ExerciseE-MECHANICNCT01264406
The Comparison of Energy in Take and Body Weight EXERCISE
An observational study of Exercise and Energy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Energy, Body Weight
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The study population group will be 198 sedentary, overweight and obese(BMI levels > 25 kg/m2 and < 40 kg/m2) individuals. Based on previous studies, we expect to enroll 132 females and 66 males. Participants will be randomly assigned to an 8 kcal/kg/week, 20 kcal/kg/week, or control group. The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory.
Who may be able to join
- Male or female 18 - 65 years old, inclusive
- Not exercising > 20 minutes on > 3 days/wk and taking < 8000 steps/d over one week measured with step counters.
- BMI > 25 kg/m2 and < 40 kg/m2
Who cannot join
- • Current consumption of more than 14 alcoholic drinks per week
- Plan to move out of the study area within the next 6 months or plan to be out of the study area for more than 4 weeks in the next 6 months
- Have another member of household participating in the study
- Residence too far from Pennington
- A past history and/or physical examination or laboratory findings of the following medical conditions:
- Table 1. Exclusion Criteria
Show all 16Show fewer
- Cardiovascular disease (CVD) or disorders Potential participants with a history of CVD
- Blood Pressure Potential participants who are on a stable dose of antihypertensive medication, with the exception of beta-blockers, and whose blood pressure is controlled will be eligible for enrollment.
- Diabetes Potential participants with a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose >125 mg/dl will be excluded from the study.
- Blood lipids Potential participants whose LDL-C 190 mg/dl or TG levels 300 mg/dl will be referred to their physician.
- Hematologic disorders Participants diagnosed with hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states, will not be allowed into the study.
- Recent blood donation or blood loss Blood donation or blood loss from surgery or trauma during the 6 weeks before the baseline evaluation
- Weight loss-20 or more kilograms in the past year Other exclusions.
- Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness. Plans to be out of the city more than 4 weeks over the next 6 months
- Other significant medical conditions Including but not limited to chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. Musculoskeletal problems interfering with exercise.
- Autoimmune or collagen vascular diseases. Immunodeficiency diseases or a positive HIV test. Malignancies in the past 5 years, with the exception of non-melanoma skin cancer therapeutically controlled. Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
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: Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation
This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. E-Mechanic trial can make important contributions to understanding of the role of exercise dose in weight management. While it is accepted that regular exercise plays an important role in general health, the exact role of exercise in prevention of weight gain, weight loss and prevention of weight regain remains poorly understood despite exercise being widely prescribed for these purposes. The idea that current weight management exercise recommendations may produce increased energy intake (or other forms on compensation) resulting in disappointing weight loss is an important public health issue. The finding of this study could help shape future exercise and weight loss recommendations and treatment plans.
Read the detailed description
The purpose of the E-MECHANIC Trial is to test the effect of two doses of exercise on energy intake, body weight, body composition, activity levels, and metabolic rate. The exercise doses will reflect current recommendations for: 1) general health (8 KKW), and 2) weight loss (20 KKW). A non-exercise control group will also be recruited. The primary outcome variables are: 1) energy intake, and 2) the discrepancy between expected weight loss and observed weight loss. Energy intake will be measured using doubly labeled water and laboratory-based food intake tests. Secondary outcome variables include resting metabolic rate, activity levels (excluding structured exercise), and body composition. Following a comprehensive baseline assessment, participants will be randomly assigned to the 8 KKW, 20 KKW, or control group in a 1:1:1 ratio. Additional assessments will be conducted at week 4, with another comprehensive assessment at week 24. The week 4 assessment is important to determine if endpoints change in the short-term, but not long-term.
- Conditions
- Exercise, Energy, Body Weight
- Medical subject headings
- Motor Activity, Body Weight
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 |
|---|---|---|
| Exercise Group (20 KKW) | Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. | |
| Exercise Group (8 KKW) | One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes | |
| Control group | This group will be instructed to maintain their baseline level of exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW]
A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance.
Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study.
Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill.
High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.
Measured: 6 months after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Other
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
- Investigators
- Corby Martin, PhD, Principal investigator, PBRCTimothy Church, MD; MPH; PhD, Principal investigator, PBRC Co-Principal InvestigatorConrad Earnest, PhD, Study chair, PBRC Co-InvestigatorCatrine Tudor-Locke, PhD, Study chair, PBRC Co-InvestigatorWilliam Johnson, PhD, Study chair, PBRC Co-InvestigatorJennifer Rood, PhD, Study chair, PBRC Co-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264406
- Sponsor's protocol ID
- PBRC 10008
- Acronym
- E-MECHANIC
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2010
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dorling JL, Hochsmann C, Fearnbach SN, Apolzan JW, Hsia DS, Johannsen NM, Church TS, Martin CK. Initial Weight Change and Long-Term Changes in Weight and Compensation during Supervised Exercise Training. Med Sci Sports Exerc. 2021 Aug 1;53(8):1675-1684. doi: 10.1249/MSS.0000000000002633.
PubMed 33731664Martin CK, Johnson WD, Myers CA, Apolzan JW, Earnest CP, Thomas DM, Rood JC, Johannsen NM, Tudor-Locke C, Harris M, Hsia DS, Church TS. Effect of different doses of supervised exercise on food intake, metabolism, and non-exercise physical activity: The E-MECHANIC randomized controlled trial. Am J Clin Nutr. 2019 Sep 1;110(3):583-592. doi: 10.1093/ajcn/nqz054.
PubMed 31172175Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.
PubMed 29437573Myers CA, Johnson WD, Earnest CP, Rood JC, Tudor-Locke C, Johannsen NM, Cocreham S, Harris M, Church TS, Martin CK. Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial. Trials. 2014 Jun 7;15:212. doi: 10.1186/1745-6215-15-212.
PubMed 24906459
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation
- ClinicalTrials.gov ID
- NCT01264406
- Acronym / sponsor ID
- E-MECHANIC / PBRC 10008
- Conditions
- Exercise, Energy, Body Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. E-Mechanic trial can make important contributions to understanding of the role of exercise dose in weight management. While it is accepted that regular exercise plays an important role in general health, the exact role of exercise in prevention of weight gain, weight loss and prevention of weight regain remains poorly understood despite exercise being widely prescribed for these purposes. The idea that current weight management exercise recommendations may produce increased energy intake (or other forms on compensation) resulting in disappointing weight loss is an important public health issue. The finding of this study could help shape future exercise and weight loss recommendations and treatment plans.
Detailed description
The purpose of the E-MECHANIC Trial is to test the effect of two doses of exercise on energy intake, body weight, body composition, activity levels, and metabolic rate. The exercise doses will reflect current recommendations for: 1) general health (8 KKW), and 2) weight loss (20 KKW). A non-exercise control group will also be recruited. The primary outcome variables are: 1) energy intake, and 2) the discrepancy between expected weight loss and observed weight loss. Energy intake will be measured using doubly labeled water and laboratory-based food intake tests. Secondary outcome variables include resting metabolic rate, activity levels (excluding structured exercise), and body composition. Following a comprehensive baseline assessment, participants will be randomly assigned to the 8 KKW, 20 KKW, or control group in a 1:1:1 ratio. Additional assessments will be conducted at week 4, with another comprehensive assessment at week 24. The week 4 assessment is important to determine if endpoints change in the short-term, but not long-term.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Group (20 KKW) | – | –Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. |
| Exercise Group (8 KKW) | – | –One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes |
| Control group | – | –This group will be instructed to maintain their baseline level of exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population group will be 198 sedentary, overweight and obese(BMI levels > 25 kg/m2 and < 40 kg/m2) individuals. Based on previous studies, we expect to enroll 132 females and 66 males. Participants will be randomly assigned to an 8 kcal/kg/week, 20 kcal/kg/week, or control group. The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory.
Key inclusion criteria (3 listed)
- Male or female 18 - 65 years old, inclusive
Key exclusion criteria (16 listed)
- • Current consumption of more than 14 alcoholic drinks per week
- Table 1. Exclusion Criteria
- Cardiovascular disease (CVD) or disorders Potential participants with a history of CVD
- Blood Pressure Potential participants who are on a stable dose of antihypertensive medication, with the exception of beta-blockers, and whose blood pressure is controlled will be eligible for enrollment.
- Diabetes Potential participants with a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose >125 mg/dl will be excluded from the study.
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
A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW]
Time frame: 6 months after screening
A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance. Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study. Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill. High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33731664Dorling JL, Hochsmann C, Fearnbach SN, Apolzan JW, Hsia DS, Johannsen NM, Church TS, Martin CK. Initial Weight Change and Long-Term Changes in Weight and Compensation during Supervised Exercise Training. Med Sci Sports Exerc. 2021 Aug 1;53(8):1675-1684. doi: 10.1249/MSS.0000000000002633.
- Derived from this study: PubMed 31172175Martin CK, Johnson WD, Myers CA, Apolzan JW, Earnest CP, Thomas DM, Rood JC, Johannsen NM, Tudor-Locke C, Harris M, Hsia DS, Church TS. Effect of different doses of supervised exercise on food intake, metabolism, and non-exercise physical activity: The E-MECHANIC randomized controlled trial. Am J Clin Nutr. 2019 Sep 1;110(3):583-592. doi: 10.1093/ajcn/nqz054.
- Derived from this study: PubMed 29437573Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.
- Derived from this study: PubMed 24906459Myers CA, Johnson WD, Earnest CP, Rood JC, Tudor-Locke C, Johannsen NM, Cocreham S, Harris M, Church TS, Martin CK. Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial. Trials. 2014 Jun 7;15:212. doi: 10.1186/1745-6215-15-212.
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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.
Corby Martin, PhD principal investigator
PBRC
Timothy Church, MD; MPH; PhD principal investigator
PBRC Co-Principal Investigator
Conrad Earnest, PhD study chair
PBRC Co-Investigator
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 Exercise and Energy, 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 16 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 7 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] (time frame: 6 months after screening). 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 NCT01264406, which also lists 4 linked publications.
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 7 Jan 2025.