Healthy Hydration Pilot in Elementary Schools

Dental Caries Clinical Trial

Official title:

Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06132763
• Other study ID #: HM20023592
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 28, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Description:

Adequate water intake plays an important role in maintaining children's overall health, cognitive performance, fine motor skills and visual attention. It also plays a role in the maintenance of healthy weight. Many children do not consume sufficient water, especially in school. There is also potential that by providing enhanced access to water, there will be corresponding decreases in sugary beverage intake. Sugary beverages have been implicated as major contributors of excessive sugar and calorie intake in children, leading to multiple health concerns, such as type 2 diabetes, overweight and obesity, and dental caries. Schools are an optimal environment to increase children's water intake. Healthy hydration is a priority for Richmond Public School (RPS), as they recently adopted a new hydration policy into their school wellness policy, with hydration stations installed in all RPS schools. The purpose of this study is to determine the feasibility of a school-based hydration intervention. This study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 610
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion:

• Lunchroom observations: All students (K-5th) who eat lunch in the cafeteria on assessment days are eligible for lunchroom observations (observing what beverages are selected and presence of water bottles)
• BMI and dental caries assessments: 1) student is in the 3rd grade; 2) English or Spanish speaking.
• Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices at RPS.
• Staff surveys: All staff in the target schools will be eligible to complete the School Environment Survey.

Exclusion:

• Lunchroom observations: None.
• BMI and dental caries assessments: Students are ineligible if they: 1) are non-English or non-Spanish speaking; 2) have a medical condition that precludes drinking water or that can put them at risk for failure to thrive or poor weight gain, 2) are unable to complete assessments due to developmental delays, 3) plan to move from the school district during the study period.
• Student surveys: Students in 4th-5th grade who are unable to complete surveys due to developmental delays will be ineligible.
• Staff surveys: None.

Related Conditions & MeSH terms

• Body Mass Index
• Dental Caries
• Hydration

Intervention

Behavioral:
• Hydration Intervention
Teacher & student ambassadors: serve as hydration role models, identify "Hydration Heroes", monitor filter lights on hydration stations, & update the water meter visual. Kick-off event: event to kick off the hydration intervention to include water bottles distribution with a station to personalize, experiential activities, and information about the intervention. Social marketing: student-developed marketing campaign "Make water your superpower" will be placed in high-traffic areas of the school. Hydration Headquarters will be located in the lunchroom displaying a water meter illustrating bottle refills from the school's hydration stations. Behavioral reinforcement: on random days, students drinking water and/or with a water bottle will receive small incentives. Education and outreach: Hydration Tip Sheets, hydration signage in classrooms, and hydration trivia on hydration stations. Teachers will deliver 1 hydration lesson per month that align with Standards of Learning.

Other:
• Control - Assessments Only
Assessments only

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of student ambassadors	Ability to recruit the required number of students at start of trial.	pre-intervention to baseline
Primary	Retention of student ambassadors	Measured by percentage of students retained.	4 months
Primary	School personnel satisfaction	Measured via surveys.	Baseline and post (month 4)
Primary	Implementation of intervention	Percentage of intervention activities conducted per protocol	4 months
Secondary	Water bottle usage	% of students with water bottles in school	Baseline, months 1, 2, & 3, post (month 4)
Secondary	Hydration station usage	Ounces of water per student per day measured by hydration station flow meters.	Baseline, months 1, 2, & 3, post (month 4)
Secondary	Sugar-sweetened beverages at lunch	% of students with sugar-sweetened beverages at lunch	Baseline, months 1, 2, & 3, post (month 4)
Secondary	Dental caries status	measured by a modified International Caries Detection and Assessment System (ICDAS)	Baseline and post (month 4)
Secondary	Body Mass Index	NHANES Anthropometry methods used to measure height and weight	Baseline and post (month 4)