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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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 11, 2015
    Last Updated
    November 26, 2015
    Sponsor
    University Hospital Tuebingen
    Collaborators
    Science Campus Tuebingen
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    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
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