Clinical Research Directory

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).

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

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.

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.

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

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.

Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)

To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.

Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.

Pedicatric Obesity - Weight - Energy - Loss - Load

Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain. Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences. Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".

Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.

The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

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

Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)

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.

Non-Invasive Diagnostic Panel for MASLD in Children With Obesity

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.

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.

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.

A Positive Food Parenting Intervention to Promote Healthy Growth in Children at Risk for Obesity

This study is the pilot of a 12 - week positive food parenting intervention focused on structure-based and autonomy promoting practices. The intervention aims to give parents the tools to promote healthy child growth and improve diet quality. The investigators are piloting to assess feasibility and efficacy of the intervention through examining participant retention, impact on parent feeding practices, and impact on parent and child diet quality.

Assessing Better Bottles for Babies

This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.

Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study

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.

Neuro-cognitive Impact of Juvenile Obesity

Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.

Comparison of Day Hospitalization Versus Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity

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.

Development and Evaluation of a Web-based Parental Role Modeling Program for Childhood Obesity Management

The goal of this clinical trial is to learn whether an online family health education program can help Vietnamese children aged 7-9 years with overweight or obesity develop healthier habits. The main questions it aims to answer are: 1. Does the program improve parents' confidence, role modeling behaviors, family communication, and healthy family practices? 2. Does the program improve children's eating habits, physical activity, screen time, and body measurements related to overweight and obesity? Researchers will compare the online family health education program with standard health education materials to see whether the program leads to greater improvements in children and their families. Participants will: 1. Complete surveys about their family's health habits and daily routines. 2. Attend health checkups that include measurements of height, weight, and waist size. 3. Receive either the online family health education program or standard health education materials. 4. Complete follow-up assessments after the program and four months later. The results of this study may help identify effective ways to support families in managing childhood overweight and obesity in Vietnam.

The Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model

The Family Stress Study is following families with young children in Guelph, Hamilton and surrounding areas over 3 years to understand how chronic stress impacts children's weight gain over time and how this association is mediated by alterations in children's cortisol production and weight-related behaviours.