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.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Childhood obesity in early life contributes to the development of specific NCDs, i.e. adult obesity. Unhealthy diet and low level of physical activity are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of NCDs. Early preventive measures to improve lifestyle behavior are of utmost importance. The aim of ELIPSE-I is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering total energy intake/total energy expenditure (TEI/TEE) ratio in their children with BMI \>97 centile (ELIPSE-I).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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 newly 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)

Locations
Other Locations
Switzerland
Department of Paediatrics, Inselspital, Bern University Hospital
RECRUITING
Bern
Contact Information
Primary
Matthias V. Kopp, Prof. Dr.
matthias.kopp@insel.ch
+41 31 66 4 13 51
Backup
Saner Christoph, PhD Dr.
christoph.saner@insel.ch
+41 31 63 2 95 52
Time Frame
Start Date: 2024-02-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 148
Treatments
Experimental: Treatment as usual (TAU) with Life-Style app
Children in the intervention group receive treatment as usual (TAU) and the parents receive a smartphone app during the main intervention period of 20 weeks. The app (life-style app) aims to promote healthy behaviour through cognitive-behavioural impact factors.
No_intervention: Treatment as usual (TAU)
The children in the control group only receive treatment-as-usual (TAU) and the parents do not have an active app during the main intervention period of 20 weeks. TAU includes lifestyle behaviour counselling, dietary counselling by specialized dieticians, prescriptions for physiotherapy, as provided at the last clinical visit.
Related Therapeutic Areas
Sponsors
Collaborators: University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov