Clinical Research Directory

Causal Mechanisms in Adolescent Arterial Stiffness

Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.

Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity

This single-site, prospective observational pilot study examines how clinically prescribed semaglutide is associated with changes in the adolescent brain, cognition, mood, interoception, and metabolic and biological markers. Adolescents 12 to 15 years old with obesity (body mass index at or above the 95th percentile for age and sex), whose own treating physician has independently decided to start weekly subcutaneous semaglutide (Wegovy) as part of routine care, complete multimodal assessments before starting the medication and again after approximately 6 months of treatment. Assessments at each timepoint include 3T structural and resting-state functional MRI, a neurobehavioral and interoceptive battery, and saliva and blood collection for biomarker analysis and biobanking; a semi-structured qualitative interview is conducted at the follow-up visit. The study does not provide, prescribe, or modify the medication-all treatment decisions are made by the participant's own physician. The primary goal is to characterize within-subject changes in resting-state functional connectivity, brain structure, cognition, and eating- and reward-related behavior associated with GLP-1 receptor agonist treatment during adolescence, and to interpret these measures relative to normative neuroimaging and cognitive data from the Adolescent Brain Cognitive Development (ABCD) Study.

Effects of Digital Health Interventions on the Motivation, Health-related Behavior and Mental Health of Middle School Students

The goal of this cluster-randomized clinical trial is to learn whether digital interventions, especially a motivational interviewing (MI) chatbot can improve adolescents' physical activity motivation and behavior, as well as support their mental health. The main questions it aims to answer are: * Does the MI chatbot improve how important participants consider physical activity, their confidence in becoming more active, and their readiness to do so? * Does the digital interventions improve their mental health? Researchers will compare the chatbot, text and video intervention groups with a blank control group. Particularly, an MI chatbot will be compared with a general-counseling chatbot. School classes will be randomly assigned to one of the arms. Participants will: * Complete baseline questionnaires about their characteristics, physical activity, and motivation. * Have a conversation about physical activity with their assigned chatbot, or watch a graphic-text poster, or a video. * Complete a post-test questionnaires after the intervention.

Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention

The goal of this non-randomized quasi experimental clinical controlled trial is to evaluate the impact of a playful family education strategy reinforced by the use of communication technologies in childhood obesity. The main questions to answer are: * Does a technogical reinforced ludical family strategy might reduce overweight and childhood obesity prevalence and incidence reduction? * Can digital reinforcement might decrease body weight, BMI, body fat mass and waist circumference in overweight or obese children? * Does dietary habits might be improved by a technologically reinforced playful family workshop? Researchers will evaluate the effect of a family-based, playful educational strategy, incorporating digital reinforcement, aimed at promoting healthy lifestyles among school-aged children, with the goal of reducing and preventing childhood obesity.

Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease.

The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week. Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition. The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children.

Growing Healthy Children and Families in Rural Arkansas

Childhood obesity is a national problem with racial and ethnic disparities specifically among Hispanic children. The primary purpose of this study is to develop and implement a culturally appropriate healthy eating intervention called Growing Healthy Children and Families in Rural Arkansas. Specific Aim (SA) 1. To develop a culturally appropriate healthy eating promotion intervention (Growing Healthy Children and Families in Rural Arkansas) in collaboration with Hispanic churches and their congregants. SA2. To conduct the Growing Healthy Children and Families in Rural Arkansas intervention in eight churches (four churches in the intervention vs four in the control/attention group), and to assess the feasibility and acceptability of implementing the intervention. SA3. To assess the impact of the Growing Healthy Children and Families in Rural Arkansas intervention on healthy food preparation (mothers) and intake of fruits and vegetables (child). The investigators will compare between the intervention group (16 mother-child dyads) versus the control/attention group (16 mother-child dyad) to see if the intervention is effective in improving diet quality and changing cooking behaviors. Participants will: 1. Participate in cooking workshops and one to one learning activities 2. Report on diet and physical activity 3. Will measure fruit and vegetable intake

Weight Gain in Pediatric Leukemia Survivors

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.

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

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

Dyad Plus Effectiveness/Feasibility

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Cardiovascular Alterations in Obese Children

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

iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Rural Families

The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.

The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement

This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.

BasketballRx: Game Changing Health

The goal of this study is to learn if BasketballRx, a basketball and health program, works well for children and teens who are overweight or have obesity. The study will also look at whether the program helps children build healthy habits, improve their health, and feel better. The main questions the BasketballRx clinical trial aims to answer are: 1. Is the BasketballRx program easy for children and families to take part in and complete? 2. Do children show changes in their healthy habits, physical health, or emotional well-being after completing the program? Participants will: * Attend 6 BasketballRx sessions over 2 months * Take part in health lessons and basketball activities * Learn about healthy eating, exercise, sleep, and ways to manage stress * Have their height, weight, waist size, blood pressure, and heart rate checked * Answer questions about how they feel and their healthy habits

PrOtein and WEight Loss in teenageRs

The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.

Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs

Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of excessive weight gain, thus, past school-based efforts are misplaced. This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two "windows of vulnerability" (ie afterschool and summer) for low-income children.

Determining the Optimal Amount of Structured Environments for Healthy Kids

Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain.

Project Viva: a Longitudinal Study of Health for the Next Generation

Project Viva is a prospective cohort study of maternal and child health, following over 2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.

Nudge-Based Exercise Intervention for Adolescents With Obesity

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.

Controlled Evaluation of an Exercise Program for Overweight Adolescents

Physical activity decreases as young people get older, especially during the shift from early to late adolescence. Unfortunately, around 81% of school-aged children worldwide between the ages of 11 and 17 do not meet the recommendation of at least one hour of physical activity per day - and this is also true in Switzerland. Not being active enough, whether normal weight or overweight, can lead to long-term health problems and is a major factor in becoming overweight over time. This results in healthcare costs and negatively affects quality of life. Supporting physical activity in overweight youth requires well-rounded, thoughtful programs. The investigators studying the impact of the movement programs now! and now!+ on the physical activity and health of young people. The goal is to look at both physical and mental changes equally. Taking part in this study involves minimal physical or mental risk for the participants. These small risks from the testing methods and activities are taken into account in how the program is explained and carried out. The benefits for the participants - feeling healthier and fitter physically, and more confident and capable mentally - clearly outweigh any potential risks, thanks to the additional, guided, and personalized exercise program. The participants take part in the now! and now!+ exercise programs run by the Basel-Stadt Sports Office and the DSBG. now! is a 90-minute group session with up to 14 young people, while now!+ is a 90-minute small-group session with 2 to 4 participants. Both programs take place once a week over a 12-month period and pause during school holidays (38 training weeks in total). Each session includes a warm-up, a strength or endurance training block, and a coordination phase. The program is modular and adapted to the physical and personal needs of each participant. This ensures that overweight adolescents are not overstrained and don't develop symptoms like pain, frustration, or lack of motivation (Behringer et al., 2011), while still allowing for a training stimulus that supports physical improvement. The results of the evaluations are directly used to improve and further develop the exercise program. The overall project includes three rounds, each consisting of one year of training and three test sessions, each lasting about two hours. The now! and now!+ programs are held weekly for a total of 38 weeks per year, with breaks during school holidays. Each of the three test sessions includes the same set of assessments (see "Study Intervention") and follows a set order: The process begins with measuring body size and blood pressure, followed by a static retinal vessel analysis. After these medical checks, participants do a 5-minute warm-up on a stationary bike at a set resistance level. Then, strength tests are performed: knee extension on the IsoMed 2000, handgrip strength, and jump power on the Leonardo force plate. The endurance test using spiroergometry marks the end of the physical assessments. Finally, impulse control is tested, and participants complete a set of questionnaires. At the end of the session, each participant is given an actigraph (a small motion sensor worn on the body) to track their physical activity over the following seven days.

Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth

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.

Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)

Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).

MEDKIDS: Nutritional Intervention With Improved Bread and Bakery Products in Children With Overweight and Obesity

The goal of this randomized crossover clinical trial is to evaluate the effect of an intervention with nutritionally improved bread and bakery products on body composition and metabolic health in children aged 6 to 12 years with overweight or obesity.

Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment

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.

Parks & Pediatrics Fit Together

The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.