ObesityKOPNCT02551978
Kids Obesity Prevention Program - Study (KOP)
A study testing The serious game KOP in people with Obesity and Child, run by University Hospital Tuebingen.
Trial summary
Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- What is being tested?
- The serious game KOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2015
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all children which belong to the 4th graders of a primary school
Who cannot join
- children with massive linguistic difficulties will be excluded (after study participation; due to ethical reasons we can not do this ahead)
About this study
Official title: Kids Obesity Prevention Program - Study (KOP). A Serious Game to Address Barriers to Prevention and Treatment of Obesity in Primary School Children
Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. It is therefore crucial to provide both prevention and treatment actions already during childhood. The prevention and treatment weight-management programs in children focus on improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One important basic requirement for any weight-management program is, that both children and their families are motivated and ready for change. Video games, including exergames, serious games or combined approaches offer additional chances in the treatment and prevention of obesity by approaching children in their environment and motivating them to deal with life-style topics.
The investigators developed a motion-controlled serious game for children aged between 9 and 12 years, addressing all the three core areas nutrition, physical activity, and psychosocial factors. In addition to the motion control, a tablet is used for knowledge-based and cognitive tasks. In comparison to other studies the nutrition part not only deals with the food pyramid but also with the energy density of foods and liquids and offers a self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects, especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises. The game consists of two sessions, having each a duration of about 35 minutes.
The aim of this study is to evaluate the program in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of the same school will be randomly allocated to an intervention and a control group. The intervention group will play the game within two weeks, whereas the control group will receive basic information. At baseline, two weeks after baseline and at four weeks follow-up, measurements will be performed. The primary outcome of the study is the gain of knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the acceptance of the game, changes of nutrition behaviour, physical activity and intentions of the children to follow a healthy lifestyle, measured by mostly validated questionnaires.
- Being tested
- The serious game KOP
- Keywords
- obesity, child, primary prevention, serious game, nutrition, physical activity, psychosocial, stress, knowledge, diet
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The serious game KOPOther
The serious game transfers knowledge about nutrition (food pyramid, energy density of foods, which foods contribute to satiety and which not, energy in liquids, self-reflexive diagnostic tool to analyze daily food intake), physical activity (a motion-control to navigate through the game is partly used, relationship between energy expenditure and energy intake) and psychological aspects (relaxation-exercises, what is stress, stress-coping strategies).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Children in a primary school, aged between 9 and 12 years, play the serious game (two sessions, duration of each session 35 minutes, within two weeks). The game equips the children with knowledge about the core areas nutrition, physical activity, and psychosocial factors. Receives: Other: The serious game KOP |
| Control | No intervention | Children in the same primary school, aged between 9 and 12 years do receive basic information during the study phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Measured: Change between baseline and two weeks after the baseline measurement
Secondary outcomes (5)
Nutrition Score (Ernährungsmusterindex) by Kleiser et al., 2007 used in the KIGGS cohort (Studie zur Gesundheit von Kindern und Jugendlichen in Deutschland)
Parents and children are independently asked to report the food frequencies for key foods in order to calculate the Ernährungsmuster index
Measured: Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Food frequency of specific foods which are addressed in the serious game
Parents and children are independently asked to report the food frequencies of specific foods
Measured: Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Physical activity using a validated questionnaire filled in by the children and also the parents
Parents and children are independently asked to fill in the questionnaire
Measured: change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Intentions of children to stick to a healthy lifestyle by using a tailored questionnaire specific for the contents of the serious game
Measured: Change between baseline, and two weeks after baseline measurement, and four weeks follow-up
Acceptance of the serious game by the children using a self-developed questionnaire specific for the serious game
Measured: At baseline and directly after the end of the second session of the game (on average two weeks after baseline measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionNov 2015
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 ObesityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Science Campus Tuebingen
- Responsible party
- Sponsor
- Investigators
- Stephan Zipfel, Prof. Dr., Principal investigator, University Hospital Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551978
- Sponsor's protocol ID
- KOP_1
- Acronym
- KOP
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mack I, Reiband N, Etges C, Eichhorn S, Schaeffeler N, Zurstiege G, Gawrilow C, Weimer K, Peeraully R, Teufel M, Blumenstock G, Giel KE, Junne F, Zipfel S. The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity. J Med Internet Res. 2020 Apr 24;22(4):e15725. doi: 10.2196/15725.
PubMed 32329742
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids Obesity Prevention Program - Study (KOP). A Serious Game to Address Barriers to Prevention and Treatment of Obesity in Primary School Children
- ClinicalTrials.gov ID
- NCT02551978
- Acronym / sponsor ID
- KOP / KOP_1
- Keywords
- obesity, child, primary prevention, serious game, nutrition, physical activity, psychosocial, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Science Campus Tuebingen
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Sep 2015 (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.
Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. It is therefore crucial to provide both prevention and treatment actions already during childhood. The prevention and treatment weight-management programs in children focus on improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One important basic requirement for any weight-management program is, that both children and their families are motivated and ready for change. Video games, including exergames, serious games or combined approaches offer additional chances in the treatment and prevention of obesity by approaching children in their environment and motivating them to deal with life-style topics.
The investigators developed a motion-controlled serious game for children aged between 9 and 12 years, addressing all the three core areas nutrition, physical activity, and psychosocial factors. In addition to the motion control, a tablet is used for knowledge-based and cognitive tasks. In comparison to other studies the nutrition part not only deals with the food pyramid but also with the energy density of foods and liquids and offers a self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects, especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises. The game consists of two sessions, having each a duration of about 35 minutes.
The aim of this study is to evaluate the program in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of the same school will be randomly allocated to an intervention and a control group. The intervention group will play the game within two weeks, whereas the control group will receive basic information. At baseline, two weeks after baseline and at four weeks follow-up, measurements will be performed. The primary outcome of the study is the gain of knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the acceptance of the game, changes of nutrition behaviour, physical activity and intentions of the children to follow a healthy lifestyle, measured by mostly validated questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: The serious game KOPChildren in a primary school, aged between 9 and 12 years, play the serious game (two sessions, duration of each session 35 minutes, within two weeks). The game equips the children with knowledge about the core areas nutrition, physical activity, and psychosocial factors. |
| Control | No intervention | –Children in the same primary school, aged between 9 and 12 years do receive basic information during the study phase. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all children which belong to the 4th graders of a primary school
Key exclusion criteria (1 listed)
- children with massive linguistic difficulties will be excluded (after study participation; due to ethical reasons we can not do this ahead)
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 |
|---|---|---|
| The serious game KOPThe serious game transfers knowledge about nutrition (food pyramid, energy density of foods, which foods contribute to satiety and which not, energy in liquids, self-reflexive diagnostic tool to analyze daily food intake), physical activity (a motion-control to navigate through the game is partly used, relationship between energy expenditure and energy intake) and psychological aspects (relaxation-exercises, what is stress, stress-coping strategies). | Other | Intervention |
Primary outcome
Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Time frame: Change between baseline and two weeks after the baseline measurement
5 secondary outcomes
Nutrition Score (Ernährungsmusterindex) by Kleiser et al., 2007 used in the KIGGS cohort (Studie zur Gesundheit von Kindern und Jugendlichen in Deutschland)
Time frame: Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Food frequency of specific foods which are addressed in the serious game
Time frame: Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Physical activity using a validated questionnaire filled in by the children and also the parents
Time frame: change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Intentions of children to stick to a healthy lifestyle by using a tailored questionnaire specific for the contents of the serious game
Time frame: Change between baseline, and two weeks after baseline measurement, and four weeks follow-up
Acceptance of the serious game by the children using a self-developed questionnaire specific for the serious game
Time frame: At baseline and directly after the end of the second session of the game (on average two weeks after baseline measurement)
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 30 Nov 2015.
- Derived from this study: PubMed 32329742Mack I, Reiband N, Etges C, Eichhorn S, Schaeffeler N, Zurstiege G, Gawrilow C, Weimer K, Peeraully R, Teufel M, Blumenstock G, Giel KE, Junne F, Zipfel S. The Kids Obesity Prevention Program: Cluster Randomized Controlled Trial to Evaluate a Serious Game for the Prevention and Treatment of Childhood Obesity. J Med Internet Res. 2020 Apr 24;22(4):e15725. doi: 10.2196/15725.
- Related InfoLink provided by the sponsor.
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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.
Stephan Zipfel, Prof. Dr. principal investigator
University Hospital Tuebingen, Germany
Questions about this trial
What is this clinical trial studying?
A study testing The serious game KOP in people with Obesity and Child, run by University Hospital Tuebingen.
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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game (time frame: Change between baseline and two weeks after the baseline measurement). 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 NCT02551978, 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 30 Nov 2015.