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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hydrate Philly Intervention
Intervention group that receives hydration station intervention
Behavioral: Hydrate Philly
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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).
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philadelphia Department of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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