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Clinical Trial Summary

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.


Clinical Trial Description

Obesity occurs more frequently in subjects of a lower socio-economic status and is associated with a lower income and unemployment. Besides the obesity-related impairments in daily life, stigmatisation additionally aggravates the difficulties of vocational integration by multiple disadvantages in the process of application for employment, job interviews and performance evaluation. On the other hand, there is limited access of individuals with low socioeconomic status to conventional obesity treatments and bariatric surgery.

In this multicenter observational study, the investigators aim to assess the acceptance of a manual based low key group intervention targeted at unemployed adolescents (BMI≥30 kg/m2; 14-24 years old) recruited on the premises of five local job centers in the Ruhr area. The study is part of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with extreme obesity Study (YES), which also comprises the recruitment and characterization of obese (BMI 30-34.9kg/m2) and extremely obese (BMI ≥ 35kg/m2) youth from different healthcare- and non healthcare settings, a structured prospective evaluation of adolescent bariatric surgery, economic assessments of the financial burden of extreme adolescent obesity on the healthcare system, and a long-term prospective observation study.

The participating job centers are located in five cities in the West (Ruhr-Area). The investigators will screen 300 unemployed adolescents aged 14 to 24.9 years with obesity and extreme obesity (BMI ≥30kg/m2) over a 24 month period. A total of 80 subjects will be enrolled. Baseline assessments include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life, as well as an in-depth medical evaluation.

Individuals who complete the baseline evaluations will be invited to participate in six group sessions over a three month period. 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 adherence and effects of the interventions on BMI, health related quality of life and psycho-social functioning will be assessed via questionnaires after six months. All statistical analyses will be exploratory/descriptive. The project will reveal the feasibility of the implementation of the described intervention approach focusing on reducing treatment barriers for unemployed adolescents with obesity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02607995
Study type Observational
Source University of Ulm
Contact
Status Completed
Phase
Start date May 28, 2015
Completion date December 4, 2017

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