Water ConsumptionECCA001LCENCT03254615
Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child
A study testing "I Prefer Plain Water" in people with Water Consumption and Healthy Lifestyle, run by Jose Francisco Gonzalez-Zamora at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Water Consumption, Healthy Lifestyle, Elementary School
- What is being tested?
- "I Prefer Plain Water"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteMexico
- Study dates
- 13 Aug 2018to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Pediatria
Mexico City, Coyoacan, 04530
About this study
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
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.
- Conditions
- Water Consumption, Healthy Lifestyle, Elementary School
- Being tested
- "I Prefer Plain Water"
- Keywords
- Plain water, Educative strategies, Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"I Prefer Plain Water"Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group I will receive "I Prefer Plain Water" only during the first grade Receives: Behavioral: "I Prefer Plain Water" |
| Group 2 | Experimental | Group II will receive "I Prefer Plain Water" during first and second grades Receives: Behavioral: "I Prefer Plain Water" |
| Group 3 | Experimental | Group III will receive "I Prefer Plain Water" during first, second, and third grades Receives: Behavioral: "I Prefer Plain Water" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of water consumed
Changes in average water consumption/ total liquid consumption
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 4 years, baseline measurement and once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start13 Aug 2018
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
- Masking
- None (open label)
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Francisco Gonzalez-Zamora
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jose Francisco Gonzalez-Zamora, National Institute of Pediatrics, Mexico
- Investigators
- Jose F Gonzalez-Zamora, MD MSc, Principal investigator, Instituto Nacional de Pediatria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254615
- Sponsor's protocol ID
- 016/2017
- Acronym
- ECCA001LCE
- Status last verified
- Feb 2020
- First submitted
- 8 Aug 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03254615
- Acronym / sponsor ID
- ECCA001LCE / 016/2017
- Conditions
- Water Consumption, Healthy Lifestyle, Elementary School
- Keywords
- Plain water, Educative strategies, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Jose Francisco Gonzalez-ZamoraOther government
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental, analytical, longitudinal, and prospective designs will be employed. The assignment will be conducted by each school.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: "I Prefer Plain Water"Group I will receive "I Prefer Plain Water" only during the first grade |
| Group 2 | Experimental | Behavioral: "I Prefer Plain Water"Group II will receive "I Prefer Plain Water" during first and second grades |
| Group 3 | Experimental | Behavioral: "I Prefer Plain Water"Group III will receive "I Prefer Plain Water" during first, second, and third grades |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | Group 1, Group 2, Group 3 |
Primary outcome
Percentage of water consumed
Time frame: Up to 4 years, baseline measurement and once a year
Changes in average water consumption/ total liquid consumption
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
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
1 secondary outcome
Effectiveness of educational strategy
Time frame: Up to 4 years, baseline measurement and once a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose F Gonzalez-Zamora, MD MSc principal investigator
Instituto Nacional de Pediatria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "I Prefer Plain Water" in people with Water Consumption and Healthy Lifestyle, run by Jose Francisco Gonzalez-Zamora at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose F Gonzalez-Zamora, MD MSc (+525550687256, jf.gonzalezzamora@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of water consumed (time frame: Up to 4 years, baseline measurement and once a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.