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

U

Universidad de Sonora

Status

Completed

Conditions

Childhood Obesity

Treatments

Other: Control Group
Behavioral: Online Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04772859
Lifestyle intervention

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

9 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 4th, 5th and 6th- grade students from the participating primary school.
  • Have access to the internet.
  • Have an electronic device (e.g. computer, laptop, tablet, or smart cell phone).
  • Nutritional status: normal weight, overweight, or obesity (based on BMI-Z-score for age).

Exclusion criteria

  • Have a medical condition that affects body weight.
  • Takes medicine that affects body weight.
  • Participating in another intervention that affects body weight.
  • Have a condition that prevents physical activity.
  • Withdrawal of informed consent or assent.
  • Have a family member who is participating in the study.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

Online Lifestyle Intervention
Experimental group
Description:
Online sessions of nutrition education, physical activity, and family participation.
Treatment:
Behavioral: Online Lifestyle Intervention
Control Group
Other group
Description:
General nutrition recommendations
Treatment:
Other: Control Group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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