NCT07738029Recruiting
OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
Obesity has increased significantly in recent decades and is starting earlier than before, even before school age. In 2023, 8% of Finnish boys aged 7-12 and 4% of girls were obese, while the corresponding figures for boys aged 13-16 were 9% and 4%, respectively. Overweight and obesity are classified using age- and gender-specific BMI percentile limits, which are derived from adult (18-year-old) BMI cutoffs for overweight (BMI 25-30 kg/m²) and obesity (BMI \> 30 kg/m²). Childhood obesity has a significant tendency to persist into adulthood. Obesity treatment and long-term weight management require an effective intervention that combines both permanent dietary modification and increased physical activity. Obesity has significant physical, psychological, social and economic impacts on both individuals and society. Obesity drug trials have always included lifestyle interventions, but their intensity and long-term follow-up data vary. In addition, for children and young people, intervention should be targeted at the entire family, if possible, because a child alone is not able to modify everyday activities. Stress, depression and other psychologically stressful factors experienced in the family increase the risk of eating habits that predispose to obesity and weight gain. The role of the family in the development of obesity in children and adolescents is central. Parental obesity is a significant risk factor for childhood obesity. Parents' lifestyles, family eating patterns, and eating habits are linked to childhood obesity. A healthy diet, regular meal times, and appropriate portion sizes are key factors in weight management. In addition, low physical activity is associated with overweight and obesity. Excessive sitting and other sedentary activities during waking hours may contribute to the development of obesity. Computer games are a challenge in the treatment of childhood obesity, both in terms of their inactivity and addictiveness. Physical activity promotes weight management, but without permanent changes in diet, it alone is not a sufficient means of losing weight. The most common comorbidities are hypertension, type 2 diabetes, metabolic syndrome, dyslipidemias, and fatty liver disease. Metabolic fatty liver disease (MASLD) is currently the most common chronic liver disease in children and adolescents and is mainly caused by obesity. Obesity in adolescence and high triglyceride, insulin, and sensitive CRP levels increase the risk of metabolic syndrome in adulthood. Type 2 diabetes diagnosed in adolescence is a more serious disease than type 1 diabetes, as it is part of the metabolic syndrome, is associated with obesity and several metabolic disorders, and has a shortening effect on the patient's lifespan.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- 17 Jun 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Tampere University Hospital
- Diseases
- Obesity
- NCT number
- NCT07738029
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 17 Jun 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any medication for the indication of obesity within the past 90 days before screening
- 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
- Treatment with a GLP-1 receptor agonist within 180 days before screening
- 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)
- 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
Other illness
- Type 1 diabetes
- Type 2 diabetes
- Uncontrolled thyroid disease at screening, in the opinion of the investigator
- 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 of malignant neoplasms within the past 5 years prior to the day of screening
- Known history of, or documented positive hepatitis B or C or HIV infection
- 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
- Participants with confirmed diagnosis of bulimia nervosa disorder
Lab values
- 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
- 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
- Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin)
- 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
Other
- Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
- Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
- History or presence of pancreatitis (acute or chronic)
- Female who is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
Who the study is looking for
- 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
Age in the registry: 10 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.