Study on the Effect of a Gamified Health Education Programme on Primary School Children (BELLOTEX-SALUD)

November 28, 2025 updated by: Francisco Jose Rodriguez Velasco, Universidad de Extremadura

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francisco José Rodríguez Velasco, PhD
  • Phone Number: 89839 +34 924289839
  • Email: fcorodriguezv@unex.es

Study Locations

  • Spain
    • Badajoz
      • Badajoz, Badajoz, Spain, 06006
        • Recruiting
        • University of Extremadura
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco José Rodríguez Velasco, PhD
        • Sub-Investigator:
          • Guadalupe Gil Fernández, PhD
        • Sub-Investigator:
          • Julio Carmona Blesa, PhD Candidate
        • Sub-Investigator:
          • José Alberto Becerra Mejías, PhD Candidate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pupils enrolled in primary education at schools in Extremadura.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Group without weekly Health Education Programme and without reward for gamified activity
Experimental: Group A
Group without weekly Health Education Programme and with reward for gamified activity
Behavioral: Intervention - A

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.
Experimental: Group B
Group with weekly Health Education Programme and no reward for gamified activity
Behavioral: Intervention - B

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.
Experimental: Group C
Group with weekly Health Education Programme and gamified activity rewards
Behavioral: Intervention - C

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 and 12 weeks
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).
0 and 12 weeks
Changes in body weight composition over 12 weeks
Time Frame: 0 and 12 weeks
Total patient weight are measured as a kilogram (kg).
0 and 12 weeks
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.
0 and 12 weeks
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 (%).
0 and 12 weeks
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 (%).
0 and 12 weeks
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.
0 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body fat-free mass composition over 12 weeks
Time Frame: 0 and 12 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
0 and 12 weeks
Changes in estimated total body water composition over 12 weeks
Time Frame: 0 and 12 weeks
Total patient estimated total body water are measured as a kilogram (kg).
0 and 12 weeks
Changes in protein composition over 12 weeks
Time Frame: 0 and 12 weeks
Total patient protein are measured as a kilogram (kg).
0 and 12 weeks
Changes in bone mineral composition over 12 weeks
Time Frame: 0 and 12 weeks
Total patient bone mineral are measured as a kilogram (kg).
0 and 12 weeks
Changes in CUN-BAE index over 12 weeks
Time Frame: 0 and 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.
0 and 12 weeks
Changes in phase angle bioimpedance over 12 weeks
Time Frame: 0 and 12 weeks
Phase angle is measured in degrees (º).
0 and 12 weeks
Changes in the percentage of protein 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 protein ingested (%).
0 and 12 weeks
Changes in the percentage of vitamins 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 vitamins ingested (%).
0 and 12 weeks
Changes in kilocalorie intake 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 shall be transformed into "Food composition tables". The value obtained will be the number of kilocalories ingested (kcal).
0 and 12 weeks
Changes in adherence to the Mediterranean diet over 12 weeks
Time Frame: 0 and 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).
0 and 12 weeks
Changes in psychological parameters over 12 weeks
Time Frame: 0 and 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.
0 and 12 weeks
Changes in digital connection time over 12 weeks
Time Frame: 0 and 12 weeks
Weekly digital connection time (minutes) reported through the Bellotex-Salud app
0 and 12 weeks
Changes in quality of life indicators over 12 weeks
Time Frame: 0 and 12 weeks
Changes in EQ-5D-Y-5L scores in children.
0 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Collaborators

Diputación Provincial de Badajoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

July 24, 2026

Study Completion (Estimated)

September 7, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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