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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group I will receive "I Prefer Plain Water" only during the first grade |
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| Group 2 | Experimental | Group II will receive "I Prefer Plain Water" during first and second grades |
|
| Group 3 | Experimental | Group III will receive "I Prefer Plain Water" during first, second, and third grades |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose F Gonzalez-Zamora, MD MSc | Contact | +525550687256 | jf.gonzalezzamora@gmail.com | |
| Claudia Pimentel-Hernández, MD MSc | Contact | +525554531524 | clauspim@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose F Gonzalez-Zamora, MD MSc | Instituto Nacional de Pediatria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Pediatria | Recruiting | Mexico City | Coyoacan | 04530 | Mexico |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2017 | Aug 8, 2017 | Prot_SAP_000.pdf |
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Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
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| 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 |