Early Life Intervention in Pediatrics Supported by E-health (ELIPSE I): Coaching Parents to Lower Obesity in Children. A Single-blind Randomized Controlled Parallel-group Clinical Trial.

What this Trial Is About

Researchers are evaluating an eHealth application intervention aimed at helping parents lower obesity in children aged 6 to 12 years with a body mass index (BMI) above the 97th percentile. Childhood obesity can lead to adult obesity and other chronic diseases, and unhealthy lifestyle behaviors such as poor diet and low physical activity contribute to this risk. This trial focuses on whether supporting parents with a smartphone app can reduce the ratio of total energy intake to total energy expenditure in their children. The trial includes 148 children randomly assigned to two groups: one group receives treatment as usual (TAU) plus access for parents to a lifestyle app for 20 weeks, while the control group receives only TAU. The app offers modules that promote healthy behaviors through psychoeducation and goal setting, guided by a psychologist who provides structured feedback. TAU includes counseling on lifestyle, diet, and physiotherapy as needed. Assessments are conducted at the start, after 20 weeks of intervention, and again at 6 months follow-up. Participants will undergo evaluations including measurements of their energy intake and expenditure ratio, BMI, body fat, waist circumference, blood pressure, glucose and lipid levels, inflammatory biomarkers, physical activity, dietary habits, grip strength, and quality of life reported by parents. The study also monitors the app's acceptance and usability. The total study duration includes baseline, post-intervention, and follow-up visits to measure both immediate and sustained effects.

Early Life Intervention in Pediatrics Supported by E-health