The Comparison of Energy in Take and Body Weight EXERCISE
The Comparison of Energy in Take and Body Weight EXERCISE
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.
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. 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.

 -  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