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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01825174
Other study ID # 213-2006-130321
Secondary ID
Status Completed
Phase N/A
First received April 2, 2013
Last updated April 4, 2013
Start date June 2006
Est. completion date June 2008

Study information

Verified date April 2013
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 11 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Ball games program
twice a week different ball games 90min
Nutrition counseling
9 units of 90min each of nutrition counseling

Locations

Country Name City State
Germany University of Heidelberg Heidelberg

Sponsors (5)

Lead Sponsor Collaborator
University Hospital Heidelberg Department for Internal Medicine Endocrinology Heidelberg University Hospital, Department for Internal Medicine Sports Medicine Heidelberg University Hospital, Department for Pediatrics and Youth Medicine Heidelberg University Hospital, Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in error points in one legged-standing test at baseline and 6 months later after intervention No
Secondary Change in angle deviation from target angle in angle reproduction test at baseline and 6 months later after intervention No
Secondary Change in range of motion at the joints of the lower extremities at baseline and 6 months later after intervention No
See also
  Status Clinical Trial Phase
Terminated NCT00863083 - Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity N/A