ObesityNCT02507310
Influence of Ambient Temperature on Office Behaviors
A study testing thermostat in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Based on preliminary data and previous studies, we hypothesize that the ambient temperature experienced by an individual influences his or her food intake. Specifically, exposure to temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in a sedentary situation. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- thermostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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?
Who cannot join
- 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).
Show all 11Show fewer
- 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?
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham School of Public Health
Birmingham, Alabama, 35294-0022
About this study
Based on preliminary data and previous studies, we hypothesize that the ambient temperature experienced by an individual influences his or her food intake. Specifically, exposure to temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers will execute a crossover randomized control trial specifically testing thermal exposure and its effect on individual female's food consumption.
Read the detailed description
Participants will receive and wear a t-shirt. They will have a thermal image taken of the inner canthus of their eye and middle finger nail bed, representing a baseline of core and peripheral temperatures, respectively. They will also have their metabolic rate measured via a canopy hood method. At their initial visit, they will be randomized to either a colder environment (66-68°F) or a warmer environment (77-79°F) under the artifice of monitoring routine office work with abnormal temperature conditions. Their knowledge of the experiment will be limited until the end. They will experience this temperature while filling out paperwork and performing basic office tasks for a 7 hour work day. At the beginning and end of each day they will fill out a questionnaire on their appetite and thermal comfort. After the first 3.5 hours, another thermal image will be taken and the participant will be presented with lasagna and water and directed to eat at their leisure and subsequently finish the office tasks over the next 3.5 hours. A thermal image will be taken and metabolic rate will be assessed at the end of the day. Snacks will be available throughout the day. The participants will return approximately 1 week later to experience the other thermal environment following the same protocols. The participants will then be debriefed on the parameters of the experiment and body measurements will be taken at the end so as to prevent bias of the subject by limiting their food intake. We will quantify energy intake by weighing remaining food and comparing to known caloric content by weight from bomb calorimetry tests. The infrared thermal images will determine whether the temperatures experienced were extreme enough to initiate a change in thermoregulation.
- Conditions
- Obesity
- Being tested
- thermostat
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermostatOther
Also called Environmental
ambient temperature as modified by thermostat
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The room will be kept at 18-20 degrees Celsius. This is within the human thermoneutral zone. It will serve as the control condition. Receives: Other: thermostat |
| Warm Environment | Experimental | The room will be kept at 25-27 degrees Celsius. This is above the human thermoneutral zone. This will serve as the experimental condition. Receives: Other: thermostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
food intake (kg)
Measured: Two workdays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly C. Bernhard, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507310
- Sponsor's protocol ID
- X141114013
- Status last verified
- Nov 2015
- First submitted
- 22 Jul 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
Publications
Richardson MB, Li P, Gohlke JM, Allison DB. Effects of Indoor Thermal Environment on Human Food Intake, Productivity, and Comfort: Pilot, Randomized, Crossover Trial. Obesity (Silver Spring). 2018 Dec;26(12):1826-1833. doi: 10.1002/oby.22328. Epub 2018 Nov 14.
PubMed 30426700
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ambient Temperature on Office Behaviors
- ClinicalTrials.gov ID
- NCT02507310
- Acronym / sponsor ID
- X141114013
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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.
Based on preliminary data and previous studies, we hypothesize that the ambient temperature experienced by an individual influences his or her food intake. Specifically, exposure to temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers will execute a crossover randomized control trial specifically testing thermal exposure and its effect on individual female's food consumption.
Detailed description
Participants will receive and wear a t-shirt. They will have a thermal image taken of the inner canthus of their eye and middle finger nail bed, representing a baseline of core and peripheral temperatures, respectively. They will also have their metabolic rate measured via a canopy hood method. At their initial visit, they will be randomized to either a colder environment (66-68°F) or a warmer environment (77-79°F) under the artifice of monitoring routine office work with abnormal temperature conditions. Their knowledge of the experiment will be limited until the end. They will experience this temperature while filling out paperwork and performing basic office tasks for a 7 hour work day. At the beginning and end of each day they will fill out a questionnaire on their appetite and thermal comfort. After the first 3.5 hours, another thermal image will be taken and the participant will be presented with lasagna and water and directed to eat at their leisure and subsequently finish the office tasks over the next 3.5 hours. A thermal image will be taken and metabolic rate will be assessed at the end of the day. Snacks will be available throughout the day. The participants will return approximately 1 week later to experience the other thermal environment following the same protocols. The participants will then be debriefed on the parameters of the experiment and body measurements will be taken at the end so as to prevent bias of the subject by limiting their food intake. We will quantify energy intake by weighing remaining food and comparing to known caloric content by weight from bomb calorimetry tests. The infrared thermal images will determine whether the temperatures experienced were extreme enough to initiate a change in thermoregulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: thermostatThe room will be kept at 18-20 degrees Celsius. This is within the human thermoneutral zone. It will serve as the control condition. |
| Warm Environment | Experimental | Other: thermostatThe room will be kept at 25-27 degrees Celsius. This is above the human thermoneutral zone. This will serve as the experimental condition. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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?
Key exclusion criteria (11 listed)
- 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?
- 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).
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 |
|---|---|---|
| thermostatAlso: Environmentalambient temperature as modified by thermostat | Other | Control, Warm Environment |
Primary outcome
food intake (kg)
Time frame: Two workdays
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 10 Nov 2015.
- Derived from this study: PubMed 30426700Richardson MB, Li P, Gohlke JM, Allison DB. Effects of Indoor Thermal Environment on Human Food Intake, Productivity, and Comfort: Pilot, Randomized, Crossover Trial. Obesity (Silver Spring). 2018 Dec;26(12):1826-1833. doi: 10.1002/oby.22328. Epub 2018 Nov 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermostat in people with Obesity, run by University of Alabama at Birmingham 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 11 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 10 Nov 2015. 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?
food intake (kg) (time frame: Two workdays). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507310, which also lists 1 linked publication.
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 10 Nov 2015.