E-health intervention for preventing childhood obesity
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.
This study is testing whether an app for parents can help kids aged 6-12 who are overweight learn healthier habits and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06208345 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and effectiveness of an eHealth application designed for parents to help reduce obesity in children aged 6-12 years with a BMI above the 97th percentile. The study involves a single-blind randomized controlled trial with 148 participants, who will be divided into control and intervention groups. While both groups will receive standard treatment, the intervention group will use a lifestyle app for 20 weeks, which promotes healthy behaviors through cognitive-behavioral strategies. Assessments will be conducted at baseline, after the intervention, and at a 6-month follow-up to measure changes in energy intake and expenditure, obesity severity, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are German-speaking children aged 6-12 years with a BMI above the 97th percentile living with their parents.
Not a fit: Patients with syndromic obesity or known congenital diseases affecting physical function may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce childhood obesity rates and improve long-term health outcomes for affected children.
How similar studies have performed: Previous studies have shown promise in using eHealth interventions for obesity management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * German speaking parents * Any ethnic background/race * Children should live/grow-up in the same household as the parental participant * Children with an age- and sex-matched BMI \>97 centile according to Swiss national growth charts * Children who attend 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) Exclusion Criteria: * Syndromic obesity * Known congenital disease affecting musculo-skeletal, cardiac or pulmonary function * Participation in another clinical trial targeting similar objectives
Where this trial is running
Bern
- Department of Paediatrics, Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Matthias V. Kopp, Prof. Dr. — Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
- Study coordinator: Matthias V. Kopp, Prof. Dr.
- Email: matthias.kopp@insel.ch
- Phone: +41 31 66 4 13 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.