Healthy Hydration Pilot in Elementary Schools

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06132763
Collaborator
(none)
610
1
2
6.7
91

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hydration Intervention
  • Other: Control - Assessments Only
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
610 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Addressing Root Causes of Under-hydration in School: A Stakeholder Collaborative Pilot Study
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydration Intervention

Students and staff at the intervention school will receive a school-based hydration intervention that includes a student-developed marketing campaign and incentivizes water bottles in school.

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.

Placebo Comparator: Control

Students and staff at the control school will participate in assessments only.

Other: Control - Assessments Only
Assessments only

Outcome Measures

Primary Outcome Measures

  1. Recruitment of student ambassadors [pre-intervention to baseline]

    Ability to recruit the required number of students at start of trial.

  2. Retention of student ambassadors [4 months]

    Measured by percentage of students retained.

  3. School personnel satisfaction [Baseline and post (month 4)]

    Measured via surveys.

  4. Implementation of intervention [4 months]

    Percentage of intervention activities conducted per protocol

Secondary Outcome Measures

  1. Water bottle usage [Baseline, months 1, 2, & 3, post (month 4)]

    % of students with water bottles in school

  2. Hydration station usage [Baseline, months 1, 2, & 3, post (month 4)]

    Ounces of water per student per day measured by hydration station flow meters.

  3. Sugar-sweetened beverages at lunch [Baseline, months 1, 2, & 3, post (month 4)]

    % of students with sugar-sweetened beverages at lunch

  4. Dental caries status [Baseline and post (month 4)]

    measured by a modified International Caries Detection and Assessment System (ICDAS)

  5. Body Mass Index [Baseline and post (month 4)]

    NHANES Anthropometry methods used to measure height and weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23235

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

  • Principal Investigator: Melanie Bean, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT06132763
Other Study ID Numbers:
  • HM20023592
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023