NCT01825174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

April 2, 2013

Last Update Submit

April 4, 2013

Conditions

Pediatric Overweight

Outcome Measures

Primary Outcomes (1)

  • Change in error points in one legged-standing test

    at baseline and 6 months later after intervention

Secondary Outcomes (2)

  • Change in angle deviation from target angle in angle reproduction test

    at baseline and 6 months later after intervention

  • Change in range of motion at the joints of the lower extremities

    at baseline and 6 months later after intervention

Study Arms (6)

Non-overweight children in ball games program

ACTIVE COMPARATOR

twice a week different ball games 90min

Behavioral: Ball games program

Overweight children in nutrition counseling program

EXPERIMENTAL

9 units of 90min each of nutrition counseling

Behavioral: Nutrition counseling

Control group overweight children

PLACEBO COMPARATOR

No intervention during six months

Overweight children in ball games program

EXPERIMENTAL

twice a week different ball games 90min

Behavioral: Ball games program

Overweight children in ball games and nutrition counseling

EXPERIMENTAL

twice a week different ball games 90min and 9 units of 90min each of nutrition counseling

Behavioral: Ball games programBehavioral: Nutrition counseling

Non-overweight control (no intervention)

PLACEBO COMPARATOR

Interventions

Ball games programBEHAVIORAL

twice a week different ball games 90min

Non-overweight children in ball games programOverweight children in ball games and nutrition counselingOverweight children in ball games program
Nutrition counselingBEHAVIORAL

9 units of 90min each of nutrition counseling

Overweight children in ball games and nutrition counselingOverweight children in nutrition counseling program

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26654525DERIVED

Study Officials

  • Holger Schmitt, M.D. Ph.D.

    University of Heidelberg/ ATOS Clinic Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic and Trauma Surgeon

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

DE(1)