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

NCT03254615 | Unknown DMC

• 1 other identifier: 016/2017
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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.

Conditions

Water Consumption; Healthy Lifestyle; Elementary School

Keywords

Plain water; Educative strategies; Effectiveness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Effectiveness of educational strategy

  Up to 4 years, baseline measurement and once a year

Other Outcomes (3)

• BMI

  Up to 4 years, baseline measurement and once a year

• Health condition

  Up to 4 years, baseline measurement and once a year

• Water consumption per school

  Up to 4 years, baseline measurement and on monthly bases

Study Arms (3)

Group 1

EXPERIMENTAL

Group I will receive "I Prefer Plain Water" only during the first grade

Behavioral: "I Prefer Plain Water"

Group 2

EXPERIMENTAL

Group II will receive "I Prefer Plain Water" during first and second grades

Behavioral: "I Prefer Plain Water"

Group 3

EXPERIMENTAL

Group III will receive "I Prefer Plain Water" during first, second, and third grades

Behavioral: "I Prefer Plain Water"

Interventions

"I Prefer Plain Water" BEHAVIORAL

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Francisco Gonzalez-Zamora: lead

Study Sites (1)

Instituto Nacional de Pediatria

Mexico City, Coyoacan, 04530, Mexico

RECRUITING

Study Officials

• Jose F Gonzalez-Zamora, MD MSc

  Instituto Nacional de Pediatria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose F Gonzalez-Zamora, MD MSc

CONTACT

+525550687256; jf.gonzalezzamora@gmail.com

Claudia Pimentel-Hernández, MD MSc

CONTACT

+525554531524; clauspim@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. MSc

Model Details: Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 18, 2017
• Study Start: August 13, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)