eHealth Based treatment of AdolescenT obesiTy with Low energy diet and sEmaglutide (eBATTLE Obesity)

Phase 1

• Conditions: Obesity; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-506289-29-00
• Lead Sponsor: Vestfold Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply: 1.Informed consent of parent(s) or legally authorized representative (LAR) of subject and assent of adolescent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2.The trial participant must be above or equal to 12 years and below 18 years of age at the time of signing the informed consent. 3.Treatment seeking male and female adolescent patients with obesity (BMI = IOTF 35 kg/m2) OR BMI = IOTF 30 kg/m2 with at least one weight related comorbidity, risk factor or complication, as considered by the treating physician (44). 4.History of at least one self-reported unsuccessful dietary effort to lose body weight 5.Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply: 1.Prepubertal patients (Tanner stage 1), self-assessed, see 8.2.1, table 1. 2.History of diabetes mellitus (type 1 or type 2) as judged by the investigator 3.Intellectual disability as judged by the investigator 4.Sub-optimal level of spoken Norwegian as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified