Childhood Obesity Prevention Project in Gran Canaria

NCT06607159 | Active Not Recruiting

• 1 other identifier: 2020-356-1
• Study Type: interventional
• Target: 557
• Locations: 1 country
• Sites: 1

Brief 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 learning of healthy lifestyle habits in children between 6 and 10 years of age.

Conditions

Weight Change; BMI; Activity Level; Cholesterol (total and HDL); Glucose; Body Composition Changes

Keywords

children; obesity prevention; schools; multicomponent

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Changes in percentage of body fat between the control and intervention group, measured with an impedance scale

  1 year

• Changes in weight from baseline to post-intervention in the control group vs the intervention group

  1 year

• Changes in waist circumference between the control and intervention group, measured with an anthropometric flexible, non-stretchable measuring tape

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Group of children in whom the protocol is implemented (the whole class)

Other: Implementation of healthy habits teaching protocol

Control

NO INTERVENTION

Group of children in whom the protocol is not implemented (the whole class)

Interventions

Implementation of healthy habits teaching protocol OTHER

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.

Intervention

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 6-10 years of age, studying in the recruited schools, who consented to participate in the study

You may not qualify if:

• Children younger than 6 or older than 10 years of age, who did not conset to participate in the study

Sponsors & Collaborators

• Complejo Hospitalario Universitario Insular Materno Infantil: lead
• Fundación Canaria de Investigación Sanitaria: collaborator
• Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las: collaborator

Study Sites (1)

CHUIMI

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

Location

Related Links

• Link that describes the study, as well as shares the printed material used by the teachers

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeray Nóvoa, MD, MPH, PhD

  Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: April 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: December 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)