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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620044
• Other study ID #: AfyonkarahisarUHS
• Secondary ID: OGU-BAP; 2020-30
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: November 2020
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Other:
• Kaledo game
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.
• Education
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 intervention
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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Kalèdo, 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. Epub 2006 May 30. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-intervention measurements	Body Mass Index ( kg/m^2)	first month
Primary	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.	first month
Primary	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.	first month
Primary	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.	first month
Secondary	Post-intervention measurements	Body Mass Index ( kg/m^2)	3rd month
Secondary	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.	3rd month
Secondary	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.	3rd month
Secondary	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.	3rd month