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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Environmental Exposures Across Urban and Rural Communities in the Deep South

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614780
• Other study ID #: 15-761
• Secondary ID: R01ES023029
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise
• Temperature

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