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

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Completed

CT.gov ID

NCT03614780

Collaborator

University of Alabama at Birmingham (Other), National Institute of Environmental Health Sciences (NIEHS) (NIH)

180

Enrollment

Location

Arm

Actual Duration (Days)

684.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Temperature Exercise Diabetes Mellitus, Type 2	Behavioral: 30 minutes outdoors	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Environmental Exposures Across Urban and Rural Communities in the Deep South

Actual Study Start Date :

Jul 11, 2017

Actual Primary Completion Date :

Jul 19, 2017

Actual Study Completion Date :

Jul 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30 additional minutes outdoors Participants were asked to go about their normal activities during the first 2 baseline days of participation. Participants were asked to spend an additional 30 minutes outdoors per day for the next 5 days of participation.	Behavioral: 30 minutes outdoors Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation

Arm

Intervention/Treatment

Experimental: 30 additional minutes outdoors

Participants were asked to go about their normal activities during the first 2 baseline days of participation. Participants were asked to spend an additional 30 minutes outdoors per day for the next 5 days of participation.

Behavioral: 30 minutes outdoors

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

Outcome Measures

Primary Outcome Measures

temperature [7 days]
participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation

Secondary Outcome Measures

steps [7 days]
participants wore a pedometer and recorded steps daily
fasting glucose [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for the Study of Community Health	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

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

Investigators

Principal Investigator: Julia M Gohlke, PhD, Virginia Polytechnic Institution and State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Julia Gohlke, Associate Professor, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT03614780

Other Study ID Numbers:

15-761
R01ES023029

First Posted:

Aug 3, 2018

Last Update Posted:

Aug 6, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Julia Gohlke, Associate Professor, Virginia Polytechnic Institute and State University

rurality

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 6, 2018