The Comparison of Energy in Take and Body Weight EXERCISE (E-MECHANIC)
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.
|Study Design:||Observational Model: Case Control|
|Official Title:||Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation|
- A Comparison of the effects of energy balance with three groups. [ Time Frame: 6 months after screening ] [ Designated as safety issue: No ]
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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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
This group will be instructed to maintain their baseline level of exercise.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264406
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Corby Martin, PhD||PBRC|
|Principal Investigator:||Timothy Church, MD; MPH; PhD||PBRC Co-Principal Investigator|
|Study Chair:||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|