Obesity Clinical Trial
— YESOfficial title:
Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1
Verified date | June 2018 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
While obese and extremely obese youth are at increased risk of health complications,
especially the extremely obese group rarely seek medical care. One of the underlying reasons
might be the lack of adequate treatment options. This study is a subproject of the "Medical
and psychosocial implications of adolescent extreme obesity - acceptance and effects of
structured care study", 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. In this subproject, information on the causes and consequences of extreme
obesity will be gathered via questionnaires and medical examinations.
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 be asked to complete a series
of questionnaires on their general health, psychosocial situation and wellbeing in 2-3
sessions. They will be offered a thorough medical examination comprising a general check-up,
a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a
sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the
acceptance of diagnostic and therapeutic procedures, and to assess the frequency of
co-morbidities in obese and extremely obese youth. This knowledge will optimize medical
treatment and support options. Interested participants will be invited to participate in
further steps of YES, which entail medical care and psycho-social support.
Status | Completed |
Enrollment | 429 |
Est. completion date | December 2014 |
Est. primary completion date | November 2014 |
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 Exclusion Criteria: |
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, Universität Duisburg-Essen, University of Leipzig, University of Witten/Herdecke |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects that participate in the fasting blood draw | Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated. | baseline | |
Secondary | Predictors of the acceptance of the diagnostic procedures | baseline | ||
Secondary | Prevalence of obesity associated psychiatric co-morbidities | Co-morbidities will be assessed via validated patient questionnaires. | baseline | |
Secondary | Percentage of patients that accept treatment of somatic co-morbidities | Appropriate medical treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated. | baselin | |
Secondary | Predictors of acceptance of treatment of co-morbidities | baseline | ||
Secondary | Health related quality of life | assessed by validated questionnaire EQ5D | baseline | |
Secondary | Socio-economic status | Assessed by standardized questionnaire. | baseline | |
Secondary | Prevalence of obesity associated somatic co-morbidities | Co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires. | baseline | |
Secondary | Percentage of patients that accept treatment of psychiatric co-morbidities | Appropriate medical treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated. | baseline | |
Secondary | Percentage of subjects that initiate a standardized low key intervention | All subjects will be offered the participation in a low key intervention as described in subproject two. The percentage of patients that accept and initiate this intervention will be calculated. | baseline | |
Secondary | Percentage of subjects that participate in diagnostic procedures. | Subjects will be offered a diagnostic liver ultrasound, sleep apnea screening, orthopedic screening, and an array of questionnaires to assess somatic- and psychiatric co-morbidities, psycho-social situation and health related quality of life. The percentage of subjects that comply with these diagnostic procedures beyond the initial visit will be calculated. | baseline |
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