TemperatureNCT03614780
Pre Post Evaluation of Temperature, Steps, and Glucose With Additional Time Spent Outdoors in an Urban and Rural Setting
A study testing 30 minutes outdoors in people with Temperature and Exercise, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temperature, Exercise, Diabetes Mellitus, Type 2
- What is being tested?
- 30 minutes outdoors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 19 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week.
Who cannot join
- Medical condition that limits the amount of time able to be spent outdoors.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Study of Community Health
Birmingham, Alabama, 35294
About this study
Official title: Environmental Exposures Across Urban and Rural Communities in the Deep South
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.
Read the 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.
- Conditions
- Temperature, Exercise, Diabetes Mellitus, Type 2
- Being tested
- 30 minutes outdoors
- Keywords
- rurality
- Medical subject headings
- Motor Activity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 minutes outdoorsBehavioural
Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 30 minutes outdoors |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature
participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation
Measured: 7 days
Secondary outcomes (2)
steps
participants wore a pedometer and recorded steps daily
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start11 Jul 2017
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Julia Gohlke, Virginia Polytechnic Institute and State University
- Investigators
- Julia M Gohlke, PhD, Principal investigator, Virginia Polytechnic Institution and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614780
- Sponsor's protocol ID
- 15-761
- Other IDs
- R01ES023029
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Exposures Across Urban and Rural Communities in the Deep South
- ClinicalTrials.gov ID
- NCT03614780
- Acronym / sponsor ID
- 15-761
- Conditions
- Temperature, Exercise, Diabetes Mellitus, Type 2
- Keywords
- rurality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 additional minutes outdoors | Experimental | Behavioral: 30 minutes outdoorsParticipants 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, age 19 to 65, willing to wear a small thermometer on shoe and pedometer on waist for one week.
Key exclusion criteria (1 listed)
- Medical condition that limits the amount of time able to be spent outdoors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 minutes outdoorsParticipants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation | Behavioural | 30 additional minutes outdoors |
Primary outcome
temperature
Time frame: 7 days
participants wore a small thermometer on their shoe that recorded temperature in 5 minute intervals for the duration of participation
2 secondary outcomes
steps
Time frame: 7 days
fasting glucose
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia M Gohlke, PhD principal investigator
Virginia Polytechnic Institution and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 minutes outdoors in people with Temperature and Exercise, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperature (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.