Clinical trial NCT04772859: Evaluation of an Online Lifestyle Intervention in Mexican School Children During COVID-19 Pandemic
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Online
Lifestyle Intervention
Prevention
Childhood Obesity
Nutrition Education
Physical Activity
COVID-19
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 54
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in BMI Z-score
timeFrame: Baseline to 4 months.
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline to 4 months
measure: Change in height
timeFrame: Baseline to 4 months
measure: Change in waist circumference
timeFrame: Baseline to 4 months.
measure: Change in body fat percentage
timeFrame: Baseline and 4 months.
measure: Change in relative fat mass
timeFrame: Baseline to 4 months.
measure: Change in nutrition knowledge
timeFrame: Baseline to 4 months
measure: Change in food frequency consumption Food consumption frequency questionnaire
timeFrame: Baseline to 4 months.
measure: Change in physical activity and sedentary behaviors
timeFrame: Baseline to 4 months
measure: Change in quality of life
timeFrame: Baseline to 4 months
measure: Retention
timeFrame: At 4 months
measure: Attendance
timeFrame: At 4 months
measure: Acceptability
timeFrame: At 4 months
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Rolando Giovanni Diaz Zavala
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Rolando G. Díaz Zavala, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: