ELIPSE: Early Life Intervention in Pediatrics Supported by E-health Coaching of Parents to Improve the Health of Overweight Children
Descrizione riassuntiva dello studio
Children, adolescents, and adults with obesity have a higher risk of non-communicable diseases (for example, cardiovascular diseases, chronic respiratory diseases). Early preventive measures that address specific lifestyle characteristics can prevent the development of these diseases. In this research project, we want to find out whether a smartphone application we developed (short form App) leads to lifestyle changes. The app has been developed according to evidence-based recommendations regarding usability and content and is aimed at parents. The goal is to provoke behavioral changes in parents that affect their children's nutrition and physical activity. Additionally, we want to investigate whether these changes impact the children's health. Parents of 6-12 year old children with obesity (BMI > 97th percentile) who attend the obesity clinic at the Children's Hospital in Bern can participate. Participation in the study involves the child and one parent/guardian. Participants will be randomly assigned to the group with an active app in addition to standard treatment (intervention group) or the group without an app (only with standard treatment). In the intervention group, parents/guardians will be coached for 20 weeks using the developed app to improve the child's nutrition and physical activity. Additional surveys and examinations will be conducted on all participating children during 3 treatment appointments at the obesity clinic: at the start, at the end of the intervention, and 24 weeks after completion. At the same time, parents/guardians will fill out questionnaires and will be asked via the app about their child's physical activity and nutrition. The results of this study contribute to the prevention of the development of common non-communicable diseases.
(BASEC)
Intervento studiato
Use of a professionally led smartphone-based eHealth application (lifestyle app) aimed at improving dietary and physical activity behavior.
(BASEC)
Malattie studiate
Obesity, children, prevention of non-communicable diseases, eHealth
(BASEC)
1. Children aged 6 to 12 years inclusive and their parents/guardians 2. German-speaking parents/guardians 3. Male and female 4. Any ethnic background/race 5. Signed consent form from parents/guardians 6. Children with an age- and sex-appropriate BMI > 97th percentile according to the national growth chart of Switzerland 7. Children should live in the same household as the participating parent/guardian. 8. Children attending the weight management clinic of the Department of Pediatric Endocrinology at the University Children's Hospital Bern (Inselspital). (BASEC)
Criteri di esclusione
1. Syndromic obesity 2. Known congenital diseases affecting the function of the musculoskeletal system, heart, or lungs 3. Insufficient knowledge of the German language 4. Participation in another study/trial with similar objectives (except for the BOCAB study; BASEC ID 2022-00968) (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
Insel Gruppe AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Christoph Saner, PhD
+41 31 63 2 95 52
christoph.saner@clutterinsel.chUniversitätsklinik für Kinderheilkunde Inselspital Freiburgstrasse 15, 3010 Bern
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
26.07.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
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