OverweightPhase 1NCT01138293
Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity
A Phase 1 study testing motion detection with a motion sensor in people with Overweight and Obesity, run by MEDIGREIF Inselklinik Heringsdorf at 1 site in Germany.
Trial summary
Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- motion detection with a motion sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 1
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All children/adolescents with overweight/obesity were included admitted to our hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
MEDIGREIF Inselklinik Heringsdorf GmbH, Haus Gothensee
Heringsdorf, 17424
About this study
Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome.
Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.
- Conditions
- Overweight, Obesity
- Being tested
- motion detection with a motion sensor
- Keywords
- differences between patients´ self-assessment and objective perception of physical activity and eating habits
- Medical subject headings
- Overweight, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motion detection with a motion sensorDevice
To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.
| Study group | Role | What they receive |
|---|---|---|
| motion sensor integrated in a mobile phone | Experimental | A motion sensor integrated in a mobile phone. The system analyses kind, intensity and duration of physical activity and eating habits. Receives: Device: motion detection with a motion sensor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDIGREIF Inselklinik Heringsdorf
- Sponsor type
- Research network
- Collaborators
- Fraunhofer Institut für Graphische Datenverarbeitung (IGD), Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138293
- Sponsor's protocol ID
- MEDIGREIF 001
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity
- ClinicalTrials.gov ID
- NCT01138293
- Acronym / sponsor ID
- MEDIGREIF 001
- Conditions
- Overweight, Obesity
- Keywords
- differences between patients´ self-assessment and objective perception of physical activity and eating habits
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- MEDIGREIF Inselklinik HeringsdorfResearch network
- Collaborators
- Fraunhofer Institut für Graphische Datenverarbeitung (IGD), Rostock, Germany
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Jun 2010 (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.
Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome.
Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motion sensor integrated in a mobile phone | Experimental | Device: motion detection with a motion sensorA motion sensor integrated in a mobile phone. The system analyses kind, intensity and duration of physical activity and eating habits. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children/adolescents with overweight/obesity were included admitted to our hospital
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| motion detection with a motion sensorTo asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits. | Device | motion sensor integrated in a mobile phone |
Primary outcome
Not reported in the source record.
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 28 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing motion detection with a motion sensor in people with Overweight and Obesity, run by MEDIGREIF Inselklinik Heringsdorf 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 0 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 28 Jun 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 28 Jun 2010.