Clinical trial NCT04620044: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood obesity
Game
Health belief model
Kaledo Game
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 192
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pre-intervention measurements
timeFrame: first month
measure: Pre-intervention measurements
timeFrame: first month
measure: Pre-intervention measurements
timeFrame: first month
measure: Pre-intervention measurements
timeFrame: first month
Secondary outcomes:
measure: Post-intervention measurements
timeFrame: 3rd month
measure: Post-intervention measurements
timeFrame: 3rd month
measure: Post-intervention measurements
timeFrame: 3rd month
measure: Post-intervention measurements
timeFrame: 3rd month
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
affiliation: Eskişehir Osmangazi University
name: Özlem ÖRSAL, PhD
role: STUDY_DIRECTOR
References:
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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.
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.
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.