Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child

Healthy Lifestyle Clinical Trial

— ECCA001LCE  

Official title:

Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Percentage of Water Consumed Among Early Elementary School Students With a 1-year Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03254615
• Other study ID #: 016/2017
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: August 2022

Study information

• Verified date: February 2020
• Source: National Institute of Pediatrics, Mexico
• Contact: Jose F Gonzalez-Zamora, MD MSc
• Phone: +525550687256
• Email: jf.gonzalezzamora[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current project seeks to evaluate the effectiveness of numerous educational strategy interventions to increase the percentage of water consumed among early elementary school students over a 1-year period.

Description:

A community intervention trial will be conducted at four public elementary schools of the Coyoacan Delegation in Mexico City. It will include healthy first graders during the 2017-2018 school year whose parents agree to participate through verbal informed consent and a signed privacy notice. These parents will complete a baseline 3-day beverage record (two weekdays and one weekend day). The four schools will be assigned to one of three groups: Group I will receive the educational strategy during the first grade; Group II will receive it during first and second grades; and Group III will receive it during the first, second, and third grades. All schools will have water dispensers inside the classrooms, and the children will receive a reusable 600-mL bottle so they are able to consume water on demand throughout the day. A second record of beverage consumption will be obtained by completing multiple interventions within each group, and a third record will be completed 1 year later.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 329
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• Healthy children

• Both girls and boys

• Children whose parents agree to participation in the study through verbal informed consent

• Children whose parents sign a privacy notice

Exclusion Criteria:

• Children who present with any pathology that interferes with the free consumption of water or with the proper execution of the study

• Children for whom it is not possible to obtain a baseline record of beverage consumption

Related Conditions & MeSH terms

• Elementary School
• Healthy Lifestyle
• Water Consumption

Intervention

Behavioral:
• "I Prefer Plain Water"
The students will receive four educational sessions of approximately 1 hour. These sessions will be given every 2 weeks, and some will be supervised by a nutritionist.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Pediatria	Ciudad de Mexico	Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Jose Francisco Gonzalez-Zamora

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI	Indicator of the relationship between weight and height	Up to 4 years, baseline measurement and once a year
Other	Health condition	Health condition that (in the opinion of the investigator) enables the participant to have free consumption of water	Up to 4 years, baseline measurement and once a year
Other	Water consumption per school	Quantity of water consumed in 1 month per participating school	Up to 4 years, baseline measurement and on monthly bases
Primary	Percentage of water consumed	Changes in average water consumption/ total liquid consumption	Up to 4 years, baseline measurement and once a year
Primary	Water consumption	Changes in the average of water consumption per child over a 3-day period	Up to 4 years, baseline measurement and once a year
Primary	Total liquid Consumption	Changes in the average of total liquids consumed per child over a 3-day period	Up to 4 years, baseline measurement and once a year
Secondary	Effectiveness of educational strategy	Changes in the percentage of water consumed, 1 year after completing the interventions within each group relative to baseline measurement	Up to 4 years, baseline measurement and once a year