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Energy Expenditure & Activity During & After Exercise-Induced Weight Loss

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ClinicalTrials.gov Identifier: NCT00622310
Recruitment Status : Active, not recruiting
First Posted : February 25, 2008
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Walking exercise Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Walking exercise
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.

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.
Behavioral: Walking exercise
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 Measures :
  1. Total daily energy expenditure, assessed using doubly labeled water [ Time Frame: Prior to exercise intervention, and 6 months ]

Secondary Outcome Measures :
  1. Total daily activity thermogenesis [ Time Frame: Prior to exercise intervention, and 6 months ]
  2. Body weight and composition [ Time Frame: Prior to exercise intervention, and 6 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT00622310


Locations
United States, Colorado
University of Colorado, School of Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Edward Melanson, PhD University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00622310     History of Changes
Other Study ID Numbers: 07-0402
R01DK077088 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms