Back to resultsEnergy Expenditure & Activity During & After Exercise-Induced Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking exercise
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- University of Colorado, School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 Exercise
2 Walk
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Total daily energy expenditure, assessed using doubly labeled water
Secondary Outcome Measures
Total daily activity thermogenesis
Body weight and composition
Full Information
NCT ID
NCT00622310
First Posted
February 21, 2008
Last Updated
July 6, 2021
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00622310
Brief Title
Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Official Title
Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
2 Walk
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total daily energy expenditure, assessed using doubly labeled water
Time Frame
Prior to exercise intervention, and 6 months
Secondary Outcome Measure Information:
Title
Total daily activity thermogenesis
Time Frame
Prior to exercise intervention, and 6 months
Title
Body weight and composition
Time Frame
Prior to exercise intervention, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Melanson, PhD
Organizational Affiliation
University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
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Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
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