Back to resultsOverweight Children - Musculoskeletal Consequences
Primary Purpose
Pediatric Overweight
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ball games program
Nutrition counseling
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Overweight
Eligibility Criteria
Inclusion Criteria:
Overweight Children:
- BMI = or > than the gender, race, and age specific 92nd percentile from the National Children Health and Nutrition Examination Survey
All participants:
- 6-11 y. old
Exclusion Criteria:
- severe impairment with functional restriction of the upper or lower extremities (due to injuries)
- neurological deficits/diseases compromising the postural control
- important communication problems due to another mother language
Sites / Locations
- University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Non-overweight children in ball games program
Overweight children in nutrition counseling program
Control group overweight children
Overweight children in ball games program
Overweight children in ball games and nutrition counseling
Non-overweight control (no intervention)
Arm Description
twice a week different ball games 90min
9 units of 90min each of nutrition counseling
No intervention during six months
twice a week different ball games 90min
twice a week different ball games 90min and 9 units of 90min each of nutrition counseling
Outcomes
Primary Outcome Measures
Change in error points in one legged-standing test
Secondary Outcome Measures
Change in angle deviation from target angle in angle reproduction test
Change in range of motion at the joints of the lower extremities
Full Information
NCT ID
NCT01825174
First Posted
April 2, 2013
Last Updated
April 4, 2013
Sponsor
University Hospital Heidelberg
Collaborators
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT01825174
Brief Title
Overweight Children - Musculoskeletal Consequences
Official Title
Musculoskeletal Consequences of Pediatric Overweight - Efficiency of Different Interventions on Health, Motor and Psychosocial Development in Overweight and Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose was to investigate the consequences of pediatric overweight on the musculoskeletal system, postural control and proprioception, and to analyze prospectively the influence of ball games and nutrition counseling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-overweight children in ball games program
Arm Type
Active Comparator
Arm Description
twice a week different ball games 90min
Arm Title
Overweight children in nutrition counseling program
Arm Type
Experimental
Arm Description
9 units of 90min each of nutrition counseling
Arm Title
Control group overweight children
Arm Type
Placebo Comparator
Arm Description
No intervention during six months
Arm Title
Overweight children in ball games program
Arm Type
Experimental
Arm Description
twice a week different ball games 90min
Arm Title
Overweight children in ball games and nutrition counseling
Arm Type
Experimental
Arm Description
twice a week different ball games 90min and 9 units of 90min each of nutrition counseling
Arm Title
Non-overweight control (no intervention)
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Ball games program
Intervention Description
twice a week different ball games 90min
Intervention Type
Behavioral
Intervention Name(s)
Nutrition counseling
Intervention Description
9 units of 90min each of nutrition counseling
Primary Outcome Measure Information:
Title
Change in error points in one legged-standing test
Time Frame
at baseline and 6 months later after intervention
Secondary Outcome Measure Information:
Title
Change in angle deviation from target angle in angle reproduction test
Time Frame
at baseline and 6 months later after intervention
Title
Change in range of motion at the joints of the lower extremities
Time Frame
at baseline and 6 months later after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight Children:
BMI = or > than the gender, race, and age specific 92nd percentile from the National Children Health and Nutrition Examination Survey
All participants:
- 6-11 y. old
Exclusion Criteria:
severe impairment with functional restriction of the upper or lower extremities (due to injuries)
neurological deficits/diseases compromising the postural control
important communication problems due to another mother language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Schmitt, M.D. Ph.D.
Organizational Affiliation
University of Heidelberg/ ATOS Clinic Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26654525
Citation
Kuni B, Ruhling NE, Hegar U, Roth C, Schmitt H. Ball games and nutrition counseling improve postural control in overweight children. BMC Pediatr. 2015 Dec 11;15:205. doi: 10.1186/s12887-015-0523-4.
Results Reference
derived
Learn more about this trial
Overweight Children - Musculoskeletal Consequences
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