ObesitySTEREONCT01703273
Low-level Intervention for Adolescents With Extreme Obesity
A study testing manual based low key group intervention (innovation) and standardized, manual based routine care in people with Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Extreme Obesity
- What is being tested?
- manual based low key group intervention (innovation) and standardized, manual based routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 6 sitesGermany
- Study dates
- Jul 2012to Dec 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI ≥30kg/m2
- sufficient German language skills
Who cannot join
- Circumstances that require immediate inpatient care (e.g. severe somatic or psychiatric illness)
- obvious cognitive disability
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Ambulatory Obesity Program, Charité University, Berlin
Berlin, 13353
Vestische Kinderklinik, University of Witten/Herdecke
Datteln
Center for Clinical Trials Essen
Essen, 45122
University Duisburg-Essen
Essen, 45147
University Hospital Leipzig
Leipzig, 04103
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, 89075
About this study
Official title: Structured Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2
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.
Read more
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.
Read the detailed description
While obese youth are at high risk for co-morbidities, especially the extremely obese individuals rarely seek medical care. The underlying reasons are poorly understood, but patient inherent factors and the lack of adequate treatment options may play a role.
In this multicenter study, we aim to assess the acceptance and effectiveness of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care. Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional control group. 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.
Based on the current state of knowledge, we will test the a priori ordered hirarchy of hypotheses:
- The compliance rate 6 months after randomization is higher in subjects in the low key intervention group compared to the standard care group.
- Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between baseline and the 6 months follow up will be more pronounced in the low key intervention group compared to the standard care group.
The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. We will screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. A total of 350 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 6 group sessions over a 3 months period. Group assignment to the low key intervention vs. standard care group will be at random. The effects of the interventions on health related quality of life and psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently, subjects will be invited to participate in additional components of YES.
The project will reveal the effectiveness and safety of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity, and thereby inform the development of new treatment and support options for these adolescents in Germany.
- Conditions
- Obesity, Extreme Obesity
- Being tested
- manual based low key group intervention (innovation), standardized, manual based routine care
- Keywords
- Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life
- 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.
manual based low key group intervention (innovation)Behavioural
6 sessions offered over the course of 3-6 months focus on improvement of quality of life and psychosocial functioning . Topics covered are: 1) social competencies, 2) body image, 3) coping with mobbing and anger, 4) coping with stress, 5) life satisfaction, and 6) psychological well being. The planned intervention does not primarily focus on weight loss.
standardized, manual based routine careBehavioural
6 sessions offered over the course of 3-6 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 | Experimental | Not described Receives: Behavioral: manual based low key group intervention (innovation) |
| routine care | Active comparator | Not described Receives: Behavioral: standardized, manual based routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.
- 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.
Measured: baseline and 6 months
Secondary outcomes (8)
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.
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
Changes in self-esteem
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
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.
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
Changes in perceived stress
The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject.
Measured: baseline and 6 months
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.
Measured: baseline and 6 months
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.
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 posted10 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Martin Wabitsch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen, University of Ulm, Zentrum für klinische Studien Essen
- Responsible party
- Sponsor-investigator, Prof. Dr. Martin Wabitsch, University of Ulm
- Investigators
- Martin Wabitsch, Prof. Dr. med., Principal investigator, University of UlmSusanna Wiegand, Dr. med., Principal investigator, Charite University, Berlin, GermanyThomas Reinehr, Prof. Dr. med., Principal investigator, University of Witten/HerdeckeJohannes Hebebrand, Prof. Dr. med., Study chair, Universität Duisburg-EssenWieland Kiess, Prof. Dr. med., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703273
- Sponsor's protocol ID
- U1111-1131-4384b
- Other IDs
- DRKS00004195, 01GI1120B
- Acronym
- STEREO
- Status last verified
- Jun 2018
- First submitted
- 7 Aug 2012
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muhlig Y, Scherag A, Bickenbach A, Giesen U, Holl R, Holle R, Kiess W, Lennerz B, Lutke Brintrup D, Moss A, Neef M, Ose C, Reinehr T, Teuner CM, Wiegand S, Wolters B, Wabitsch M, Hebebrand J. A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial. Obes Facts. 2017;10(4):341-352. doi: 10.1159/000475717. Epub 2017 Aug 9.
PubMed 28787738Wabitsch M, Moss A, Reinehr T, Wiegand S, Kiess W, Scherag A, Holl R, Holle R, Hebebrand J. Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES). BMC Public Health. 2013 Aug 29;13:789. doi: 10.1186/1471-2458-13-789.
PubMed 23987123
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 Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2
- ClinicalTrials.gov ID
- NCT01703273
- Acronym / sponsor ID
- STEREO / U1111-1131-4384b
- Conditions
- Obesity, Extreme Obesity
- Keywords
- Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Prof. Dr. Martin WabitschUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen, University of Ulm, Zentrum für klinische Studien Essen
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 2012 (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.
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.
Detailed description
While obese youth are at high risk for co-morbidities, especially the extremely obese individuals rarely seek medical care. The underlying reasons are poorly understood, but patient inherent factors and the lack of adequate treatment options may play a role.
In this multicenter study, we aim to assess the acceptance and effectiveness of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity (BMI≥35kg/m2), in comparison to routine care. Youth with more moderate degrees of obesity (BMI 30-34.9kg/m2) will serve as an additional control group. 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.
Based on the current state of knowledge, we will test the a priori ordered hirarchy of hypotheses:
- The compliance rate 6 months after randomization is higher in subjects in the low key intervention group compared to the standard care group.
- Covariant-adjusted changes in quality of life (assessed by DISABKIDS scale) between baseline and the 6 months follow up will be more pronounced in the low key intervention group compared to the standard care group.
The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. We will screen a 600 adolescents age 14 to 24.9 years (initially up to 21 years; this was changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. A total of 350 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 6 group sessions over a 3 months period. Group assignment to the low key intervention vs. standard care group will be at random. The effects of the interventions on health related quality of life and psycho-social functioning will be assessed via questionnaires after 6 months. Subsequently, subjects will be invited to participate in additional components of YES.
The project will reveal the effectiveness and safety of a manual based low key group intervention focusing on improving compliance and psychosocial functioning in adolescents with morbid obesity, and thereby inform the development of new treatment and support options for these adolescents in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low key intervention | Experimental | Behavioral: manual based low key group intervention (innovation) |
| routine care | Active comparator | Behavioral: standardized, manual based routine care |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI ≥30kg/m2
- sufficient German language skills
Key exclusion criteria (2 listed)
- Circumstances that require immediate inpatient care (e.g. severe somatic or psychiatric illness)
- obvious cognitive disability
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 |
|---|---|---|
| manual based low key group intervention (innovation)6 sessions offered over the course of 3-6 months focus on improvement of quality of life and psychosocial functioning . Topics covered are: 1) social competencies, 2) body image, 3) coping with mobbing and anger, 4) coping with stress, 5) life satisfaction, and 6) psychological well being. The planned intervention does not primarily focus on weight loss. | Behavioural | low key intervention |
| standardized, manual based routine care6 sessions offered over the course of 3-6 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 | routine care |
Primary outcome
Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.
Time frame: baseline and 6 months
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.
8 secondary outcomes
Changes in the 6 subscales of DISABKIDS
Time frame: baseline and 6 months
Changes in quality of life
Time frame: baseline and 6 months
Changes in self-esteem
Time frame: baseline and 6 months
Changes in self reported time spent outside the home
Time frame: baseline and 6 months
Changes in depression symptoms
Time frame: baseline and 6 months
Changes in perceived stress
Time frame: baseline and 6 months
Changes in the self reported attendance of school, apprenticeship, or work
Time frame: baseline and 6 months
Changes in self reported physician- / and therapist contacts
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.
- Derived from this study: PubMed 28787738Muhlig Y, Scherag A, Bickenbach A, Giesen U, Holl R, Holle R, Kiess W, Lennerz B, Lutke Brintrup D, Moss A, Neef M, Ose C, Reinehr T, Teuner CM, Wiegand S, Wolters B, Wabitsch M, Hebebrand J. A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial. Obes Facts. 2017;10(4):341-352. doi: 10.1159/000475717. Epub 2017 Aug 9.
- Derived from this study: PubMed 23987123Wabitsch M, Moss A, Reinehr T, Wiegand S, Kiess W, Scherag A, Holl R, Holle R, Hebebrand J. Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES). BMC Public Health. 2013 Aug 29;13:789. doi: 10.1186/1471-2458-13-789.
- study homepageLink provided by the sponsor.
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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.
Martin Wabitsch, Prof. Dr. med. principal investigator
University of Ulm
Susanna Wiegand, Dr. med. principal investigator
Charite University, Berlin, Germany
Thomas Reinehr, Prof. Dr. med. principal investigator
University of Witten/Herdecke
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual based low key group intervention (innovation) and standardized, manual based routine care in people with Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 6 sites 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 2 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 6 sites 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?
Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life. (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01703273, which also lists 2 linked publications.
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.