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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03614780
Other study ID # 15-761
Secondary ID R01ES023029
Status Completed
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date July 19, 2017

Study information

Verified date August 2018
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date July 19, 2017
Est. primary completion date July 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 65 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Center for the Study of Community Health Birmingham Alabama

Sponsors (3)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University National Institute of Environmental Health Sciences (NIEHS), University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary temperature participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation 7 days
Secondary steps participants wore a pedometer and recorded steps daily 7 days
Secondary fasting glucose Participants (N=46) that self reported diagnosed T2DM and measured daily fasting glucose were asked to log their fasting glucose level each morning. 7 days
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