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
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2021
CompletedFebruary 7, 2022
September 1, 2021
6 months
February 13, 2021
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in BMI Z-score
The measurement will be obtained using the sex, age, weight (kg) and height (m) of the participants.The height and weight will be combined (kg/m2) to obtain the BMI Z- score, expressed in units of standard deviation. The WHO Anthro Plus software will be used to obtain the BMI-Z-score for age.
Baseline to 4 months.
Secondary Outcomes (12)
Change in weight
Baseline to 4 months
Change in height
Baseline to 4 months
Change in waist circumference
Baseline to 4 months.
Change in body fat percentage
Baseline and 4 months.
Change in relative fat mass
Baseline to 4 months.
- +7 more secondary outcomes
Study Arms (2)
Online Lifestyle Intervention
EXPERIMENTALOnline sessions of nutrition education, physical activity, and family participation.
Control Group
OTHERGeneral nutrition recommendations
Interventions
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.
They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.
Eligibility Criteria
You may qualify if:
- th, 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rolando Giovanni Diaz Zavala
Hermosillo, Sonora, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolando G. Díaz Zavala, Ph.D
Universidad de Sonora
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The primary outcome (BMI Z-score) and some secondary outcomes (body fat percentage and waist circumference), will be measured by a person blinded to the assignment group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2021
First Posted
February 26, 2021
Study Start
February 1, 2021
Primary Completion
July 16, 2021
Study Completion
July 16, 2021
Last Updated
February 7, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
The database of the study are available from the corresponding author on reasonable request.