Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia...
SchizophreniaBipolar I DisorderTo compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Targeted vs Standard Fortification of Breast Milk
BPD - Bronchopulmonary DysplasiaNEC - Necrotizing Enterocolitis3 moreBACKGROUND: Human milk (HM) is recommended for all very low birth infants (VLBW)). Breast-milk is highly variable in nutrient content, failing to meet the nutritional demands of VLBW. Fortification of HM is recommended to prevent extra-uterine growth retardation and associated poor neurodevelopmental outcome. However, standard fortification with fixed dose multicomponent fortifier does not account for the variability in milk composition. Targeted fortification is a promising alternative and needs further investigation. The aim of the study is to evaluate if targeted fortification of human milk may optimize growth and development in preterm infants. STUDY DESIGN: Randomized single blind controlled trial. METHODS & ANALYSIS: We will recruit preterm infants (≤ 32 weeks of gestation) within the first 7 days of life. After reaching 80 ml/kg/day of enteral feeding, patients will be randomised to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialko, Nutricia - protein, Fantomalt, Nutricia - carbohydrates, Calogen, Nutricia - lipids). The intervention will continue until 37 weeks of post-conception age, or hospital discharge. Parents and outcome assessors will be blinded to the intervention. The primary outcome - weight gain velocity will be measured starting from the day infants regain their birth weight up to 4 weeks, then weekly until discharge. Secondary outcomes such as neurodevelopment at 12 months of corrected age (CA) will be assessed with Bayley Scale of Development III, repeated at 36 months of CA. Additionally a Wescheler Preschool and Primary Scale of Intelligence IV test will be applied at 3,5 years of CA. Secondary outcomes such as length and head growth, body composition will be assesed at discharge and at 4 months. Incidence of necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) will also be followed.
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide...
HIV InfectionsThe primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC).
Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
ObesityOverweight1 moreThe purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.
Go Girls! Fitness Support Group Intervention Effectiveness Study
Polycystic Ovary SyndromeAbnormal Weight Gain4 moreThe main purpose of this study is to determine if the Go Girls! program to take place at the Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to introduce girls to a fun, non-threatening environment of exercise with peer support, improves scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of physical activity before and after the program will allow objective evaluation of whether the program is achieving its mission. Qualitative responses to the questionnaires will give program leaders a better sense of potential attitudes and barriers to regular exercise for teen girls. These responses will be used to shape activities during this or future programs for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk factors can be seen from this 6-month once weekly intervention.
A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy...
Weight Gain During PregnancyThe study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.
Effect of Hindmilk on Growth Velocity of Very Preterm Infants
Weight GainResearch question: Does feeding hindmilk improve weight gain in very preterm infants with poor growth velocity? Hypothesis: In very preterm infants (born less than 32 weeks gestation) with poor postnatal growth velocity (<15 g/kg/day), feeding hindmilk would improve average weight gain by at least 4 g/kg per day. Study design: This will be a prospective cohort study in very preterm infants admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre
ClockWork Postpartum Weight Management Study
ObesityPostpartum Weight Retention2 moreThe ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy obesity during the first 4 months postpartum.
DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
ObesityMorbid1 moreThis study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.
Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate...
Weight GainThe aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST_IMF). Own mother milk (OMM) fed infants will serve as reference group.