Clinical Research Directory

Magnetic Resonance Imaging Assessment of Multiorgan Health in Obesity

The goal of this study is to quantify the body composition and organ fat distribution changes with obesity interventions in adolescents with severe obesity. The main question the investigators aim to answer is if there is improvement in organ health with weight loss intervention. The investigators will be comparing the degree of these changes between children being treated with GLP1 receptor agonists in addition to lifestyle changes and those managed with lifestyle changes alone. Participants will undergo MRI body composition at baseline and after 9 months.

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

The Bottle Optimization Testing Tiny Little Eaters Study

The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.

Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities

The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in low-resource communities.

Phentermine's Impact on Treatment in Teens

PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \<18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.

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.

EBT Fruit and Vegetable Prescription

Eating Better Together is a 6-month pilot program that teaches families about healthy eating and activity and provides home deliveries of fresh fruits and vegetables from a local retail partner.

The LEADS Trial (Linking Exericise for Advancing Daily Stress Management)

Chronic stressors have wide-reaching harmful effects on the physical, social, and psychological well-being of many African American (AA) families. These stressors place some AA adolescents, who already experience low rates of physical activity (PA) and high rates of obesity, at even greater risk for developing chronic diseases. Previous family-based interventions have targeted PA, diet, and sedentary behaviors to prevent and manage overweight and obesity, but few have been successful for AA adolescents. The investigators propose that this may be because chronic stressors are a major challenge to engagement in health promotion efforts, which has been significantly overlooked in previous interventions for AA families. Resilience-based interventions that empower youth to cope with daily stressors have shown improvements across a broad range of outcomes including mental health, academic achievement, and risk-taking behaviors. However, no previous study has evaluated a family-based stress and coping plus positive parenting intervention on improving engagement in PA in AA families. The Linking Exercise for Advancing Daily Stress (LEADS) Management intervention integrates a family-based intervention to address chronic stressors to promote behavioral skills for increasing PA in overweight AA adolescents and their parents. Based on Lazarus and Folkman's Stress and Coping Model, Family Systems, and Social Cognitive Theories, the proposed intervention integrates components that build coping skills (mindfulness, deep breathing, active coping, cognitive reframing), self-esteem (self-affirmation), and positive parenting practices (parent support, nurturance, family routines). The investigators propose that these protective factors as integrated into the LEADS intervention will buffer the negative effects of chronic stressors, which will lead to greater improvements in PA. The investigators pilot research indicates that the LEADS family-based intervention was feasible and acceptable and led to increased moderate-to-vigorous PA (MVPA) for adolescents. Thus, the primary aim of this study is 1) to evaluate the efficacy of the LEADS intervention on increasing MVPA from baseline to post-intervention, and maintenance at a 6-month follow-up in overweight AA adolescents. Secondary aims will examine 2) the effect of the LEADS intervention on light PA, dietary intake, family mealtime, body mass index, waist circumference, and blood pressure outcomes, 3) the effects of the intervention on parent outcomes, as well as examining 4) mediators of the intervention effect on changes in PA.

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

Integrating Food Rx With Best Feeding Practices With EFNEP

To assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.

Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)

The objective of this proposed study is to collect initial efficacy data on a telehealth family-based behavioral program for Latino children with overweight or obesity, which also includes additional caregiver support (PBT-AC), compared with health education (HE).

The Effect of Exercise With AR Glasses on Metabolic Parameters and Anthropometric Measurements in Obese Adolescents

This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Goggles (AR) on metabolic parameters and anthropometric measurement values in obese children aged 10-19 years. The study will be conducted with children diagnosed with obesity between the ages of 10-19 years who are followed up in the Pediatric Endocrinology Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. According to the sample calculation, a total of 20 obese children aged 10-19 years (AR exercise group=10 and control group=10) will be included in the sample of the study. The data of the study will be collected using the Descriptive Characteristics Form for Obese Children and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Augmented Reality Goggles, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Measurement Device. Ethics committee permission was obtained from "Erciyes University Clinical Research Ethics Committee" and institutional permission was obtained from ERU Health Practice and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study, it is expected that exercise application with AR glasses will improve metabolic parameters and anthropometric measurement values in obese children.

Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity. Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months. In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.

Time Restricted Eating in Childhood Obesity (TRECO)

The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. It will also learn about the safety and long-term adherence of 12-hour TRE, in comparison to calory restricted diet (CRD) . The main questions it aims to answer are: 1. Is the weight-losing effect of 12-hour TRE better than CRD? 2. Is 12-hour TRE easier to adhere to than CRD? Researchers will compare 12-hour TRE to CRD (the primary treatment for obesity) to see if 12-hour TRE works to treat childhood obesity. Participants will: 1. Follow the 12-hour TRE or CRD diet every day for 48 weeks; 2. Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests; 3. Keep a diary of their diet, physical activity, and symptoms

The Evira Study: Additional Support During Obesity Treatment

The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity. The main question it aims to answer is: \- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone? This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only). Participants will be followed for six months.

Reducing Obesity Through Play Among Toddlers: Tiny Steps to Health (TSHS) Study

The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.

Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool

The goal of this observational study is to evaluate the risk of developing disordered eating behavior or an eating disorder among children and adolescents with obesity who have used a digi-physical treatment tool with daily measurements conducted at home. The primary outcomes are to: * Evaluate the proportion of patients exhibiting documented signs of disordered eating behaviors during or after treatment (e.g., caloric restriction, skipping meals, binge eating). * Evaluate the proportion of patients diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder) during or after treatment. Patients at Martina Childrens Hospital, Stockholm, Sweden, who have been treated with the digi-physical treatment tool will be included and their patient records will be reviewed for eating disorder diagnosis or a disturbed eating behavior.

Eat Healthy Grow Healthy Program to Promote Fruit and Vegetable Intake in Preschoolers

The Eat Healthy, Grow Healthy (EatGrow) program is a family-based, fully virtual nutrition education intervention designed to improve fruit and vegetable intake among preschool-aged children. Parents and their children participate together in interactive online lessons over eight weeks, including parent-child cooking, taste-testing, and engaging nutrition education. Recruitment was conducted via schools, but schools are not involved in delivering the program. The study measures changes in children's fruit and vegetable intake and willingness to try new foods, as well as parental nutrition literacy, attitudes, and self-efficacy. Weekly tasks are included for engagement.

Weight Status, Resilience, and Quality of Life in Indian Children

A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents. Primary Objective To assess differences in overall resilience (total score of Adolescent Resilience score from ARQ49) between normal-weight and overweight/obese Indian adolescents aged 14-16 years. Secondary Objectives 1. To compare differences in Adolescent Resilience Questionnaire (ARQ49) subscale scores between normal-weight and overweight/obese adolescents. The internal resilience factors assessed by the ARQ49 include confidence, emotional insight, negative cognition, social skills, empathy, and tolerance, while the external resilience factors include family connectedness, family availability, peer connectedness, peer availability, supportive school environment, school connectedness, and community connectedness. 2. To assess differences in internal resilience factors (diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism) between normal-weight and overweight/obese adolescents and to examine parental nutrition knowledge as an external resilience resource and moderator in association analyses. 3. To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents. 4. To examine the associations among resilience, dietary and physical activity behaviors, and PedsQL within the overall sample and within different weight groups, and to evaluate parental nutrition knowledge as a moderator of the relationship between weight status and resilience or health outcomes. Exploratory Objective 5. To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents. Study hypotheses The investigators hypothesized that adolescents with overweight/obesity, compared with their normal-weight peers, would demonstrate lower scores on total resilience (primary outcome), as well as on internal and external resilience indices; report lower diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism; report less frequent health-promoting behaviors (including lower fruit and vegetable intake and fewer days achieving ≥ 60 min/day of moderate-to-vigorous physical activity); and report lower PedsQL scores. Parental nutrition knowledge will not be treated as a between-group outcome; instead, it will be tested as a moderator in association analyses, examining whether parental nutrition knowledge influences the relationship between weight status and resilience or health outcomes. Furthermore, the investigators hypothesized that higher resilience scores would be positively associated with healthier dietary behaviors, greater physical activity participation, and higher PedsQL scores across the overall sample, with these associations expected to hold true within both normal-weight and overweight/obese groups. In addition, analyses involving underweight adolescents will be exploratory and descriptive in nature. We will explore whether underweight adolescents show different levels of resilience, health behaviors, and HRQoL compared with adolescents with normal weight.

Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns

The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp. Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve quality of life, and risk factors for type 2 diabetes.

MOVI-OLE! [Open Learning Environments]

This study will evaluate the effectiveness of MOVI-OLE! (Open Learning Environment), a school-based intervention designed to reduce sedentary time and enhance multiple aspects of child development, including cognitive function, physical fitness, body composition, psychological well-being, and student engagement. The intervention combines dynamic classroom furniture with student-centered teaching practices. Additionally, a qualitative component will explore how students, teachers, and families perceive the feasibility and acceptability of implementing MOVI-OLE! in real-world school settings.

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

Exercise, Arterial Modulation and Nutrition in Youth South Africa Study

The ExAMIN Youth SA study aims to generate new knowledge on the pathophysiology involved in early vascular aging among South African children and to identify early novel biological markers for predicting the subclinical development of hypertension and target organ damage related to cardiovascular disease. This study further implements state-of-the-art biochemical technology to measure a variety of biological markers including multiplex analyses and metabolomics. With the increasing prevalence of childhood hypertension and obesity, this study will be able to address especially behavioural contributors to hypertension development and to subsequently provide a backdrop for school-based primary prevention interventions.

Mountain West Prevention Research Center Core Research Project

This hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial will assess the impact of integrating population health management (PHM) strategies-text messaging and enrollment in Building Healthy Families (BHF)-for lower-income families with a child with obesity identified through electronic health record (EHR) data. BHF promotes family healthy eating, physical activity, and lifestyle behavior strategies to manage weight. The research team will partner with clinical sites (community health clinics, pediatric clinics, rural hospitals) and Community-Based Organizations (CBOs). Clinical partners will execute data-sharing agreements enabling the research team to identify eligible children and caregivers and conduct outreach via text messaging. CBO partners will deliver BHF and provide de-identified data for program evaluation. Community Implementation Teams (CITs) will complete training, surveys, interviews, learning collaborative activities, fidelity assessments, and time tracking as part of quality improvement. The BHF Action Learning Collaborative will use quarterly sessions and Plan-Do-Study-Act cycles to address recruitment, implementation, sustainability, social determinants of health, and team coordination. The research team will record sessions, conduct direct observations of BHF delivery, and take field notes to assess fidelity and adaptations. Families will be identified through EHR records and mailed a consent and authorization cover letter, postcard, QR code, and intervention information with opt-out options. Those who do not opt out will be randomized to bidirectional text messaging with one-touch response and enrollment opportunities, with or without active outreach (telephone or text) from the local CIT. Enrolled families will complete orientation, baseline assessment, and weekly group sessions with ongoing follow-up. Attendance, body weight, goals, and self-monitoring will be recorded in a CIT data portal. Families will be randomized to receive either simple text reminders or reminders with motivational and skill-building prompts matched to session topics. CITs will also connect families to food assistance programs and local resources. Each CIT will complete two cohorts over two years. The primary outcome is reach; secondary outcomes include session attendance, changes in child BMI-z scores, changes in parent or caregiver weight, and changes in adoption, implementation, and maintenance at the community level.