Ustekinumab in paediatric patients with moderately to severely active Crohn's disease: UniStar study long-term extension results.

Objectives: To assess the efficacy, safety, immunogenicity, and pharmacokinetics through 240 weeks of ustekinumab treatment in paediatric patients from the long-term extension (LTE) of the phase 1, double-blind UniStar trial.

Methods: Paediatric patients with moderately to severely active Crohn's disease (CD) were randomised 1:1 and stratified by body weight (<40 or ≥40 kg) to low- or high-dose intravenous ustekinumab followed by a subcutaneous maintenance dose at Week 8. At Week 16, patients were eligible to enter the LTE at the discretion of the investigator and continued maintenance dosing every 8 weeks up to Week 240.

Using multiple imputation of real-world data to estimate clinical remission in pediatric inflammatory bowel disease.

To evaluate the performance of the multiple imputation (MI) method for estimating clinical effectiveness in pediatric Crohn's disease in the ImproveCareNow registry; to address the analytical challenge of missing data. Simulation studies were performed by creating missing datasets based on fully observed data from patients with moderate-to-severe Crohn's disease treated with non-ustekinumab biologics. MI was used to impute sPCDAI remission statuses in each simulated dataset.

Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity.

Background: To demonstrate treatment efficacy in Crohn's disease (CD), regulatory authorities require that trials include an endoscopic remission/response end point; however, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn's Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was developed to be easy to use in routine clinical practice and as a trial end point. We conducted a study to assess and validate the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity.

Sugar-sweetened beverage purchases and intake at event arenas with and without a portion size cap.

This is the first real-world study to examine the association between a voluntary 16-ounce (oz) portion-size cap on sugar-sweetened beverages (SSB) at a sporting arena on volume of SSBs and food calories purchased and consumed during basketball games. Cross-sectional survey data from adults exiting a Brooklyn, NY, USA arena (Barclays, n = 464) with a 16-oz portion-size restriction and a Manhattan, NY, USA arena with no portion-size restriction (Madison Square Garden, control, n = 295) after the portion cap policy was put in place from March through June 2014 were analyzed. Linear regression models adjusting for sex, age, BMI, ethnicity, race, marital status, education, and income were used to compare the two arenas during the post-implementation period.

Protein levels and protease activity in milk from mothers of pre-term infants: A prospective longitudinal study of human milk macronutrient composition.

Background And Aims: The composition and enzymology of human milk changes throughout the lactation period, and differ for mothers who give birth prematurely compared to those who deliver at full-term. Understanding the composition of milk from mothers of very low birth weight premature infants is of great significance, and the objective of this study was to evaluate the composition, protein profile and plasmin activity of milk from mothers who delivered infants at different gestational ages.

Methods: Samples of human milk were donated by women (n = 74) in the Cork, Ireland, area who gave birth to full-term (>37 weeks gestation, FT), pre-term (32-37 weeks, PT) and very pre-term (≤32 weeks, VPT) infants.

Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.

Background: Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high -2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance.

Methods: In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days.

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies.

Background: Ustekinumab is currently approved globally in Crohn's disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn's disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses.

Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group.

Background: The term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN.

Objectives: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued.

Correction: Early childhood obesity prevention efforts through a life course health development perspective: A scoping review.

[This corrects the article DOI: 10.1371/journal.pone.

Early childhood obesity prevention efforts through a life course health development perspective: A scoping review.

Introduction: The obesity rate in preschool children in the United States (US) is 13.9%, while even higher rates are associated with racial and ethnic minorities and children from low-income families. These prevalence patterns underscore the need to identify effective childhood obesity prevention programs.

A descriptive system for the Infant health-related Quality of life Instrument (IQI): Measuring health with a mobile app.

Background: The assessment of health-related quality of life (HRQoL) is important for health outcomes research, disease modeling studies and comparisons of different healthcare interventions. Yet, only a few tools are available to assess HRQoL in 0-1-year-old infants. Furthermore, there is a need for an instrument able to assess HRQoL with a single, standardized, overall score in the first year of life.

Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study.

Background: The rising prevalence of childhood obesity in Asia has led to interest in potential risk factors such as infant health-related quality of life (HRQoL), temperament and eating behaviors. This pilot study evaluated the utility of administering parent-reported outcome measures (PROMs) to explore these factors in Filipino infants and examined the relationships between these factors and infant sex, formula intake and weight, over time.

Methods: Forty healthy, 4-week-old, formula-fed infants (n = 20 males) were enrolled in this 6-week, prospective, uncontrolled study during which infants were exclusively fed a standard term infant formula enriched with alpha-lactalbumin.

Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines.

Background: Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother, fetus and infant. The primary objective of this study was to assess the effect of a maternal nutritional supplement enriched with probiotics during pregnancy and early lactation on the incidence of infant diarrhea.

Methods: Healthy, pregnant (24-28 weeks gestation) women were randomized 1:1:1 to receive either no supplement or two servings per day of an oral supplement (140 kcal/serving) providing 7.

Feasibility and Psychometric Properties of the Infant Toddler Quality of Life (ITQOL) Questionnaire in a Community-Based Sample of Healthy Infants in China.

Objective Evaluate the feasibility and psychometric properties of the Infant Toddler Quality of Life (ITQOL) questionnaire as a measure of health-related quality of life (HRQOL) in a sample of Chinese infants. Methods The linguistically validated Simplified Chinese version of the ITQOL was used in a multicenter, observational study of healthy, term infants (N = 427), age 6 weeks at enrollment, in China. At Days 1 and 48, parents/guardians completed the ITQOL, the Short Form Health Survey (SF-12v2) and the Infant Gastrointestinal Symptom Questionnaire (IGSQ).

Healthcare interventions for the prevention and control of gestational diabetes mellitus in China: a scoping review.

Background: Gestational Diabetes Mellitus (GDM) is a type of diabetes which occurs during pregnancy. Women with GDM are at greater risk of complications during pregnancy and delivery, while babies born from mothers with GDM are at greater risk of post-natal complications. Using the most updated diagnosis criteria, the GDM prevalence is estimated at 9.

Nutrient intake and dietary patterns in children 2.5-5 years of age with picky eating behaviours and low weight-for-height.

Background And Objectives: Picky eating behaviours are common in young children and may adversely affect dietary intake. This study examined the adequacy of dietary patterns and nutrient intake in preschool-aged children in China and Hong Kong with picky eating behaviours and weight-for-height in the lowest quartile of the WHO Growth Standards.

Methods And Study Design: Dietary intake was assessed using baseline 3-day food records from a multicenter, randomized trial in Chinese children (N=151) ages 2.

Infant feeding and health-related quality of life in healthy Chinese infants: results from a prospective, observational cohort study.

Background: Infant feeding regimens, including breastfeeding, formula-feeding, or a combination of the two, may influence infant health-related quality of life (HRQOL). However, few studies have examined this association.

Methods: This prospective cohort study assessed HRQOL in relation to three parent-selected feeding regimens: exclusively breastfed (n = 136), exclusively study formula-fed (n = 140), and mixed-fed with study formula and breast milk (n = 151).

Effects of a 2-year behavioral weight loss intervention on sleep and mood in obese individuals treated in primary care practice.

Objective: To examine the effect of weight loss on sleep duration, sleep quality, and mood in 390 obese men and women who received one of three behavioral weight loss interventions in the Practice-based Opportunities for Weight Reduction trial at the University of Pennsylvania (POWER-UP).

Methods: Sleep duration and quality were assessed at baseline and months 6 and 24 by the Pittsburgh Sleep Quality Index (PSQI) questionnaire and mood by the Patient Health Questionnaire-8 (PHQ-8). Changes in sleep and mood were examined according to treatment group and based on participants' having lost ≥5% of initial weight vs.

Nutritional management of type 2 diabetes mellitus and obesity and pharmacologic therapies to facilitate weight loss.

Diet plays an integral role in the treatment of type 2 diabetes mellitus (T2DM). Unfortunately, many patients with T2DM do not have access to a registered dietitian or certified diabetes educator, and rates of physician counseling about diet remain low. This article provides an overview of the current recommendations for the nutritional management of T2DM, which are endorsed by the American Diabetes Association (ADA).

Relationship between sexual function and quality of life in obese persons seeking weight reduction.

Objective: This study investigated sexual functioning in persons with obesity and seeking weight loss, and the associations of sexual functioning with relevant demographic and clinical variables as well as quality of life were investigated.

Design And Methods: Participants were enrolled in a two-year randomized clinical trial. Participants were obese and had at least two components of metabolic syndrome.

A two-year randomized trial of obesity treatment in primary care practice.

Background: Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices.

Methods: We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss.

Patients' preferred terms for describing their excess weight: discussing obesity in clinical practice.

The increasing prevalence of obesity has become one of the most challenging problems facing healthcare providers. Despite recommendations from the US Preventive Services Task Force, many health professionals fail to discuss obesity with their patients. This study sought to identify terms that obese individuals who were treated in primary care would find the most and least acceptable for describing their excess weight.

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

Background: The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials.