Study on the Effect of a Gamified Health Education Programme on Primary School Children

NCT07276412 | Recruiting

• 1 other identifier: 32/2025
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gamification in Health Education; Health Education

Keywords

school; child; obesity; physical activities; Health Education; Quality of Life; Gamification; sedentary

Outcome Measures

Primary Outcomes (7)

• 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.

  0 and 12 weeks

• Changes in body fat mass composition over 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

  Total patient weight are measured as a kilogram (kg).

  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.

  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 (%).

  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 (%).

  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.

  0 and 12 weeks

Secondary Outcomes (13)

• Changes in body fat-free mass composition over 12 weeks

  0 and 12 weeks

• Changes in estimated total body water composition over 12 weeks

  0 and 12 weeks

• Changes in protein composition over 12 weeks

  0 and 12 weeks

• Changes in bone mineral composition over 12 weeks

  0 and 12 weeks

• Changes in CUN-BAE index over 12 weeks

  0 and 12 weeks

Study Arms (4)

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

Behavioral: Intervention - A

Group B

EXPERIMENTAL

Group with weekly Health Education Programme and no reward for gamified activity

Behavioral: Intervention - B

Group C

EXPERIMENTAL

Group with weekly Health Education Programme and gamified activity rewards

Behavioral: Intervention - C

Interventions

Intervention - A BEHAVIORAL

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.

Group A

Intervention - B BEHAVIORAL

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.

Group B

Intervention - C BEHAVIORAL

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.

Group C

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pupils enrolled in primary education at schools in Extremadura.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diputación Provincial de Badajoz: collaborator
• Universidad de Extremadura: lead

Study Sites (1)

University of Extremadura

Badajoz, Badajoz, 06006, Spain

RECRUITING

MeSH Terms

Conditions

Health Education; Obesity; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Francisco José Rodríguez Velasco, PhD

CONTACT

+34 924289839; fcorodriguezv@unex.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD, University of Extremadura

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: September 2, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)