Clinical trial NCT06132763: Healthy Hydration Pilot in Elementary Schools
Official title: Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Dental Caries
Body Mass Index
Keywords: Hydration
Water bottle
Sugary Beverages
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 591
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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 in their district.
* 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.

Primary outcomes:
measure: Recruitment of student ambassadors
timeFrame: pre-intervention to baseline
measure: Retention of student ambassadors
timeFrame: 4 months
measure: School personnel satisfaction
timeFrame: Baseline and post (month 4)
measure: Implementation of intervention
timeFrame: 4 months
Secondary outcomes:
measure: Water bottle usage
timeFrame: Baseline, months 1, 2, & 3, post (month 4)
measure: Hydration station usage
timeFrame: Baseline, months 1, 2, & 3, post (month 4)
measure: Sugar-sweetened beverages at lunch
timeFrame: Baseline, months 1, 2, & 3, post (month 4)
measure: Dental caries status
timeFrame: Baseline and post (month 4)
measure: Body Mass Index
timeFrame: Baseline and post (month 4)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Melanie Bean
role: PRINCIPAL_INVESTIGATOR
References: