The Comparison of Energy in Take and Body Weight 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.

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