Clinical trial NCT03254615: Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Water Consumption
Healthy Lifestyle
Elementary School
Keywords: Plain water
Educative strategies
Effectiveness
Lead sponsor: National Institute of Pediatrics, Mexico
Sponsor class: OTHER_GOV
First posted: 2017-08-18
Enrollment: 329
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of water consumed
timeFrame: Up to 4 years, baseline measurement and once a year
measure: Water consumption
timeFrame: Up to 4 years, baseline measurement and once a year
measure: Total liquid Consumption
timeFrame: Up to 4 years, baseline measurement and once a year
Secondary outcomes:
measure: Effectiveness of educational strategy
timeFrame: Up to 4 years, baseline measurement and once a year
Other outcomes:
measure: BMI
timeFrame: Up to 4 years, baseline measurement and once a year
measure: Health condition
timeFrame: Up to 4 years, baseline measurement and once a year
measure: Water consumption per school
timeFrame: Up to 4 years, baseline measurement and on monthly bases
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Pediatria
state: Coyoacan
Study officials:
affiliation: Instituto Nacional de Pediatria
name: Jose F Gonzalez-Zamora, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: