Low-level Intervention for Adolescents With Extreme Obesity (STEREO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Ulm
Sponsor:
Collaborators:
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
University of Ulm
Zentrum für klinische Studien Essen
Information provided by (Responsible Party):
Prof. Dr. Martin Wabitsch, University of Ulm
ClinicalTrials.gov Identifier:
NCT01703273
First received: August 7, 2012
Last updated: October 22, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

  1. The compliance rate 6 months after randomization is higher in subjects in the low key intervention group compared to the standard care group.
  2. 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703273

Contacts
Contact: Johannes Hebebrand, Prof. Dr. +49 201 8707 466 johannes.hebebrand@uni-due.de

Locations
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: Barbara Wolters, D. med.         
University Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Johannes Hebebrand, Prof. Dr.med.    +49 201 8707 466    ja-studie@uni-due.de   
Principal Investigator: Johannes Hebebrand, Prof. Dr.med.         
Sub-Investigator: Yvonne Mühlig         
Center for Clinical Trials Essen Active, not recruiting
Essen, Germany, 45122
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Madlen Neef    +49 341 9726000    Madlen.Neef@medizin.uni-leipzig.de   
Principal Investigator: Wieland Kiess, Prof. Dr. med.         
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.         
Sponsors and Collaborators
Prof. Dr. Martin Wabitsch
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
University of Ulm
Zentrum für klinische Studien Essen
Investigators
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 by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 22, 2013
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 October 19, 2014