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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03637465
Other study ID # 49200
Secondary ID 74395
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date October 30, 2018

Study information

Verified date April 2019
Source Philadelphia Department of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date October 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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).

Locations

Country Name City State
United States Philadelphia Department of Public Health, Division of Chronic Disease Prevention Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Philadelphia Department of Public Health Children's Hospital of Philadelphia, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center water consumption 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).
Primary Outside beverages during programs 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 Single use beverage containers 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).
Secondary Staff consumption of sugary beverages 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).
Secondary Fountain related maintenance problems 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
Secondary Center attendance 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).
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