eHealth-based Behavioral Treatment, Diet and Medication against Obesity
This study aims to evaluate the feasibility, efficacy, and side effects of an 8-week low-calorie diet followed by a 52-week eHealth-based behavioral treatment program, with or without weight-reducing medication (semaglutide), for treatment-seeking adolescents suffering from obesity. The Department of Digital Health Research at Oslo University Hospital has developed a digital app to support this eHealth-based treatment.
About the trial
Objective
Overweight and obesity in children and adolescents can lead to various health problems, including reduced self-esteem, lower quality of life, joint pain, shortness of breath, poor physical fitness, social isolation, anxiety, and depression. While weight loss can mitigate these issues, sustaining it can be difficult.
The main goal of this study is to prevent weight regain following an initial rapid weight loss. Specifically, the primary aim is to compare the weight-stabilizing effect of a 1-year eHealth-based behavioral treatment program with or without the addition of a weight-reducing medication (semaglutide), within specialized healthcare services in Norway.
Study description
Participants: All participants will follow an 8-week low-calorie diet, targeting an average weight loss of approximately 8%. This will be followed by a 52-week eHealth based behavioral treatment program to prevent weight regain. Additionally, two thirds of the participants will be randomized to receive weekly injections of semaglutide or placebo as an adjunct to behavioral therapy. After 1 year, we anticipate an average weight reduction of at least 9% in both treatment groups, with the greatest reduction expected in those receiving the active medication.
Approval and Timeline: The study has received approval from the regulatory authorities (CTIS; EUCT number: 2023-506289-29-00) and plans to start in February/March 2025. Participants will be recruited from adolescents undergoing obesity treatment at one of the six study centers/obesity clinics (Finnmark Hospital, Nordland Hospital, St. Olav’s Hospital, Haukeland University Hospital, Oslo University Hospital, and Vestfold Hospital). Further information can be obtained by contacting each of these study centers.
Scientific title
eHealth Based treatment of AdolescenT obesiTy with Low energy diet and sEmaglutide (eBATTLE Obesity)
Read about the trial
Project page in Cristin (Current research information system in Norway)Information about participation
The trial is open for recruitment from 1/1/2025 until 1/1/2027
Who can participate?
Adolescents aged 12 to <18 years with severe obesity (BMI ≥ iso-BMI 35/IOTF 35) or obesity (BMI ≥ iso-BMI 30/IOTF 30) with at least one weight-related comorbidity, complication, or risk factor, who have not succeeded with previous weight reduction attempts and who seek intensive weight loss treatment, may be considered for participation.
Who Cannot Participate? Adolescents with diabetes mellitus, monogenic obesity, severe somatic or psychiatric illness, or who have undergone weight-reducing surgery, cannot participate in the study. Additionally, those who have changed their body weight by more than 5 kg or who have been treated with weight-reducing medication (e.g., Wegovy, Saxenda, Xenical) during the last 90 days, are not allowed to participate.
What does the trial entail?
Procedure: Adolescents expressing interest in participating will be pre-screened to determine if they meet the eligibility criteria. Those meeting the criteria will receive comprehensive information about the study. Adolescents who wish to participate in the study, and one of their parents/guardians if under 16 years old, must sign a so-called voluntary informed written consent. After consent, participants will undergo a medical examination, including health queries, clinical assessments (heart, lungs, blood pressure, pulse, weight, height, waist circumference, and puberty stage), and complete several questionnaires regarding mental health symptoms and quality of life. Blood samples will also be collected to analyze risk factors for various weight-related diseases.
Benefits: All participants will be provided with a treatment program which is expected to be more effective than standard care in specialized healthcare services. Additionally, participants will benefit from close and frequent contact with trial staff and healthcare providers. Finally, participants may benefit from an eHealth-based self-management program, including an app, a smart scale and a smartwatch, to enhance motivation and adherence, thereby facilitating sustained health behavior changes.
Risks: Potential disadvantages include side effects that can occur during the low-calorie diet, such as headaches, dizziness, constipation, and nausea. Common side effects of semaglutide include stomach pain, diarrhea, constipation, nausea, and vomiting. A rare but serious side effect of semaglutide is pancreatitis.
Relevant treatments
Collaboration partners
Cooperation with
- Finnmarkssykehuset
- Helse Bergen
- Nordlandssykehuset
- Oslo universitetssykehus
- St. Olavs hospital
OpenAI/GPT UiO has been used in the translation of this text from Norwegian. The content has been quality-assured afterwards.