Obesity Clinical Trial
— YESOfficial title:
Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study
Verified date | May 2024 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth. However, as few of these adolescents seek medical care, little is known about the longitudinal course of adolescent extreme obesity. In this study, the investigators aim to provide structured care for adolescents with obesity and extreme obesity over a prolonged period of time, and to gain information on the course of obesity and the success of different treatment options. The study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with Extreme obesity Study (YES)", which aims at improving the medical care and social support structures for youth with obesity and extreme obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to participate. Participants will have a physical check-up every 12 months (initially every 6 months), complete questionnaires on their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to assess comorbidities. Participants are offered support and guidance for social and vocational integration. The study will evaluate and inform treatment and support options for adolescents with extreme obesity.
Status | Completed |
Enrollment | 429 |
Est. completion date | July 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 24 Years |
Eligibility | Inclusion Criteria: - BMI = 30kg/m2 - sufficient German language skills |
Country | Name | City | State |
---|---|---|---|
Germany | Ambulatory Obesity Program, Charité University, Berlin | Berlin | |
Germany | Vestische Kinderklinik, University of Witten/Herdecke | Datteln | |
Germany | University Duisburg-Essen | Essen | |
Germany | University Hospital Leipzig | Leipzig | |
Germany | Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic | Ulm |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Martin Wabitsch | Charite University, Berlin, Germany, Helmholtz Zentrum München, Universität Duisburg-Essen, University of Leipzig, University of Witten/Herdecke |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adherence with structured care | The percentage of subjects that comply with the structured follow up program will be calculated once a year. | 12 months after subject inclusion | |
Secondary | percentage of subjects that can be integrated into the job-market or into an apprenticeship training position | The percentage of subjects who can be integrated into the job-market or into an apprenticeship training position will be determined via standardized questionnaire (modified after KIGGS and TeenLABS). | every 12 months for 9 years | |
Secondary | percentage of subjects that undergo the recommended diagnostic procedures | Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo the recommended diagnostic procedures will be documented. | every 12 months for 9 years | |
Secondary | changes in somatic co-morbidities | Incidences and changes of somatic co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires (modified after KIGGS and TeenLABS). | every 12 months for 9 years | |
Secondary | changes in psychiatric co-morbidities | Incidences and changes of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year. | every 12 months for 9 years | |
Secondary | compliance with treatment of somatic co-morbidities | Appropriate treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS). | every 12 months for 9 years | |
Secondary | compliance with treatment of psychiatric co-morbidities | Appropriate treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS). | every 12 months for 9 years | |
Secondary | changes in health related quality of life | Assessed via validated questionnaires (EQ5D, DISABKIDS). | every 12 months for 9 years | |
Secondary | changes in socio-economic status | Assessed via standardized questionnaires (modified after KIGGS and TeenLABS). | every 12 months for 9 years | |
Secondary | incidence of extreme obesity | The incidence of extreme obesity (BMI =35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2). | every 12 months for 9 years | |
Secondary | changes in BMI-SDS | Height and weight will be measured with standardized instruments and BMI-SDS will be calculated. | every 12 months for 9 years | |
Secondary | predictors of the above outcomes | Psycho-social, psychiatric, and medical variables will be assessed via standardized physical examination, laboratory and apparative tests, standardized patient questionnaires (modified after KIGGS and TeenLABS), and validated psychiatric instruments once a year, and correlation with the outcome variable will be assessed via multiple regression analyses. | every 12 months for 9 years | |
Secondary | adherence with structured care | The percentage of subjects that comply with the structured follow up program will be calculated once a year. | every 12 months from 2-9 years post enrollment |
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