An interventional study of Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment and Education plus usual care behavioral treatment in Obesity, Childhood, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Stanford University · 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 143rd largest by planned enrollment of the 475 interventional ones that give a count, is one of 3 that started in 2027, is one of 422 with no phase, reaches primary completion later than 103 of the 110 other live ones, and was the 557th 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:
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
University of Florida · 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: 10 Years to 15 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. 3 started in 2027.
This study's planned enrollment of 200 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:
Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Stanford University has 6 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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Past modest, transient and highly variable outcomes from many behavioral treatments for pediatric obesity may be, in part, because of the psychological barriers children with obesity face when trying to control their weight. The goal of this randomized controlled trial is to test whether adding two innovative, brief, social psychological activities (termed "wise" interventions) to a high quality, family-based, group behavioral weight control program, will produce better outcomes among participating children with obesity.
The primary hypothesis is that children who receive the family-based, group, behavioral weight control program plus the wise social psychological interventions will have significantly less body mass index growth over 12 months than children who receive the family-based, group, behavioral weight control program plus additional educational content.
Participants will be asked to do participate in the six month treatment program and complete measurements at the beginning of the study, after 3 months, after 6 months (the end of the behavioral treatment program), and after 12 months (6 months after completing the behavioral treatment program).
This study has the potential to substantially improve the outcomes of pediatric weight control treatments and significantly reduce concurrent and future health, psychological and social harms from childhood obesity.
The investigators propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of adding two innovative "wise" social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care family-based, group behavioral intervention for weight control in children with obesity, to reduce body mass index trajectory over 12 months, compared to the usual care behavioral intervention alone.
A total of 200 10-15-year-old children with obesity (BMI ≥ 95th percentile) will participate. All children will participate with their parents in a usual care six-month, family-based, group, behavioral weight control program. In addition, families randomized to the wise intervention condition will receive two, innovative social psychological interventions-growth mindset and self-affirmation-strategically selected and timed to enhance the behavioral intervention.
There remains a great need for innovative approaches to increase and sustain weight loss among children with obesity. The investigators propose that existing weight control interventions are limited in their success with many children in part because of the many psychological barriers and threats they face when attempting to manage their weight. One novel and potentially effective and efficient way to enhance the success of behavioral treatments may be to focus on changing the mindsets and preparedness of the participant.
Measures will be collected at baseline, 3 months, 6 months (end of the behavioral treatment), and 12 months (follow-up 6 months after the end of treatment) from children and parents. Body mass index (BMI) trajectory over the entire 12 months is the primary outcome measure. Secondary outcome measures and potential moderating and/or mediating variables include waist circumference and triceps skinfold thickness, parent weight outcomes, physical activity (accelerometery), energy intake (24-hour dietary recalls), screen time, and hypothesized mediators of the behavioral intervention and the two social psychological interventions. The investigators propose highly rigorous and transparent RCT methods.
Primary Hypothesis: Compared to children randomized to receive the usual care family-based, group behavioral weight control program alone, children randomized to receive the usual care family-based, group behavioral weight control program plus the wise social psychological interventions will have a significantly attenuated BMI trajectory over 12 months.
Secondary Analysis: The investigators will examine the effects of the intervention on secondary outcome measures and explore possible moderators and mediators of intervention responsiveness. Sex will be examined as a biological variable, and risk factor/targeting and process/delivery of intervention analyses will be performed.
Innovation: This research is particularly exciting because it: 1. tests a novel theory and paradigm for pediatric weight control, one that emphasizes how precisely changing perceptions of oneself and one's environment can unleash one's ability to benefit from available resources and behavioral strategies, 2. introduces a new theory of change for weight control, involving small changes in perceptions triggering recursive feedback loops that domino into large changes in weight over time, 3. applies methods from educational research, to a new domain of weight control, and 4. involves a truly transdisciplinary effort between social psychology and health creating a fundamentally new, integrated approach to health behavior change.
The criteria were revised on the registry on Sep 28, 2026. See what changed
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care family-based, group, behavioral intervention for weight control.
Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
Health education plus a family-based, group, usual care behavioral intervention for weight control
Behavioral: Education plus usual care behavioral treatment
Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity
6-month health education plus usual care behavioral intervention for weight control in children with obesity
Change in body mass index from baseline to 12 months
body mass index = weight in kilograms divided by the squared height in meters
Time frame: Change from baseline to 12 months
Plan to share: Yes — Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards and specific terms outlined in the consent forms. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.
Access criteria: User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Feb 2030, 37 months later.
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 37 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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