Effect of Exercise-Induced Weight Loss on Energy Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01775163
First received: January 22, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. We aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.


Condition Phase
Metabolism
Weight Loss
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: E-MECHANIC Ancillary Study: Effect of Exercise-Induced Weight Loss on Energy Metabolism

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in 24h energy expenditure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    24h energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program


Secondary Outcome Measures:
  • Metabolic adaptation in 24h energy expenditure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The difference between the actual change in 24 energy expenditure and the energy expenditure estimated on the basis of body size will be compared between: 1) exercise groups and 2) between individuals who lost the expected amount of weight and individuals who did not lose the expected amount of weight during the exercise program


Other Outcome Measures:
  • Sleeping energy expenditure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Sleeping energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program

  • Spontaneous physical activity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Spontaneous physical activity will be measured in a room calorimeter before and after a 24 week exercise program


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Self Directed Exercise
Participants randomized to the self-directed group will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. Participants will not be given a specific exercise recommendation in terms of weekly energy expenditure.
Low Intensity Exercise
Individuals assigned to the low dose exercise group will be required to expend 8 calories per kg of body weight per week in structured aerobic exercise on a treadmill or stationary bicycle. The exercise intensity will be maintained at 65% of VO2peak. The caloric goal of each session will be calculated by dividing the weekly caloric expenditure goal by participant selected exercise frequency (i.e., 3, 4 or 5 times per week). The training program consists of a 3-min warm-up at a progressively increasing intensity until the prescribed training intensity is reached. All exercise sessions are conducted at the PBRC Fitness Center and will be supervised by staff trained on the aspects of the study protocol.
High Intensity Exercise
Individuals assigned to the low dose exercise group will be required to expend 20 calories per kg of body weight per week in structured aerobic exercise on a treadmill or stationary bicycle. The exercise intensity will be maintained at 65% of VO2peak. The caloric goal of each session will be calculated by dividing the weekly caloric expenditure goal by participant selected exercise frequency (i.e., 3, 4 or 5 times per week). The training program consists of a 3-min warm-up at a progressively increasing intensity until the prescribed training intensity is reached. All exercise sessions are conducted at the PBRC Fitness Center and will be supervised by staff trained on the aspects of the study protocol.

Detailed Description:

This is an ancillary study to E-Mechanic, which is an National Institutes of Health study in 198 individuals with the objective to understand why certain people fail to lose weight in exercise programs. In E-Mechanic changes in body weight, body composition, energy intake and energy expenditure are measured before and after 3 different exercise programs of 24 weeks in duration. The 3 exercise programs being compared are self-directed exercise, low dose exercise and high dose exercise. The goal of this ancillary study is to undertake comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese individuals enrolled in the main study. We will compare differences in the changes in 24h energy expenditure and spontaneous physical activity between the 3 exercise programs. We will also test if changes in energy metabolism might explain why people don't lose the expected amount of weight after 24 weeks of exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men and Women enrolled in E-MECHANIC

Criteria

Inclusion Criteria:

  • Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.

Exclusion Criteria:

  • Not enrolled in the E-MECHANIC main study (NCT#01264406).
  • Have a body mass index (BMI) less than 30 kg/m2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775163

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Angela Eldredge, B.S.    225-763-2559    angela.eldredge@pbrc.edu   
Principal Investigator: Leanne M Redman, Ph.D.         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01775163     History of Changes
Other Study ID Numbers: PBRC10008-A, PBRC 10008-A
Study First Received: January 22, 2013
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Energy
Metabolism
Weight Loss
Exercise

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

ClinicalTrials.gov processed this record on September 22, 2014