OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.

NCT07738029 | Recruiting

• 1 other identifier: R26057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity & Overweight

Keywords

Obesity; Children; Adolescent; Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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.

  one year from the start of the study

Secondary Outcomes (2)

• Change in weight and in laboratory values

  one year

• Other benefits of the lifestyle treatment

  one year

Study Arms (1)

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.

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

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.

Lifestyle treatment

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Salla Kuusela, Pediatrician

CONTACT

+358444722901; salla.kuusela@pirha.fi

Heidi Alanen, Study cordinator

CONTACT

+358505112371; heidi.alanen@pirha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 30, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

FI (1)