Kids Obesity Prevention Program - Study (KOP)

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551978
• Other study ID #: KOP_1
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: November 26, 2015
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child
• Obesity

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Science Campus Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game		Change between baseline and two weeks after the baseline measurement	No
Secondary	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	Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))	No
Secondary	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	Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))	No
Secondary	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	change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))	No
Secondary	Intentions of children to stick to a healthy lifestyle by using a tailored questionnaire specific for the contents of the serious game		Change between baseline, and two weeks after baseline measurement, and four weeks follow-up	No
Secondary	Acceptance of the serious game by the children using a self-developed questionnaire specific for the serious game		At baseline and directly after the end of the second session of the game (on average two weeks after baseline measurement)	No

External Links

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