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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Online Lifestyle Intervention
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Lifestyle Intervention<br>Online sessions of nutrition education, physical activity, and family participation. | Behavioral: Online Lifestyle Intervention<br>* 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.<br>|
| Other: Control Group<br>General nutrition recommendations | Other: Control Group<br>* They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online, Lifestyle Intervention, Prevention, Childhood Obesity, Nutrition Education, Physical Activity, COVID-19