Obesity Clinical Trial
— STEREOplusOfficial title:
Structured Psychoeducation for Unemployed Adolescents With Extreme Obesity in a Multicenter Observational Study Focusing on Feasibility
Verified date | June 2018 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Obesity occurs more frequently in subjects of a lower socioeconomic status and is associated
with a lower income and unemployment. On the other hand, there is limited access of
individuals with low socioeconomic status to conventional obesity treatments and bariatric
surgery.
In STEREOplus the investigators will ascertain unemployed adolescents with obesity and
extreme obesity at five job centers in the Ruhr area. Unemployed obese youths and young
adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 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 six group
sessions of conventional obesity treatment over a three months period. After six months,
participants will complete further questionnaires to evaluate the effects of the
interventions on quality of life and psychosocial functioning. Weight status (BMI) will also
be measured. Adolescents who attended at least five sessions and are interested in bariatric
surgery will have access to a structured information and preparation program for bariatric
surgery.
The overall objective of STEREOplus is to generate data on the feasibility of the planned
implementation of a treatment targeted to a high risk group with a low socioeconomic
background in order to reduce treatment barriers.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 4, 2017 |
Est. primary completion date | December 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 24 Years |
Eligibility |
Inclusion Criteria: - BMI = 30 kg/m2 - written informed consent - sufficient knowledge of the German language to participate in the intervention - participation in subproject 1 Exclusion Criteria: - any psychiatric disorder that requires inpatient treatment (e.g. psychotic disorder, severe depression with suicidal behavior) - IQ < 70 |
Country | Name | City | State |
---|---|---|---|
Germany | University Duisburg-Essen | Essen |
Lead Sponsor | Collaborator |
---|---|
University of Ulm | Center for Sepsis Control and Care, Germany, Jobcenter Bottrop, JobCenter Essen Mitte, Jobcenter Gelsenkirchen, Jobcenter Mülheim an der Ruhr, Jobcenter Oberhausen, Universität Duisburg-Essen, Zentrum für klinische Studien Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in BMI | The BMI will be measured and compared | baseline and 6 months | |
Primary | Adherence measured as the participation rate in the intervention | Adherence will be measured as the participation rate in the intervention | 6 months | |
Primary | Change in participation rate in the first and second labor market | The number of patients able to integrate themselves into the job market will be assessed | baseline and 6 months | |
Secondary | Change in quality of life (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 | Change in depression score (Beck Depression Inventory-II) | 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 | Change in self-esteem (Rosenberg scale) | 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 | Change in perceived stress (PSQ Fliege scale) | The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject | baseline and 6 months | |
Secondary | Change in somatic and psychiatric disorders (standardized patient questionnaire) | The occurrence of somatic and psychiatric disorders will be assessed twice via a standardized patient questionnaire, and changes evaluated for each patient | baseline and 6 months | |
Secondary | Change in self-reported physician and therapist contact (standardized patient questionnaire) | The frequency of self-reported physician and therapist contact 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 | |
Secondary | Change in self-reported time spent outside the home (standardized patient questionnaire) | The self-reported time spent outside the home 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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