NCT04620044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

October 22, 2020

Last Update Submit

November 7, 2020

Conditions

Keywords

Childhood obesityGameHealth belief modelKaledo Game

Outcome Measures

Primary Outcomes (4)

  • Pre-intervention measurements

    Body Mass Index ( kg/m\^2)

    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.

    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.

    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.

    first month

Secondary Outcomes (4)

  • Post-intervention measurements

    3rd month

  • Post-intervention measurements

    3rd month

  • Post-intervention measurements

    3rd month

  • Post-intervention measurements

    3rd month

Study Arms (3)

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.

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?

Other: Education

Control

EXPERIMENTAL

There was no intervention in the control group.

Other: No intervention

Interventions

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.

Kaledo Game

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.

Education

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.

Control

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 29845514BACKGROUND
  • 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.

    PMID: 25048788BACKGROUND
  • 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.

    PMID: 22909283BACKGROUND
  • 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.

    PMID: 16733670BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Özlem ÖRSAL, PhD

    Eskişehir Osmangazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student (researcher)

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 6, 2020

Study Start

September 15, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations