Low-level Intervention for Adolescents With Extreme Obesity

NCT01703273 | Completed DMC

• 3 other identifiers: U1111-1131-4384bDRKS0000419501GI1120B
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity; Extreme Obesity

Keywords

Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint (tested hierarchically) of a) compliance rate and b) changes in health related quality of life.

  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.

  baseline and 6 months

Secondary Outcomes (8)

• Changes in the 6 subscales of DISABKIDS

  baseline and 6 months

• Changes in quality of life

  baseline and 6 months

• Changes in self-esteem

  baseline and 6 months

• Changes in self reported time spent outside the home

  baseline and 6 months

• Changes in depression symptoms

  baseline and 6 months

Study Arms (2)

low key intervention

EXPERIMENTAL

Behavioral: manual based low key group intervention (innovation)

routine care

ACTIVE COMPARATOR

Behavioral: standardized, manual based routine care

Interventions

manual based low key group intervention (innovation) 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.

low key intervention

standardized, manual based routine care 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.

routine care

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI ≥30kg/m2
• sufficient German language skills

You may not qualify if:

• Circumstances that require immediate inpatient care (e.g. severe somatic or psychiatric illness)
• obvious cognitive disability

Sponsors & Collaborators

• Prof. Dr. Martin Wabitsch: lead
• University of Witten/Herdecke: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Leipzig: collaborator
• Universität Duisburg-Essen: collaborator
• University of Ulm: collaborator
• Zentrum für klinische Studien Essen: collaborator

Study Sites (6)

Ambulatory Obesity Program, Charité University, Berlin

Berlin, 13353, Germany

Location

Vestische Kinderklinik, University of Witten/Herdecke

Datteln, Germany

Location

Center for Clinical Trials Essen

Essen, 45122, Germany

Location

University Duisburg-Essen

Essen, 45147, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

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

Ulm, 89075, Germany

Location

Related Publications (2)

• 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.

  PMID: 28787738 DERIVED

• 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.

  PMID: 23987123 DERIVED

Related Links

• study homepage

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Johannes Hebebrand, Prof. Dr. med.

  Universität Duisburg-Essen

  STUDY CHAIR

• Wieland Kiess, Prof. Dr. med.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: October 10, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

DE (6)