Childhood ObesityNCT04620044
Kaledo Game and The Nutrition Education Prepared According to Health Belief Model
A study testing Kaledo game and Education in people with Childhood Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Kaledo game and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being studying in the 5th 6th and 7th grade
- BMI percentile value above 85
- Volunteering to participate in research
- Parents' consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26040
About this study
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
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Kaledo game, Education, No intervention
- Keywords
- Childhood obesity, Game, Health belief model, Kaledo Game
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaledo gameOther
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.
EducationOther
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.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Kaledo Game | Experimental | 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. Receives: Other: Kaledo game |
| Education | Experimental | 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? Receives: Other: Education |
| Control | Experimental | There was no intervention in the control group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-intervention measurements
Body Mass Index ( kg/m^2)
Measured: first month
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.
Measured: first month
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.
Measured: first month
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.
Measured: first month
Secondary outcomes (4)
Post-intervention measurements
Body Mass Index ( kg/m^2)
Measured: 3rd month
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.
Measured: 3rd month
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.
Measured: 3rd month
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.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start15 Sep 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cahide Çevik, Eskisehir Osmangazi University
- Investigators
- Özlem ÖRSAL, PhD, Study director, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620044
- Sponsor's protocol ID
- AfyonkarahisarUHS
- Other IDs
- OGU-BAP; 2020-3027
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29845514Viggiano 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.
PubMed 25048788Haney 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.
PubMed 22909283Amaro 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.
PubMed 16733670
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04620044
- Acronym / sponsor ID
- AfyonkarahisarUHS
- Conditions
- Childhood Obesity
- Keywords
- Childhood obesity, Game, Health belief model, Kaledo Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kaledo Game | Experimental | Other: Kaledo gameKaledo 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. |
| Education | Experimental | Other: EducationThe 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? |
| Control | Experimental | Other: No interventionThere was no intervention in the control group. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being studying in the 5th 6th and 7th grade
- BMI percentile value above 85
- Volunteering to participate in research
- Parents' consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaledo gameBefore 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. | Other | Kaledo Game |
| EducationBefore 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. | Other | Education |
| No interventionBody 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. | Other | Control |
Primary outcome
Pre-intervention measurements
Time frame: first month
Body Mass Index ( kg/m^2)
Pre-intervention measurements
Time frame: first month
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
Time frame: first month
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
Time frame: first month
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.
4 secondary outcomes
Post-intervention measurements
Time frame: 3rd month
Post-intervention measurements
Time frame: 3rd month
Post-intervention measurements
Time frame: 3rd month
Post-intervention measurements
Time frame: 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 29845514Sen 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.
- Background: PubMed 25048788Viggiano 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.
- Background: PubMed 22909283Haney 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.
- Background: PubMed 16733670Amaro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem ÖRSAL, PhD study director
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaledo game and Education in people with Childhood Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-intervention measurements (time frame: first month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620044, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.