NCT01454882

Brief Summary

Although instruments such as pedometers and heart rate monitors are helpful for those who use exercise to maintain their weight, they do not actually measure calories expended, which is a critical piece of information necessary for sustained weight management. The purpose of this study is to determine the accuracy of a new device that measures calories burned based upon heat produced by the body. Since heat production is directly proportional to calories burned, this device has the potential to accurately measure energy expended in many different settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

October 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

3.8 years

First QC Date

October 14, 2011

Last Update Submit

January 7, 2016

Conditions

TemperatureClothingSexAgeAdiposity

Keywords

Direct calorimetryIndirect calorimetryEnergy Expenditure

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    The aim of this trial is to determine the accuracy of measuring energy expenditure using portable direct calorimetry. Energy expenditure will be measured with a new device worn on the arm that measures heat flux. The accuracy of the new device will be compared against simultaneous measurements of energy expenditure made using indirect calorimetry and doubly labeled water.

    24 hrs to 2 weeks

Study Arms (3)

Behavioral effects of clothing and temperature

In this first study, we will determine how variations in clothing and ambient temperature influence the accuracy of EE determined from measurements of total heat production. 65 individuals will be studied. This will be a randomized cross-over trial with two within subject factors: 1) ambient temperature and 2) amount of clothing. There will be two temperature conditions; warm temperature \[WT, 75°F (24°C)\] and cool temperature \[CT, 60°F (16°C)\]. During each condition, subjects will vary the amount of clothing they are wearing at specified times

Behavioral: Effects of ClothingBehavioral: Effects of Temperature

Behavioral effects of age, sex, and adiposity

THe aim of this study is to Determine how age, sex, and adiposity influence the accuracy of EE determined from measurements of total heat production . This will be a randomized study with two within subject conditions(high and low physical activity levels). A heterogenous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age range (≥ 18 yrs).

Behavioral: Low Physical ActivityBehavioral: High Physical Activity

Effects of free living energy expenditure

The primary aim of this study is to compare the accuracy of measuring free-living energy expenditure in humans measured using portable direct calorimetry. This will be a comparison study; TDEE will be measured simultaneously for 14 days using direct calorimetry and doubly labeled water. A heterogeneous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age (\>18 yrs).

Behavioral: Direct calorimetry and doubly labeled water

Interventions

Effects of ClothingBEHAVIORAL

There will be two temperature conditions; warm temperature \[WT, 75°F (24°C)\] and cool temperature \[CT, 60°F (16°C)\]. During each condition, subjects will vary the amount of clothing they are wearing at specified times

Behavioral effects of clothing and temperature
Effects of TemperatureBEHAVIORAL

There will be two temperature conditions; warm temperature \[WT, 75°F (24°C)\] and cool temperature \[CT, 60°F (16°C)\]. During each condition, subjects will vary the amount of clothing they are wearing at specified times

Behavioral effects of clothing and temperature
Low Physical ActivityBEHAVIORAL

This will be a randomized study with two within subject conditions (high and low physical activity levels)

Behavioral effects of age, sex, and adiposity
High Physical ActivityBEHAVIORAL

This will be a randomized study with two within subject conditions (high and low physical activity levels)

Behavioral effects of age, sex, and adiposity
Direct calorimetry and doubly labeled waterBEHAVIORAL

TDEE will be measured simultaneously for 14 days using direct calorimetry and doubly labeled water. A heterogeneous sample of adult men and women in stable health will be studied.

Effects of free living energy expenditure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study #1: Lean (body mass index (BMI) \< 25.0 kg/m2), adult men and women (18-45 yrs) in stable health will be studied. Study #2 \& #3: A heterogenous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age range (≥ 18 yrs).

You may qualify if:

  • Body mass index (BMI) 19-25 kg/m2
  • Age 18-45 years

You may not qualify if:

  • Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease)
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who are or who were recently (past year) pregnant or lactating.
  • Resting diastolic blood pressure \> 100 mm HG or resting systolic blood pressure \> 160 mm HG
  • Contra-indications to exercise (e.g. orthopedic limitations)
  • Study #2 (Effect of age, sex, and adiposity)
  • Weight \> 300 lbs (due to DXA limitations)
  • Self-reported acute or chronic disease (diabetes, heart disease, thyroid disease)
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who are or who were recently (past year) pregnant or lactating.
  • Resting diastolic blood pressure \> 100 mm HG or resting systolic blood pressure \> 160 mm HG
  • Contra-indications to exercise (e.g. orthopedic limitations)
  • Study #3 (Doubly labeled water)
  • Age ≥18 yrs
  • Weight \> 300 lbs (due to DXA limitations)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Links

MeSH Terms

Conditions

CoitusObesity

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward L Melanson, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 19, 2011

Study Start

January 1, 2012

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

US(1)