Kids Obesity Prevention Program - Study (KOP) (KOP)

November 26, 2015 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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).
NO_INTERVENTION: Control
Children in the same primary school, aged between 9 and 12 years do receive basic information during the study phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change between baseline and two weeks after the baseline measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Parents and children are independently asked to report the food frequencies for key foods in order to calculate the Ernährungsmuster index
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))
Parents and children are independently asked to report the food frequencies of specific foods
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))
Parents and children are independently asked to fill in the questionnaire
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
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)
At baseline and directly after the end of the second session of the game (on average two weeks after baseline measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Science Campus Tuebingen

Investigators

  • Principal Investigator: Stephan Zipfel, Prof. Dr., University Hospital Tuebingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (ESTIMATE)

September 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOP_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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