Gamification in Health EducationBELLOTEX-SALUDNCT07276412
Study on the Effect of a Gamified Health Education Programme on Primary School Children
A study testing Intervention - A, Intervention - B and Intervention - C in people with Gamification in Health Education and Health Education, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Gamification in Health Education, Health Education
- What is being tested?
- Intervention - A, Intervention - B and Intervention - C
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2024to 7 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pupils enrolled in primary education at schools in Extremadura.
Who cannot join
- All pupils diagnosed with special educational needs will be excluded.
- Pupils who join after the programme has started.
- Absence of informed consent signature to participate in the study and use of the BELLOTEX-SALUD application by the child's parents or legal guardians.
- Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Extremadura
Badajoz, Badajoz, 06006
Francisco José Rodríguez Velasco, PhD, +34 924289839 ext. 89839, fcorodriguezv@unex.es
Julio Carmona Blesa, RN, +34 927251277 ext. 51277, jucarmonab@unex.es
About this study
Official title: Study on the Effect of a Health Education Programme Based on Gamification Strategies on Diet, Sedentary Behaviour and Daily Physical Activity in Primary School Children.
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.
Read the detailed description
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.
- Conditions
- Gamification in Health Education, Health Education
- Being tested
- Intervention - A, Intervention - B, Intervention - C
- Keywords
- school, child, obesity, physical activities, Health Education, Quality of Life, Gamification, sedentary
- Medical subject headings
- Health Education, Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - ABehavioural
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.
Intervention - BBehavioural
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.
Intervention - CBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Group without weekly Health Education Programme and without reward for gamified activity |
| Group A | Experimental | Group without weekly Health Education Programme and with reward for gamified activity Receives: Behavioral: Intervention - A |
| Group B | Experimental | Group with weekly Health Education Programme and no reward for gamified activity Receives: Behavioral: Intervention - B |
| Group C | Experimental | Group with weekly Health Education Programme and gamified activity rewards Receives: Behavioral: Intervention - C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 12 weeks
Changes in body fat mass composition over 12 weeks
Total patient body fat mass are measured as a kilogram (kg).
Measured: 0 and 12 weeks
Changes in body weight composition over 12 weeks
Total patient weight are measured as a kilogram (kg).
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 0 and 12 weeks
Secondary outcomes (13)
Changes in body fat-free mass composition over 12 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
Measured: 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).
Measured: 0 and 12 weeks
Changes in protein composition over 12 weeks
Total patient protein are measured as a kilogram (kg).
Measured: 0 and 12 weeks
Changes in bone mineral composition over 12 weeks
Total patient bone mineral are measured as a kilogram (kg).
Measured: 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.
Measured: 0 and 12 weeks
Changes in phase angle bioimpedance over 12 weeks
Phase angle is measured in degrees (º).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 0 and 12 weeks
Changes in digital connection time over 12 weeks
Weekly digital connection time (minutes) reported through the Bellotex-Salud app
Measured: 0 and 12 weeks
Changes in quality of life indicators over 12 weeks
Changes in EQ-5D-Y-5L scores in children.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start2 Sep 2024
- Primary completion24 Jul 2026 (estimated)
- Study completion7 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gamification in Health EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Diputación Provincial de Badajoz
- Responsible party
- Principal investigator, Francisco Jose Rodriguez Velasco, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276412
- Sponsor's protocol ID
- 32/2025
- Acronym
- BELLOTEX-SALUD
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of a Health Education Programme Based on Gamification Strategies on Diet, Sedentary Behaviour and Daily Physical Activity in Primary School Children.
- ClinicalTrials.gov ID
- NCT07276412
- Acronym / sponsor ID
- BELLOTEX-SALUD / 32/2025
- Conditions
- Gamification in Health Education, Health Education
- Keywords
- school, child, obesity, physical activities, Health Education, Quality of Life, Gamification, sedentary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- Diputación Provincial de Badajoz
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 7 Sep 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Group without weekly Health Education Programme and without reward for gamified activity |
| Group A | Experimental | Behavioral: Intervention - AGroup without weekly Health Education Programme and with reward for gamified activity |
| Group B | Experimental | Behavioral: Intervention - BGroup with weekly Health Education Programme and no reward for gamified activity |
| Group C | Experimental | Behavioral: Intervention - CGroup with weekly Health Education Programme and gamified activity rewards |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pupils enrolled in primary education at schools in Extremadura.
Key exclusion criteria (4 listed)
- All pupils diagnosed with special educational needs will be excluded.
- Pupils who join after the programme has started.
- Absence of informed consent signature to participate in the study and use of the BELLOTEX-SALUD application by the child's parents or legal guardians.
- Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention - AFor 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. | Behavioural | Group A |
| Intervention - BIn 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. | Behavioural | Group B |
| Intervention - CFor 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. | Behavioural | Group C |
Primary outcome
Changes in weekly physical activity at 12 weeks
Time frame: 0 and 12 weeks
Changes in time (minutes), distance (kilometres) and speed (km/h) measured by GPS through the BELLOTEX-SALUD application.
Changes in body fat mass composition over 12 weeks
Time frame: 0 and 12 weeks
Total patient body fat mass are measured as a kilogram (kg).
Changes in body weight composition over 12 weeks
Time frame: 0 and 12 weeks
Total patient weight are measured as a kilogram (kg).
Changes in Body Mass Index over 12 weeks
Time frame: 0 and 12 weeks
Weight (kg) and Height (m) will be combined to report BMI in kg/m^2.
Changes in the percentage of carbohydrates ingested over 12 weeks
Time frame: 0 and 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 (%).
Changes in the percentage of fat ingested over 12 weeks
Time frame: 0 and 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 (%).
Changes in sedentary activity time over 12 weeks
Time frame: 0 and 12 weeks
Changes in "Screen-Time-Sedentary Behaviour Questionnaire" scores. The questionnaire consists of 23 items and assesses sedentary activity on weekdays and weekends.
13 secondary outcomes
Changes in body fat-free mass composition over 12 weeks
Time frame: 0 and 12 weeks
Changes in estimated total body water composition over 12 weeks
Time frame: 0 and 12 weeks
Changes in protein composition over 12 weeks
Time frame: 0 and 12 weeks
Changes in bone mineral composition over 12 weeks
Time frame: 0 and 12 weeks
Changes in CUN-BAE index over 12 weeks
Time frame: 0 and 12 weeks
Changes in phase angle bioimpedance over 12 weeks
Time frame: 0 and 12 weeks
Changes in the percentage of protein ingested over 12 weeks
Time frame: 0 and 12 weeks
Changes in the percentage of vitamins ingested over 12 weeks
Time frame: 0 and 12 weeks
Changes in kilocalorie intake over 12 weeks
Time frame: 0 and 12 weeks
Changes in adherence to the Mediterranean diet over 12 weeks
Time frame: 0 and 12 weeks
Changes in psychological parameters over 12 weeks
Time frame: 0 and 12 weeks
Changes in digital connection time over 12 weeks
Time frame: 0 and 12 weeks
Changes in quality of life indicators over 12 weeks
Time frame: 0 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention - A, Intervention - B and Intervention - C in people with Gamification in Health Education and Health Education, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco José Rodríguez Velasco, PhD (+34 924289839 ext. 89839, fcorodriguezv@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weekly physical activity at 12 weeks (time frame: 0 and 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.