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Treatment of Overweight Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
University of Bremen
Information provided by (Responsible Party):
Thomas Reinehr, University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT00422916
First received: January 16, 2007
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Overweight
Behavioral: behavioral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents

Further study details as provided by University of Witten/Herdecke:

Primary Outcome Measures:
  • change of weight status [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of eating and exercise behaviour [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change of quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention arm
Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment
Behavioral: behavioral intervention
No Intervention: waiting list
waiting 6 months for Intervention without any intervention

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • overweight children

Exclusion Criteria:

  • primary disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422916

Locations
Germany
Vestische Youth Hospital
Datteln, Germany, 45711
Sponsors and Collaborators
University of Witten/Herdecke
University of Bremen
Investigators
Study Chair: Petra Kolip, Prof University of Bremen, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Reinehr, Head of Department of Pediatric Endocrinology, Diabetes, and Nutrition Medicine, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT00422916     History of Changes
Other Study ID Numbers: GFEL011174505 
Study First Received: January 16, 2007
Last Updated: October 24, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on December 06, 2016