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.
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
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)
Single group
Lifestyle Management
BehavioralEach 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.
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.
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.
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.
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