Kids Obesity Prevention Program - Study (KOP) (KOP)
Primary Purpose
Obesity, Child
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The serious game KOP
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, child, primary prevention, serious game, nutrition, physical activity, psychosocial, stress, knowledge, diet
Eligibility Criteria
Inclusion Criteria:
- all children which belong to the 4th graders of a primary school
Exclusion Criteria:
- children with massive linguistic difficulties will be excluded (after study participation; due to ethical reasons we can not do this ahead)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Children in the same primary school, aged between 9 and 12 years do receive basic information during the study phase.
Outcomes
Primary Outcome Measures
Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game
Secondary Outcome Measures
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
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
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
Intentions of children to stick to a healthy lifestyle by using a tailored questionnaire specific for the contents of the serious game
Acceptance of the serious game by the children using a self-developed questionnaire specific for the serious game
Full Information
NCT ID
NCT02551978
First Posted
September 11, 2015
Last Updated
November 26, 2015
Sponsor
University Hospital Tuebingen
Collaborators
Science Campus Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02551978
Brief Title
Kids Obesity Prevention Program - Study (KOP)
Acronym
KOP
Official Title
Kids Obesity Prevention Program - Study (KOP). A Serious Game to Address Barriers to Prevention and Treatment of Obesity in Primary School Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Science Campus Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Child
Keywords
obesity, child, primary prevention, serious game, nutrition, physical activity, psychosocial, stress, knowledge, diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in the same primary school, aged between 9 and 12 years do receive basic information during the study phase.
Intervention Type
Other
Intervention Name(s)
The serious game KOP
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Nutrition Score (Ernährungsmusterindex) by Kleiser et al., 2007 used in the KIGGS cohort (Studie zur Gesundheit von Kindern und Jugendlichen in Deutschland)
Description
Parents and children are independently asked to report the food frequencies for key foods in order to calculate the Ernährungsmuster index
Time Frame
Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Title
Food frequency of specific foods which are addressed in the serious game
Description
Parents and children are independently asked to report the food frequencies of specific foods
Time Frame
Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Title
Physical activity using a validated questionnaire filled in by the children and also the parents
Description
Parents and children are independently asked to fill in the questionnaire
Time Frame
change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))
Title
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
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all children which belong to the 4th graders of a primary school
Exclusion Criteria:
children with massive linguistic difficulties will be excluded (after study participation; due to ethical reasons we can not do this ahead)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Zipfel, Prof. Dr.
Organizational Affiliation
University Hospital Tuebingen, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32329742
Citation
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.
Results Reference
derived
Links:
URL
http://www.wissenschaftscampus-tuebingen.de
Description
Related Info
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Kids Obesity Prevention Program - Study (KOP)
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