Obesity Clinical Trial
— STEREOOfficial title:
Structured Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2
Verified date | June 2018 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
While adolescents with obesity and extreme obesity are at increased risk for health
complications, especially adolescents with extreme obesity rarely seek medical care, and
sustained weigh loss is hardly ever achieved. One of the underlying reasons might be the lack
of adequate treatment options.
In this multicenter study, we aim to test a new, low key group intervention focusing on
improving compliance and psychosocial functioning. 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 be asked to complete a series
of questionnaires on their general health, psychosocial situation and wellbeing, and will be
offered a thorough medical evaluation. Individuals who complete the baseline evaluations will
be invited to participate in 6 group sessions over a 3 months period. Group assignment to the
psycho-social intervention vs. routine care group will be at random, like throwing a dice.
After 6 months, participants will complete further questionnaires to evaluate the effects of
the interventions on quality of life and psycho-social functionning.
The study will show the acceptance and effectiveness of a new intervention focusing on
improving compliance and psychosocial functioning in adolescents with extreme obesity, and
thereby inform the development of new treatment and support options for these adolescents. If
interested, participants are invited to participate in additional components of YES, and to
receive medical care and psycho-social support.
Status | Completed |
Enrollment | 119 |
Est. completion date | December 2014 |
Est. primary completion date | December 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: - Circumstances that require immediate inpatient care (e.g. severe somatic or psychiatric illness) - obvious cognitive disability |
Country | Name | City | State |
---|---|---|---|
Germany | Ambulatory Obesity Program, Charité University, Berlin | Berlin | |
Germany | Vestische Kinderklinik, University of Witten/Herdecke | Datteln | |
Germany | Center for Clinical Trials Essen | Essen | |
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 Ulm, University of Witten/Herdecke, Zentrum für klinische Studien Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life. | a) Number of regular participants at 6 months follow up will be divided by number of participants at baseline. b) Changes (randomization - 6 months follow up) in the 37 item DISABKIDS questionnaire will be assessed. | baseline and 6 months | |
Secondary | Changes in the 6 subscales of DISABKIDS | The 37 item DISABKIDS questionnaire will be applied twice, and the score difference in each of the 6 subscales will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in quality of life | The 52 item KIDSCREEN-52 questionnaire will be applied twice, and the score difference will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in self-esteem | The Rosenberg's scale patient questionnaire will be applied twice, and the score difference will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in self reported time spent outside the home | The time spent outside the home will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in depression symptoms | The Becks Depression Inventory 2 questionnaire will be applied twice, and the score difference will be calculated for each subject. Answers will be reviewed immediately to identify and treat subjects at risk for self harm. | baseline and 6 months | |
Secondary | Changes in perceived stress | The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in the self reported attendance of school, apprenticeship, or work | The attendance of school, apprenticeship, or work will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the time difference will be calculated for each subject. | baseline and 6 months | |
Secondary | Changes in self reported physician- / and therapist contacts | Physician- / and therapist contacts will be elicited twice via standardized patient questionnaire (modified after KIGGS and TeenLABS), and the difference will be calculated for each subject. | baseline and 6 months |
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