NCT03614780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

8 days

First QC Date

July 27, 2018

Last Update Submit

August 2, 2018

Conditions

Keywords

rurality

Outcome Measures

Primary Outcomes (1)

  • temperature

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

    7 days

Secondary Outcomes (2)

  • steps

    7 days

  • fasting glucose

    7 days

Study Arms (1)

30 additional minutes outdoors

EXPERIMENTAL

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

Interventions

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

30 additional minutes outdoors

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Study of Community Health

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor ActivityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julia M Gohlke, PhD

    Virginia Polytechnic Institution and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 3, 2018

Study Start

July 11, 2017

Primary Completion

July 19, 2017

Study Completion

July 19, 2017

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations