CClinicalTrials.gg
Status unknownNCT03254615ECCA001LCEUpdated Feb 11, 2020

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

An interventional study of "I Prefer Plain Water" in Water Consumption, Healthy Lifestyle and Elementary School, sponsored by Jose Francisco Gonzalez-Zamora. Status unknown at 1 site in Mexico. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Jose Francisco Gonzalez-Zamora · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
329
Allocation
Non-randomized
Ages
5 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Water Consumption
  • Healthy Lifestyle
  • Elementary School

Keywords

  • Plain water
  • Educative strategies
  • Effectiveness
03

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
329 participants (estimated)

Study arms

  • Experimental
    Group 1

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

    Behavioral: "I Prefer Plain Water"

  • Experimental
    Group 2

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

    Behavioral: "I Prefer Plain Water"

  • Experimental
    Group 3

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

    Behavioral: "I Prefer Plain Water"

Interventions

  • 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.

05

What researchers measure

Primary outcomes

  1. Percentage of water consumed

    Changes in average water consumption/ total liquid consumption

    Time frame: Up to 4 years, baseline measurement and once a year

  2. Water consumption

    Changes in the average of water consumption per child over a 3-day period

    Time frame: Up to 4 years, baseline measurement and once a year

  3. Total liquid Consumption

    Changes in the average of total liquids consumed per child over a 3-day period

    Time frame: Up to 4 years, baseline measurement and once a year

Secondary outcomes

  1. Effectiveness of educational strategy

    Changes in the percentage of water consumed, 1 year after completing the interventions within each group relative to baseline measurement

    Time frame: Up to 4 years, baseline measurement and once a year

Other outcomes

  1. BMI

    Indicator of the relationship between weight and height

    Time frame: Up to 4 years, baseline measurement and once a year

  2. Health condition

    Health condition that (in the opinion of the investigator) enables the participant to have free consumption of water

    Time frame: Up to 4 years, baseline measurement and once a year

  3. Water consumption per school

    Quantity of water consumed in 1 month per participating school

    Time frame: Up to 4 years, baseline measurement and on monthly bases

06

Study locations

1 of 1 sites recruiting
  • Instituto Nacional de Pediatria
    Ciudad de Mexico, Coyoacan 04530, Mexico
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03254615
Lead sponsor
Jose Francisco Gonzalez-Zamora
Responsible party
Jose Francisco Gonzalez-Zamora (M.D. MSc, National Institute of Pediatrics, Mexico) — Sponsor-investigator
First posted
Aug 18, 2017
Start date
Aug 13, 2018
Primary completion
Aug 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Feb 11, 2020

Study contacts

Jose F Gonzalez-Zamora, MD MSc
Contact
jf.gonzalezzamora@gmail.com
+525550687256
Claudia Pimentel-Hernández, MD MSc
Contact
clauspim@hotmail.com
+525554531524
Jose F Gonzalez-Zamora, MD MSc
principal investigator · Instituto Nacional de Pediatria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion