Clinical trial NCT06778252: UrbanHEAT: Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
Official title: UrbanHEAT: Pilot of Prospective Observational Study of Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temperature
Keywords: Physical Activity
Observational Study
Sleep
Climate Change
Cardiometabolic Risk Behaviors and Outcomes
Stress/mental well-being
Neighborhoods
TEMPERATURE
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 and over with home addresses located within Washington, DC.

Brief summary: 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....

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

Eligibility criteria: * 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.

Primary outcomes:
measure: Physical Activity
timeFrame: 2 weeks
measure: Sedentary Behavior
timeFrame: 2 weeks
measure: Stress/mental Well-being
timeFrame: 2 weeks
measure: Sleep Quantity
timeFrame: 2 weeks
measure: Sleep Quality
timeFrame: 2 weeks
Secondary outcomes:
measure: Daily mean individually experienced temperature
timeFrame: 2 weeks
measure: Daily maximum individually experienced temperature
timeFrame: 2 weeks
measure: Daily degree minutes above threshold
timeFrame: 2 weeks
measure: Longest daily exposure period
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute on Minority Health and Health Disparities
state: Maryland
Study officials:
affiliation: National Institute on Minority Health and Health Disparities (NIMHD)
name: Kelly K Jones
role: PRINCIPAL_INVESTIGATOR
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