NCT02507310

Brief 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. Researchers will execute a crossover randomized control trial specifically testing thermal exposure and its effect on individual female's food consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

July 22, 2015

Last Update Submit

November 9, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • food intake (kg)

    Two workdays

Study Arms (2)

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.

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.

Other: thermostat

Interventions

thermostatOTHER

ambient temperature as modified by thermostat

Also known as: Environmental
ControlWarm Environment

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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?

You may not qualify if:

  • \- 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?

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham School of Public Health

Birmingham, Alabama, 35294-0022, United States

Location

Related Publications (1)

  • 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.

    PMID: 30426700DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Environment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 23, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

US(1)