ELIPSE: Early Life Intervention in Pediatrics Supported by E-health Coaching of Parents to Improve the Health of Overweight Children
Zusammenfassung der Studie
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)
Untersuchte Intervention
Use of a professionally led smartphone-based eHealth application (lifestyle app) aimed at improving dietary and physical activity behavior.
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Bern
(BASEC)
Sponsor
Insel Gruppe AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Christoph Saner, PhD
+41 31 63 2 95 52
christoph.saner@clutterinsel.chUniversitätsklinik für Kinderheilkunde Inselspital Freiburgstrasse 15, 3010 Bern
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.07.2023
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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