One Year of Intensive Lifestyle Treatment for Children with ISO-BMI Over 30 and Their Families
Official title: OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.
Run by Tampere University Hospital · NCT07738029 · Data updated 2026-11-12
This trial tests a year-long intensive lifestyle program for kids aged 10–16 with ISO-BMI of 30 or higher, and also involves their families.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 16 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere, Pirkanmaa) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07738029 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 10–16 with ISO-BMI ≥30 kg/m2 who have not achieved sufficient weight loss through prior lifestyle efforts.
✕Probably not a fit
Patients with obesity due to secondary medical causes or those currently on obesity medications may be less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study is an interventional program aimed at improving weight management in children and adolescents with severe obesity, focusing on sustained dietary changes and increased physical activity. Participants and their families will participate in a structured lifestyle modification plan over 12 months, with ongoing support and monitoring. The trial seeks to observe changes in weight-related outcomes and overall health metrics in a real-world pediatric setting at Tampere University Hospital. Eligibility includes age 10–16, Tanner stage 1–5, ISO-BMI ≥30 kg/m2, and prior insufficient weight loss with lifestyle efforts. Exclusion criteria cover recent obesity medications, certain endocrine conditions, and secondary obesity causes.
Why it matters
Potential benefit: If successful, participants may achieve better weight management, improved health markers, and enhanced quality of life with a family-centered approach.
How similar studies have gone: There is prior experience with structured lifestyle interventions in pediatric obesity, though this specific intensive year-long approach with child-family involvement is part of ongoing efforts to optimize outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 10 to 16 years * Tanner stage 1-5 pubertal development at the time of signing informed consent * ISO-BMI ≥30kg/m2 * History of failing to lose sufficient weight with lifestyle modification as judged by the Exclusion Criteria: * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Type 2 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes) * Uncontrolled thyroid disease at screening, in the opinion of the investigator * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes) * History of major depressive disorder within 2 years before screening * Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) * A lifetime history of suicidal attempt * Subjects with confirmed diagnosis of bulimia nervosa disorder * History or presence of pancreatitis (acute or chronic) * Impaired renal function defined as serum-creatinine \>UNR for age in children unless renal function is proven normal by further assessments at the discretion of the investigator * History of malignant neoplasms within the past 5 years prior to the day of screening * Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate för the study * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator * Known or suspected abuse of alcohol or recreational drugs * Previous participation in this trial. Participation is defined as signed informed consent * Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening * Female who is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) * Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin) * Treatment with a GLP-1 receptor agonist within 180 days before screening * Known history of, or documented positive hepatitis B or C or HIV infection * Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 x upper-limit of normal * Creatinine clearance (CrCl) \< 60 ml/min measured by 24-hour urine collection or estimated from the Cockcroft and Gault formula * Clinically significant ECG findings as judged by the investigator ((including history of clinically significant arrhythmias or conduction delays on electrocardiogram \[ECG\]) within 180 days before screening, new clinically significant arrhythmias, or conduction delays on ECG identified at screening) * Known history of other heart diseases * History of major depressive disorder within 2 years before screening * Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) * A lifetime history of suicidal attempt * Suicidal behavior within 30 days before screening * Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening * Participants with confirmed diagnosis of bulimia nervosa disorder
Where it's running
-
Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital
Tampere, Pirkanmaa, Finland Recruiting
Study contacts
- Study coordinator: Salla Kuusela, Pediatrician
- Email: salla.kuusela@pirha.fi
- Phone: +358444722901
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.