Health BehaviorHydrate PhillyNCT03637465
Increasing Water Access and Appeal in Community Recreation Centers
A study testing Hydrate Philly in people with Health Behavior, run by Philadelphia Department of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Hydrate Philly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling to accept randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Department of Public Health, Division of Chronic Disease Prevention
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
- Conditions
- Health Behavior
- Being tested
- Hydrate Philly
- Keywords
- hydration, water intake, sugar sweetened beverages, youth, children
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrate PhillyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Hydrate Philly Intervention | Experimental | Intervention group that receives hydration station intervention Receives: Behavioral: Hydrate Philly |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Changes in the average number of sugary beverages per day brought to summer camp.
Measured: 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 outcomes (4)
Single use beverage containers
Average number of single use containers (bottled water + sugary beverages) as measured by recreation center staff daily reports
Measured: 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
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.
Measured: 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
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).
Measured: Questionnaire administered 2-5 times per site up to 8 months post intervention
Center attendance
The number of youth attending the recreation center program daily
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 May 2017
- Primary completion30 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster RCT involves 14 matched pairs; study recruitment and randomization occurs at the recreation center-level. Participating sites are matched based on center size, summer program enrollment, presence of indoor gym, neighborhood income \& race/ethnicity. Then, an intervention site and control site are randomly determined by a coin flip within each pair.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philadelphia Department of Public Health
- Sponsor type
- Other government
- Collaborators
- Stanford University, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Hannah Lawman, Philadelphia Department of Public Health
- Investigators
- Hannah G Lawman, PhD, Principal investigator, Philadelphia Department of Public Health, Division of Chronic Disease Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637465
- Sponsor's protocol ID
- 49200
- Other IDs
- 74395
- Acronym
- Hydrate Philly
- Status last verified
- Apr 2019
- First submitted
- 31 Jul 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32078503Lawman 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.
PubMed 30771559
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Comprehensive Multi-level Intervention to Increase Water Access and Appeal in Community Recreation Centers
- ClinicalTrials.gov ID
- NCT03637465
- Acronym / sponsor ID
- Hydrate Philly / 49200
- Conditions
- Health Behavior
- Keywords
- hydration, water intake, sugar sweetened beverages, youth, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Philadelphia Department of Public HealthOther government
- Collaborators
- Stanford University, Children's Hospital of Philadelphia
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This cluster RCT involves 14 matched pairs; study recruitment and randomization occurs at the recreation center-level. Participating sites are matched based on center size, summer program enrollment, presence of indoor gym, neighborhood income \& race/ethnicity. Then, an intervention site and control site are randomly determined by a coin flip within each pair.
| Arm | Type | Receives |
|---|---|---|
| Hydrate Philly Intervention | Experimental | Behavioral: Hydrate PhillyIntervention group that receives hydration station intervention |
| Control | No intervention | –Control group that receives no intervention, but observational data is collected; converted to wait-listed intervention status after enrollment and randomization was completed |
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling to accept randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrate PhillyHydrate 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). | Behavioural | Hydrate Philly Intervention |
Primary outcome
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.
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.
4 secondary outcomes
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).
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).
Fountain related maintenance problems
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 32078503Lawman 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.
- Derived from this study: PubMed 30771559Lawman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah G Lawman, PhD principal investigator
Philadelphia Department of Public Health, Division of Chronic Disease Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrate Philly in people with Health Behavior, run by Philadelphia Department of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637465, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.