OBE2026 - Effect of One Year Intensive Lifestyle Treatment in Children With ISO-BMI Over 30kg/m² and Their Families.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adrerence to the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Adrerence to the study
时间窗: 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.
次要结局
- Change in weight and in laboratory values(one year)
- Other benefits of the lifestyle treatment(one year)