1. Protocol for a randomised, double-blinded, controlled trial of youth with childhood-onset obesity treated with semaglutide 2.4 mg/week: the RESETTLE trial
- Author
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Torben Hansen, Simon Birk Kjær Jensen, Lærke Bruun Madsen, Jens-Christian Holm, Sarah Byberg, Joachim Holt, Rasmus Michael Sandsdal, Louise Aas Holm, Bodil Just Christensen, and Signe Torekov
- Subjects
Medicine - Abstract
Introduction Childhood-onset obesity poses significant health risks, including early-onset type 2 diabetes, cardiovascular disease, and reduced quality of life. Hospital-based non-pharmacological obesity care can reduce childhood obesity, but 25% of children do not respond. Therefore, this study investigates the effect of the glucagon-like peptide-1 receptor agonist, semaglutide, as an add-on to hospital-based obesity care in youth who still have obesity following hospital-based obesity care as children. Furthermore, biomedical and psychosocial factors linked to treatment response will be investigated, alongside an exercise-based strategy to prevent weight regain and maintain a healthy body composition after semaglutide treatment.Methods and analysis This is an investigator-initiated, randomised, placebo-controlled, double-blind trial. We will enrol expectedly 180–270 young adults aged 18–28 years based on their previous response to a paediatric obesity management programme and their current body mass index (BMI). Participants are categorised into four groups: low treatment response (BMI SD score (SDS) reduction 0.25; BMI ≥30 kg/m2); high treatment response (BMI SDS reduction >0.50; BMI
- Published
- 2024
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