The Comparison of Energy in Take and Body Weight EXERCISE (E-MECHANIC)
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ClinicalTrials.gov Identifier: NCT01264406 |
Recruitment Status
:
Completed
First Posted
: December 21, 2010
Last Update Posted
: February 4, 2016
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Condition or disease |
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Exercise Energy Body Weight |
Study Type : | Observational |
Actual Enrollment : | 198 participants |
Observational Model: | Case Control |
Official Title: | Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | December 2015 |
Group/Cohort |
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Exercise Group (20 KKW)
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
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Exercise Group (8 KKW)
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
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Control group
This group will be instructed to maintain their baseline level of exercise.
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- A Comparison of the effects of energy balance with three groups. [ Time Frame: 6 months after screening ]
A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance.
Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study.
Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill.
High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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Male or female 18 - 65 years old, inclusive
- Not exercising > 20 minutes on > 3 days/wk and taking < 8000 steps/d over one week measured with step counters.
- BMI > 25 kg/m2 and < 40 kg/m2
Exclusion Criteria:
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• Current consumption of more than 14 alcoholic drinks per week
- Plan to move out of the study area within the next 6 months or plan to be out of the study area for more than 4 weeks in the next 6 months
- Have another member of household participating in the study
- Residence too far from Pennington
- A past history and/or physical examination or laboratory findings of the following medical conditions:
Table 1. Exclusion Criteria
- Cardiovascular disease (CVD) or disorders Potential participants with a history of CVD
- Blood Pressure Potential participants who are on a stable dose of antihypertensive medication, with the exception of beta-blockers, and whose blood pressure is controlled will be eligible for enrollment.
- Diabetes Potential participants with a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose >125 mg/dl will be excluded from the study.
- Blood lipids Potential participants whose LDL-C 190 mg/dl or TG levels 300 mg/dl will be referred to their physician.
- Hematologic disorders Participants diagnosed with hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states, will not be allowed into the study.
- Recent blood donation or blood loss Blood donation or blood loss from surgery or trauma during the 6 weeks before the baseline evaluation
- Weight loss-20 or more kilograms in the past year Other exclusions.
- Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness. Plans to be out of the city more than 4 weeks over the next 6 months
- Other significant medical conditions Including but not limited to chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. Musculoskeletal problems interfering with exercise.
- Autoimmune or collagen vascular diseases. Immunodeficiency diseases or a positive HIV test. Malignancies in the past 5 years, with the exception of non-melanoma skin cancer therapeutically controlled. Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264406
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Corby Martin, PhD | PBRC | |
Principal Investigator: | Timothy Church, MD; MPH; PhD | PBRC Co-Principal Investigator | |
Study Chair: | Conrad Earnest, PhD | PBRC Co-Investigator | |
Study Chair: | Catrine Tudor-Locke, PhD | PBRC Co-Investigator | |
Study Chair: | William Johnson, PhD | PBRC Co-Investigator | |
Study Chair: | Jennifer Rood, PhD | PBRC Co-Investigator |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT01264406 History of Changes |
Other Study ID Numbers: |
PBRC 10008 |
First Posted: | December 21, 2010 Key Record Dates |
Last Update Posted: | February 4, 2016 |
Last Verified: | February 2016 |
Additional relevant MeSH terms:
Body Weight Signs and Symptoms |