Trial document




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  DRKS00003424

Trial Description

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Title

Development and Evaluation of an
Age-Appropriate Training Program
for Obese Adolescents and Young
Adults

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Trial Acronym

YOUTH

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URL of the Trial

http://www.psych.uni-potsdam.de/counseling/research/youth-d.html

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Brief Summary in Lay Language

Pathological overweight in adolescents and young adults is an increasing problem. The affected youth suffer from beeing abnormally overweight and accompanying diseases. The society and health care system have to bear the consequential costs of treatment expenses and loss of income tax.
In Germany, a scientifically evaluated training program is missing for obese adolescents and young adults in actual medical and rehabilitational care. Therfore we want to develop and evaluate a training program which is specifically designed for the needs and requirements of obese youth aged 16 to 21. The training is going to be age specific, with topics like "drug abuse" or "extreme diating" and gender-related, with themes like "differences in percieved burden of overweight". Topics like "beeing indepented of parents", "finding your own identity" or "career choice" will be important components of the program. Its focus lies on age-appropriate encouragement of self management skills, to ensure long lasting therapeutic success after inpatient rehabilitation. Particular attention is paid to socially disadvantaged adolescents and young adults, who have been neglected by prior research in this field.
Based on a requirements analysis and in line with preliminary work we will develop an interactive, patient-oriented program.
At the time of the follow-up, significant differences between both groups are expected, i.e. the study group shows a more favourable progression in terms of weight status (BMI-SDS) and quality of life than the active control group does. Predictors of therapy success will be analysed.

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Brief Summary in Scientific Language

This project aims to develop and evaluate an intervention program specifically designed for obese adolescents aged 16 - 21 years (YOUTH). Its focus lies on age-appropriate encouragement of self management skills, to ensure long lasting therapeutic success after inpatient rehabilitation. Based on a requirements analysis and in line with preliminary work we will develop an interactive, patient-oriented program. At the time of the follow-up, significant differences between both groups are expected, i.e. the study group shows a more favourable progression in terms of the BMI-status and quality of life. Predictors of therapy success will be analysed. In advance of the program development 20 qualitative interviews with obese adolescents and a questionnaire survey with 100 male and female youths will be accomplished, asking them about their needs and wishes regarding such program. In order to evaluate the programs short (6 months) and long term (12 months) effectiveness concerning the weight status (BMI-SDS, primary outcome) and quality of life (secondary outcome), a controlled intervention study will be conducted with 125 obese adolescents. Due to ethical and contentual reasons (training programs are already established and successful), the control group (n=125) will be a "treatment as usual" group including all age groups and the conventional training implemented in all facilities.

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Organizational Data

  •   DRKS00003424
  •   2012/01/09
  •   [---]*
  •   yes
  •   Approved
  •   6/2011, Potsdam - Ethikkommission der Universität Potsdam
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Youth specific intervention program YOUTH:
    - 4 weeks inpatient rehabilitation treatment for obese youth age 16-21
    - 6-8 group therapy sessions à 90 min, temporarily divided by gender
    - Topics of training program: nutritional advice, analysis and exercise of eating behavior, training of grocery shopping, use of alcohol and fast food, body image, making opposite-sex relationships, analysis of problems, competence training and strenghten resources such as self esteem, self efficacy and motivation, vocational preparation...
    - usage of cognitive-behavioral techniques (i.e. stimulus control, diary technique, roleplay, target agreements, repeated exercising, etc.)
    - Integration of a DVD, showing others in the same age and situation to provide relevant models and support discussion and motivation amongst the participants
  •   standard education program
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Single blind
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Body Mass Index-Standard Deviation Score (BMI-SDS); modified ratio weight/height; messures with calibrated scales and stadiometers; measurements taken by medical staff; weight classification according to Kromeyer-Hausschild;
four mesurement time points: beginning of inpatient treatment, end of inpatient treatment, 6 and 12 months after treatment

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Secondary Outcome

- Qualitiy of Life (QoL), Instruments: GW-LQ-KJ modified for adolescents, Peds-QL subscales
- Eating behavior, Instruments: FKE-KJ modified for adolescents, FSE-KJ modified for adolescents, food frequency list, food responsiveness, FEV-Path-KJ subscale, FVG-KJ
- Physical activity, Instruments: self developed scale
- Body dissatifaction: Instruments: body sillhouettes (Harris et al.) and self developed scale for satisfaction with figure and body
- Resources: Instruments: self developed resources questionnaire;

four mesurement time points, the same as for primary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2012/01/10
  •   249
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   21   Years
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Additional Inclusion Criteria

Participants in inpatient rehabilitation
BMI over 97.th percentile or BMI >
30 at age 16-21 years with
accompanying diseases

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Exclusion Criteria

none

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Addresses

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    • Lehrstuhl für Beratungspsychologie Department Psychologie Universität Potsdam
    • Ms.  Prof.  Petra  Warschburger 
    • Karl-Liebknecht-Str. 24/25
    • 14476  Potsdam OT Golm
    • Germany
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    • Univeristät Potsdam
    • Ms.  Dipl.-Psych.  Sophia  Neugebauer 
    • Karl-Liebknecht-Str. 14
    • 14476  Potsdam
    • Germany
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    • Univeristät Potsdam
    • Ms.  Dipl.-Psych.  Sophia  Neugebauer 
    • Karl-Liebknecht-Str. 14
    • 14476  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.