An interventional study of Intensive Behavioral Lifestyle Modification in Childhood Obesity, sponsored by Vanderbilt University Medical Center. Recruiting at 2 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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 36th largest by planned enrollment of the 475 interventional ones that give a count, is one of 30 that started in 2025, is one of 422 with no phase, reaches primary completion later than 83 of the 110 other live ones, and was the 516th 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
Ages 10–15
Children's Hospital Los Angeles · Sites in United States
Ages 12–18
Virginia Commonwealth University · Sites in United States
Ages 12–15 · Healthy volunteers
University of Michigan · Sites in United States
Ages 4 mo+ · Healthy volunteers
Russell McCulloh, MD · Sites in United States
Ages 12–17
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: 5 Years to 17 Years · all sexes · no healthy volunteers.
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. 30 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 900 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:
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Vanderbilt University Medical Center has 9 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 |
Add all 38 to your calendar (.ics) → With an account.
Among the 558 studies in Pediatric Obesity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT.
Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's:
The Dose study aims to evaluate the optimal number of contact hours (i.e., dose) of intensive behavioral lifestyle interventions for childhood obesity. Current recommendations by the American Academy of Pediatrics (AAP) and the United States Preventive Services Task Force (USPSTF) suggest that intensive behavioral lifestyle interventions should have at least 26 hours of contact time. This is a difficult standard to achieve, as it requires significant resources from healthcare systems and time from families. This study\'s purpose is to test whether 26 hours is needed to achieve clinically meaningful reductions in child weight among children with obesity.
The investigators will conduct a randomized clinical trial (RCT) where children are randomized to one of five treatment intensities: 26 hours, 22 hours, 19 hours, 16 hours, or 13 hours. The study will use a non-inferiority design: can equal effectiveness be achieved comparing the 26-hour standard to reduced intensities?
900 children with obesity ages 5-17 years old will be randomized, with a focus on rural and minority communities in Tennessee (TN) and Louisiana (LA). The study will engage approximately 15 clinics in TN and 15 in LA.
The intervention will be integrated into local pediatric primary care practices. Participants in all arms will receive the same number of visits with their child's primary care provider (4 visits, 1 hour total), on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), and community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total). The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session), 12 sessions (60 minutes per session), 9 sessions (60 minutes per session), 8 sessions (45 minutes per session), or 6 sessions (30 minutes per session).
The primary outcome is child body mass index (BMI) expressed as a percentage of the 95th percentile (%BMIp95) of the CDC growth curves, over 12 months, measured approximately 5 times. Our primary hypothesis is that 13-hours will be non-inferior to 26-hours. The analysis also includes multiple, pre-specified sub-group analyses, as there may be important subgroups who require more than 13 hours (e.g., children with a very high starting BMI). Secondary outcomes include changes in child quality of life and health behaviors. The analysis will assess reach, feasibility, and accessibility of this approach for both participants and pediatric healthcare providers, guided by the RE-AIM framework.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).
Behavioral: Intensive Behavioral Lifestyle Modification
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).
Behavioral: Intensive Behavioral Lifestyle Modification
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).
Behavioral: Intensive Behavioral Lifestyle Modification
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).
Behavioral: Intensive Behavioral Lifestyle Modification
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).
Behavioral: Intensive Behavioral Lifestyle Modification
Participants in all arms will receive visits with their child's primary care provider (4 visits, 1 hour total), on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), and community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total). The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session), 12 sessions (60 minutes per session), 9 sessions (60 minutes per session), 8 sessions (45 minutes per session), or 6 sessions (30 minutes per session).
Percent of the 95th BMI Percentile
The primary outcome is child body mass index (BMI) expressed as a percentage of the 95th percentile (%BMIp95) of the CDC growth curves.
Time frame: 5 times over 12 months
Child Diet
Diet Recall, using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. A variety of dietary measures will be abstracted from this dietary recall including the total number of calories consumed daily and the Healthy Eating Index (HEI) which has a range of 0-100, where higher numbers represent a healthier diet.
Time frame: 12 months
Child physical activity
Physical Activity Questionnaire for Children or Adolescents, which provides a summary physical activity score derived from nine items, each scored on a 5-point scale. High scores represent more physical activity.
Time frame: 12 months
Child Media Use
Cumulative Media Use Index, which is a summary score ranging from 0 to 14, where high numbers represent more media use.
Time frame: 12 months
Child Sleep
Short Form Children's Sleep Habits Questionnaire, scored with a range of 23 to 39 where a higher score is indicative of more disturbed sleep
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Aug 2028, 41 months after the start.
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 planned 41 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.
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