- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00622310
Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
July 6, 2021 updated by: University of Colorado, Denver
This project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise.
The study will compare two separate exercise interventions to determine if this is influenced by exercise intensity.
Study Overview
Detailed Description
The primary aim of this proposed study is to determine how total daily activity thermogenesis (TDAT) and total daily energy expenditure (TDEE) are regulated in obese humans attempting to lose weight and maintain weight loss through exercise.
Two exercise interventions will be compared; a structured aerobic exercise program and a walking program.
exercise activity thermogenesis (EAT) will be verified, and non-exercise physical activity (NEAT), total daily activity thermogenesis (TDAT), and TDEE will be measured using state-of-the-art technologies.
Subjects will be studied during a 6 month intervention period and then during a 6 month follow-up period.
It is hypothesized that the walking program will have more favorable effects on TDAT and TDEE during both the intervention and follow-up periods.
If the investigators hypotheses are correct, then data from the proposed study could be used to improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado, School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Body mass index (BMI) 30-35.0 kg/m2
- Age 18-45 years
- Weight stable (<2 kg weight fluctuation during previous 6 months)
- No regular exercise (> 1 bout of exercise/wk or participation in any sporting activities > 1 hr/wk)
- No self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular)
- No current use of prescribed medications
- No plans to relocate within the next year
- No plans for extended travel (> 1 week) within the next 6 months
- No tobacco use
For Females:
- No evidence of amenorrhea (Regular menstrual cycles of 21-35 days)
- Pre-menopausal status (self-report, to be confirmed during screening)
- Pregnancy or lactating within the past year
- No pregnancy or planned pregnancies; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control.
Exclusion Criteria:
- Claustrphobia;
- Any contraindication(s) to > MRI, e.g. aneurysm, cochlear implant, cardiac pacemaker, or implantable cardiac defibrillator, artificial heart valve, metallic stents, any implantable devices or shunt, weight less than 300 lbs;
- Left Handed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 Exercise
Subjects in the EX group will perform supervised exercise 5 d/wk.
Exercise will consist primarily of walking on an inclined motor-driven treadmill, but alternate activities will be permitted for 20% of the total exercise sessions (1 of 5 days).
Exercise sessions will be preceded by a 5 min warm-up performed at a HR corresponding to 40% of VO2max.
The initial exercise duration and intensity at baseline will be 20 minutes at an intensity that elicits a heart rate (HR) corresponding to 60% of VO2max.
The target EE will be achieved by a gradual progression of exercise duration and intensity over the first 8 weeks of the exercise program.
The target exercise intensity will be the workload corresponding to 75% of VO2max.
|
Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program.
Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
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|
Experimental: 2 Walk
Subjects in the WALK group will also perform exercise 5 d/wk.
Exercise will consist exclusively of walking on level grades, and will be prescribed in two equal duration bouts each day.
Subjects in the WALK group will be individually prescribed a walking program based on the EE during moderate intensity walking.
The target exercise intensity will be walking speeds corresponding 45% of VO2max.
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Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program.
Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total daily energy expenditure, assessed using doubly labeled water
Time Frame: Prior to exercise intervention, and 6 months
|
Prior to exercise intervention, and 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total daily activity thermogenesis
Time Frame: Prior to exercise intervention, and 6 months
|
Prior to exercise intervention, and 6 months
|
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Body weight and composition
Time Frame: Prior to exercise intervention, and 6 months
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Prior to exercise intervention, and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward Melanson, PhD, University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 21, 2008
First Posted (Estimate)
February 25, 2008
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0402
- R01DK077088 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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