Low-level Intervention for Adolescents With Extreme Obesity

NCT01703273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2018-06-13

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Witten/Herdecke

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • University of Leipzig

    collaborator OTHER
  • Universität Duisburg-Essen

    collaborator OTHER
  • University of Ulm

    collaborator OTHER
  • Zentrum für klinische Studien Essen

    collaborator OTHER
  • Prof. Dr. Martin Wabitsch

    lead OTHER

Principal Investigators

  • Martin Wabitsch, Prof. Dr. med. · University of Ulm

  • Susanna Wiegand, Dr. med. · Charite University, Berlin, Germany

  • Thomas Reinehr, Prof. Dr. med. · University of Witten/Herdecke

  • Johannes Hebebrand, Prof. Dr. med. · Universität Duisburg-Essen

  • Wieland Kiess, Prof. Dr. med. · University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01703273 on ClinicalTrials.gov