Obesity & OverweightNCT07738029
OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.
A study testing Lifestyle Management in people with Obesity & Overweight, run by Tampere University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 17 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital
Tampere, Pirkanmaa, 33520
Salla Kuusela, Pediatrician, +358444722901, salla.kuusela@pirha.fi
Heidi Alanen, Study coordinator, +358505112371, heidi.alanen@pirha.fi
About this study
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.
Read more
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.
Read the detailed description
Childhood and adolescent overweight and obesity have increased significantly in Finland and other Western countries, beginning at younger ages than before. In 2023, approximately 26% of boys and 17% of girls aged 2-16 years were overweight. Obesity has major physical, psychological, social, and economic consequences. Prevention and treatment aim to halt weight gain, reduce comorbidities, and improve quality of life, with strong involvement of the child's family.
Childhood obesity often persists into adulthood; obese children are at significantly higher risk of becoming obese adults. Therefore, monitoring weight development throughout childhood is essential, particularly in primary care and school health services. Obesity is assessed using height-weight ratios and ISO-BMI, which adjust BMI according to age and sex.
The causes of obesity are multifactorial, involving genetic predisposition alongside environmental, behavioral, and societal influences. The fundamental mechanism is an imbalance between energy intake and expenditure. Family-related factors, including parental obesity, dietary habits, and daily routines, play a central role.
Dietary patterns strongly influence weight gain. High consumption of energy-dense foods, refined grains, sweets, and sugary drinks increases risk. Problematic eating behaviors such as emotional eating, uncontrolled eating, and binge eating are also common contributors. Regular meals and appropriate portion sizes help regulate intake and prevent overeating.
Low physical activity and excessive sedentary behavior are key risk factors. Recommendations suggest 1-2 hours of daily physical activity for school-aged children, with screen time limited to two hours, but these targets are increasingly unmet. Insufficient or poor-quality sleep also contributes to weight gain.
Obesity in children is associated with multiple comorbidities, including hypertension, type 2 diabetes, metabolic syndrome, dyslipidemia, and fatty liver disease. It also increases early risk factors for cardiovascular disease, such as inflammation and insulin resistance. Type 2 diabetes developing in adolescence is particularly severe. Early identification and lifestyle intervention can reduce these risks.
The cornerstone of treatment is sustained lifestyle change, combining dietary improvements and increased physical activity. Effective interventions require sufficient intensity, long-term follow-up, and strong family commitment. Psychosocial challenges may reduce adherence. Pharmacological treatments, such as GLP-1 analogues, may be used in selected adolescents but often result in weight regain after discontinuation.
The purpose of the described study is to develop an effective, closely monitored lifestyle intervention for obese children (ISO-BMI >30 kg/m²). The intervention combines nutritional counseling, physical activity guidance, psychological support, and family participation. Physical activity is tracked using wearable devices, and metabolic health-including liver status-is monitored.
The primary objective is to assess adherence and its impact on weight reduction in children aged 10-16 years undergoing intensive lifestyle treatment. Secondary outcomes include changes in metabolic markers such as glucose, HbA1c, lipids, and insulin resistance. Additional measures include BMI change, waist circumference, blood pressure, and physical fitness over a 59-week follow-up.
- Conditions
- Obesity & Overweight
- Being tested
- Lifestyle Management
- Keywords
- Obesity, Children, Adolescent, Lifestyle
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
Each participant is scheduled for visits with a nutritionist, physiotherapist, and short-term therapist, and these are personalized according to each person's needs during follow-up visits. At the same time, participants regularly see a doctor for check-ups.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle treatment | Experimental | Each participant is scheduled for visits with a nutritionist, physiotherapist, and short-term therapist, and these are personalized according to each person's needs during follow-up visits. At the same time, participants regularly see a doctor for check-ups. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrerence to the study
The primary outcome variable is the feasibility of the study: the goal is to find out whether the study can actually be carried out on a larger scale. Things being assessed include the time it takes to recruit participants (weeks from the start of the study), how many of those recruited actually take part in the study, and how many participants stay engaged throughout the entire intervention.
If more than 70% of families who are screened stick with the study until the end, we'll consider the intervention feasible, and if the commitment is weaker than that, we'll try to adjust the plan before starting a larger study.
Measured: one year from the start of the study
Secondary outcomes (2)
Change in weight and in laboratory values
Secondary outcome variables include changes in weight/ISO-BMI (kg,kg/m²), waist circumference (cm), lab test results (ALT, HbA1c and glucose levels, insulin resistance and the change in lipoproteins at certain timepoints). In the laboratory tests we evaluate the percentage change from the baseline.
Measured: one year
Other benefits of the lifestyle treatment
Benefits and experiences of lifestyle treatment to child's physical and mental health. Family's commitment to the study will be estimated and its value to the weight after first year of.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start17 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738029
- Sponsor's protocol ID
- R26057
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data will be provided upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.
- ClinicalTrials.gov ID
- NCT07738029
- Acronym / sponsor ID
- R26057
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Children, Adolescent, Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood and adolescent overweight and obesity have increased significantly in Finland and other Western countries, beginning at younger ages than before. In 2023, approximately 26% of boys and 17% of girls aged 2-16 years were overweight. Obesity has major physical, psychological, social, and economic consequences. Prevention and treatment aim to halt weight gain, reduce comorbidities, and improve quality of life, with strong involvement of the child's family.
Childhood obesity often persists into adulthood; obese children are at significantly higher risk of becoming obese adults. Therefore, monitoring weight development throughout childhood is essential, particularly in primary care and school health services. Obesity is assessed using height-weight ratios and ISO-BMI, which adjust BMI according to age and sex.
The causes of obesity are multifactorial, involving genetic predisposition alongside environmental, behavioral, and societal influences. The fundamental mechanism is an imbalance between energy intake and expenditure. Family-related factors, including parental obesity, dietary habits, and daily routines, play a central role.
Dietary patterns strongly influence weight gain. High consumption of energy-dense foods, refined grains, sweets, and sugary drinks increases risk. Problematic eating behaviors such as emotional eating, uncontrolled eating, and binge eating are also common contributors. Regular meals and appropriate portion sizes help regulate intake and prevent overeating.
Low physical activity and excessive sedentary behavior are key risk factors. Recommendations suggest 1-2 hours of daily physical activity for school-aged children, with screen time limited to two hours, but these targets are increasingly unmet. Insufficient or poor-quality sleep also contributes to weight gain.
Obesity in children is associated with multiple comorbidities, including hypertension, type 2 diabetes, metabolic syndrome, dyslipidemia, and fatty liver disease. It also increases early risk factors for cardiovascular disease, such as inflammation and insulin resistance. Type 2 diabetes developing in adolescence is particularly severe. Early identification and lifestyle intervention can reduce these risks.
The cornerstone of treatment is sustained lifestyle change, combining dietary improvements and increased physical activity. Effective interventions require sufficient intensity, long-term follow-up, and strong family commitment. Psychosocial challenges may reduce adherence. Pharmacological treatments, such as GLP-1 analogues, may be used in selected adolescents but often result in weight regain after discontinuation.
The purpose of the described study is to develop an effective, closely monitored lifestyle intervention for obese children (ISO-BMI >30 kg/m²). The intervention combines nutritional counseling, physical activity guidance, psychological support, and family participation. Physical activity is tracked using wearable devices, and metabolic health-including liver status-is monitored.
The primary objective is to assess adherence and its impact on weight reduction in children aged 10-16 years undergoing intensive lifestyle treatment. Secondary outcomes include changes in metabolic markers such as glucose, HbA1c, lipids, and insulin resistance. Additional measures include BMI change, waist circumference, blood pressure, and physical fitness over a 59-week follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle treatment | Experimental | Behavioral: Lifestyle ManagementEach participant is scheduled for visits with a nutritionist, physiotherapist, and short-term therapist, and these are personalized according to each person's needs during follow-up visits. At the same time, participants regularly see a doctor for check-ups. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementEach participant is scheduled for visits with a nutritionist, physiotherapist, and short-term therapist, and these are personalized according to each person's needs during follow-up visits. At the same time, participants regularly see a doctor for check-ups. | Behavioural | Lifestyle treatment |
Primary outcome
Adrerence to the study
Time frame: one year from the start of the study
The primary outcome variable is the feasibility of the study: the goal is to find out whether the study can actually be carried out on a larger scale. Things being assessed include the time it takes to recruit participants (weeks from the start of the study), how many of those recruited actually take part in the study, and how many participants stay engaged throughout the entire intervention. If more than 70% of families who are screened stick with the study until the end, we'll consider the intervention feasible, and if the commitment is weaker than that, we'll try to adjust the plan before starting a larger study.
2 secondary outcomes
Change in weight and in laboratory values
Time frame: one year
Other benefits of the lifestyle treatment
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. Pseudonymized data will be provided upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Obesity & Overweight, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salla Kuusela, Pediatrician (+358444722901, salla.kuusela@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrerence to the study (time frame: one year from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.