ObesityKOP-2NCT02942823
Kids Obesity Prevention Program Part 2
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"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2016to 20 Jul 2017
- 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 and their parents
Who cannot join
- children and their parents 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 Part 2 (KOP-2)
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.
As children do not decide alone what they eat - but their parents - the involvement of parents in the intervention appears to be very important to reach a sustained effect.
Read more
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 and a reflexion exercise about leisure behaviour. The game consists of two sessions, having each a duration of about 35 minutes.
The aim of the KOP-1 study was to evaluate the game regarding its acceptance and efficacy in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. The aim of the here presented KOP-2 study is to evaluate the game regarding its acceptance and efficacy in a randomized controlled trial in parents of primary school children aged 9 to 12 years receiving the KOP-1 intervention. Therefore, 4th grade pupils of the same school will be randomly allocated to an intervention and a control group. Both groups will play the game within two weeks, whereas the intervention group will take the game home on a tablet computer to play it with their parents in between session 1 and 2. At baseline, one day after session 2 and at four weeks follow-up, measurements will be performed in pupils and the parents of the intervention group. The primary outcomes of the study are the gain of knowledge (nutrition, psychosocial aspects) in parents and children, measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the interaction of pupils and their parents for the intervention group, 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, energy density, beverages, food pyramide
- 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 "KOP"Other
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). Additionally, the intervention group will take the game home on a tablet computer to play it with their parents in between session 1 and 2. The game equips the children and their parents with knowledge about the core areas nutrition, physical activity, and psychosocial factors. Receives: Other: The serious game "KOP" |
| Control | No intervention | 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. The parents are not involved. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the parents about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Measured: Change between baseline and intervention end, on average 4 weeks after baseline measurement
Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Measured: Change between baseline and intervention end, on average 4 weeks after baseline measurement
Secondary outcomes (6)
Interaction of pupils and their parents for the intervention group by a self-developed questionnaire tailored for this study
Measured: At the end of intervention, on average 4 weeks after baseline measurement (intervention group only)
Acceptance of the serious game by the parents using a self-developed questionnaire specific for the serious game
Measured: At the end of intervention, on average 4 weeks after baseline measurement (intervention group only)
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
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
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
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 end of intervention, on average 4 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 posted24 Oct 2016 (estimated)
- Study start24 Nov 2016
- Primary completion17 Feb 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Science Campus Tuebingen, Department of School Psychology, University of Tuebingen
- Responsible party
- Sponsor
- Investigators
- Stephan Zipfel, Prof., Principal investigator, University Hospital Tuebingen, Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942823
- Sponsor's protocol ID
- KOP_2
- Acronym
- KOP-2
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids Obesity Prevention Program Part 2 (KOP-2)
- ClinicalTrials.gov ID
- NCT02942823
- Acronym / sponsor ID
- KOP-2 / KOP_2
- Keywords
- obesity, child, primary prevention, serious game, nutrition, physical activity, psychosocial, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Science Campus Tuebingen, Department of School Psychology, University of Tuebingen
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 24 Oct 2016 (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.
As children do not decide alone what they eat - but their parents - the involvement of parents in the intervention appears to be very important to reach a sustained effect.
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 and a reflexion exercise about leisure behaviour. The game consists of two sessions, having each a duration of about 35 minutes.
The aim of the KOP-1 study was to evaluate the game regarding its acceptance and efficacy in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. The aim of the here presented KOP-2 study is to evaluate the game regarding its acceptance and efficacy in a randomized controlled trial in parents of primary school children aged 9 to 12 years receiving the KOP-1 intervention. Therefore, 4th grade pupils of the same school will be randomly allocated to an intervention and a control group. Both groups will play the game within two weeks, whereas the intervention group will take the game home on a tablet computer to play it with their parents in between session 1 and 2. At baseline, one day after session 2 and at four weeks follow-up, measurements will be performed in pupils and the parents of the intervention group. The primary outcomes of the study are the gain of knowledge (nutrition, psychosocial aspects) in parents and children, measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the interaction of pupils and their parents for the intervention group, 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 "KOP"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). Additionally, the intervention group will take the game home on a tablet computer to play it with their parents in between session 1 and 2. The game equips the children and their parents with knowledge about the core areas nutrition, physical activity, and psychosocial factors. |
| Control | No intervention | –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. The parents are not involved. |
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 and their parents
Key exclusion criteria (1 listed)
- children and their parents 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 "KOP"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). | Other | Intervention |
Primary outcome
Knowledge of the parents about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Time frame: Change between baseline and intervention end, on average 4 weeks after baseline measurement
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 intervention end, on average 4 weeks after baseline measurement
6 secondary outcomes
Interaction of pupils and their parents for the intervention group by a self-developed questionnaire tailored for this study
Time frame: At the end of intervention, on average 4 weeks after baseline measurement (intervention group only)
Acceptance of the serious game by the parents using a self-developed questionnaire specific for the serious game
Time frame: At the end of intervention, on average 4 weeks after baseline measurement (intervention group only)
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
Food frequency of specific foods which are addressed in the serious game
Time frame: Change between baseline and four weeks follow-up
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
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 end of intervention, on average 4 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 18 Apr 2022.
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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. principal investigator
University Hospital Tuebingen, 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 18 Apr 2022. 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 parents about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game (time frame: Change between baseline and intervention end, on average 4 weeks after baseline measurement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Apr 2022.