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

NCT ID: NCT03254615

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Water Consumption Healthy Lifestyle Elementary School

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

"I Prefer Plain Water"

Intervention Type 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 2

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

Group Type EXPERIMENTAL

"I Prefer Plain Water"

Intervention Type 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 3

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

Group Type EXPERIMENTAL

"I Prefer Plain Water"

Intervention Type 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.

Interventions

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"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jose Francisco Gonzalez-Zamora

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jose Francisco Gonzalez-Zamora

M.D. MSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose F Gonzalez-Zamora, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Pediatria

Locations

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Instituto Nacional de Pediatria

Mexico City, Coyoacan, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Jose F Gonzalez-Zamora, MD MSc

Role: CONTACT

+525550687256

Claudia Pimentel-Hernández, MD MSc

Role: CONTACT

+525554531524

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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016/2017

Identifier Type: -

Identifier Source: org_study_id

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