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OpenTrials
Completed

NCT Number: NCT03614780

Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting

This research was designed with partners to determine differences in temperature exposures in urban and rural communities in Alabama. The investigators hypothesized that significant differences in temperature exposure exist between urban and rural settings. Time spent outdoors has been previously positively associated with greater physical activity. Built environment components in urban versus rural environments and ambient temperatures experienced during the summer may pose barriers to time spent outdoors. Persons with Type II Diabetes Mellitus may find it more difficult to overcome temperature barriers due to reduced thermoregulation capacity. This analysis will result in a more precise picture of temperature exposure as well as behavioral factors that may mediate exposure.

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Key information

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for the Study of Community Health

Birmingham, Alabama, 35294, United States

About this study

The investigators gathered individual-level temperature exposure data by asking 180 female participants to wear a small thermometer on their shoe for 7 days. Ninety participants were recruited from Birmingham AL (urban) and 90 from rural West Central Alabama. The first two days participants were asked to go about their normal daily activities. During the next 5 days of participation, participants were asked to add an additional 30 minutes of time spent outdoors. As a secondary outcome, steps were measured via pedometers worn by participants. A subgroup of participants with self-reported doctor diagnosed Type II Diabetes also recorded their fasting glucose each morning of participation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week.

Exclusion criteria

  • Medical condition that limits the amount of time able to be spent outdoors.

Treatment and study plan

30 minutes outdoors

Behavioral

Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation

Primary outcomes

  1. temperature

    Time frame: 7 days

    participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation

Secondary outcomes

  1. steps

    Time frame: 7 days

    participants wore a pedometer and recorded steps daily

  2. fasting glucose

    Time frame: 7 days

    Participants (N=46) that self reported diagnosed T2DM and measured daily fasting glucose were asked to log their fasting glucose level each morning.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • University of Alabama at Birmingham

Registry information

Official study title

Environmental Exposures Across Urban and Rural Communities in the Deep South

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2018
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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