- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507310
Influence of Ambient Temperature on Office Behaviors
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294-0022
- University of Alabama at Birmingham School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Are you willing to have your height and weight taken? Are you willing and able to give informed consent? Are you able to communicate with the pertinent staff? Are you comfortable reading independently and answering a couple written questions related to the passage that you've read? Are you willing to sit in a small office with a closed door for an entire workday? Do you feel uncomfortable in confined spaces for extended periods of time?
Exclusion Criteria:
- Do you have any food allergy, including, but not limited to lactose or gluten intolerance? Do you have any religious affiliations that include specific food guidelines? Do you have any personal dietary restrictions, including but not limited to veganism? Have you participated in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months? Have you had weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss? Are you currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetics medications? Do you have a history of prior surgical procedure for weight control or liposuction? Are you currently taking statins? Do you have high blood pressure (above 140 systolic, 90 diastolic)? Are you a current smoker or have you quit smoking less than 6 months prior?
Do you have any major disease, including:
- Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
- Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
- Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Active renal disease.
- Lung disease: chronic obstructive airway disease requiring use of oxygen.
- Diagnosed diabetes (type 1 or 2).
- Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
Do you have a history of or currently have an eating disorder? Have you ever been diagnosed with Raynaud's syndrome? Do you have another household member is a participant or staff member in the trial? Are you currently or do you anticipate participating in another intervention research project that would interfere with the intervention offered in the session? Are you willing to accept condition that you are randomized to? Are you currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months? Do you have a recent or ongoing problem with drug abuse or addiction? Do you on average consume 3 or more alcohol containing beverages daily? Have you consumed 7 or more alcoholic beverages within a 24-hr period in the past 12 months? Are you a student in the Environmental Health Science Department, Nutrition Sciences School, any student, trainee, or post-doctoral fellow who is directly or indirectly receiving funding from the Nutrition Obesity Research Center? Are you currently pregnant or less than 3 months post-partum? Are you currently nursing or within 6 weeks of having completed nursing? Do you anticipate a pregnancy between time of screening and session date? Are you willing to report possible or confirmed pregnancies promptly at the time of the session?
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control
The room will be kept at 18-20 degrees Celsius.
This is within the human thermoneutral zone.
It will serve as the control condition.
|
ambient temperature as modified by thermostat
Other Names:
|
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EXPERIMENTAL: Warm Environment
The room will be kept at 25-27 degrees Celsius.
This is above the human thermoneutral zone.
This will serve as the experimental condition.
|
ambient temperature as modified by thermostat
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
food intake (kg)
Time Frame: Two workdays
|
Two workdays
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- X141114013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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