NCT04772859

Evaluation of an Online Lifestyle Intervention in Mexican School Children During COVID-19 Pandemic

Evaluation of a 4-month Online Lifestyle Intervention on the BMI Z-score of Mexican School Children During COVID-19 Pandemic: Randomized Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Introduction: School closures due to the COVID-19 pandemic represent a risk factor for the development of childhood obesity due to the increase in unhealthy behaviors. Online lifestyle interventions in schoolchildren could help to mitigate this problem. However, to date, no randomized controlled trials have been performed to prevent obesity in schoolchildren during the COVID-19 pandemic. The aim of this study is to evaluate the effect of a 4-month online lifestyle intervention on the BMI Z-score of Mexican schoolchildren during the COVID-19 pandemic in an intervention group compared to a control group. Methodology: This is a pilot randomized controlled trial. Schoolchildren from a public elementary school in Hermosillo, Sonora, Mexico will be invited to participate. Participants will be randomized to an intervention group (online lifestyle intervention) or a control group. The intervention will include online sessions of nutrition education and physical activity and nutrition information for parents. The control group will receive a digital brochure with nutrition recommendations at the beginning of the study. The measurements will be performed at baseline and 4 months. The primary outcome will be the BMI Z- score. Secondary outcomes: waist circumference, fat percentage, nutritional knowledge, lifestyle parameters, retention, attendance at the program sessions, and acceptability of the intervention. The difference between groups in changes in the outcomes will be analyzed using an intention to treat analysis. The protocol was approved by the Research Ethics Committee of the University of Sonora Nursing Department (EPM-003-2020). Conclusion: The study will provide the first evidence of the evaluation of online interventions for the prevention of obesity in schoolchildren derived from a Randomized Controlled Trial. This information will be important for the development and implementation of other school-level obesity prevention programs around the world.

Conditions

• Childhood Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Online Lifestyle Intervention	The intervention will be based on the Planet Nutrition program. This program was previously designed by the present research group and has a handbook that includes nutrition topics, framed by different behavior change strategies. The nutrition education and physical activity sessions will be offered 3 days a week, in the same 1-hour class: 30 minutes for each. Nutrition education: presentations based on the Planet Nutrition program, a dedicated website, and the Zoom application, will be used to deliver the intervention. The website will be used to upload the nutrition materials and the recorded sessions. Participants will work on self-monitoring of different health behaviors. Physical activity: The classes will be delivered by the Physical Activity team through the Zoom application. A website will be used to upload the recorded sessions. Parents participation. The same website and a private Facebook group will be used to upload nutrition information once a week.
OTHER	Control Group	They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2021-02-26
• Last updated: 2022-02-07

Locations

1 site across 1 country: Mexico