An interventional study of Intervention - A and Intervention - B in Gamification in Health Education and Health Education, sponsored by Universidad de Extremadura. Recruiting at 1 site in Spain. Open to participants aged 6 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment
This randomised study evaluates the effectiveness of Health Education through a Gamified Health Programme on diet, sedentary behaviour and daily physical activity in primary school children.
The prevalence of childhood obesity is high, being a serious health problem in our country, where 4 out of ten boys and girls are overweight.
Among the risk factors associated with obesity, the most prominent continue to be: lack of physical activity, those related to eating habits and excess time in front of screens.
Given that obesity is considered one of the most serious epidemics of the 21st century and that, if it is not stopped in childhood, it can cause serious health problems in adulthood, it is very important to work on this stage to reduce it.
In this evolutionary stage, children spend a lot of time in schools; Involving their teachers and teachers is important, but it is still necessary to do it with families as well. In this field, in that of fathers, mothers and/or guardians, the data shows parental weakness in aspects related to Health Education, such as those shown by the ALADINO 2019 study, where they point out that 7 out of 10 schoolchildren with excess weight are perceived by their parents as within a normal weight.
Our Health Education Program aims to ensure that the main actors (children) are accompanied and guided by their families and their teachers in the implementation of a series of activities associated with the achievement or improvement of daily habits. related to the previously indicated risk factors.
The Health Program, lasting 6 months, consists of daily, weekly or fortnightly activities. All of them interrelated and connected under the common objective of initiating or consolidating the aforementioned habits, in such a way that they improve the values of overweight in our sample.
We try to involve the child through gamification, through a story embodied in an interface that makes them feel involved. The achievement and fulfillment of each entrusted task will mean a series of achievements that will motivate the participants to continue accepting challenges.
481 studies on the registry are indexed under Health Education; 110 are open to participants now.
This study's planned enrollment of 500 is above the median of 132 across 450 interventional studies indexed under Health Education.
Browse Health Education studies →Universidad de Extremadura is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group without weekly Health Education Programme and without reward for gamified activity
Group without weekly Health Education Programme and with reward for gamified activity
Behavioral: Intervention - A
Group with weekly Health Education Programme and no reward for gamified activity
Behavioral: Intervention - B
Group with weekly Health Education Programme and gamified activity rewards
Behavioral: Intervention - C
For this Intervention Group, rewards act as the main motivating factor for the children in this intervention group. Each time they complete the activities proposed in the application, they receive a "Bellotex Salud" avatar card, which symbolises their progress and identifies them as "Bellotex Masters". This gamified recognition boosts their involvement and reinforces their adherence to the intervention. In addition, this group does not attend weekly health education sessions, so the improvements observed can be attributed to the use of the app and the motivation generated by the rewards associated with the healthy habits worked on.
In this Intervention Group, participants will not have access to the rewards that act as the main motivating factor. Each time they complete the activities proposed in the application, they will pass the challenge but will not receive the "Bellotex Health" avatar card, which symbolises their progress and identifies them as "Bellotex Masters", thus allowing them to assess their potential involvement and adherence to the intervention without the reinforcement of gamified recognition. However, this group has access to weekly health education sessions, so the improvements observed can be attributed to the use of the app and the training received through these capsules associated with different healthy habits.
For this Intervention Group, rewards act as the main motivating factor. Each time they complete the activities proposed in the application, they receive a "Bellotex Salud" avatar card, which symbolises their progress and identifies them as "Bellotex Masters". This gamified recognition boosts their involvement and reinforces their adherence to the intervention. In addition, this group has access to weekly health education sessions, so that the improvements observed can be attributed to the use of the app and the training received through these capsules associated with different healthy habits.
Changes in weekly physical activity at 12 weeks
Changes in time (minutes), distance (kilometres) and speed (km/h) measured by GPS through the BELLOTEX-SALUD application.
Time frame: 0 and 12 weeks
Changes in body fat mass composition over 12 weeks
Total patient body fat mass are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in body weight composition over 12 weeks
Total patient weight are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in Body Mass Index over 12 weeks
Weight (kg) and Height (m) will be combined to report BMI in kg/m\^2.
Time frame: 0 and 12 weeks
Changes in the percentage of carbohydrates ingested over 12 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of carbohydrates (%).
Time frame: 0 and 12 weeks
Changes in the percentage of fat ingested over 12 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of fat ingested (%).
Time frame: 0 and 12 weeks
Changes in sedentary activity time over 12 weeks
Changes in "Screen-Time-Sedentary Behaviour Questionnaire" scores. The questionnaire consists of 23 items and assesses sedentary activity on weekdays and weekends.
Time frame: 0 and 12 weeks
Changes in body fat-free mass composition over 12 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in estimated total body water composition over 12 weeks
Total patient estimated total body water are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in protein composition over 12 weeks
Total patient protein are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in bone mineral composition over 12 weeks
Total patient bone mineral are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Changes in CUN-BAE index over 12 weeks
CUN-BAE are calculated as -44.988+(0.503×age) +(10.689 ×sex) +(3.172×BMI) -(0.026×BMI2) +(0.181×BMI×sex) -(0.02×BMI×age) -(0.005×BMI2 ×sex) +(0.00021×BMI2×age), where male=0 and female=1 for sex, measuring age in years.
Time frame: 0 and 12 weeks
Changes in phase angle bioimpedance over 12 weeks
Phase angle is measured in degrees (º).
Time frame: 0 and 12 weeks
Changes in the percentage of protein ingested over 12 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of protein ingested (%).
Time frame: 0 and 12 weeks
Changes in the percentage of vitamins ingested over 12 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of vitamins ingested (%).
Time frame: 0 and 12 weeks
Changes in kilocalorie intake over 12 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake shall be transformed into "Food composition tables". The value obtained will be the number of kilocalories ingested (kcal).
Time frame: 0 and 12 weeks
Changes in adherence to the Mediterranean diet over 12 weeks
Changes in adherence to the Mediterranean diet. This will be studied using the KIDMED questionnaire, which consists of 16 items with values ranging from -1 (low adherence) to \>1 (good adherence).
Time frame: 0 and 12 weeks
Changes in psychological parameters over 12 weeks
Changes in DAILY STRESS scores measured by the Inventory of Children's Daily Stress (IECI). The ICSI is a self-report questionnaire consisting of 22 items that assess the presence of daily stressors in children aged 6 to 12 years. The items are answered dichotomously (Yes/No) and are grouped into three subscales: Family, School, and Health/Psychosomatic, in addition to providing a total daily stress score. The direct scores reflect the number of stressful situations present for the child, with a possible total range of 0 to 22. There are no clinical cut-off points, but the scores are transformed into percentiles or T-scores adjusted for gender and school year, allowing the relative intensity of daily stress to be interpreted in comparison with the normative population.
Time frame: 0 and 12 weeks
Changes in digital connection time over 12 weeks
Weekly digital connection time (minutes) reported through the Bellotex-Salud app
Time frame: 0 and 12 weeks
Changes in quality of life indicators over 12 weeks
Changes in EQ-5D-Y-5L scores in children.
Time frame: 0 and 12 weeks
Plan to share: No
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Universidad de Extremadura