Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2007
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJuly 12, 2021
July 1, 2021
9 months
February 21, 2008
July 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Total daily energy expenditure, assessed using doubly labeled water
Prior to exercise intervention, and 6 months
Secondary Outcomes (2)
Total daily activity thermogenesis
Prior to exercise intervention, and 6 months
Body weight and composition
Prior to exercise intervention, and 6 months
Study Arms (2)
1 Exercise
EXPERIMENTALSubjects 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.
2 Walk
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado, School of Medicine
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Melanson, PhD
University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 25, 2008
Study Start
September 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 12, 2021
Record last verified: 2021-07