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Trial record 4 of 148 for:    Recruiting, Not yet recruiting, Available Studies | "Drinking Water"

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

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ClinicalTrials.gov Identifier: NCT03254615
Recruitment Status : Not yet recruiting
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jose Francisco Gonzalez-Zamora, National Institute of Pediatrics, Mexico

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.

Condition or disease Intervention/treatment Phase
Water Consumption Healthy Lifestyle Elementary School Behavioral: "I Prefer Plain Water" Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 329 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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.




Primary Outcome Measures :
  1. Percentage of water consumed [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Changes in average water consumption/ total liquid consumption

  2. Water consumption [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Changes in the average of water consumption per child over a 3-day period

  3. Total liquid Consumption [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Changes in the average of total liquids consumed per child over a 3-day period


Secondary Outcome Measures :
  1. Effectiveness of educational strategy [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Changes in the percentage of water consumed, 1 year after completing the interventions within each group relative to baseline measurement


Other Outcome Measures:
  1. BMI [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Indicator of the relationship between weight and height

  2. Health condition [ Time Frame: Up to 4 years, baseline measurement and once a year ]
    Health condition that (in the opinion of the investigator) enables the participant to have free consumption of water

  3. Water consumption per school [ Time Frame: Up to 4 years, baseline measurement and on monthly bases ]
    Quantity of water consumed in 1 month per participating school



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254615


Contacts
Contact: Jose F Gonzalez-Zamora, MD MSc +525550687256 jf.gonzalezzamora@gmail.com
Contact: Claudia Pimentel-Hernández, MD MSc +525554531524 clauspim@hotmail.com

Sponsors and Collaborators
Jose Francisco Gonzalez-Zamora
Investigators
Principal Investigator: Jose F Gonzalez-Zamora, MD MSc Instituto Nacional de Pediatria
  Study Documents (Full-Text)

Documents provided by Jose Francisco Gonzalez-Zamora, National Institute of Pediatrics, Mexico:

Responsible Party: Jose Francisco Gonzalez-Zamora, M.D. MSc, National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier: NCT03254615     History of Changes
Other Study ID Numbers: 016/2017
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jose Francisco Gonzalez-Zamora, National Institute of Pediatrics, Mexico:
Plain water
Educative strategies
Effectiveness