Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child (ECCA001LCE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Lifestyle; Water Consumption; Elementary School
• Intervention / Treatment: Behavioral: "I Prefer Plain Water"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 329
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Coyoacan
    • Ciudad de Mexico, Coyoacan, Mexico, 04530
      • Recruiting
      • Instituto Nacional de Pediatría

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Group I will receive "I Prefer Plain Water" only during the first grade	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.
Experimental: Group 2; Group II will receive "I Prefer Plain Water" during first and second grades	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.
Experimental: Group 3; Group III will receive "I Prefer Plain Water" during first, second, and third grades	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of water consumed	Changes in average water consumption/ total liquid consumption	Up to 4 years, baseline measurement and once a year
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Indicator of the relationship between weight and height	Up to 4 years, baseline measurement and once a year
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
Water consumption per school	Quantity of water consumed in 1 month per participating school	Up to 4 years, baseline measurement and on monthly bases

Collaborators and Investigators

• Sponsor: Jose Francisco Gonzalez-Zamora
• Investigators: Principal Investigator: Jose F Gonzalez-Zamora, MD MSc, Instituto Nacional de Pediatría

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Effectiveness; Plain water; Educative strategies
• Other Study ID Numbers: 016/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No