Overweight Children - Musculoskeletal Consequences

NCT ID: NCT01825174

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-overweight children in ball games program

twice a week different ball games 90min

Group Type ACTIVE_COMPARATOR

Ball games program

Intervention Type BEHAVIORAL

twice a week different ball games 90min

Overweight children in nutrition counseling program

9 units of 90min each of nutrition counseling

Group Type EXPERIMENTAL

Nutrition counseling

Intervention Type BEHAVIORAL

9 units of 90min each of nutrition counseling

Control group overweight children

No intervention during six months

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Overweight children in ball games program

twice a week different ball games 90min

Group Type EXPERIMENTAL

Ball games program

Intervention Type BEHAVIORAL

twice a week different ball games 90min

Overweight children in ball games and nutrition counseling

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

Group Type EXPERIMENTAL

Ball games program

Intervention Type BEHAVIORAL

twice a week different ball games 90min

Nutrition counseling

Intervention Type BEHAVIORAL

9 units of 90min each of nutrition counseling

Non-overweight control (no intervention)

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ball games program

twice a week different ball games 90min

Intervention Type BEHAVIORAL

Nutrition counseling

9 units of 90min each of nutrition counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Benita Kuni, MD

Orthopedic and Trauma Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Holger Schmitt, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg/ ATOS Clinic Heidelberg

Locations

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University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26654525 (View on PubMed)

Other Identifiers

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213-2006-130321

Identifier Type: -

Identifier Source: org_study_id

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