Fitbit / Healthy Weight Management Study

Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve
gastrectomy surgery, the investigators would like to determine if the Fitbit is associated
with health outcomes in this population.

Primary Outcome

• Percentage of excess weight loss - Does the use of a Fitbit positively affect the
percentage of excess body weight loss in vertical sleeve gastrectomy patients?

Secondary Outcomes

- Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive
lifestyle and exercise pattern changes in post-operative VSG patients?

- Resolution of comorbidity - Does the use of a Fitbit positively affect patient health
via reduction of co-morbid conditions associated with morbid obesity following VSG
surgery?

Research Methodology This study will be focused on a bariatric post-surgical population and
is designed as a randomized controlled trial (RCT) with three arms; a RCT with a control and
intervention group and a historical control group. For the RCT, subjects, after providing
informed consent, will be randomized into either the control arm or the intervention arm. In
the control arm, subjects will be provided normal/standard of care for post-surgical
bariatric patients. This includes physician visits, dietary and exercise consults, education
and other therapy as appropriate for their care. In the intervention arm, subjects will be
provided with a Fitbit bracelet and software to monitor their physical activity in addition
to the normal/standard of care provided in the control group. Both groups will receive the
recommended aerobic and strength training exercise guidelines. Furthermore, each group will
have identical exercise education regarding appropriate intensity using either rate of
perceived exertion or target heart rate range. At the end of the 12-month tracking period of
the study, the control group will be provided with a Fitbit bracelet so that they can begin
tracking their activity levels during the 2nd post-operative year. A third group, the
historical controls, at the end of the study will be extracted from the electronic medical
records from patients who have meet the same inclusion/exclusion criteria and were surgical
patients with completed follow-up prior to the start of the RCT portion of the trial.

RCT subjects randomized to the intervention group will be provided with step by step
instructions on how to set-up the Fitbit app on their smartphone and or view the data on the
Fitbit secure portal. Additionally, subjects will be shown how to track their weekly
structured aerobic and strength training exercise within the app. Users will also be shown
how to access Fitbit data on the MyLGHealth portal. Data from the Fitbit will also be
accessible to the provider on EPIC flow sheets. Providers will be able to incorporate this
data into discussions with patient at visits. RCT subjects randomized to the control group
will receive the same training and a Fitbit device after they complete their 12 month visit.

Just prior to the start of the RCT, we will be conducting a pilot study to test the
implementation of the Fitbit in this patient population. The pilot phase will initially
target 5 patients to enroll as a test of the set-up of the Fitbit monitoring, data transfer,
activity logs and other data collection procedures. Subjects in this pilot phase will only
participate for a period of 1 month and all individuals will receive a Fitbit device. The
investigators will employ all inclusion/exclusion criteria, recruitment procedures and
complete all data collection procedures (baseline and follow-up) as planned for the
randomized trial. If additional adjustments need to be made relative to the Fitbit set-up or
training/reference materials for patients, another 5 pilot patients may be recruited. Data
collection and study procedures on all pilot subjects will be completed before the randomized
trial begins. This pilot study will be submitted to the IRB for review and approval as a
separate study prior to the RCT portion of the study.

For the RCT portion of the study, subjects will be recruited, enrolled and randomized into
the study and then baseline data will be collected and entered into the study database. These
data elements include subject demographics (age, gender, weight entering program,
preoperative weight, comorbidities, lifestyle and physical activity patterns, etc.). Subjects
will be followed for one year or until lost to follow-up with data collected at each
physician office visit. At each office visit, the investigators will extract from Epic the
date of the visit, subject weight and comorbidities. Lifestyle and physical activity patterns
will only be assessed at the 2 week, 1 month, 4 month, 8 month and 12 month visits. The
historical control group will be extracted at the end of the study when RCT subjects are
nearing the completion of their 12 month follow-up.

The historical controls will consist of a group of patients that will have already received
surgery and completed 12 month follow-up prior to the start of the pilot and RCT portions of
the project. There will be no interaction with them as a part of the study. The investigators
are planning to identify them and collect data at the end of the RCT portion of the project.

Inclusion Criteria:

- Naive bariatric surgery procedure patients - approved for surgery

- Laparoscopic VSG patients

- Completion of all pre-surgical requirements

- Age ≥ 18

- Subject must have a My LG Health account activated

- Subject must have a PC and/or Bluetooth enabled device at home

Exclusion Criteria:

- Band procedures

- Revisions

- All other bariatric procedures

- Non-English speaking patient (justification - My LG Health information and support is
only available in English)

- Already own and use a Fitbit type device

- Cognitive impairments or lack of support that would limit the abilities to comply with
study procedures or use of a diary/Fitbit