NCT Number: NCT07276412
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.
Interested in participating?
Request Info6 year–7 year
All sexes
Interventional
Not applicable
Badajoz, 06006, Spain
Location status: Recruiting
Francisco José Rodríguez Velasco, PhD
CONTACT
+34 924289839 ext. 89839
Francisco José Rodríguez Velasco, PhD
PRINCIPAL_INVESTIGATOR
Guadalupe Gil Fernández, PhD
SUB_INVESTIGATOR
José Alberto Becerra Mejías, PhD Candidate
SUB_INVESTIGATOR
Julio Carmona Blesa, PhD Candidate
SUB_INVESTIGATOR
Julio Carmona Blesa, RN
CONTACT
+34 927251277 ext. 51277
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 0 and 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
Total patient body fat mass are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Total patient weight are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Weight (kg) and Height (m) will be combined to report BMI in kg/m^2.
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 (%).
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 (%).
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.
Time frame: 0 and 12 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Total patient estimated total body water are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Total patient protein are measured as a kilogram (kg).
Time frame: 0 and 12 weeks
Total patient bone mineral are measured as a kilogram (kg).
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.
Time frame: 0 and 12 weeks
Phase angle is measured in degrees (º).
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 (%).
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 (%).
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).
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).
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.
Time frame: 0 and 12 weeks
Weekly digital connection time (minutes) reported through the Bellotex-Salud app
Time frame: 0 and 12 weeks
Changes in EQ-5D-Y-5L scores in children.
Contact information is provided by the study sponsor or research team.
Universidad de Extremadura
Other
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.
Acronym: BELLOTEX-SALUD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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