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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Online Lifestyle Intervention
Control Group
Sponsored by
Universidad de Sonora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Online, Lifestyle Intervention, Prevention, Childhood Obesity, Nutrition Education, Physical Activity, COVID-19

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Rolando Giovanni Diaz Zavala

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Online Lifestyle Intervention

Control Group

Arm Description

Online sessions of nutrition education, physical activity, and family participation.

General nutrition recommendations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in weight
To obtain the weight (kg), a TANITA SC-240 will be used. The measurement will be used to obtain the BMI Z-score.
Change in height
To obtain the measure, a SECA 213 stadiometer will be used, following the Frankfurt plan. This measure will be used to obtain the BMI Z-score.
Change in waist circumference
A Lufkin metallic anthropometric tape will be used. The umbilical scar will be taken as reference.
Change in body fat percentage
It will be estimated with the measurement of the tricipital fold, using a formula validated for Mexican children. To take the tricipital fold, the ISAK methodology will be followed.
Change in relative fat mass
This is an estimator of total body fat. A formula carried out with children (8-14 years) will be used where the data of waist circumference (cm), height and sex (0 boys and 1 girls) will be needed .
Change in nutrition knowledge
A questionnaire designed by the study team will be used to assess knowledge on nutrition. It consists of 32 questions on nutrition and health.
Change in food frequency consumption Food consumption frequency questionnaire
A questionnaire will be used to ask the frequency and quantity of consumption of ultra-processed food such as sweet beverages, cookies, pastries and chips (are associated with the development of obesity). In addition, some natural foods like fruits, vegetables and water will included in the questionnaire.
Change in physical activity and sedentary behaviors
The physical activity and sedentary lifestyle questions from the questionnaire, "The Health Behavior in School-Age Children" (HBSC), which is used internationally and was validated in school-age children, will be used. The questionnaire includes the days and time spent doing physical activity and sedentary activities both during the week and at the weekend.
Change in quality of life
The PedsQL ™ (pediatric quality of life inventory) questionnaire will be used, which was designed to assess quality of life aspects in healthy pediatric patients (2 to 18 years old) .The questionnaire consists of 23 questions about physical, emotional, social and school functioning.
Retention
The retention will be obtained using the % of participants who finished the intervention and the final measurements at 4 months.
Attendance
The attendance will be measured using the % of the program sessions attended.
Acceptability
The acceptability will be obtained with a questionnaire applied to the children and parents to rate the intervention, materials and benefits obtained with the intervention.

Full Information

First Posted
February 13, 2021
Last Updated
January 21, 2022
Sponsor
Universidad de Sonora
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1. Study Identification

Unique Protocol Identification Number
NCT04772859
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Sonora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Online, Lifestyle Intervention, Prevention, Childhood Obesity, Nutrition Education, Physical Activity, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Lifestyle Intervention
Arm Type
Experimental
Arm Description
Online sessions of nutrition education, physical activity, and family participation.
Arm Title
Control Group
Arm Type
Other
Arm Description
General nutrition recommendations
Intervention Type
Behavioral
Intervention Name(s)
Online Lifestyle Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.
Primary Outcome Measure Information:
Title
Change in BMI Z-score
Description
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.
Time Frame
Baseline to 4 months.
Secondary Outcome Measure Information:
Title
Change in weight
Description
To obtain the weight (kg), a TANITA SC-240 will be used. The measurement will be used to obtain the BMI Z-score.
Time Frame
Baseline to 4 months
Title
Change in height
Description
To obtain the measure, a SECA 213 stadiometer will be used, following the Frankfurt plan. This measure will be used to obtain the BMI Z-score.
Time Frame
Baseline to 4 months
Title
Change in waist circumference
Description
A Lufkin metallic anthropometric tape will be used. The umbilical scar will be taken as reference.
Time Frame
Baseline to 4 months.
Title
Change in body fat percentage
Description
It will be estimated with the measurement of the tricipital fold, using a formula validated for Mexican children. To take the tricipital fold, the ISAK methodology will be followed.
Time Frame
Baseline and 4 months.
Title
Change in relative fat mass
Description
This is an estimator of total body fat. A formula carried out with children (8-14 years) will be used where the data of waist circumference (cm), height and sex (0 boys and 1 girls) will be needed .
Time Frame
Baseline to 4 months.
Title
Change in nutrition knowledge
Description
A questionnaire designed by the study team will be used to assess knowledge on nutrition. It consists of 32 questions on nutrition and health.
Time Frame
Baseline to 4 months
Title
Change in food frequency consumption Food consumption frequency questionnaire
Description
A questionnaire will be used to ask the frequency and quantity of consumption of ultra-processed food such as sweet beverages, cookies, pastries and chips (are associated with the development of obesity). In addition, some natural foods like fruits, vegetables and water will included in the questionnaire.
Time Frame
Baseline to 4 months.
Title
Change in physical activity and sedentary behaviors
Description
The physical activity and sedentary lifestyle questions from the questionnaire, "The Health Behavior in School-Age Children" (HBSC), which is used internationally and was validated in school-age children, will be used. The questionnaire includes the days and time spent doing physical activity and sedentary activities both during the week and at the weekend.
Time Frame
Baseline to 4 months
Title
Change in quality of life
Description
The PedsQL ™ (pediatric quality of life inventory) questionnaire will be used, which was designed to assess quality of life aspects in healthy pediatric patients (2 to 18 years old) .The questionnaire consists of 23 questions about physical, emotional, social and school functioning.
Time Frame
Baseline to 4 months
Title
Retention
Description
The retention will be obtained using the % of participants who finished the intervention and the final measurements at 4 months.
Time Frame
At 4 months
Title
Attendance
Description
The attendance will be measured using the % of the program sessions attended.
Time Frame
At 4 months
Title
Acceptability
Description
The acceptability will be obtained with a questionnaire applied to the children and parents to rate the intervention, materials and benefits obtained with the intervention.
Time Frame
At 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolando G. Díaz Zavala, Ph.D
Organizational Affiliation
Universidad de Sonora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rolando Giovanni Diaz Zavala
City
Hermosillo
State/Province
Sonora
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The database of the study are available from the corresponding author on reasonable request.

Learn more about this trial

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

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