MetabolismNCT01775163
Effect of Exercise-Induced Weight Loss on Energy Metabolism
An observational study of Metabolism and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Weight Loss
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and Women enrolled in E-MECHANIC
Who may be able to join
- Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.
Who cannot join
- Not enrolled in the E-MECHANIC main study (NCT#01264406).
- Have a body mass index (BMI) less than 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: E-MECHANIC Ancillary Study: Effect of Exercise-Induced Weight Loss on Energy Metabolism
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.
Read the 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.
- Conditions
- Metabolism, Weight Loss
- Keywords
- Energy, Metabolism, Weight Loss, Exercise
- Medical subject headings
- Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24h energy expenditure
24h energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program
Measured: 24 weeks
Secondary outcomes (1)
Metabolic adaptation in 24h energy expenditure
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startDec 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775163
- Sponsor's protocol ID
- PBRC 10008-A
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2013
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
PubMed 24500151
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-MECHANIC Ancillary Study: Effect of Exercise-Induced Weight Loss on Energy Metabolism
- ClinicalTrials.gov ID
- NCT01775163
- Acronym / sponsor ID
- PBRC 10008-A
- Conditions
- Metabolism, Weight Loss
- Keywords
- Energy, Metabolism, Weight Loss, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and Women enrolled in E-MECHANIC
Key inclusion criteria (1 listed)
- Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.
Key exclusion criteria (2 listed)
- Not enrolled in the E-MECHANIC main study (NCT#01264406).
- Have a body mass index (BMI) less than 30 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 24h energy expenditure
Time frame: 24 weeks
24h energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program
1 secondary outcome
Metabolic adaptation in 24h energy expenditure
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 24500151Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne M Redman, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24h energy expenditure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01775163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.