Childhood ObesityNCT04772859
Evaluation of an Online Lifestyle Intervention in Mexican School Children During COVID-19 Pandemic
A study testing Online Lifestyle Intervention in people with Childhood Obesity, run by Universidad de Sonora at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Online Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2021to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Childhood Obesity
- Being tested
- Online Lifestyle Intervention, Control Group
- Keywords
- Online, Lifestyle Intervention, Prevention, Childhood Obesity, Nutrition Education, Physical Activity, COVID-19
- Medical subject headings
- Pediatric Obesity, Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Lifestyle InterventionBehavioural
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.
Control GroupOther
They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.
| Study group | Role | What they receive |
|---|---|---|
| Online Lifestyle Intervention | Experimental | Online sessions of nutrition education, physical activity, and family participation. Receives: Behavioral: Online Lifestyle Intervention |
| Control Group | Other | General nutrition recommendations Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 months.
Secondary outcomes (12)
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.
Measured: 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.
Measured: Baseline to 4 months
Change in waist circumference
A Lufkin metallic anthropometric tape will be used. The umbilical scar will be taken as reference.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4 months
Attendance
The attendance will be measured using the % of the program sessions attended.
Measured: 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.
Measured: At 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2021
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G. Díaz Zavala, Ph.D, Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772859
- Sponsor's protocol ID
- Lifestyle intervention
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database of the study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04772859
- Acronym / sponsor ID
- Lifestyle intervention
- Conditions
- Childhood Obesity
- Keywords
- Online, Lifestyle Intervention, Prevention, Childhood Obesity, Nutrition Education, Physical Activity, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Lifestyle Intervention | Experimental | Behavioral: Online Lifestyle InterventionOnline sessions of nutrition education, physical activity, and family participation. |
| Control Group | Other | Other: Control GroupGeneral nutrition recommendations |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Lifestyle InterventionThe 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. | Behavioural | Online Lifestyle Intervention |
| Control GroupThey will receive one digital brochure with general information on a healthy diet, at the beginning of the program. | Other | Control Group |
Primary outcome
Change in BMI Z-score
Time frame: Baseline to 4 months.
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.
12 secondary outcomes
Change in weight
Time frame: Baseline to 4 months
Change in height
Time frame: Baseline to 4 months
Change in waist circumference
Time frame: Baseline to 4 months.
Change in body fat percentage
Time frame: Baseline and 4 months.
Change in relative fat mass
Time frame: Baseline to 4 months.
Change in nutrition knowledge
Time frame: Baseline to 4 months
Change in food frequency consumption Food consumption frequency questionnaire
Time frame: Baseline to 4 months.
Change in physical activity and sedentary behaviors
Time frame: Baseline to 4 months
Change in quality of life
Time frame: Baseline to 4 months
Retention
Time frame: At 4 months
Attendance
Time frame: At 4 months
Acceptability
Time frame: At 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No. The database of the study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando G. Díaz Zavala, Ph.D principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Lifestyle Intervention in people with Childhood Obesity, run by Universidad de Sonora at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI Z-score (time frame: Baseline to 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.