- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637465
Increasing Water Access and Appeal in Community Recreation Centers (Hydrate Philly)
April 1, 2019 updated by: Hannah Lawman, Philadelphia Department of Public Health
A Randomized Trial of a Comprehensive Multi-level Intervention to Increase Water Access and Appeal in Community Recreation Centers
This study is a cluster randomized controlled trial with n=28 City of Philadelphia recreation centers (14 matched pairs) designed to determine the effectiveness of a comprehensive multi-level intervention to increase water access and appeal in community recreation centers on 1) center-level water intake as measured by water meters, and 2) purchase of outside beverages as measured by observations of recreation center youth.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Philadelphia Department of Public Health, Division of Chronic Disease Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recreation center is located in a low-income neighborhood in the City of Philadelphia, defined by ≥20% of the residents in the zip code at or below Federal Poverty Level
- Recreation center includes both summer and after-school programming
- Recreation center is willing to comply with City of Philadelphia Healthy Vending standards and discourage sugar sweetened beverage consumption
- Recreation center has water lines appropriate for installing indoor hydration stations
Exclusion Criteria:
- Unwilling to accept randomization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hydrate Philly Intervention
Intervention group that receives hydration station intervention
|
Hydrate Philly is a multi-component intervention that includes water safety testing, provision of 1-2 hydration stations per recreation center, distribution of reusable water bottles for youth, a campaign to promote the acceptability of tap water, and the reduction of access to competing unhealthy beverages through vending machine standards and discouraging "black bags" (characteristic small, black, plastic bags provided to customers with their corner store purchases, typically including a sugar sweetened beverage and/or unhealthy snack foods).
|
|
No Intervention: Control
Control group that receives no intervention, but observational data is collected; converted to wait-listed intervention status after enrollment and randomization was completed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Center water consumption
Time Frame: Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Change in average gallons of water per day used at the center drinking water source as measured by flow meters over each 2-week measurement period.
|
Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
|
Outside beverages during programs
Time Frame: Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Changes in the average number of sugary beverages per day brought to summer camp.
|
Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single use beverage containers
Time Frame: Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Average number of single use containers (bottled water + sugary beverages) as measured by recreation center staff daily reports
|
Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
|
Staff consumption of sugary beverages
Time Frame: Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Change in frequency of staff consumption of sugary beverages (i.e., number of days in past 30 days with sugary beverages consumed) as measured by the Beverage Intake Questionnaire (BEVQ-15) survey assessing past 30 day recall of overall beverage intake.
Range is 0 - 30 with higher values indicating more days sugary beverages were consumed.
|
Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
|
Fountain related maintenance problems
Time Frame: Questionnaire administered 2-5 times per site up to 8 months post intervention
|
Average maintenance rating of scale with 8 items (4-point scale; i.e., everyday, 3-4 times, once or twice, or never) at post as measured by staff self-report.
Subscales include average routine maintenance (3 items) versus average maintenance problems (5 items).
|
Questionnaire administered 2-5 times per site up to 8 months post intervention
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Center attendance
Time Frame: Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
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The number of youth attending the recreation center program daily
|
Three measurement periods, each lasting 2 weeks, will occur: baseline (2-4 months pre-intervention), mid-point (3-5 months post intervention), and post (7-10 months post intervention).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hannah G Lawman, PhD, Philadelphia Department of Public Health, Division of Chronic Disease Prevention
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lawman HG, Grossman S, Lofton X, Tasian G, Patel AI. Hydrate Philly: An Intervention to Increase Water Access and Appeal in Recreation Centers. Prev Chronic Dis. 2020 Feb 20;17:E15. doi: 10.5888/pcd17.190277.
- Lawman HG, Lofton X, Grossman S, Root M, Perez M, Tasian G, Patel A. A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers. Contemp Clin Trials. 2019 Apr;79:14-20. doi: 10.1016/j.cct.2019.02.003. Epub 2019 Feb 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
July 31, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 2, 2019
Last Update Submitted That Met QC Criteria
April 1, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 49200
- 74395 (Other Grant/Funding Number: Robert Wood Johnson Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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