- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06778252
UrbanHEAT: Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
UrbanHEAT: Pilot of Prospective Observational Study of Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
We are conducting a research study to learn about how individuals living in Washington, DC perceive and experience temperature.
Participation in this study will include:
2 remote visits over the phone and/or computer (these will each last about1.5 to 2 hours)
During the remote visits, you will be asked to respond to a series of surveys, so that we can learn about your life, behaviors, and health
2 weeks of data collection where you will be asked to:
Wear monitoring devices
- These will collect information on your location and physical activity
- We will ask you to wear the monitors on a belt around your waist all day every day during these 2 weeks of data collection.
- All of the monitors will be sent to you in the mail.
- Leave a temperature tracker near where you sleep to measure the temperature of your environment.
Use a phone app
- We will also send you questions through the phone app that will ask about your stress level, sleep duration, sleep quality, and how you feel about the current temperature.
Risks of participating in this study are minimal. They include the inconvenience of wearing the monitors and the possibility of a breach of your confidentiality. We are collecting personal information about you and the location monitor will collect information about where you spend your time. We will take every precaution in order to safeguard the data that you provide, including limiting who has access to it, storing it safely, and removing the capacity to identify you individually, as much as possible.
You will receive no immediate benefits from participating in this study. We hope what we learn will help us to develop policies and programs to help keep urban populations safe during increasingly warm summer temperatures.
You are eligible for this study if you are 18 years of age or older, live in Washington, DC, can read and write in English, and have access to a smartphone that you can use for the 2 week data collection period....
Study Overview
Status
Conditions
Detailed Description
Study Description:
This pilot study will test measures for cardiometabolic behaviors and outcomes (e.g., physical activity, sedentary behavior, stress, sleep quality, sleep quantity) and individually experienced temperature with intensive longitudinal data collected via wearable devices and smart phone-based ecological momentary assessment. The primary hypothesis is that there are associations between individually experienced temperature and the identified behaviors and outcomes.
Objectives:
Primary:
To explore within and between-person associations between individually experienced temperature and cardiometabolic risk behaviors and outcomes.
Secondary:
Aim 1: Explore disparities in individually experienced temperature based on race, ethnicity, socioeconomic factors, sex, and age.
Aim 2: Explore multilevel determinants of individually experienced temperature: neighborhood environment (residential and activity space), home, workplace, and preferences
Endpoints:
Primary:
- Physical Activity
- Sedentary behavior
- Stress/mental well-being
- Sleep quantity
- Sleep quality
Secondary:
- Daily mean individually experienced temperature
- Daily maximum individually experienced temperature
- Daily degree minutes above threshold
- Longest daily exposure period
Study Type
Contacts and Locations
Study Locations
-
-
Maryland
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Bethesda, Maryland, United States, 20892-5465
- National Institute on Minority Health and Health Disparities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Aged at least 18 years.
- Ability to read and write in English. This is justified by the novelty of the survey instruments (e.g., momentary thermal comfort conducted in an ecological momentary assessment context).
- Home address in Washington, DC
- Availability of a smart phone on which Metricwire Ecological Momentary Assessment software can be downloaded and used during the 14-day data collection period.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Requirement of hospitalization at enrollment.
- Inability to consent.
- Unwillingness to comply with study procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy Volunteers
Healthy Volunteers with home address in Washington, DC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 2 weeks
|
Daily/Weekly Minutes MVPA (Moderate to Vigorous Physical Activity) as measured via waist-worn acceleromter
|
2 weeks
|
|
Sedentary Behavior
Time Frame: 2 weeks
|
Daily/Weekly Minutes Sedentary Behavior as measured via waist-worn accelerometer
|
2 weeks
|
|
Stress/mental Well-being
Time Frame: 2 weeks
|
Momentary/Daily Mean/Weekly Mean score on ecological momentary assessment random prompt questions derived from PSS-4 stress survey
|
2 weeks
|
|
Sleep Quantity
Time Frame: 2 weeks
|
Daily/Weekly Mean Hours Sleep collected via daily ecological momentary assessment morning prompt
|
2 weeks
|
|
Sleep Quality
Time Frame: 2 weeks
|
Daily/Weekly Mean Score derived from PSQI sleep survey collected via daily ecological momentary assessment morning prompt
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily mean individually experienced temperature
Time Frame: 2 weeks
|
average of all daily minute-epoch individual environmental temperature measures collected via iButton Hygrochron aggregated to (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
|
2 weeks
|
|
Daily maximum individually experienced temperature
Time Frame: 2 weeks
|
highest measured minute-epoch individual environmental temperature collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
|
2 weeks
|
|
Daily degree minutes above threshold
Time Frame: 2 weeks
|
minutesXdegrees exceeding test thresholds ranging from 80F-105F collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
|
2 weeks
|
|
Longest daily exposure period
Time Frame: 2 weeks
|
minutes of longest daily period exceeding test thresholds ranging from 80F-105F collected via iButton Hygrochron for (1) 24-hour days, (2) daylight only days, and (3) nighttime only days
|
2 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kelly K Jones, National Institute on Minority Health and Health Disparities (NIMHD)
Publications and helpful links
General Publications
- Beyer KMM, Szabo A, Hoormann K, Stolley M. Time spent outdoors, activity levels, and chronic disease among American adults. J Behav Med. 2018 Aug;41(4):494-503. doi: 10.1007/s10865-018-9911-1. Epub 2018 Jan 30.
- Tran Trong T, Riera F, Rinaldi K, Briki W, Hue O. Ingestion of a cold temperature/menthol beverage increases outdoor exercise performance in a hot, humid environment. PLoS One. 2015 Apr 9;10(4):e0123815. doi: 10.1371/journal.pone.0123815. eCollection 2015.
- Kuras ER, Richardson MB, Calkins MM, Ebi KL, Hess JJ, Kintziger KW, Jagger MA, Middel A, Scott AA, Spector JT, Uejio CK, Vanos JK, Zaitchik BF, Gohlke JM, Hondula DM. Opportunities and Challenges for Personal Heat Exposure Research. Environ Health Perspect. 2017 Aug 1;125(8):085001. doi: 10.1289/EHP556.
- McGregor GR, Vanos JK. Heat: a primer for public health researchers. Public Health. 2018 Aug;161:138-146. doi: 10.1016/j.puhe.2017.11.005. Epub 2017 Dec 28.
- Song X, Wang S, Hu Y, Yue M, Zhang T, Liu Y, Tian J, Shang K. Impact of ambient temperature on morbidity and mortality: An overview of reviews. Sci Total Environ. 2017 May 15;586:241-254. doi: 10.1016/j.scitotenv.2017.01.212. Epub 2017 Feb 7.
- Waugh DW, He Z, Zaitchik B, Peng RD, Diette GB, Hansel NN, Matsui EC, Breysse PN, Breysse DH, Koehler K, Williams D, McCormack MC. Indoor heat exposure in Baltimore: does outdoor temperature matter? Int J Biometeorol. 2021 Apr;65(4):479-488. doi: 10.1007/s00484-020-02036-2. Epub 2020 Oct 21.
- White-Newsome JL, Sanchez BN, Jolliet O, Zhang Z, Parker EA, Dvonch JT, O'Neill MS. Climate change and health: indoor heat exposure in vulnerable populations. Environ Res. 2012 Jan;112:20-7. doi: 10.1016/j.envres.2011.10.008. Epub 2011 Nov 8.
- Xiang J, Bi P, Pisaniello D, Hansen A. Health impacts of workplace heat exposure: an epidemiological review. Ind Health. 2014;52(2):91-101. doi: 10.2486/indhealth.2012-0145. Epub 2013 Dec 21.
- Zuurbier M, van Loenhout JAF, le Grand A, Greven F, Duijm F, Hoek G. Street temperature and building characteristics as determinants of indoor heat exposure. Sci Total Environ. 2021 Apr 20;766:144376. doi: 10.1016/j.scitotenv.2020.144376. Epub 2020 Dec 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10002097
- 002097-MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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