los niveles del bebé al nacer (r = 0,89; p < 0,01) y a los 4 meses (r = 0,9; p = 0,04), y con los niveles de glucosa (r = 0,79; p = 0,03) e insulina (r = 0,83; p = 0,04) a los 4 meses. Conclusión: el nivel materno de vitamina D se asoció con los marcadores maternos e infantiles de glucosa en esta muestra.

Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.

Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 µg/serotype/dose adjuvanted with aluminum, AS01E or AS03B, or aluminum-adjuvanted 4 µg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03B). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03B: 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.

Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study.

BACKGROUND: MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this study, we assessed the immunogenicity and safety of another MMR vaccine (MMR-RIT [Priorix, GlaxoSmithKline]) compared with those of the MMR II in 12- to 15-month-old children who received it as a first dose. METHODS: In this phase III, observer-blinded, noninferiority, lot-to-lot consistency clinical trial (ClinicalTrials.gov identifier NCT01702428), 5003 healthy children were randomly assigned to receive 1 dose of MMR-RIT (1 of 3 production lots) or MMR II along with other age-recommended routine vaccines. We evaluated the immunogenicity of all vaccines in terms of antibody concentrations (by using an enzyme-linked immunosorbent assay or electrochemiluminescence assay) and/or seroresponse rates 43 days after vaccination. We also assessed the reactogenicity and safety of the vaccines. RESULTS: Immunoresponses after vaccination with MMR-RIT were robust and noninferior to those after vaccination with the MMR II. Immunogenicity of the 3 production lots of MMR-RIT was consistent; more than 97% of the children had a seroresponse to MMR components. The coadministered vaccines elicited similar immunoresponses in the MMR-RIT and MMR II groups. Both MMR vaccines resulted in comparable reactogenicity profiles, and no safety concerns were detected. CONCLUSIONS: If licensed, the MMR-RIT could provide a valid option for the prevention of measles, mumps, and rubella in children in the United States and would reduce potential risks of a vaccine shortage.

Amount, Preparation and Type of Formula Consumed and Its Association with Weight Gain in Infants Participating in the WIC Program in Hawaii and Puerto Rico.

The aim of this study was to assess the association between amount (below or above recommendations), preparation (liquid vs. powder), and type (regular vs. hydrolysate) of infant formula consumed and weight in infants participating in the Women, Infant and Children (WIC) Program in Hawaii (HI) and Puerto Rico (PR). This was a secondary analysis of 162 caregivers with healthy term 0⁻2-month-old infants. Socio-demographics, infant food frequency questionnaires, and weight and length were assessed at baseline and after four months. Infant feeding practices were associated with weight-for-length z-scores using multivariable logistic regression. In total, 37.7% were exclusively breastfed and 27.2% were exclusively formula-fed. Among formula users, regular (63.6%) and powder (87.0%) formula were the most common; 43.2% consumed formula above recommendations. Most infants had rapid weight gain (61.1%). Infants fed regular formula had higher odds of overweight after four months (adjusted OR = 8.77, 95% CI: 1.81⁻42.6) and higher odds of rapid weight gain (adjusted OR = 3.10, 95% CI: 1.12, 8.61). Those exclusively formula fed had higher odds of slow weight gain (adjusted OR = 4.07, 95% CI: 1.17⁻14.2). Formula preparation and amount of formula were not associated with weight. These results could inform the WIC program's nutrition education messages on infant feeding. Studies with longer follow-up are needed to confirm these results.

PEARLS randomized lifestyle trial in pregnant Hispanic women with overweight/obesity: gestational weight gain and offspring birthweight.

BACKGROUND: Inappropriate gestational weight gain (GWG) has been associated with adverse perinatal events. High rates of GWG have been reported among Hispanic women. Observational studies indicate that dietary and physical activity interventions during the prenatal period may improve maternal and infant health, but very few randomized trials have been conducted among high-risk overweight/obese Hispanic women. Accordingly, we conducted a lifestyle intervention among high-risk pregnant women and evaluated its impact on achieving appropriate GWG and on improving birthweight. METHODS: Eligible overweight/obese women presenting at the University Hospital in Puerto Rico with a singleton pregnancy before 16 gestational weeks were recruited and randomized to lifestyle intervention (n=15) or control group (n=16). The lifestyle intervention focused on improving physical activity and diet quality and optimizing caloric intake. We evaluated the impact of the lifestyle intervention on achieving appropriate GWG and on infant birthweight. Poisson and linear regression analyses were performed. RESULTS: The primary intent to treat analysis showed no significant effect on achievement of appropriate GWG/week through 36 weeks in the intervention group (4/15 women) when compared with the control group (3/16 women) (adjusted incidence rate ratio =1.14; 95% CI: 0.20, 6.67). Although not statistically significant, women in the intervention group (6/15) were 1.7 times more likely to achieve appropriate weekly GWG until delivery when compared with controls (4/16 women) (adjusted incidence rate ratio = 1.67; 95% CI: 0.40, 6.94). We observed lower adjusted birthweight-for-length z-scores in the intervention compared with the control group among male newborns with z-score difference -1.74 (-3.04, -0.43), but not among females -0.83 (-3.85, 2.19). These analyses were adjusted for age and baseline body mass index. CONCLUSION: Although larger studies are required to determine whether women with obesity may benefit from prenatal lifestyle interventions targeting GWG, our results are suggestive of the intervention improving adherence to established Institute of Medicine guidelines.

Comparison of postdischarge growth in adequate for gestational age and small for gestational age very low birthweight infants.

INTRODUCTION: Some small for gestational age (SGA) neonates have a higher weight gain rate than adequate for gestational age (AGA) neonates. The objectives of this study were to evaluate the postdischarge growth of a cohort of very low birthweight infants to determine the percentage of those born SGA that achieve catch-up growth and whether AGA infants maintain adequate growth. METHODS: We performed a record review at the high-risk follow-up clinics of a previously paired group of infants. The infant's weight, height, and head circumference percentile at their last clinic visit were determined by using sex-adjusted curves. We also documented if the patient had presented any type of delay. RESULTS: Of 216 infants that were included in the original cohort, only 116 had evidence of enrollment in the clinic. The percentage of SGA that achieved catch-up growth was 18.6% (n = 59). The percentage of adequate for gestational age that maintained adequate growth was 42.1% (n = 57). The rate of developmental delay was not different between the groups (44.0% vs 38.6%, P = .5). CONCLUSIONS: We conclude that a high percentage of high-risk infants are developing postdischarge growth delay. This study demonstrates that both SGA infants as well as AGA infants present growth problems after discharge from the hospital, which emphasizes the importance of long-term followup.

Rate of weight gain in very-low birth weight Puerto Rican neonates.

BACKGROUND: Small for gestational age neonates have a higher risk of growth delay. The purpose of the study is to determine if there are differences in their early weight gain patterns that persist after adjusting for confounding variables. METHODS: Two-hundred sixteen neonates born between 1999 and 2003 were included. The group for analysis was derived by matching all the SGA infants with AGA infants by sex, year of birth, and birth weight. The period of observation was from birth to date of discharge. Weight gain rate was defined as grams gained per kilogram of birth weight per day. Two sample T-test was used to determine the difference in growth rate between the groups. Simple regression was used to establish the effect of morbidities on weight gain rate. RESULTS: The total mean birth weight was 1105 g (+/- 223 g), the mean gestational age was 30 weeks (+/- 2.7 weeks), and the mean weight gain rate was 13.4 g/kg/d (+/- 6.8 g/kg/d). The mean weight gain rate for the adequate for gestational age group was lower (11.9 g/kg/d +/- 7.6g versus 14.9 g/kg/d +/- 5.5 g) (P < 0.001). When all variables were analyzed using the lineal regression model, only having a low APGAR score (P = 0.02) and being small for gestational age (P = 0.0004) were significant. CONCLUSIONS: We conclude that the growth patterns of very low birth weight neonates are different based on the adequacy of their birth weight, and that the disparity in growth rate is not explained by the differences in the incidence of morbidities that affect growth.

Evidenced based management of neonatal hemangiolymphangioma: a case report.

Hemangiolymphangioma is a mixed vascular malformation that is detected in the prenatal period by sonography. Five cases of prenatal diagnosis have been reported that have resulted in termination of pregnancy (two) or aggressive versus purely surgical post-natal management. We present the case of an infant with pre-natal diagnosis of a multicystic intra-abdominal mass that received surgical management followed by conservative treatment.

Associations between gestational weight gain and rate of infancy weight gain in Hawai'i and Puerto Rico WIC participants.

BACKGROUND: Excessive gestational weight gain and rapid infancy weight gain (RIWG) are associated with increased susceptibility to childhood obesity. Since low-income and minority children are particularly at risk, investigation of the associations between gestational weight gain and rate of infancy weight gain may inform childhood obesity prevention. This study investigated the associations between gestational weight gain and rate of infancy weight gain during the first four to six months postpartum in participants from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Hawai'i and Puerto Rico. METHODS: This was a cross-sectional secondary data analysis from a text message-based intervention in WIC participants in Hawai'i and Puerto Rico. The analysis included 80 mother/infant pairs from the control group who completed the follow-up visit when infants were four to six months old. Maternal weight, height, and gestational weight gain were self-reported. Infant weight was measured at baseline and follow-up. A proportional odds model was used to investigate the association between gestational weight gain and infancy weight gain rate (rapid or extremely rapid, on-track, or slow), adjusting for maternal age, pregravid body mass index (BMI) status, parity, and being up-to-date with infant vaccinations. RESULTS: In comparison to recommended gestational weight gain, excessive and inadequate (under the recommended amount) gestational weight gain was associated with 77% decreased (adjusted odds ratio [AOR] = 0.23; 95% confidence interval [CI] = 0.08, 0.70; p = 0.01) and 71% decreased (AOR = 0.29; 95% CI = 0.09, 0.94; p = 0.04) odds of RIWG versus on-track or slow infant weight gain, respectively. In comparison to women with one child, women with two children (AOR = 0.31; 95% CI = 0.11, 0.87; p = 0.03) or three or four children (AOR = 0.24; 95% CI = 0.07, 0.88; p = 0.03) had significantly lower odds of RIWG versus on-track or slow infancy weight gain. CONCLUSIONS: Women with excessive or inadequate gestational weight gain had lower proportional odds of RIWG and were more likely to have slower infant weight gain than women who gained the recommended amount of weight. TRIAL REGISTRATION: ClinicalTrials.gov Identifier; NCT02903186; September 16, 2016.

Insulin resistance predicts the risk of gingival/periodontal inflammation.

OBJECTIVES: Evaluate whether insulin resistance (IR) predicts the risk of oral inflammation, assessed as the number of sites with bleeding on probing (BOP) and number of teeth with probing pocket depths (PPD) ≥ 4 mm and BOP. METHODS: Data on 870 overweight/obese diabetes free adults, aged 40-65 years from the San Juan Overweight Adults Longitudinal Study over a three-year period, was analyzed. Baseline IR, assessed using the Homeostasis Model Assessment of IR (HOMA-IR) index, was divided into tertiles. BOP was assessed at buccal and lingual sites, and PPD at six sites per tooth. Negative binomial regression was used to estimate the risk ratios (RRs) for oral inflammation adjusted for baseline age, gender, smoking status, alcohol intake, education, physical activity, waist circumference, mean plaque index, and baseline number of sites with BOP, or number of teeth with PPD≥4 mm and BOP. The potential impact of tertiles of serum TNF-α and adiponectin on the IR-oral inflammation association was also assessed in a subsample of 597 participants. RESULTS: Participants in the highest HOMA-IR tertile at baseline had significantly higher numbers of sites with BOP [RR = 1.19, 95% confidence interval (CI): 1.03-1.36] and number of teeth with PPD ≥ 4 mm and BOP (RR = 1.39, 95% CI: 1.09-1.78) at follow-up, compared with individuals in the lower two HOMA-IR tertiles. Neither TNF-α nor adiponectin confounded the associations. CONCLUSION: IR significantly predicts gingival/periodontal inflammation in this population.

Phase I Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico.

The safety and immunogenicity of four adjuvanted formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV) were evaluated in a predominantly dengue-primed population in Puerto Rico. In this placebo-controlled, randomized, observer-blind, phase I trial, 100 healthy adults were randomized 1:1:1:1:1 to receive DPIV at Day (D)0 and D28 (1 µg per dengue virus [DENV] type 1-4 adjuvanted with either alum, AS01E or AS03B, or 4 µg per DENV type adjuvanted with alum) or saline placebo. Functional antibody responses were assessed using a microneutralization assay at D56, Month (M)7, and M13. All DPIV formulations were well tolerated and no safety signals were identified through M13. The M13 according-to-protocol (ATP) immunogenicity cohort included 83 participants. The ATP analysis of immunogenicity was performed only on the 78 subjects seropositive for ≥ 1 DENV type at baseline: 69 tetravalent, three trivalent, two bivalent, and four monovalent. In all DPIV groups, geometric mean antibody titers (GMTs) increased from D0 to D56 and waned modestly through M13, while remaining well above prevaccination levels. The 4 µg + alum and the AS01E- and AS03B-adjuvanted formulations were highly immunogenic, with M13-neutralizing antibody GMTs against all four DENV types above 1,000. M13/D0 GMT ratios were highest in the 1 µg + AS03B group (ranging 3.2-3.7 depending on the DENV type). These results encourage continued clinical development of DPIV (ClinicalTrials.gov: NCT01702857).

Association between within-visit systolic blood pressure variability and development of pre-diabetes and diabetes among overweight/obese individuals.

Short-term blood pressure variability is associated with pre-diabetes/diabetes cross-sectionally, but there are no longitudinal studies evaluating this association. The objective of this study is to evaluate the association between within-visit systolic and diastolic blood pressure variability and development of pre-diabetes/diabetes longitudinally. The study was conducted among eligible participants from the San Juan Overweight Adults Longitudinal Study (SOALS), who completed the 3-year follow-up exam. Participants were Hispanics, 40-65 years of age, and free of diabetes at baseline. Within-visit systolic and diastolic blood pressure variability was defined as the maximum difference between three measures, taken a few minutes apart, of systolic and diastolic blood pressure, respectively. Diabetes progression was defined as development of pre-diabetes/diabetes over the follow-up period. We computed multivariate incidence rate ratios adjusting for baseline age, gender, smoking, physical activity, waist circumference, and hypertension status. Participants with systolic blood pressure variability ≥10 mmHg compared to those with <10 mmHg, showed higher progression to pre-diabetes/diabetes (RR = 1.77, 95% CI: 1.30-2.42). The association persisted among never smokers. Diastolic blood pressure variability ≥10 mmHg (compared to <10 mmHg) did not show an association with diabetes status progression (RR = 1.20, 95% CI: 0.71-2.01). Additional adjustment of baseline glycemia, C-reactive protein, and lipids (reported dyslipidemia or baseline HDL or triglycerides) did not change the estimates. Systolic blood pressure variability may be a novel independent risk factor and an early predictor for diabetes, which can be easily incorporated into a single routine outpatient visit at none to minimal additional cost.

A Semi-Quantitative Food Frequency Questionnaire Validated in Hispanic Infants and Toddlers Aged 0 to 24 Months.

BACKGROUND: There are limited validated food frequency questionnaires (FFQs) for infants and toddlers, most of which were evaluated in Europe or Oceania, and the ones available for use in the United States have important limitations. OBJECTIVE: Our aim was to assess the validity of an FFQ developed for infants and toddlers. DESIGN: A semi-quantitative FFQ was developed that included 52 food items, their sources, and portion sizes. The FFQ inquired about diets over the previous 7 days. Its validity was assessed in a cross-sectional study. Participants completed the FFQ, followed by a 24-hour recall on two occasions with 1 week between data collection. PARTICIPANTS/SETTING: A total of 296 caregivers of infants and toddlers aged 0 to 24 months enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children, Puerto Rico. MAIN OUTCOME MEASURES: Intake of nutrients and food groups were averaged for the two FFQs and the two 24-hour food recalls, and adjusted for energy intake. STATISTICAL ANALYSES PERFORMED: Spearman correlations were performed for intakes of energy, nutrients, and foods between administrations and between instruments. Correlation coefficients were de-attenuated to account for variation in the 24-hour recalls. RESULTS: A total of 241 participants completed the study. Intake of all nutrients and foods were significantly correlated between FFQs and 24-hour recalls and between the means of FFQs and 24-hour food recalls. The de-attenuated correlation for nutrients between the FFQs and 24-hour recalls ranged from 0.26 (folate) to 0.77 (energy), with a mean correlation of 0.53. The de-attenuated correlation for food groups between the FFQs and 24-hour recalls ranged from 0.28 (sweets) to 0.80 (breast milk), with a mean correlation of 0.55. When analyses were restricted to those consuming foods other than breast milk or formula (n=186), results were similar. CONCLUSIONS: This semi-quantitative FFQ is a tool that offers reasonably valid rankings for intake of energy, nutrients, foods, and food groups in this sample of infants and toddlers.