Early Life Intervention in Children Ages 6 to 12 Using an E-Health App to Help Parents Reduce Childhood Obesity
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-18
148
Participants Needed
1
Research Sites
22 weeks
Total Duration
AI-Summary
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 apps acceptance and usability. The total study duration includes baseline, post-intervention, and follow-up visits to measure both immediate and sustained effects.
CONDITIONS
Brief Title
Early Life Intervention in Pediatrics Supported by E-health
Research Team
M
Matthias V. Kopp, Prof. Dr.
S
Saner Christoph, PhD Dr.
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Children living and growing up in the same household as the participating parent
Children aged 6 to 12 years with a BMI above the 97th percentile according to Swiss national growth charts
Children attending the outpatient weight management clinic at the Division of Pediatric Endocrinology at the University Children's Hospital Bern
Signed informed consent form from parent(s)
You will not qualify if you...
Syndromic obesity
Known congenital disease affecting musculo-skeletal, cardiac, or pulmonary function
Participation in another clinical trial targeting similar objectives
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 20 weeks
Participants receive treatment as usual. Parents of children in the intervention group also use a smartphone app to promote healthy behavior with coaching support for 20 weeks.
Baseline visit and follow-up visit at 20 weeks
Follow-up
Duration - Approximately 6 months
Participants are monitored to assess long-term effects 6 months after the intervention ends.
1 visit at 48 weeks post-baseline
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Early Life Intervention in Paediatrics Supported by E-Health (ELIPSE)-a coaching app for parents to reduce obesity and second-hand smoke exposure in children: study protocols for two parallel-group randomised controlled trials.