Low-level Intervention for Adolescents With Extreme Obesity
Condition: Obesity; Extreme Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Intervention name(s): manual based low key group intervention (innovation); standardized, manual based routine care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extreme Obesity Keywords: obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life