An interventional study of Student Wellness Champions and Teacher Wellness Champions in Obesity, Childhood, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 7 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-28.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
Among 558 studies in Pediatric Obesity with a site in United States — 76 open to participants now, 111 under way, 3 of them phase 3. Pediatric Obesity · United States.
Among the 558 studies in Pediatric Obesity with a site in United States, this one is the 9th largest by enrollment of the 475 interventional ones that give a count, is one of 46 that started in 2017, is one of 422 with no phase, and was the 257th registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →76 of the 558 studies in Pediatric Obesity with a site in United States are open now. Recruiting first, the newest first:
Stanford University · Sites in United States
Children's Hospital Los Angeles · Sites in United States
Virginia Commonwealth University · Sites in United States
University of Michigan · Sites in United States
Russell McCulloh, MD · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 7 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
558 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 28 · Phase 3 10 · Phase 4 11
First in 1998; this study’s year is marked. 46 started in 2017.
This study's enrollment of 2,773 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 95 across the 475 interventional studies, 120 across the 81 observational. Of the 417 that completed or were terminated, 116 (28%) have results posted.
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7 of 558 have an industry lead sponsor. The 10 most frequent:
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
University of Maryland, Baltimore has 3 studies filed under Pediatric Obesity — fewer than ten, so there is no comparison to draw.
38 of the studies in Pediatric Obesity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04974554Medical University of South CarolinaFIT Families Multicomponent Obesity Intervention for African American Adolescents | 2026-11-30 |
| NCT06810557Temple UniversityBrief Behavioral Sleep Intervention for Obesity Prevention in Primary Care | 2026-11-30 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT04128995Children's Hospital Medical Center, CincinnatiSurgical or Medical Treatment | 2026-12 |
| NCT04752293Wake Forest University Health SciencesPediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE) | 2026-12 |
Among the 558 studies in Pediatric Obesity with a site in United States, from their registry updates:
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The Wellness Champions for Change (WCC) study aims to reduce pediatric obesity among students who attend schools in Maryland by training teacher and student-led wellness teams to increase opportunities for physical activity and healthy eating at school.
The study uses a cluster randomized design to allocate 6 schools (3 elementary, 3 middle) in 5 school systems to one of 3 arms: "A" (teacher and student training), "B" (teacher training only), and "C") (delayed teacher training/control). Approximately 36 3rd/6th graders and their caregivers ("evaluation cohort"), 15 4th/7th graders ("student leaders"), and 20 teachers from each school will be recruited in the spring before the intervention. All schools will identify a teacher "Wellness Champion" who will coordinate intervention activities. In "A" and "B" schools, wellness champions will attend a training to learn how to build a wellness team and create more opportunities for students to make healthy choices. In "A" schools, student leaders ("Student Wellness Champions") will meet weekly during lunch with a health educator to receive training as peer leaders and help the Wellness Champion with wellness initiatives. Student leaders in "B" and "C" schools will receive a monthly general Adolescent Health Curriculum. To assess the impact of the teacher and student-led interventions, the evaluation cohort will be followed for 2.5 years, with measures including: anthropometry (height/weight), 7-day accelerometry (physical activity), and validated questionnaires to assess healthy eating. Student leaders will be followed for 1.5 years to assess the impact of their participation, with measures including: anthropometry, 7-day accelerometry, validated questionnaires to assess healthy eating, and validated questionnaires and focus groups to assess leadership/advocacy skills. Teachers will complete validated questionnaires to investigate their perceptions of the school environment, classroom practices, and role modeling skills. Prior to data collection and analysis, participants will be assigned an identification number, and all documents linking participant information to identification numbers will be locked/ password-protected.
The long-term goal of this project is to create health promoting school environments that support healthy growth and development of children in order to prevent obesity. The approach for creating health promoting school environments involves the school-level implementation of existing Local Wellness Policies (LWPs). Implementation science suggests that policy implementation may occur through diffusion ("letting it happen"), dissemination ("helping it happen"), or implementation ("making it happen"). Since LWPs were initially mandated in 2006, most school systems have relied on a diffusion or dissemination approach to LWP implementation, leading to limited implementation on the school-level. We propose a school-level LWP implementation strategy ("making it happen") that relies on educating/training teachers and students to be wellness champions. Through this proposed study, the impact of a school-level intervention to enhance LWP implementation (WCC) and the added benefit of training students to be wellness champions (WCC-students, "WCC-S") on student-level outcomes [diet, physical activity (PA), and obesity] will be examined through a randomized controlled trial.
Objectives are presented at the student and student wellness champion level:
Student Objectives:
Aim 1: To determine the impact of a school-based intervention ("Wellness Champions for Change" (WCC)) to enhance implementation of LWPs, on health behaviors (diet and PA) and weight status of elementary and middle school students through a randomized controlled trial.
Hypothesis 1: WCC will have a positive impact on health behaviors of students, compared to control.
Aim 2: To examine the added impact of a student-led school-based intervention ("Wellness Champions for Change-Students" (WCC-S) on health behaviors (diet and PA) and weight status of elementary and middle school students through a randomized controlled trial.
Hypothesis 2: WCC+WCC-S will have a greater impact on health behaviors of students, compared to WCC and control.
Aim 3: To examine factors in the home and school-neighborhood environments that moderate the impact of WCC/WCC-S on health behavior (diet and PA) and weight status change of elementary/middle school students.
Hypothesis 3: Students living in a moderately health-promoting home and school-neighborhood environment will experience a greater change in health behaviors when exposed to WCC or WCC+WCC-S compared to students in high or low health-promoting environments.
Aim 4: To examine the reach and fidelity of WCC and WCC-S when disseminated via eXtension through an online continuing education credit model for teachers and a toolkit for students.
Hypothesis 4: WCC and WCC-S dissemination schools will experience positive changes in LWP implementation.
Student Wellness Champion Objectives:
One part of our study involves developing a Student Wellness Champions curriculum (WCC-S group) to train 5th and 8th graders in diverse schools across Maryland to make policy and environmental changes that create a "health-promoting environment" in their schools. We plan to evaluate individual and organizational outcomes for the 5th and 8th grade student wellness champions:
Aim 1: To assess the individual effectiveness of WCC-S to improve student wellness champions youth advocacy, health literacy and public health literacy constructs, and changes in diet and physical activity behaviors and/or weight status compared to control students.
Aim 2: To asses organizational effectiveness of WCC-S to improve school level LWP implementation and environmental change compared to control or WCC-only schools.
Aim 3: To describe reach, adoption, implementation, and maintenance factors including- reach and representativeness of student champions, extent to which the intervention reaches other students in WCC-S schools, representativeness of adopting schools compared to non-adopting schools, implementation fidelity, barriers and challenges of implementation of training and goal achievement, which intervention aspects (if any) are institutionalized.
A portion of participating schools will receive a Student Wellness Champion curriculum, training for their wellness team, as well as technical assistance provided by a Wellness Specialist (WCC-S Group). Other participating schools will only receive the training and technical assistance (WCC Group) and some will solely receive resources (Control Group). The process to determine which school receives which intervention is completely random, and will not be decided until after baseline data collection.
In the spring prior to the intervention, all participating schools will be asked to select a group of about 15 students (4th graders in elementary schools, 7th graders in middle schools) to be a part of a Health Leader group that begins the following year (when the same students are 5th graders in elementary, 8th graders in middle school). Students can either be nominated by teachers or write a few sentences on why the student thinks it is important to make his/her school a healthier place. At the beginning of the next school year, the health leaders that attend schools randomized to WCC-S will become Student Wellness Champions. These students will meet with a Wellness Specialist (member of our project team) once a week during lunch to receive a health education/ health literacy curriculum in order to be well-versed on the importance of being active and eating healthy foods, and how to communicate health information to key stakeholders (administration and teachers) to enact policy change and to fellow students to enact behavior change. These students will work with the Wellness Specialist and staff members from their school to implement wellness policies and practices. Health leaders that attend schools randomized to the WCC or control schools will remain Health Leaders, and will have the opportunity to participate in an Adolescent Health Curriculum, taught by the Wellness Specialist, during their 5th or 8th grade year. These students will meet once a month, during lunch, and the curriculum will focus on general public health topics including dental health, stress management and hygiene. At the end of the year, participants will also have the opportunity to participate in a public health leadership workshop.
Schools randomized to WCC-S and WCC will select a teacher to become the Wellness Champion (WC). This person may be a teacher or other school leader (nurse, counselor, etc.) who is passionate about creating a healthy school environment. The wellness champions will attend a Wellness Champions for Change training prior to the start of the intervention. During the training, the Wellness Champion will work with a Wellness Specialist to set achievable LWP implementation goals and design a plan for implementing those goals over the academic year. Furthermore, this training will equip the Wellness Champion to build a school-level wellness team, assess the school's wellness environment, develop, monitor, and report a school LWP action plan, and conduct wellness activities that align with the LWP.
Following the training, the Wellness Champion will work with the school's wellness team to develop and implement a school LWP action plan. All Wellness Champions in a given school system will meet monthly, as a group, with the Wellness Specialist to discuss progress, pitfalls, and successes (bi-monthly in-person and/or bi-monthly by phone). In addition, all Wellness Champions will receive year-long technical assistance from the Wellness Specialist that focuses on implementing and monitoring LWP's at the school-level. The WCC intervention will formally last for one school year, with schools continually followed for an additional year to assess sustainability.
In order to measure the success of the intervention, evaluations on a group of 36 students from all participating schools will be conducted (recruited as 3rd grade students in elementary school and 6th grade students in middle schools). These students will become members of the Evaluation Cohort, and will be asked to be followed for 2.5 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Schools randomized to the WCC+S arm will receive both the Teacher Intervention and the Student Wellness Champion Intervention.
Behavioral: Student Wellness Champions · Behavioral: Teacher Wellness Champions
Schools randomized to the WCC+S arm will receive only the Teacher Intervention.
Behavioral: Teacher Wellness Champions
The control group will not receive either intervention. Schools will be given a modified SWC curriculum as well as the teacher training at the end of the data collection period.
Student Wellness Champions participate in a training to, develop a rapport, and build trust with the wellness specialist. SWCs will meet once/week during lunch. The SWC's will receive a health education/ health literacy curriculum in order to be well-versed on the importance of being active and eating healthy foods and how to communicate health information to key stakeholders to enact policy change and to fellow students to enact behavior change. These students will work with the Wellness Specialist and Wellness Champion to implement wellness policies and practices. Target policies/practices will be presented as a menu of options. The mechanisms used to enact change are based in the tenets of health literacy anchored in nutrition and PA promotion. Components of the curriculum include raising awareness of school system's local wellness policies and improving student skills surrounding the five standards of health literacy, using examples/activities linked to the local wellness policy.
Schools will be asked to identify a Wellness Champion (WC), someone at the school who is passionate about creating a healthy school environment. All WC's will be asked to attend a Wellness Champions for Change (WCC) training, led by a Wellness Specialist (health educator part of our study team). The WC's will learn about the skills necessary to make health promoting changes to the School Environment. Following the WCC training, the Wellness Champion will receive technical assistance from the Wellness Specialist. The Wellness Specialist will work with the Wellness Champion and the school's Wellness Team to conduct a needs assessment, and develop and implement a school action plan. The Wellness Specialist will provide support and resources to the Wellness Champion and the school to help them work towards their goals. All Wellness Champions in a given school system will meet monthly, as a group, with their Wellness Specialist to discuss progress, pitfalls, and successes.
Overweight/obesity
BMI-for-age z-score (calculated based on measured height and weight; self-reported gender and date of birth)
Time frame: 5 years
In-school diet behaviors
Dietary screener (Patterns of Diet at School: PODS)
Time frame: 5 years
Minutes per day in Moderate-Vigorous Physical Activity
Accelerometry (Actical); placed on the ankle
Time frame: 5 years
School environment specific to healthy eating and physical activity
School audit
Time frame: 5 years
School environment specific to healthy eating and physical activity
Survey (Perceptions of the Environment At School: PEAS)
Time frame: 5 years
Plan to share: No
Ran from May 2017 to primary completion in Dec 2021, 55 months.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 55 months is above that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore →