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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02158130
Other study ID # PBRC 2014-028
Secondary ID
Status Completed
Phase N/A
First received June 4, 2014
Last updated March 21, 2016
Start date September 2014
Est. completion date March 2016

Study information

Verified date March 2016
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.


Description:

Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure. The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- Completed the E-Mechanic study

- Be willing to archive blood samples

- Not participating in a study that would alter body weight, energy intake, or energy expenditure.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


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 Circumferences Waist and hip circumferences Week 64-88 post study randomization No
Other Blood Pressure Week 64-88 post study randomization No
Other Body Composition Whole Body Scan GE iDXA (Dual energy x-ray absorptiometry) Week 64 - 88 post study randomization No
Other Triglycerides Week 64 - 88 post study randomization No
Other Cholesterol Total, HDL, and LDL cholesterol Week 64 - 88 post study randomization No
Primary Body Weight Fasting body weight Week 64 - 88 post study randomization No
Secondary Energy Expenditure Energy expenditure is calculated with the Sensewear Armband. Week 64 - 90 since study randomization No
Secondary Energy Intake Energy expenditure is calculated with the Sensewear Armband and furthermore, energy intake is calculated by adjusting TDEE for change in body weight following the methods used in doubly labeled water adjustment. Week 64 - 90 post study randomization No
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