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

Primary Purpose

Temperature, Exercise, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
30 minutes outdoors
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Temperature focused on measuring rurality

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for the Study of Community Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

30 additional minutes outdoors

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

steps
participants wore a pedometer and recorded steps daily
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.

Full Information

First Posted
July 27, 2018
Last Updated
August 2, 2018
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
University of Alabama at Birmingham, National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT03614780
Brief Title
Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting
Official Title
Environmental Exposures Across Urban and Rural Communities in the Deep South
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
University of Alabama at Birmingham, National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature, Exercise, Diabetes Mellitus, Type 2
Keywords
rurality

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 additional minutes outdoors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
30 minutes outdoors
Intervention Description
Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation
Primary Outcome Measure Information:
Title
temperature
Description
participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation
Time Frame
7 days
Secondary Outcome Measure Information:
Title
steps
Description
participants wore a pedometer and recorded steps daily
Time Frame
7 days
Title
fasting glucose
Description
Participants (N=46) that self reported diagnosed T2DM and measured daily fasting glucose were asked to log their fasting glucose level each morning.
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia M Gohlke, PhD
Organizational Affiliation
Virginia Polytechnic Institution and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for the Study of Community Health
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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