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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after screening |
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Inclusion Criteria:
Male or female 18 - 65 years old, inclusive
Exclusion Criteria:
• Current consumption of more than 14 alcoholic drinks per week
Table 1. Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Corby Martin, PhD | PBRC | Principal Investigator |
| Timothy Church, MD; MPH; PhD | PBRC Co-Principal Investigator | Principal Investigator |
| Conrad Earnest, PhD | PBRC Co-Investigator | Study Chair |
| Catrine Tudor-Locke, PhD | PBRC Co-Investigator | Study Chair |
| William Johnson, PhD | PBRC Co-Investigator | Study Chair |
| Jennifer Rood, PhD | PBRC Co-Investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33731664 | Derived | 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. | |
| 31172175 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group (20 KKW) | Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. |
| FG001 | 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 |
| FG002 | Control Group | This group will be instructed to maintain their baseline level of exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group (20 KKW) | Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | kcal/day | 6 months after screening |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Group (20 KKW) | Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pelvis fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sinus infection/URI | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corby Martin | Pennington Biomedical Research Center | 763-2585 | corby.martin@pbrc.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Martin 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. |
| 29437573 | Derived | Sarzynski 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. |
| 24906459 | Derived | Myers 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. |
| BG002 | Control Group | This group will be instructed to maintain their baseline level of exercise. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Exercise Group (20 KKW) |
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. |
| OG001 | 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 |
| OG002 | Control Group | This group will be instructed to maintain their baseline level of exercise. |
|
|
| 0 |
| 67 |
| 3 |
| 67 |
| 11 |
| 67 |
| EG001 | 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 | 0 | 66 | 3 | 66 | 14 | 66 |
| EG002 | Control Group | This group will be instructed to maintain their baseline level of exercise. | 0 | 65 | 0 | 65 | 5 | 65 |
| global amnesia | Psychiatric disorders | Non-systematic Assessment |
|
| venous engorgement and orbital swelling | Vascular disorders | Non-systematic Assessment | VENOUS ENGORGEMENT AND ORBITAL SWELLING O.D. PRIOR CAROTID ULTRASOUND STUDY AND MRI SUGGEST A-VSHUNT IN RIGHT CAROTID ARTERY SYSTEM |
|
| pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| prostate biopsy positive for malignant cells | Reproductive system and breast disorders | Non-systematic Assessment |
|
| basal cell carcinoma removed from ear | Surgical and medical procedures | Non-systematic Assessment |
|
| rotator cuff repair | Surgical and medical procedures | Non-systematic Assessment | ARTHROSCOPIC RIGHT SHOULDER ROTATOR CUFF REPAIR |
|
| motor vehicle collision | Injury, poisoning and procedural complications | Non-systematic Assessment | had brushing to L thigh area |
|
| foot pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| pelvic and pudenda pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| laprascopic myomectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| bone fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | FRACTURED BONE IN LEFT FOOT. OCCURRED WITH MISSTEP ON STAIRS ON CRUISE SHIP. |
|
| fell down stairs at work | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| pain from degenerative disk disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| acute chest pain | Cardiac disorders | Non-systematic Assessment |
|
| migraine headaches | Nervous system disorders | Non-systematic Assessment |
|
| light headed and hypotensive | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| skin abrasions from EKG leads | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| knee sprain | Injury, poisoning and procedural complications | Non-systematic Assessment | unrelated to study protocol |
|
| ER visit | Gastrointestinal disorders | Non-systematic Assessment | COMPLICATIONS WERE FROM REFLUX AND AIRWAY COMPLICATIONS RELIEVED WITH ALBUTERAL AND PROTONIX. |
|
| kidney stones | Renal and urinary disorders | Non-systematic Assessment |
|
| intra-abdominal mass found | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
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