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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775163
Other study ID # PBRC 10008-A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2010
Est. completion date February 2015

Study information

Verified date August 2021
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. We aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.


Description:

This is an ancillary study to E-Mechanic, which is an National Institutes of Health study in 198 individuals with the objective to understand why certain people fail to lose weight in exercise programs. In E-Mechanic changes in body weight, body composition, energy intake and energy expenditure are measured before and after 3 different exercise programs of 24 weeks in duration. The 3 exercise programs being compared are self-directed exercise, low dose exercise and high dose exercise. The goal of this ancillary study is to undertake comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese individuals enrolled in the main study. We will compare differences in the changes in 24h energy expenditure and spontaneous physical activity between the 3 exercise programs. We will also test if changes in energy metabolism might explain why people don't lose the expected amount of weight after 24 weeks of exercise.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2. Exclusion Criteria: - Not enrolled in the E-MECHANIC main study (NCT#01264406). - Have a body mass index (BMI) less than 30 kg/m2.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Sleeping energy expenditure Sleeping energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program 24 weeks
Other Spontaneous physical activity Spontaneous physical activity will be measured in a room calorimeter before and after a 24 week exercise program 24 weeks
Primary Change in 24h energy expenditure 24h energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program 24 weeks
Secondary Metabolic adaptation in 24h energy expenditure The difference between the actual change in 24 energy expenditure and the energy expenditure estimated on the basis of body size will be compared between: 1) exercise groups and 2) between individuals who lost the expected amount of weight and individuals who did not lose the expected amount of weight during the exercise program 24 weeks
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