Body Weight, Energy, Exercise
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* • 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Group (20 KKW) Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. | 51 |
| 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 | 59 |
| Control Group This group will be instructed to maintain their baseline level of exercise. | 61 |
| Total | 171 |
Baseline characteristics
| Characteristic | Exercise Group (20 KKW) | Exercise Group (8 KKW) | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 12.4 | 48.3 years STANDARD_DEVIATION 11.2 | 49.5 years STANDARD_DEVIATION 10.8 | 48.9 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 20 Participants | 21 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 37 Participants | 39 Participants | 38 Participants | 114 Participants |
| Sex: Female, Male Female | 36 Participants | 43 Participants | 45 Participants | 124 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 16 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 66 | 0 / 65 |
| other Total, other adverse events | 11 / 67 | 14 / 66 | 5 / 65 |
| serious Total, serious adverse events | 3 / 67 | 3 / 66 | 0 / 65 |
Outcome results
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.
Time frame: 6 months after screening
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Group (20 KKW) | A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] | 123.6 kcal/day |
| Exercise Group (8 KKW) | A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] | 90.7 kcal/day |
| Control Group | A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] | -2.3 kcal/day |