Weight ChangePOINCT06607159
Childhood Obesity Prevention Project in Gran Canaria
A study testing Implementation of healthy habits teaching protocol in people with Weight Change and BMI, run by Complejo Hospitalario Universitario Insular Materno Infantil at 1 site in Spain.
Trial summary
Given the alarming rates of obesity and overweight in our child population, the investigators have developed an intervention strategy, based on a multidisciplinary, school-centered approach, which addresses nutritional education, physical activity, behavioral intervention techniques and tools that facilitate the… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Change, BMI, Activity Level
- What is being tested?
- Implementation of healthy habits teaching protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 557 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6-10 years of age, studying in the recruited schools, who consented to participate in the study
Who cannot join
- Children younger than 6 or older than 10 years of age, who did not conset to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Given the alarming rates of obesity and overweight in our child population, the investigators have developed an intervention strategy, based on a multidisciplinary, school-centered approach, which addresses nutritional education, physical activity, behavioral intervention techniques and tools that facilitate the learning of healthy lifestyle habits in children between 6 and 10 years of age.
Read the detailed description
This is a cluster-randomized, controlled, parallel clinical trial assessing the impact of an educational intervention in the prevalence of obesity in children.
Boys and girls aged 6-10 years (1st to 4th grades of primary school) from public, state-subsidized and private schools on the island of Gran Canaria, Canary Islands, Spain, were recruited. The selection of schools was based on convenience. After obtaining a list of schools from contacts with the local diabetic association and members of the team, the project was explained and schools were invited to participate. After obtaining the consent from several schools, the inclusion in both arms of the study was randomized with a 1:1 ratio (even though we performed cluster randomization, the aim was to have a 1:1 participants´ratio, not a 1:1 classroom ratio), and the parents of the students in the aforementioned classes were invited to participate. Finally, those children whose parents consented to their participation were included. To randomize the participant schools, the researchers employed a stratified cluster randomization approach. First, the researchers categorized schools into three types: public, private, and subsidized. Within each category, the researchers assigned a random number to each school and then ranked them from highest to lowest based on these numbers. Given that the researchers knew the number of children in each class, the researchers started allocating schools with the highest random numbers to either the intervention or control arm, continuing this process until the target number of children in each arm was reached. This approach ensured a 1:1 ratio of participants between arms while maintaining randomization integrity, even though it could result in an unequal number of schools per arm. To maintain cluster integrity, all children from a given school were assigned to the same study arm. Randomization was performed by the main investigator (YNM). No changes to the methodology were implemented after trial commencement.
The project for the prevention of childhood obesity in the Canary Islands seeks to increase knowledge about healthy lifestyle habits in the pediatric age group as a tool to reduce the rate of childhood overweight and obesity (based on recommendations on diet, physical activity, leisure time devoted to screens and hours of sleep published by official bodies such as the WHO, the American Academy of Pediatrics (AAP) and the American Centre for Disease Control and Prevention (CDC)). One of the main goals of the research team was to develop cost-free strategies and tools for schools. To achieve this, the researchers decided to involve teachers as the primary drivers of change and schools as the implementation sites for the study protocol. To this end, the pediatric endocrinology and gastroenterology units of the Complejo Hospitalario Universitario Materno Infantil de Las Palmas de Gran Canaria have collaborated with the group specializing in Learning Difficulties, Psycholinguistics and Information and Communication Technologies; of the University of La Laguna (https://viinv.ull.es/grupos/1119/), which includes psychologists, teachers and pedagogues among its members.
As a result of this collaboration, a protocol for teaching healthy lifestyle habits has been developed, aimed at school-age children (initially between 1st and 4th grade of primary school), to be implemented transversally in schools. This protocol takes into account three levels of action: school, family and pupils.
- Materials in paper format: These materials are mainly used in the classroom, although they can also be used at home. They have been designed according to the grade level and the level of competence of the students. These workbooks are based on the curricular contents linked to healthy lifestyle habits that should be worked on according to the school year as established in DECREE 89/2014, of 1 August, which establishes the organization and curriculum of Primary Education in the Autonomous Community of the Canary Islands (19). Likewise, from an inclusive perspective, suitable materials have been designed for students with Specific Educational Support Needs (SEN) that make it difficult for them to access the written code (Image 1a). The books can be found in the following link: https://www.fundacionmapfrecanarias.org/formacion-prevencion/actividades-didacticas/programa-obesidad-infantil-fmc/
- Digital materials: Gamification has been proven to motivate and promote improvements in the nutrition of children(20). For our intervention, 6 games have been designed in application format aimed at increasing daily physical activity time (2 games: 5 minutes of movement and active breaks), a balanced diet (2 games: healthy breakfasts and the cool recipe) and knowledge and reflection on healthy lifestyle habits (2 games: asking questions and my alien) (Image 1b). The digital materials are embedded in a web platform that allows teachers to know the health status of the classroom based on the scores obtained by the students in each of the mini-games. The games can be used in the classroom or at home (with a time limit of 30 min/day), thus trying to facilitate parental interaction with the program. It is important to emphasize that we will always work with the classroom score, emphasizing that health is everyone´s responsibility.
The project has an evaluation phase (April-June 2022), a teacher training phase (April-June 22) and a teaching project implementation phase (school year 2022-2023).
- Conditions
- Weight Change, BMI, Activity Level, Cholesterol (total and HDL), Glucose, Body Composition Changes
- Being tested
- Implementation of healthy habits teaching protocol
- Keywords
- children, obesity prevention, schools, multicomponent
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of healthy habits teaching protocolOther
Protocol for teaching healthy lifestyle habits, aimed at school-age children (initially between 1st and 4th grade of primary school), to be implemented transversally in schools. This protocol takes into account three levels of action: school, family and pupils. It includes materials in paper format and digital materials, that can be used both at school and at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group of children in whom the protocol is implemented (the whole class) Receives: Other: Implementation of healthy habits teaching protocol |
| Control | No intervention | Group of children in whom the protocol is not implemented (the whole class) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body mass index from baseline to post-intervention in the control group vs the intervention group
Body mass index (weight in kg/height in meters squared) will be determined after weight and height have been measured both at baseline and after the intervention period. The change in BMI from the control and intervention groups will be compared to determine if there is a difference in the rate of change between both groups.
Measured: 1 year
Secondary outcomes (3)
Changes in percentage of body fat between the control and intervention group, measured with an impedance scale
The investigators will determine de percentage of body fat using the Tanita Impedance Scale (Tokyo, Japan) model DC-360. The rate of change in the percentage of body fat between the 2 groups will be compared at the end of the study period.
Measured: 1 year
Changes in weight from baseline to post-intervention in the control group vs the intervention group
The investigators will determine de weight of all children using the Tanita Impedance Scale (Tokyo, Japan) model DC-360. The rate of change between the 2 groups will be compared at the end of the study period.
Measured: 1 year
Changes in waist circumference between the control and intervention group, measured with an anthropometric flexible, non-stretchable measuring tape
The investigators will determine de waist circumference of all children using an anthropometric flexible, non-stretchable measuring tape. The rate of change between the 2 groups will be compared at the end of the study period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Apr 2022
- Primary completion15 Jul 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight ChangeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster-randomized, controlled, parallel clinical trial assessing the impact of an educational intervention in the prevalence of obesity in children. The inclusion in both arms of the study was randomized with a 1:1 ratio (even though we performed cluster randomization, the aim was to have a 1:1 participants´ratio, not a 1:1 classroom ratio). To randomize the participant schools, we employed a stratified cluster randomization approach. First, we categorized schools into three types: public, private, and subsidized. Within each category, we assigned a random number to each school a and then ranked them from highest to lowest based on these numbers. Given that we knew the number of children in each class, we started allocating schools with the highest random numbers to either the intervention or control arm, continuing this process until the target number of children in each arm was reached. All children from a given school were assigned to the same study arm
- Masking
- None (open label)
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario Insular Materno Infantil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
- Responsible party
- Principal investigator, Yeray Nóvoa Medina, Complejo Hospitalario Universitario Insular Materno Infantil
- Investigators
- Yeray Nóvoa, MD, MPH, PhD, Principal investigator, Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607159
- Sponsor's protocol ID
- 2020-356-1
- Acronym
- POI
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no need to share IPD data
Publications
Novoa-Medina Y, Leon SDC, Barreiro-Bautista M, Batista-Davila V, Fabelo H, Pavlovic S, Garcia-Delgado Y, Jimenez JE, Lopez-Lopez S; Gran Canarian Diabetes and Obesity Research Group; Wagner AM, Pena-Quintana L. A School-Based Nutrition and Physical Activity Intervention for the Prevention of Childhood Obesity: Study Design and Baseline Findings From a Cluster-Randomized Trial. J Nutr Metab. 2026 May 31;2026:1016106. doi: 10.1155/jnme/1016106. eCollection 2026.
PubMed 42254083
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity Prevention Project in Gran Canaria
- ClinicalTrials.gov ID
- NCT06607159
- Acronym / sponsor ID
- POI / 2020-356-1
- Conditions
- Weight Change, BMI, Activity Level, Cholesterol (total and HDL), Glucose, Body Composition Changes
- Keywords
- children, obesity prevention, schools, multicomponent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Complejo Hospitalario Universitario Insular Materno InfantilUniversity, hospital or other
- Collaborators
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Sep 2024 (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.
Given the alarming rates of obesity and overweight in our child population, the investigators have developed an intervention strategy, based on a multidisciplinary, school-centered approach, which addresses nutritional education, physical activity, behavioral intervention techniques and tools that facilitate the learning of healthy lifestyle habits in children between 6 and 10 years of age.
Detailed description
This is a cluster-randomized, controlled, parallel clinical trial assessing the impact of an educational intervention in the prevalence of obesity in children.
Boys and girls aged 6-10 years (1st to 4th grades of primary school) from public, state-subsidized and private schools on the island of Gran Canaria, Canary Islands, Spain, were recruited. The selection of schools was based on convenience. After obtaining a list of schools from contacts with the local diabetic association and members of the team, the project was explained and schools were invited to participate. After obtaining the consent from several schools, the inclusion in both arms of the study was randomized with a 1:1 ratio (even though we performed cluster randomization, the aim was to have a 1:1 participants´ratio, not a 1:1 classroom ratio), and the parents of the students in the aforementioned classes were invited to participate. Finally, those children whose parents consented to their participation were included. To randomize the participant schools, the researchers employed a stratified cluster randomization approach. First, the researchers categorized schools into three types: public, private, and subsidized. Within each category, the researchers assigned a random number to each school and then ranked them from highest to lowest based on these numbers. Given that the researchers knew the number of children in each class, the researchers started allocating schools with the highest random numbers to either the intervention or control arm, continuing this process until the target number of children in each arm was reached. This approach ensured a 1:1 ratio of participants between arms while maintaining randomization integrity, even though it could result in an unequal number of schools per arm. To maintain cluster integrity, all children from a given school were assigned to the same study arm. Randomization was performed by the main investigator (YNM). No changes to the methodology were implemented after trial commencement.
The project for the prevention of childhood obesity in the Canary Islands seeks to increase knowledge about healthy lifestyle habits in the pediatric age group as a tool to reduce the rate of childhood overweight and obesity (based on recommendations on diet, physical activity, leisure time devoted to screens and hours of sleep published by official bodies such as the WHO, the American Academy of Pediatrics (AAP) and the American Centre for Disease Control and Prevention (CDC)). One of the main goals of the research team was to develop cost-free strategies and tools for schools. To achieve this, the researchers decided to involve teachers as the primary drivers of change and schools as the implementation sites for the study protocol. To this end, the pediatric endocrinology and gastroenterology units of the Complejo Hospitalario Universitario Materno Infantil de Las Palmas de Gran Canaria have collaborated with the group specializing in Learning Difficulties, Psycholinguistics and Information and Communication Technologies; of the University of La Laguna (https://viinv.ull.es/grupos/1119/), which includes psychologists, teachers and pedagogues among its members.
As a result of this collaboration, a protocol for teaching healthy lifestyle habits has been developed, aimed at school-age children (initially between 1st and 4th grade of primary school), to be implemented transversally in schools. This protocol takes into account three levels of action: school, family and pupils.
- Materials in paper format: These materials are mainly used in the classroom, although they can also be used at home. They have been designed according to the grade level and the level of competence of the students. These workbooks are based on the curricular contents linked to healthy lifestyle habits that should be worked on according to the school year as established in DECREE 89/2014, of 1 August, which establishes the organization and curriculum of Primary Education in the Autonomous Community of the Canary Islands (19). Likewise, from an inclusive perspective, suitable materials have been designed for students with Specific Educational Support Needs (SEN) that make it difficult for them to access the written code (Image 1a). The books can be found in the following link: https://www.fundacionmapfrecanarias.org/formacion-prevencion/actividades-didacticas/programa-obesidad-infantil-fmc/
- Digital materials: Gamification has been proven to motivate and promote improvements in the nutrition of children(20). For our intervention, 6 games have been designed in application format aimed at increasing daily physical activity time (2 games: 5 minutes of movement and active breaks), a balanced diet (2 games: healthy breakfasts and the cool recipe) and knowledge and reflection on healthy lifestyle habits (2 games: asking questions and my alien) (Image 1b). The digital materials are embedded in a web platform that allows teachers to know the health status of the classroom based on the scores obtained by the students in each of the mini-games. The games can be used in the classroom or at home (with a time limit of 30 min/day), thus trying to facilitate parental interaction with the program. It is important to emphasize that we will always work with the classroom score, emphasizing that health is everyone´s responsibility.
The project has an evaluation phase (April-June 2022), a teacher training phase (April-June 22) and a teaching project implementation phase (school year 2022-2023).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster-randomized, controlled, parallel clinical trial assessing the impact of an educational intervention in the prevalence of obesity in children. The inclusion in both arms of the study was randomized with a 1:1 ratio (even though we performed cluster randomization, the aim was to have a 1:1 participants´ratio, not a 1:1 classroom ratio). To randomize the participant schools, we employed a stratified cluster randomization approach. First, we categorized schools into three types: public, private, and subsidized. Within each category, we assigned a random number to each school a and then ranked them from highest to lowest based on these numbers. Given that we knew the number of children in each class, we started allocating schools with the highest random numbers to either the intervention or control arm, continuing this process until the target number of children in each arm was reached. All children from a given school were assigned to the same study arm
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Implementation of healthy habits teaching protocolGroup of children in whom the protocol is implemented (the whole class) |
| Control | No intervention | –Group of children in whom the protocol is not implemented (the whole class) |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 6-10 years of age, studying in the recruited schools, who consented to participate in the study
Key exclusion criteria (1 listed)
- Children younger than 6 or older than 10 years of age, who did not conset to participate 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 |
|---|---|---|
| Implementation of healthy habits teaching protocolProtocol for teaching healthy lifestyle habits, aimed at school-age children (initially between 1st and 4th grade of primary school), to be implemented transversally in schools. This protocol takes into account three levels of action: school, family and pupils. It includes materials in paper format and digital materials, that can be used both at school and at home. | Other | Intervention |
Primary outcome
Changes in body mass index from baseline to post-intervention in the control group vs the intervention group
Time frame: 1 year
Body mass index (weight in kg/height in meters squared) will be determined after weight and height have been measured both at baseline and after the intervention period. The change in BMI from the control and intervention groups will be compared to determine if there is a difference in the rate of change between both groups.
3 secondary outcomes
Changes in percentage of body fat between the control and intervention group, measured with an impedance scale
Time frame: 1 year
Changes in weight from baseline to post-intervention in the control group vs the intervention group
Time frame: 1 year
Changes in waist circumference between the control and intervention group, measured with an anthropometric flexible, non-stretchable measuring tape
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Derived from this study: PubMed 42254083Novoa-Medina Y, Leon SDC, Barreiro-Bautista M, Batista-Davila V, Fabelo H, Pavlovic S, Garcia-Delgado Y, Jimenez JE, Lopez-Lopez S; Gran Canarian Diabetes and Obesity Research Group; Wagner AM, Pena-Quintana L. A School-Based Nutrition and Physical Activity Intervention for the Prevention of Childhood Obesity: Study Design and Baseline Findings From a Cluster-Randomized Trial. J Nutr Metab. 2026 May 31;2026:1016106. doi: 10.1155/jnme/1016106. eCollection 2026.
- Link that describes the study, as well as shares the printed material used by the teachersLink provided by the sponsor.
- Individual participant dataSharing planned: No. there is no need to share IPD data
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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. This study is not recruiting at the moment.
Yeray Nóvoa, MD, MPH, PhD principal investigator
Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of healthy habits teaching protocol in people with Weight Change and BMI, run by Complejo Hospitalario Universitario Insular Materno Infantil 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 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body mass index from baseline to post-intervention in the control group vs the intervention group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607159, which also lists 1 linked publication.
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 23 Sep 2024.