Back to resultsTreatment of Overweight Children and Adolescents
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
behavioral intervention
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- overweight children
Exclusion Criteria:
- primary disease
Sites / Locations
- Vestische Youth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention arm
waiting list
Arm Description
Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment
waiting 6 months for Intervention without any intervention
Outcomes
Primary Outcome Measures
change of weight status
Secondary Outcome Measures
Change of eating and exercise behaviour
change of quality of life
Full Information
NCT ID
NCT00422916
First Posted
January 16, 2007
Last Updated
October 24, 2016
Sponsor
University of Witten/Herdecke
Collaborators
University of Bremen
1. Study Identification
Unique Protocol Identification Number
NCT00422916
Brief Title
Treatment of Overweight Children and Adolescents
Official Title
Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke
Collaborators
University of Bremen
4. Oversight
5. Study Description
Brief Summary
The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.
The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
waiting 6 months for Intervention without any intervention
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Primary Outcome Measure Information:
Title
change of weight status
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of eating and exercise behaviour
Time Frame
6 months
Title
change of quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
overweight children
Exclusion Criteria:
primary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Kolip, Prof
Organizational Affiliation
University of Bremen, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Vestische Youth Hospital
City
Datteln
ZIP/Postal Code
45711
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28882396
Citation
Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.
Results Reference
derived
PubMed Identifier
23759033
Citation
Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.
Results Reference
derived
PubMed Identifier
23281620
Citation
Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.
Results Reference
derived
PubMed Identifier
20106567
Citation
Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.
Results Reference
derived
Learn more about this trial
Treatment of Overweight Children and Adolescents
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