Pediatric Obesity

This cross-sectional study aims to assess cardiovascular structural and electrophysiological alterations in obese children attending Assiut University Children's Hospital.

This study will evaluate whether a nudge-based exercise program can improve body mass index (BMI) and physical activity in adolescents with obesity. About 140 adolescents aged 10-19 years will participate. Participants will be placed into one of two groups according to the order in which they are admitted to the hospital. One group will receive a standard exercise intervention, while the other group will receive an 8-week nudge-based exercise program designed to make regular physical activity easier to start and maintain. The nudge-based program uses simple behavioral strategies to make exercise easier to start and maintain, including framed and visual information, default exercise options, reminders, peer comparison and support, goal commitment, progress feedback, and small incentives. The program combines face-to-face sessions during hospitalization with home-based support, exercise tools, activity recording, and online follow-up. The main outcomes are changes in BMI and physical activity. Other outcomes include body composition, blood metabolic markers, health-related quality of life, and exercise self-efficacy. Assessments will be conducted before and after the intervention, with follow-up assessments used to examine whether the effects are maintained over time.

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.

This pragmatic randomized clinical trial tests a novel intensive health behavior and lifestyle intervention, conducted via telehealth, to treat class I adolescent obesity in pediatric primary care. Results will inform scalable approaches that meet the recommended treatment dose and effectively treat obesity in this setting.

This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

This single-center, prospective, observational, cross-sectional mechanistic pilot study will evaluate whether polycystic ovary syndrome (PCOS) contributes to hepatic steatosis in adolescent girls independently of adiposity. A total of 150 girls aged 10-18 years will be enrolled into three groups of 50: girls with PCOS and obesity, age- and body mass index-matched girls with obesity but without PCOS, and healthy normal-weight girls. Each participant will undergo a single evaluation comprising anthropometry, clinical and biochemical phenotyping, transient elastography with controlled attenuation parameter and two-dimensional shear wave elastography, and a single venous blood sample. An extended biomarker panel will be measured by enzyme-linked immunosorbent assay (Fetuin-A, fibroblast growth factor 21, adiponectin, visfatin, cytokeratin-18 M30 and M65, soluble CD163, growth differentiation factor 15, 11-ketotestosterone, and 11beta-hydroxyandrostenedione), together with liquid chromatography-tandem mass spectrometry measurement of testosterone and sex hormone-binding globulin, and genotyping of PNPLA3 rs738409 and HSD17B13 rs72613567. The primary objective is to compare hepatic steatosis and the hepatokine/adipokine profile between the PCOS with obesity group and the adiposity-matched obesity control group, adjusting for body mass index z-score, insulin resistance, and free androgen index. No therapeutic intervention is assigned by the study protocol.

This prospective, single-center, two-group observational study evaluates a non-invasive multi-parameter diagnostic panel for metabolic dysfunction-associated steatotic liver disease (MASLD) in children with obesity. A total of 180 children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex are planned for enrollment at a single tertiary pediatric center. Each participant attends a single study visit comprising a fasting venous blood sample for serum biomarkers (cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin, and routine biochemistry), abdominal ultrasonography with two-dimensional shear wave elastography, and genotyping of three MASLD-associated variants (PNPLA3 rs738409, TM6SF2 rs58542926, HSD17B13 rs72613567). Participants are classified as MASLD-positive or MASLD-negative according to a guideline-based composite reference standard consisting of ultrasonographic steatosis grading and cardiometabolic risk factor criteria, assessed independently of the candidate index tests. The primary objective is to determine the discriminative performance, expressed as the area under the receiver operating characteristic curve, of a LASSO-regularized logistic regression model combining biomarker, elastography, and genetic predictors. No therapeutic intervention is assigned by the study protocol. Reporting will follow the STARD 2015 statement.

This is a trial assessing the efficacy of two weight maintenance programs for children with acute lymphoblastic leukemia (ALL) and the patients' caregivers. Patients and their caregivers will be randomized 1:1 to Arm A, a non-intensive educational intervention using National Institute of Health (NIH) Educational Resources (We Can! for children 8-13 and Take Charge of Your Health for teenagers 14-18), or Arm B, a Modified Guided Self-Help Family Intervention for Leukemia patients (mL-GSH). Outcomes will be assessed through activity trackers, obesity biometrics, and nutrition and physical activity assessments.

This is a multicentre, single-arm, feasibility study in adolescents with T2DM and obesity to investigate the recruitment and retention rates to a study using Low Energy Diets(LED). It will also provide estimates of weight loss needed to bring about remission to inform a larger randomised study. In addition a subgroup of participants and their parents/carers undertaking a period of LED will be interviewed to understand the participants experience of taking part. Two further groups will also be interviewed: participants and their parents/carers who have declined to take part in the LED to understand their motivations and barriers and healthcare practitioners who have participated in conducting the trial to understand their experience of the study.

The goal of this feasibility study is to learn whether a trauma therapy intervention for children and adolescents who have experienced weight-based bullying can be successfully delivered within a pediatric weight management program. The intervention is informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) principles and is designed to address trauma-related distress, body image concerns, emotional difficulties, and eating-related challenges associated with weight-based bullying. The main questions this study aims to answer are: * Can this trauma therapy intervention be feasibly implemented within the HEAL Program at Children's Hospital, London Health Sciences Centre? * Is the intervention acceptable and helpful for participating children, adolescents, and caregivers? * Are exploratory changes observed in trauma symptoms, emotional well-being, self-esteem, eating-related concerns, and weight-related distress following participation in the intervention? Participants will: * Participate in approximately 12 weekly virtual therapy sessions, with flexibility for additional sessions if clinically needed * Complete questionnaires before and after treatment related to emotional well-being, trauma symptoms, eating-related concerns, and body image * Participate in selected caregiver-supported sessions during treatment * Optionally complete a brief feedback interview about their experience in the program after treatment is completed The study will also examine recruitment, attendance, treatment completion, and participant satisfaction to help determine whether this intervention can be implemented in routine clinical care settings.

This multicenter prospective quasi-experimental study aims to compare the effectiveness of day hospitalization versus full-time hospitalization for adolescents with severe obesity. The primary outcome is the change in BMI z-score measured six months after the end of treatment.

Obstructive sleep-disordered breathing, including obstructive sleep apnea (OSA), represents a significant yet underdiagnosed condition in the pediatric population, particularly among adolescents with obesity. The tongue is a central anatomical contributor to upper airway collapsibility; however, its biomechanical properties have been investigated almost exclusively in adult populations, leaving a critical gap in knowledge regarding younger individuals. This study aims to assess tongue biomechanical and echographic characteristics using quantitative ultrasound modalities - shear-wave elastography (SWE), acoustic attenuation, and echo intensity - in adolescents aged 12 to 18 years with obesity and obstructive sleep disorders. The study adopts a mixed design combining (1) an observational cross-sectional comparison between participants with obesity and OSDB and age- and sex-matched healthy controls at baseline, and (2) a prospective longitudinal cohort component evaluating changes in tongue ultrasound characteristics over the course of a 30-week multidisciplinary inpatient weight-loss program delivered as standard care at the Zeepreventorium (De Haan, Belgium). An additionnal methodological objective consists in determining intra-rater and inter-rater reliability of the ultrasound acquisition protocol providing a reproducible framework for future studies.

The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter).

This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.

Increased availability of high-energy dense foods has contributed to a pediatric obesity epidemic, with 23% of United States children currently presenting with the disease. How children eat contributes to both overconsumption and greater adiposity. However, it is unclear if laboratory measures of children's eating style generalize to the home environment, where children consume two thirds of their total energy. The study will 1) test if child eating styles observed in the lab generalize to more ecologically valid home environments and 2) identify aspects of home food environment that amplify obesogenic eating behaviors. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children to constrain variability in energy requirements. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory (counter-balanced order) in addition to a 'typical' meal at home. To study how adiposity relates to "obesogenic" styles of eating, gold standard dual x-ray absorptiometry will be used.

This longitudinal observational study aims to validate ultrasound-based tongue markers related to tongue characteristics, including fat accumulation, morphologic and mechanical properties of the tongue in children and adolescents with obesity. Participants are assessed at baseline and after completion of a standardized 30-week inpatient weight-loss rehabilitation program at the Zeepreventorium (De Haan, Belgium). Tongue ultrasound parameters are examined in relation to anthropometric characteristics and obstructive sleep apnea condition.

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

Studying the causal roles of components of the renin-angiotensin-aldosterone system (including angiotensin-(1-7) (Ang-(1-7)), angiotensin-converting enzyme 2 (ACE2), Ang II, and ACE), uric acid, and klotho in pediatric hypertension and related target organ injury, including in the heart, kidneys, vasculature, and brain. Recruiting children with a new hypertension diagnosis over a 2-year period from the Hypertension and Pediatric Nephrology Clinics affiliated with Brenner Children's Hospital at Atrium Health Wake Forest Baptist and Atrium Health Levine Children's Hospital. Healthy control participants will be recruited from local general primary care practices. Collecting blood and urine samples to analyze components of the renin-angiotensin-aldosterone system (Ang-(1-7), ACE2, Ang II, ACE), uric acid, and klotho, and measuring blood pressure, heart structure and function, autonomic function, vascular function, and kidney function at baseline, year 1, and year 2. Objectives are to investigate phenotypic and treatment response variability and to causally infer if Ang-(1-7), ACE2, Ang II, ACE, uric acid, and klotho contribute to target organ injury due to hypertension.

The goal of this observational study is to understand how children's food preferences, physical activity, and decision-making change over time and how these behaviors relate to body weight and overall health.

High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.

The aims is to evaluate the effects of an multidimensional intervention on the physical-built and social environment around schools and the nutritional status of the school population, through a randomized community trial, in schools in 3 states of the Mexican Republic, using anthropometric indicators, biological, psychological, behavioral and environmental. The main questions it aims to answer are: 1. What are the main risk and protective factors for overweight and obesity in the school environment and in the environments around schools in primary education schools in three states of the Mexican Republic? 2. Is there a relationship between risky eating behaviors and the body mass index of schoolchildren? 3. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the presence of protective factors for overweight and obesity in the school environment and in the environments around schools? 4. Are the strategies that are being implemented effective in reducing the presence of risk factors and increasing the protective factors for overweight and obesity in the family environment?

The randomized controlled trial will compare the effects of a High-intensity interval training (HIIT) protocol versus a HIIT plus plyometric training in the muscle-tendon structure function and metabolism of the pediatric population with obesity at different biological maturational stages (pre-to-age peak velocity \[APHV\] and post-APHV). Both groups perform baseline evaluations of the main and secondary outcomes and receive the intervention for twelve weeks, three times per week. Once the interventions are completed, the participants undergo the same evaluations they performed at baseline.

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma. Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity

Childhood obesity in Singapore is rising with a record prevalence of 13% in 2017 (1). Given that 70% of overweight children remain so into adulthood (2), this will further increase the public health epidemic of diabetes among Singaporeans. Early intervention is thus critical to improve the weight trajectory of overweight children and foster life long healthy lifestyle habits. Family-based interventions combining dietary, physical activity and behavioural interventions are currently recommended as the best practice in the management of childhood obesity in children younger than 12 years old (3-7). Our pilot study on family-based intervention in the tertiary setting demonstrated feasibility and short-term effectiveness. However, its outreach and sustainable results are limited. Currently, school-based screening, weight management clinics and community recreational facilities are operating in silos with limited effectiveness. Here, the investigators will integrate our family-based intervention into a school, clinic and community partnership to achieve an impactful and sustainable outcome for families with overweight children. The community Lifestyle InTervention for Everyone (LITE) program is a structured, group family-based multicomponent lifestyle intervention. Community LITE program will introduce various exercise programs within the family based online sessions to reduce perceived barrier and promote self-efficacy of community sports facilities to increase physical activity. Children have minimal control over their food and physical activity choices especially in current obesogenic environment (8). Parents are the most important influencers(9) to impose interventions for childhood obesity through parental practices and parenting style(10). Therefore, they are the main focus of the community-based intervention program.

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.