Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese

The primary aim of this study is to compare changes in body weight between an in-person
behavioral weight loss program, a technology-based system, and an enhanced version of a
technology-based system during a 6 month behavioral weight loss intervention in obese
adults. Additional aims will compare changes in body composition, physical activity, dietary
intake, and the frequency of self-monitoring of weight loss behaviors between the 3 groups.
A total of 84 sedentary, healthy obese adults (BMI: 35.0-45.0 kg/m2) between the ages of
21-55 will be recruited to participate. Assessments will be conducted at 0, 3, and 6 months
and will include measurements of height, weight, body composition, blood pressure, physical
activity, dietary intake, and eating behaviors. This is a randomized controlled trial in
which participants will be randomized after the completion of assessments to one of three
groups: standard behavioral weight loss (SBWL), BodyMedia® FIT System (FIT), and BodyMedia®
FIT System with Bluetooth® enhancements (FIT-BT). Subjects in SBWL will participate in a
behavioral weight loss intervention which includes weekly group sessions throughout the 6
month program. FIT and FIT-BT will not attend weekly group sessions, but will have identical
intervention materials mailed each week. FIT will receive the BodyMedia® FIT System, and
FIT-BT will receive the BodyMedia® FIT System with Bluetooth® enhancements to use throughout
the 6 month program. FIT and FIT-BT will receive a telephone intervention call 1x per month.

Inclusion Criteria:

- 21-55 years of age

- Body mass index (BMI) between 35.0-45.0 kg/m2

Exclusion Criteria:

- Reports not having access to a computer, access to the Internet, or the availability
to download software onto a computer.

- Reports not having a smart phone device that is compatible with the BodyMedia® FIT
Bluetooth® System that will be examined in this study.

- Has a physical limitation that would prevent engaging in physical activity.

- Participates in structured aerobic exercise for ≥ 60 minutes per week over the prior
≥ 3 months.

- Reports being treated for a current medical condition that could affect body weight.
These may include the following: cancer; diabetes mellitus; hyperthyroidism;
inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver
disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or
malabsorption syndromes, etc.

- Reports current congestive heart failure, angina, uncontrolled arrhythmia, symptoms
indicative of increase risk of an acute cardiovascular event, coronary artery bypass
grafting or angioplasty, prior myocardial infarction, and conditions requiring
anticoagulation therapy (i.e. deep vein thrombosis).

- Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure
of ≥ 100 mmHg or taking medications to control blood pressure.

- Being treated for any psychological issues (i.e., depression, bipolar disorder, etc)
or taking psychotropic medications within the previous 12 months.

- Taking prescription or over-the-counter medications that affect body weight and
metabolism.

- Has lost > 5% of current body weight in the past 3 months and maintained this weight
loss at the time of recruitment for this study.

- Currently participating in an exercise or weight control study, had participated in
an exercise or weight control study within the previous 6 months, or a current
participant in a commercial weight reduction program.

- Has undergone bariatric surgery (e.g., gastric bypass, lap-band) for weight loss.

- Currently being treated for an eating disorder.

- Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3
months, lactating, to planning on becoming pregnant in the next 3 months.

- Planning on relocating outside of the greater Pittsburgh area within the next 6
months.