Pediatric OverweightNCT01825174
Overweight Children - Musculoskeletal Consequences
A study testing Ball games program and Nutrition counseling in people with Pediatric Overweight, run by University Hospital Heidelberg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Overweight
- What is being tested?
- Ball games program and Nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pediatric Overweight
- Being tested
- Ball games program, Nutrition counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ball games programBehavioural
twice a week different ball games 90min
Nutrition counselingBehavioural
9 units of 90min each of nutrition counseling
| Study group | Role | What they receive |
|---|---|---|
| Non-overweight children in ball games program | Active comparator | twice a week different ball games 90min Receives: Behavioral: Ball games program |
| Overweight children in nutrition counseling program | Experimental | 9 units of 90min each of nutrition counseling Receives: 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 Receives: 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 Receives: Behavioral: Ball games program; Behavioral: Nutrition counseling |
| Non-overweight control (no intervention) | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in error points in one legged-standing test
Measured: at baseline and 6 months later after intervention
Secondary outcomes (2)
Change in angle deviation from target angle in angle reproduction test
Measured: at baseline and 6 months later after intervention
Change in range of motion at the joints of the lower extremities
Measured: at baseline and 6 months later after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Principal investigator, Dr. med. Benita Kuni, MD, University Hospital Heidelberg
- Investigators
- Holger Schmitt, M.D. Ph.D., Principal investigator, University of Heidelberg/ ATOS Clinic Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825174
- Sponsor's protocol ID
- 213-2006-130321
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26654525
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Consequences of Pediatric Overweight - Efficiency of Different Interventions on Health, Motor and Psychosocial Development in Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT01825174
- Acronym / sponsor ID
- 213-2006-130321
- Conditions
- Pediatric Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Non-overweight children in ball games program | Active comparator | Behavioral: Ball games programtwice a week different ball games 90min |
| Overweight children in nutrition counseling program | Experimental | Behavioral: Nutrition counseling9 units of 90min each of nutrition counseling |
| Control group overweight children | Placebo comparator | –No intervention during six months |
| Overweight children in ball games program | Experimental | Behavioral: Ball games programtwice a week different ball games 90min |
| Overweight children in ball games and nutrition counseling | Experimental | Behavioral: Ball games program, Behavioral: Nutrition counselingtwice a week different ball games 90min and 9 units of 90min each of nutrition counseling |
| Non-overweight control (no intervention) | Placebo comparator | – |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- BMI = or > than the gender, race, and age specific 92nd percentile from the National Children Health and Nutrition Examination Survey
- 6-11 y. old
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ball games programtwice a week different ball games 90min | Behavioural | Non-overweight children in ball games program, Overweight children in ball games and nutrition counseling, Overweight children in ball games program |
| Nutrition counseling9 units of 90min each of nutrition counseling | Behavioural | Overweight children in ball games and nutrition counseling, Overweight children in nutrition counseling program |
Primary outcome
Change in error points in one legged-standing test
Time frame: at baseline and 6 months later after intervention
2 secondary outcomes
Change in angle deviation from target angle in angle reproduction test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Derived from this study: PubMed 26654525Kuni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Schmitt, M.D. Ph.D. principal investigator
University of Heidelberg/ ATOS Clinic Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ball games program and Nutrition counseling in people with Pediatric Overweight, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in error points in one legged-standing test (time frame: at baseline and 6 months later after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013; AzTrials last refreshed its copy on 30 Oct 2026.