- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620044
Kaledo Game and The Nutrition Education Prepared According to Health Belief Model
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Eskişehir, Turkey, 26040
- Eskisehir Osmangazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Kaledo Game
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.
|
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.
|
|
EXPERIMENTAL: Education
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? |
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.
|
|
EXPERIMENTAL: Control
There was no intervention in the control group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-intervention measurements
Time Frame: first month
|
Body Mass Index ( kg/m^2)
|
first month
|
|
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.
|
first month
|
|
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.
|
first month
|
|
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.
|
first month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-intervention measurements
Time Frame: 3rd month
|
Body Mass Index ( kg/m^2)
|
3rd month
|
|
Post-intervention measurements
Time Frame: 3rd 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.
|
3rd month
|
|
Post-intervention measurements
Time Frame: 3rd 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.
|
3rd month
|
|
Post-intervention measurements
Time Frame: 3rd 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.
|
3rd month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Özlem ÖRSAL, PhD, Eskisehir Osmangazi University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AfyonkarahisarUHS
- OGU-BAP; 2020-3027 (OTHER: Osmangazi University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Universidad de SonoraCentro de Investigación en Alimentación y Desarrollo A.C.; Instituto Nacional...Not yet recruitingChildhood Obesity Pevention
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Universidad Autonoma de Nuevo LeonUniversidad de la SabanaCompletedPrevention Childhood ObesityMexico
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
Clinical Trials on Kaledo game
-
Institut National de la Santé Et de la Recherche...Completed
-
Texas A&M UniversityUnited States Department of Defense; Immersive Experience Labs; Richmond VA Medical...RecruitingNeuropathic Pain | Spinal Cord InjuriesUnited States, Australia
-
Penn State UniversityNational Institute of Mental Health (NIMH)CompletedAutism Spectrum Disorder | AutismUnited States
-
Center for Communication and Change IndiaJohns Hopkins University; Carnegie Mellon University; Hofstra University; FriendsLearn... and other collaboratorsCompletedPediatric Nutrition
-
Boston University Charles River CampusCarnegie Mellon UniversityWithdrawnAutism Spectrum Disorder | AutismUnited States
-
Hebrew University of JerusalemaMoon fundCompletedDepressive Symptoms | Mood DisturbanceIsrael
-
The University of Hong KongNot yet recruiting
-
Texas A&M UniversityUnited States Department of Defense; Immersive Experience LabsRecruitingNeuropathic Pain | Spinal Cord InjuriesUnited States
-
Fondation LenvalCompletedAutistic DisorderFrance