Low-level Intervention for Adolescents With Extreme Obesity (STEREO)
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Obesity Extreme Obesity |
Behavioral: manual based low key group intervention (innovation) Behavioral: standardized, manual based routine care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Structured Low-level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents With Extreme Obesity, Subproject 2 |
- Composite primary endpoint(tested hirarchically) of a) Compliance rate and b) changes in health related quality of life. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in the 6 subscales of DISABKIDS [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in quality of life [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]The 52 item KIDSCREEN-52 questionnaire will be applied twice, and the score difference will be calculated for each subject.
- Changes in self-esteem [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]The Rosenberg's scale patient questionnaire will be applied twice, and the score difference will be calculated for each subject.
- Changes in self reported time spent outside the home [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in depression symptoms [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in perceived stress [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]The Fliege scale questionnaire will be applied twice, and the score difference will be calculated for each subject.
- Changes in the self reported attendance of school, apprenticeship, or work [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in self reported physician- / and therapist contacts [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 350 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: low key intervention |
Behavioral: 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.
|
| Active Comparator: routine care |
Behavioral: standardized, manual based routine care
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.
|
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 21 years 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.
Eligibility| Ages Eligible for Study: | 14 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Johannes Hebebrand, Prof. Dr. | +49 201 8707 466 | johannes.hebebrand@uni-due.de |
| Germany | |
| Ambulatory Obesity Program, Charité University, Berlin | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Annika Bickenbach, Dr.med. +49 30 450 566 889 babeluga@charite.de | |
| Principal Investigator: Susanna Wiegand, Dr. med. | |
| Sub-Investigator: Annika Bickenbach, Dr. med. | |
| Vestische Kinderklinik, University of Witten/Herdecke | Recruiting |
| Datteln, Germany | |
| Contact: Anke Schaefer +49 2363 975 349 A.Schaefer@kinderklinik-datteln.de | |
| Principal Investigator: Thomas Reinehr, Prof. Dr. med. | |
| Sub-Investigator: Anke Schaefer | |
| Sub-Investigator: Barbara Wolters, D. med. | |
| Sub-Investigator: Alex Geisel | |
| University Duisburg-Essen | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Johannes Hebebrand, Prof. Dr.med. +49 201 8707 466 johannes.hebebrand@uni-due.de | |
| Principal Investigator: Johannes Hebebrand, Prof. Dr.med. | |
| Sub-Investigator: André Scherag, Dr. rer. physiol. | |
| Sub-Investigator: Claudia Ose | |
| Sub-Investigator: Ulrike Caspar, Dipl. Psych. | |
| Center for Clinical Trials Essen | Active, not recruiting |
| Essen, Germany, 45122 | |
| University Hospital Leipzig | Recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Annett Witzmann +49 341 9726000 Annett.Witzmann@medizin.uni-leipzig.de | |
| Principal Investigator: Wieland Kiess, Prof. Dr. med. | |
| Sub-Investigator: Annett Witzmann | |
| Sub-Investigator: Madlen Neef | |
| Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic | Recruiting |
| Ulm, Germany, 89075 | |
| Contact: Anja S Moss, Dr. biol. hum. +49 7031 500 57401 ja-studie@uni-ulm.de | |
| Contact: Belinda Lennerz, Dr. med. +49 7031 500 57401 ja-studie@uni-ulm.de | |
| Principal Investigator: Martin Wabitsch, Prof. Dr. med. | |
| Sub-Investigator: Belinda S Lennerz, Dr. med. | |
| Sub-Investigator: Anja Moss, Dr. hum. biol. | |
| Principal Investigator: | Martin Wabitsch, Prof. Dr. med. | University of Ulm |
| Principal Investigator: | Susanna Wiegand, Dr. med. | Charite University, Berlin, Germany |
| Principal Investigator: | Thomas Reinehr, Prof. Dr. med. | University of Witten/Herdecke |
| Study Chair: | Johannes Hebebrand, Prof. Dr. med. | Universität Duisburg-Essen |
| Principal Investigator: | Wieland Kiess, Prof. Dr. med. | University of Leipzig |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Dr. Martin Wabitsch, Prof. Dr. med, University of Ulm |
| ClinicalTrials.gov Identifier: | NCT01703273 History of Changes |
| Other Study ID Numbers: | U1111-1131-4384b, DRKS00004195, 01GI1120B |
| Study First Received: | August 7, 2012 |
| Last Updated: | October 9, 2012 |
| Health Authority: | Germany: Federal Ministry of Education and Research Germany: Ethics Commission |
Keywords provided by University of Ulm:
|
Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013