Overweight Children - Musculoskeletal Consequences

April 4, 2013 updated by: Dr. med. Benita Kuni, MD, University Hospital Heidelberg

Musculoskeletal Consequences of Pediatric Overweight - Efficiency of Different Interventions on Health, Motor and Psychosocial Development in Overweight and Obese Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-overweight children in ball games program
twice a week different ball games 90min
Behavioral: Ball games program
twice a week different ball games 90min
Experimental: Overweight children in nutrition counseling program
9 units of 90min each of nutrition counseling
Behavioral: Nutrition counseling
9 units of 90min each of nutrition counseling
Placebo Comparator: Control group overweight children
No intervention during six months
Experimental: Overweight children in ball games program
twice a week different ball games 90min
Behavioral: Ball games program
twice a week different ball games 90min
Experimental: Overweight children in ball games and nutrition counseling
twice a week different ball games 90min and 9 units of 90min each of nutrition counseling
Behavioral: Ball games program
twice a week different ball games 90min
Behavioral: Nutrition counseling
9 units of 90min each of nutrition counseling
Placebo Comparator: Non-overweight control (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in error points in one legged-standing test
Time Frame: at baseline and 6 months later after intervention
at baseline and 6 months later after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in angle deviation from target angle in angle reproduction test
Time Frame: at baseline and 6 months later after intervention
at baseline and 6 months later after intervention
Change in range of motion at the joints of the lower extremities
Time Frame: at baseline and 6 months later after intervention
at baseline and 6 months later after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Heidelberg University

Investigators

  • Principal Investigator: Holger Schmitt, M.D. Ph.D., University of Heidelberg/ ATOS Clinic Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213-2006-130321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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