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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772859
• Other study ID #: Lifestyle intervention
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 16, 2021

Study information

• Verified date: September 2021
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• COVID-19
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Mexico	Rolando Giovanni Diaz Zavala	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to 4 months
Secondary	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.	Baseline to 4 months
Secondary	Change in waist circumference	A Lufkin metallic anthropometric tape will be used. The umbilical scar will be taken as reference.	Baseline to 4 months.
Secondary	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.	Baseline and 4 months.
Secondary	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 .	Baseline to 4 months.
Secondary	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.	Baseline to 4 months
Secondary	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.	Baseline to 4 months.
Secondary	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.	Baseline to 4 months
Secondary	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.	Baseline to 4 months
Secondary	Retention	The retention will be obtained using the % of participants who finished the intervention and the final measurements at 4 months.	At 4 months
Secondary	Attendance	The attendance will be measured using the % of the program sessions attended.	At 4 months
Secondary	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.	At 4 months