Low-level Intervention for Adolescents With Extreme Obesity

NCT ID: NCT01703273

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

Brief 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.

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:

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

low key intervention

Group Type: EXPERIMENTAL

manual based low key group intervention (innovation)

Intervention Type: BEHAVIORAL

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.

routine care

Group Type: ACTIVE_COMPARATOR

standardized, manual based routine care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

University of Ulm

OTHER

Sponsor Role: collaborator

Zentrum für klinische Studien Essen

OTHER

Sponsor Role: collaborator

Prof. Dr. Martin Wabitsch

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Martin Wabitsch

Prof. Dr. med

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Wabitsch, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Susanna Wiegand, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Thomas Reinehr, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Johannes Hebebrand, Prof. Dr. med.

Role: STUDY_CHAIR

Universität Duisburg-Essen

Wieland Kiess, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

Ambulatory Obesity Program, Charité University, Berlin

Berlin, , Germany

Vestische Kinderklinik, University of Witten/Herdecke

Datteln, , Germany

Center for Clinical Trials Essen

Essen, , Germany

University Duisburg-Essen

Essen, , Germany

University Hospital Leipzig

Leipzig, , Germany

Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 28787738 (View on PubMed)

Wabitsch 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.

Reference Type: DERIVED

PMID: 23987123 (View on PubMed)

Related Links

http://www.adipositasforschung-ulm.de/index.php?id=69

study homepage

Other Identifiers

DRKS00004195

Identifier Type: REGISTRY

Identifier Source: secondary_id

01GI1120B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U1111-1131-4384b

Identifier Type: -

Identifier Source: org_study_id