ObesitySTEREOplusNCT02607995
Structured Psychoeducation for Unemployed Adolescents With Extreme Obesity in a Multicenter Observational Study Focusing on Feasibility
An observational study of Obesity and Extreme Obesity, run by University of Ulm at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Obesity, Extreme Obesity
- What is being tested?
- Behavioral standardized manual-based multidisciplinary routine care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 28 May 2015to 4 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: obese adolescents or young adults presenting at 5 different job centers
Who may be able to join
- BMI ≥ 30 kg/m2
- written informed consent
- sufficient knowledge of the German language to participate in the intervention
- participation in subproject 1
Who cannot join
- any psychiatric disorder that requires inpatient treatment (e.g. psychotic disorder, severe depression with suicidal behavior)
- IQ < 70
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Extreme Obesity
- Being tested
- Behavioral standardized manual-based multidisciplinary routine care
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral standardized manual-based multidisciplinary routine careBehavioural
Behavioral standardized manual-based multidisciplinary routine care (lifestyle intervention). Six sessions offered over the course of three to six months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media will be covered.
| Study group | Role | What they receive |
|---|---|---|
| low key intervention | for the whole group Receives: Behavioral: Behavioral standardized manual-based multidisciplinary routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
The BMI will be measured and compared
Measured: baseline and 6 months
Adherence measured as the participation rate in the intervention
Adherence will be measured as the participation rate in the intervention
Measured: 6 months
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
Measured: baseline and 6 months
Secondary outcomes (7)
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start28 May 2015
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Sepsis Control and Care, Germany, Zentrum für klinische Studien Essen, JobCenter Essen Mitte, Jobcenter Bottrop, Jobcenter Gelsenkirchen, Jobcenter Oberhausen, Jobcenter Mülheim an der Ruhr, Universität Duisburg-Essen
- Responsible party
- Principal investigator, Prof. Dr. Martin Wabitsch, University of Ulm
- Investigators
- Johannes Hebebrand, Prof. Dr. med., Principal investigator, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607995
- Sponsor's protocol ID
- U1111-1131-4384f
- Acronym
- STEREOplus
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Psychoeducation for Unemployed Adolescents With Extreme Obesity in a Multicenter Observational Study Focusing on Feasibility
- ClinicalTrials.gov ID
- NCT02607995
- Acronym / sponsor ID
- STEREOplus / U1111-1131-4384f
- Conditions
- Obesity, Extreme Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Center for Sepsis Control and Care, Germany, Zentrum für klinische Studien Essen, JobCenter Essen Mitte, Jobcenter Bottrop, Jobcenter Gelsenkirchen, Jobcenter Oberhausen, Jobcenter Mülheim an der Ruhr, Universität Duisburg-Essen
- Study start
- 28 May 2015 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low key intervention | – | Behavioral: Behavioral standardized manual-based multidisciplinary routine carefor the whole group |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- obese adolescents or young adults presenting at 5 different job centers
Key inclusion criteria (4 listed)
- BMI ≥ 30 kg/m2
- written informed consent
- sufficient knowledge of the German language to participate in the intervention
- participation in subproject 1
Key exclusion criteria (2 listed)
- any psychiatric disorder that requires inpatient treatment (e.g. psychotic disorder, severe depression with suicidal behavior)
- IQ < 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral standardized manual-based multidisciplinary routine careBehavioral standardized manual-based multidisciplinary routine care (lifestyle intervention). Six sessions offered over the course of three to six months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media will be covered. | Behavioural | low key intervention |
Primary outcome
Change in BMI
Time frame: baseline and 6 months
The BMI will be measured and compared
Adherence measured as the participation rate in the intervention
Time frame: 6 months
Adherence will be measured as the participation rate in the intervention
Change in participation rate in the first and second labor market
Time frame: baseline and 6 months
The number of patients able to integrate themselves into the job market will be assessed
7 secondary outcomes
Change in quality of life (DISABKIDS)
Time frame: baseline and 6 months
Change in depression score (Beck Depression Inventory-II)
Time frame: baseline and 6 months
Change in self-esteem (Rosenberg scale)
Time frame: baseline and 6 months
Change in perceived stress (PSQ Fliege scale)
Time frame: baseline and 6 months
Change in somatic and psychiatric disorders (standardized patient questionnaire)
Time frame: baseline and 6 months
Change in self-reported physician and therapist contact (standardized patient questionnaire)
Time frame: baseline and 6 months
Change in self-reported time spent outside the home (standardized patient questionnaire)
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Hebebrand, Prof. Dr. med. principal investigator
Universität Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Extreme Obesity, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.