OverweightNCT00422916
Treatment of Overweight Children and Adolescents
A study testing behavioral intervention in people with Overweight, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific. The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Overweight
- What is being tested?
- behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2010
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- overweight children
Who cannot join
- primary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents
The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.
The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.
- Conditions
- Overweight
- Being tested
- behavioral intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Lifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment Receives: Behavioral: behavioral intervention |
| waiting list | No intervention | waiting 6 months for Intervention without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of weight status
Measured: 6 months
Secondary outcomes (2)
Change of eating and exercise behaviour
Measured: 6 months
change of quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bremen
- Responsible party
- Principal investigator, Thomas Reinehr, University of Witten/Herdecke
- Investigators
- Petra Kolip, Prof, Study chair, University of Bremen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422916
- Sponsor's protocol ID
- GFEL011174505
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2007
- Last updated
- 25 Oct 2016
- Results posted
- No
Publications
Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.
PubMed 28882396Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.
PubMed 23759033Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.
PubMed 23281620Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.
PubMed 20106567
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents
- ClinicalTrials.gov ID
- NCT00422916
- Acronym / sponsor ID
- GFEL011174505
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- University of Bremen
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Jan 2007 (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 intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.
The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: behavioral interventionLifestyle Intervention based on Nutrition Treatment, exercise Treatment and behavorial treatment |
| waiting list | No intervention | –waiting 6 months for Intervention without any intervention |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- overweight children
Key exclusion criteria (1 listed)
- primary disease
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 |
|---|---|---|
| behavioral intervention | Behavioural | intervention arm |
Primary outcome
change of weight status
Time frame: 6 months
2 secondary outcomes
Change of eating and exercise behaviour
Time frame: 6 months
change of quality of life
Time frame: 6 months
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 25 Oct 2016.
- Derived from this study: PubMed 28882396Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.
- Derived from this study: PubMed 23759033Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.
- Derived from this study: PubMed 23281620Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.
- Derived from this study: PubMed 20106567Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.
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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.
Petra Kolip, Prof study chair
University of Bremen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral intervention in people with Overweight, run by University of Witten/Herdecke 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 1 inclusion and 1 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 25 Oct 2016. 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. 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 of weight status (time frame: 6 months). 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 NCT00422916, which also lists 4 linked publications.
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 25 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.