Motor ActivityE-Mechanic_FolNCT02158130
Effects of Aerobic Exercise Detraining
An observational study of Motor Activity and Body Weight, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Body Weight, Obesity
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants that successfully enrolled and completed the E-Mechanic study and are not past 88 weeks study randomization.
Who may be able to join
- Completed the E-Mechanic study
- Be willing to archive blood samples
- Not participating in a study that would alter body weight, energy intake, or energy expenditure.
Who cannot join
None listed.
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: Effects of Aerobic Exercise Detraining on Energy Balance in Overweight Persons
The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.
Read the detailed description
Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure. The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.
- Conditions
- Motor Activity, Body Weight, Obesity
- Keywords
- Physical Inactivity, Aerobic Exercise Detraining, Body Weight, Energy Expenditure, Metabolic Syndrome
- Medical subject headings
- Motor Activity, Body Weight, Obesity, Sedentary Behavior, Metabolic Syndrome
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 |
|---|---|---|
| Healthy Living | non exercise healthy living control group | |
| General Health | Exercise Group (8 KKW) One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes. We will recruit 1 year post study intervention. | |
| Weight Loss | Exercise Group (20 KKW) Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. We will recruit 1 year post study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Fasting body weight
Measured: Week 64 - 88 post study randomization
Secondary outcomes (2)
Energy Expenditure
Energy expenditure is calculated with the Sensewear Armband.
Measured: Week 64 - 90 since study randomization
Energy Intake
Energy expenditure is calculated with the Sensewear Armband and furthermore, energy intake is calculated by adjusting TDEE for change in body weight following the methods used in doubly labeled water adjustment.
Measured: Week 64 - 90 post study randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
- Investigators
- John W Apolzan, PhD, Principal investigator, PBRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158130
- Sponsor's protocol ID
- PBRC 2014-028
- Acronym
- E-Mechanic_Fol
- Status last verified
- Mar 2016
- First submitted
- 4 Jun 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Detraining on Energy Balance in Overweight Persons
- ClinicalTrials.gov ID
- NCT02158130
- Acronym / sponsor ID
- E-Mechanic_Fol / PBRC 2014-028
- Conditions
- Motor Activity, Body Weight, Obesity
- Keywords
- Physical Inactivity, Aerobic Exercise Detraining, Body Weight, Energy Expenditure, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Jun 2014 (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 proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.
Detailed description
Eligibility criteria include having successfully completed the main E-Mechanic study, be willing to archive blood samples and not being currently enrolled in another study that may effect body, energy intake or energy expenditure. The investigators will measure body weight, waist/hip circumference, blood pressure, body composition, physical activity, questionnaire about appetite/food intake and physical fitness.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Living | – | –non exercise healthy living control group |
| General Health | – | –Exercise Group (8 KKW) One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes. We will recruit 1 year post study intervention. |
| Weight Loss | – | –Exercise Group (20 KKW) Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. We will recruit 1 year post study intervention. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that successfully enrolled and completed the E-Mechanic study and are not past 88 weeks study randomization.
Key inclusion criteria (3 listed)
- Completed the E-Mechanic study
- Be willing to archive blood samples
- Not participating in a study that would alter body weight, energy intake, or energy expenditure.
Key exclusion criteria (0 listed)
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
Body Weight
Time frame: Week 64 - 88 post study randomization
Fasting body weight
2 secondary outcomes
Energy Expenditure
Time frame: Week 64 - 90 since study randomization
Energy Intake
Time frame: Week 64 - 90 post study randomization
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 22 Mar 2016.
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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.
John W Apolzan, PhD principal investigator
PBRC
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 Motor Activity and Body Weight, 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 3 inclusion and 0 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 22 Mar 2016. 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?
Body Weight (time frame: Week 64 - 88 post study randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2016.