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Kaledo Game and The Nutrition Education Prepared According to Health Belief Model

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kaledo game
Education
No intervention
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood obesity, Game, Health belief model, Kaledo Game

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being studying in the 5th 6th and 7th grade
  • BMI percentile value above 85
  • Volunteering to participate in research
  • Parents' consent

Exclusion Criteria:

  • Not being studying in the 5th 6th and 7th grade
  • BMI percentile value below 85
  • Not being willing to participate in research
  • Student's parents not giving consent
  • Being on a diet under the control of any specialist or using medication for weight control

Sites / Locations

  • Eskişehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Kaledo Game

Education

Control

Arm Description

Kaledo game, which is a board game, has been developed to inform children about healthy eating. The aim of this game is to teach children calorie balance through the calorie values of foods. Kaledo game gives children the opportunity to stay motivated and have fun. While children are having fun, they also gain the knowledge necessary for healthy eating behavior change. The game is played with 2-4 people. A game session takes 15-30 minutes Children in the playgroup played 15-30 minutes (1 round) Kaledo game every week for 12 weeks.

The students in the training group were trained for 20 minutes once a week for 12 weeks. Training subjects were prepared in line with health belief model components. The following subjects were included in the training content. What is obesity?Risk factors for obesity, Characteristics of obese individuals, What is a healthy diet?Relationship between unhealthy nutrition and obesity, The consequences of unhealthy diet Health problems caused by obesity, What should be done to prevent and control obesity. How should nutrition be to lose weight? Positive results which show up with weight loss, Barriers to a healthy diet, Ways to reduce and eliminate barriers How to take action to lose weight?, Benefits of weight loss, Success stories in the fight against obesity, How are eating habits changed?, How can we achieve self-efficacy to change eating habits?

There was no intervention in the control group.

Outcomes

Primary Outcome Measures

Pre-intervention measurements
Body Mass Index ( kg/m^2)
Pre-intervention measurements
nutrition self-efficacy scale to measure nutrition self-efficacy The scale consisting of 15 items has a triple Likert type, single factor structure. Scale items take values in the -1, +1 point range (-1: not sure, 0: somewhat sure, +1: very sure). The total score is between -15 and +15. The higher the total score obtained from the scale indicates the high self-efficacy value.
Pre-intervention measurements
nutrition attitude scale to measure nutrition attitude Scale items take values between 1-4 points (1- strongly disagree, 2- disagree, 3-agree, 4- strongly agree). Its total score is between 4-16. A high total score from the scale indicates a positive attitude.
Pre-intervention measurements
nutrition behavior scale to measure nutrition behavior Scale items take -1 value for unhealthy food and +1 value for healthy food, total score is between -14, +14. The high total score obtained from the scale indicates the healthy eating habits.

Secondary Outcome Measures

Post-intervention measurements
Body Mass Index ( kg/m^2)
Post-intervention measurements
nutrition self-efficacy scale to measure nutrition self-efficacy The scale consisting of 15 items has a triple Likert type, single factor structure. Scale items take values in the -1, +1 point range (-1: not sure, 0: somewhat sure, +1: very sure). The total score is between -15 and +15. The higher the total score obtained from the scale indicates the high self-efficacy value.
Post-intervention measurements
nutrition attitude scale to measure nutrition attitude Scale items take values between 1-4 points (1- strongly disagree, 2- disagree, 3-agree, 4- strongly agree). Its total score is between 4-16. A high total score from the scale indicates a positive attitude.
Post-intervention measurements
nutrition behavior scale to measure nutrition behavior Scale items take -1 value for unhealthy food and +1 value for healthy food, total score is between -14, +14. The high total score obtained from the scale indicates the healthy eating habits.

Full Information

First Posted
October 22, 2020
Last Updated
November 7, 2020
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04620044
Brief Title
Kaledo Game and The Nutrition Education Prepared According to Health Belief Model
Official Title
Comparison of The Effect of The Kaledo Game and The Nutrition Education Prepared According to Health Belief Model on Weight Loss in Overweight and Obez Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
According to the World Health Organization, childhood obesity is the most serious problem of this century. Childhood obesity is an important risk factor for many chronic diseases such as insulin resistance, dyslipidemia, hypertension, diabetes, coronary heart disease.Childhood obesity is a serious public health problem and the public health nurse plays an important role in the prevention of obesity. Especially in schools, positive health behaviors of children should be developed by considering them within the scope of school health. Changing the diet in children will make important contributions to the fight against obesity.In order to change the child's diet, it is necessary to teach the child the correct diet. School is the most appropriate educational environment in which the right nutrition can be learned and permanent behavior change can be established.There is a need for effective methods to teach proper nutrition and to achieve weight loss. The aim of this study was to compare the effect of Kaledo game and nutrition education prepared according to health belief model on weight loss in overweight and obese children. This study is randomized controlled experimental study. There were 2 experiments and a control group in the study. Children in the first experimental group were a play session one day a week, and the second experimental group received 20 minutes of nutrition education once a week. No intervention applied to the control group. Children in all three groups were 0, 3. Month-weight measurements made and personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale applied.
Detailed Description
The population of the study consists of overweight and obese students studying in 5th, 6th and 7th grades of secondary school. However, due to the very large population, 3 secondary schools were selected. It was decided to select a sample from these three secondary schools.The children included in the sample were likely to be in different groups. Also, no intervention would be applied to children in the control group. There could be problems such as children labeling each other. To avoid these problems, the groups are divided into schools. The three schools where the research will be conducted were determined by lot method. The first school formed the Kaledo game group, the second school the nutrition education group, and the third school the control group. BMI was determined by making anthropometric measurements of the children attending these schools. These students were stratified according to their overweight and obese status and gender. According to the power analysis, the minimum sample size for the experimental and control groups was calculated as 57 for each group. In this context, the sample size for each group was planned to consist of 64 people, taking into account incomplete and incorrect data and absenteeism. In this study population, students up to the sample size (n = 64) determined (32 overweight students and 32 obese students) by Power analysis for each school were determined by drawing of lots method. Later, the interventions defined in the groups were initiated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, Game, Health belief model, Kaledo Game

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kaledo Game
Arm Type
Experimental
Arm Description
Kaledo game, which is a board game, has been developed to inform children about healthy eating. The aim of this game is to teach children calorie balance through the calorie values of foods. Kaledo game gives children the opportunity to stay motivated and have fun. While children are having fun, they also gain the knowledge necessary for healthy eating behavior change. The game is played with 2-4 people. A game session takes 15-30 minutes Children in the playgroup played 15-30 minutes (1 round) Kaledo game every week for 12 weeks.
Arm Title
Education
Arm Type
Experimental
Arm Description
The students in the training group were trained for 20 minutes once a week for 12 weeks. Training subjects were prepared in line with health belief model components. The following subjects were included in the training content. What is obesity?Risk factors for obesity, Characteristics of obese individuals, What is a healthy diet?Relationship between unhealthy nutrition and obesity, The consequences of unhealthy diet Health problems caused by obesity, What should be done to prevent and control obesity. How should nutrition be to lose weight? Positive results which show up with weight loss, Barriers to a healthy diet, Ways to reduce and eliminate barriers How to take action to lose weight?, Benefits of weight loss, Success stories in the fight against obesity, How are eating habits changed?, How can we achieve self-efficacy to change eating habits?
Arm Title
Control
Arm Type
Experimental
Arm Description
There was no intervention in the control group.
Intervention Type
Other
Intervention Name(s)
Kaledo game
Intervention Description
Before starting the study, the height and weight of the children in the play group were measured and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.Then the game sessions were started.Game sessions lasted 12 weeks. After 12 weeks, the height and weight measurements of the students were made and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Before starting the study, the height and weight of the children in the education group were measured and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.Then the education sessions were started.education sessions lasted 12 weeks. After 12 weeks, the height and weight measurements of the students were made and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Body mass indexes were calculated by measuring the height and weight of the students.Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.The same measurements and scale applications were repeated after 12 weeks.
Primary Outcome Measure Information:
Title
Pre-intervention measurements
Description
Body Mass Index ( kg/m^2)
Time Frame
first month
Title
Pre-intervention measurements
Description
nutrition self-efficacy scale to measure nutrition self-efficacy The scale consisting of 15 items has a triple Likert type, single factor structure. Scale items take values in the -1, +1 point range (-1: not sure, 0: somewhat sure, +1: very sure). The total score is between -15 and +15. The higher the total score obtained from the scale indicates the high self-efficacy value.
Time Frame
first month
Title
Pre-intervention measurements
Description
nutrition attitude scale to measure nutrition attitude Scale items take values between 1-4 points (1- strongly disagree, 2- disagree, 3-agree, 4- strongly agree). Its total score is between 4-16. A high total score from the scale indicates a positive attitude.
Time Frame
first month
Title
Pre-intervention measurements
Description
nutrition behavior scale to measure nutrition behavior Scale items take -1 value for unhealthy food and +1 value for healthy food, total score is between -14, +14. The high total score obtained from the scale indicates the healthy eating habits.
Time Frame
first month
Secondary Outcome Measure Information:
Title
Post-intervention measurements
Description
Body Mass Index ( kg/m^2)
Time Frame
3rd month
Title
Post-intervention measurements
Description
nutrition self-efficacy scale to measure nutrition self-efficacy The scale consisting of 15 items has a triple Likert type, single factor structure. Scale items take values in the -1, +1 point range (-1: not sure, 0: somewhat sure, +1: very sure). The total score is between -15 and +15. The higher the total score obtained from the scale indicates the high self-efficacy value.
Time Frame
3rd month
Title
Post-intervention measurements
Description
nutrition attitude scale to measure nutrition attitude Scale items take values between 1-4 points (1- strongly disagree, 2- disagree, 3-agree, 4- strongly agree). Its total score is between 4-16. A high total score from the scale indicates a positive attitude.
Time Frame
3rd month
Title
Post-intervention measurements
Description
nutrition behavior scale to measure nutrition behavior Scale items take -1 value for unhealthy food and +1 value for healthy food, total score is between -14, +14. The high total score obtained from the scale indicates the healthy eating habits.
Time Frame
3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being studying in the 5th 6th and 7th grade BMI percentile value above 85 Volunteering to participate in research Parents' consent Exclusion Criteria: Not being studying in the 5th 6th and 7th grade BMI percentile value below 85 Not being willing to participate in research Student's parents not giving consent Being on a diet under the control of any specialist or using medication for weight control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem ÖRSAL, PhD
Organizational Affiliation
Eskişehir Osmangazi University
Official's Role
Study Director
Facility Information:
Facility Name
Eskişehir Osmangazi University
City
Eskişehir
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29845514
Citation
Sen M, Uzuner A, Akman M, Bahadir AT, Borekci NO, Viggiano E. Examination of a board game approach to children's involvement in family-based weight management vs. traditional family-based behavioral counseling in primary care. Eur J Pediatr. 2018 Aug;177(8):1231-1238. doi: 10.1007/s00431-018-3177-z. Epub 2018 May 29.
Results Reference
background
PubMed Identifier
25048788
Citation
Viggiano A, Viggiano E, Di Costanzo A, Viggiano A, Andreozzi E, Romano V, Rianna I, Vicidomini C, Gargano G, Incarnato L, Fevola C, Volta P, Tolomeo C, Scianni G, Santangelo C, Battista R, Monda M, Viggiano A, De Luca B, Amaro S. Kaledo, a board game for nutrition education of children and adolescents at school: cluster randomized controlled trial of healthy lifestyle promotion. Eur J Pediatr. 2015 Feb;174(2):217-28. doi: 10.1007/s00431-014-2381-8. Epub 2014 Jul 22.
Results Reference
background
PubMed Identifier
22909283
Citation
Haney MO, Erdogan S. Factors related to dietary habits and body mass index among Turkish school children: a Cox's interaction model-based study. J Adv Nurs. 2013 Jun;69(6):1346-56. doi: 10.1111/j.1365-2648.2012.06126.x. Epub 2012 Aug 22.
Results Reference
background
PubMed Identifier
16733670
Citation
Amaro S, Viggiano A, Di Costanzo A, Madeo I, Viggiano A, Baccari ME, Marchitelli E, Raia M, Viggiano E, Deepak S, Monda M, De Luca B. Kaledo, a new educational board-game, gives nutritional rudiments and encourages healthy eating in children: a pilot cluster randomized trial. Eur J Pediatr. 2006 Sep;165(9):630-5. doi: 10.1007/s00431-006-0153-9. Epub 2006 May 30.
Results Reference
background

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Kaledo Game and The Nutrition Education Prepared According to Health Belief Model

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