Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ball games program

+ Nutrition counseling

+ Ball games program

Behavioral
Who is being recruted

From 6 to 11 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2006
See protocol details

Summary

Principal SponsorUniversity Hospital Heidelberg
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2006

Actual date on which the first participant was enrolled.

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.

NCT01825174
Principal SponsorUniversity Hospital Heidelberg
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

137 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
twice a week different ball games 90min

Group II

Experimental
9 units of 90min each of nutrition counseling

Group III

Placebo
No intervention during six months

Group IV

Experimental
twice a week different ball games 90min

Group 5

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

Group 6

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Heidelberg

Heidelberg, GermanyOpen University of Heidelberg in Google Maps
CompletedOne Study Center