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The eBATTLE Obesity study

The eBATTLE obesity study (EU CT number: 2023-5096289-29) is a multicenter RCT that investigates the effect of the drug semaglutide in the treatment of severe obesity in adolescents aged 12-18 years. It is a 60-week prospective pragmatic clinical trial consisting of two phases. Phase 1 is a single-arm feasibility study of a low-calorie intervention (eLED) over 8 weeks. The second phase of the study, which starts right after eLED, is a 52-week RCT, two-armed, double-blinded multicenter study that compares semaglutide versus placebo, as an addition to a family-based cognitive behavioral therapy for obesity (25 sessions; E-BT) mainly conducted through telehealth. 220 adolescents with severe obesity will be recruited to the first part of the study, and 150 to the RCT.

Project period: 2023-

REK identifier: 

Funding: The study is funded by the program KlinBeForsk.

Collaborators: The study is led and coordinated by the Center for Morbid Obesity at Vestfold Hospital (PI: Professor Jøran Hjælmseth), but includes the specialized units for obesity treatment of children and adolescents in all health regions in Norway. Department of Digital Health Research, Oslo University Hospital. And an international advisory board from University of Queensland, Karolinska Institutet in Stockholm and University of Washington St. Louis. Yngvild S. Danielsen is member of the steering group, leader for work package (E-BT), training of health personnel in all health regions and mentor for postdoctoral fellow in the project, and contributes in the development of content for an app as a support tool for E-BT together with department for digital health research, OUS.

The FABO study: A randomized controlled trial

The FABO study (REK identifier 8109) is a randomized controlled trial that evaluates the effect of family-based behavioral therapy for obesity in children and adolescents. The main objective of the FABO-study is to evaluate the effectiveness of family-based behavioral therapy, developed for work with lifestyle changes in families, compared to standard treatment for obesity in children and young people in a normal clinical setting in Norway. The study also examines sleep, physical activity, mental health, self-image and disturbed eating behavior in children and adolescents with severe obesity. 

Collaboration: The study is a collaborative project between the University of Bergen, The Obesity Outpatient Clinic at Haukeland University Hospital and Washington University, St. Louis, and Department of Psychiatry, University of Pittsburgh. PI is Professor Petur Juliusson. Yngvild S. Danielsen is Co-PI, researcher and main supervisor for PhD candidate in the project (thesis).

Project period: 2014 - 2029

Funding: The study is funded by The Health Authorities of Western Norway, University of Bergen and The Norwegian Competence Service for Sleep Disorders (SOVno).

EDIT Collaboration - international research collaboration on eating disorders in obesity treatment

The EDIT Collaboration is a collaboration between researchers, clinicians and users with the goal of improving treatment for people with obesity and eating disorders. There is a lack of knowledge about which factors in different interventions in obesity treatment can increase or decrease the risk of developing eating disorders. The same applies to individual characteristics that can affect the risk of developing eating disorders during and after obesity treatment. By conducting meta-analyses where data from lifestyle treatments for obesity from around the world are combined, this study tries to examine these objectives: 1) To identify characteristics of adolescents and adults with obesity that are associated with increased risk of developing eating disorders during and after obesity treatment 2) To deconstruct behavioral treatments aimed at obesity and examine whether subcomponents and strategies in the treatments increase or reduce the risk of developing eating disorders

Collaborators: The project is led by Hiba Jebeile at University of Sydney, but represents a collaboration between researchers from around the world. Yngvild S. Danielsen contributes with data from the FABO-study to the meta-analyses and input to protocol, and sits in specialist group that discusses/investigates dietary restraint as a risk factor for developing eating disorders. 

Obesity and binge eating disorder: Prevalence, diagnosis, and clinical implications

There is little knowledge about the prevalence of eating disorders among patients seeking treatment for severe obesity, and which screening tools for eating disorders work best for this group. The project (REK identifier: 634874) will map eating disorder symptoms and symptoms of anxiety and depression in 200 patients with severe overweight who are referred to treatment for severe obesity at Haukeland University Hospital. The patients will undergo assessment with a wide range of questionnaires that address different types of eating disorder symptoms and disturbed eating behaviors that are common with obesity, as well as a comprehensive standardized clinical diagnostic interview (Eating Disorder Examination Interview). The aim of the project is to investigate the prevalence of eating disorders in adults seeking treatment for severe obesity, as well as compare the results from the different screening tools for eating disorders with the results from the clinical diagnostic interview.

Project period: 2023-

Funding: The study is funded by Stiftelsen Dam and The Heath Authorities of Western Norway.

Collaboration: The study is a collaboration between The Obesity Outpatient Clinic, Haukeland University Hospital, University of Bergen and the user organization Counseling on eating disorders. PI is Chief Physician Pål Methlie. Yngvild S. Danielsen is part of the steering group, co-supervisor for PhD candidate and researcher. 

Cognitive behavioral therapy for eating disorders (CBT-E) in the treatment of anorexia nevrosa (AN): a prospective multidisciplinary study

The study (REK identifier: 2328) has as its main objective to evaluate the effectiveness of outpatient CBT-E in the treatment of patients with anorexia nervosa (age>16) at the Regional Department for Eating Disorders at Haukeland University Hospital in Bergen, Norway. The study has a longitudinal design with five main measurement points: before treatment, at 3 months, at the end of treatment, 20 weeks after treatment and 12 months after treatment. Outcome measures are eating disorder psychopathology, BMI, bone density, other symptoms of mental disorders, quality of life and changes in potassium, venous base, estradiol and FSH measured from blood samples. Biological samples are also collected in a biobank, for the purpose of analyzing gut microbiome and genetic variables. Sub-studies focus on therapeutic alliance in the treatment of eating disorders and excessive/compulsive exercise in AN. A comparison group without eating disorders will also be recruited.

Publication: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5053175/

Project period: 2015 - 2026

Collaboration: The study is a collaboration between the Regional Department for Eating Disorders at Haukeland University Hospital, University of Bergen and has international partners at University of Oxford and Department of Eating and weight disorders at Villa Garda, Verona, Italy. PI is Chief Physician Ute Kessler. Yngvild S. Danielsen is Co-PI and researcher. 

Funding: The study is funded by the Health authorities of Western Norway and  the Norwegian Competence Service for Sleep Disorders (SOVno).