Effect of a Technology-Based Intervention on Weight Change Post-Bariatric Surgery

This randomized controlled trial will examine the effect of a minimal contact
technology-based system in comparison to standard care on body weight in adults 1 year
post-bariatric surgery. This 6 month intervention will be conducted at the University of
Pittsburgh, Physical Activity and Weight Management Research Center. Eligible participants
who obtain physician's consent will undergo baseline assessments. Assessments will be
described in further detail below.

Eligible participants who complete all baseline assessment procedures will be randomized to
one of two intervention groups: The minimal contact technology-based intervention using the
Jawbone UP3 System combined with a monthly intervention telephone call (TECH), or Standard
Care.

Standard Care serves as the no treatment control in this project. Participants in this group
will receive the typical care from their surgeon following bariatric surgery. No additional
interventions will be given to participants randomized to this group.

TECH Intervention: TECH is the experimental group in this project. A minimal-contact
technology-based intervention for weight management will be given to this group in addition
to the standard or typical care received from their surgeon following bariatric surgery. The
following information outlines the protocol for this intervention group.

Dietary Component: Dietary recommendations will be based on the subjects' baseline body
weight, with calorie and fat intake goals ranging from 1200-2100 kcal/day and 20-30% of daily
calories respectively. The calorie goals are based on intake recommendations that have been
shown to result in successful short-term weight loss with fat intake goals consistent with
the USDA Dietary Guidelines. To facilitate adoption and maintenance of these dietary intake
goals, participants will be provided with meal plans and sample recipes. In addition,
participants will be taught how to read food labels and will be provided with The Calorie
King Calorie, Fat, and Carbohydrate Counter to facilitate self-monitoring of calorie and fat
intake. Intervention lessons will be sent to the participants via email and will also include
information related to behavior strategies for achieving the desired calorie and fat intake
goals.

Physical Activity Component: The physical activity component will include an unsupervised
home-based exercise program. Participants will be asked to perform aerobic physical activity
recommended at a moderate intensity defined as 3-6 metabolic equivalents (METS). This
intensity is similar to brisk walking, however can be achieved through aerobic-based
activities of the participants' choice. Equipment will not be provided to the participants.
To facilitate adoption of this intensity of physical activity, participants will be provided
both a target heart rate (60-70% of age-predicted maximal heart rate) and rating of perceived
exertion (11-13 on the 15-category Borg Scale). Baseline physical activity participation will
be evaluated and intervention recommendations will be prescribed to progress to 250 minutes
per week by 13th week of the intervention, which is consistent with the recommendations of
the American College of Sports Medicine (ACSM). Participants will be encouraged to complete
the prescribed doses of physical activity each week, with daily goals achieved by performing
the activity in one continuous bout or accumulated across several shorts bouts that are each
at least 10 minutes in duration. Intervention lessons will be sent to the participants via
email and will also include information related to behavior strategies for achieving the
desired activity goals for this study.

Participants in this group will be provided with the Jawbone UP3 System. The Jawbone UP3
System includes a wearable device to monitor physical activity and energy expenditure that
will transmit real-time feedback on calories expended and physical activity directly to a
smart phone containing the web-interface/application. In addition, the smart phone supports
self-monitoring of dietary behaviors and body weight to provide real-time feedback of goal
achievement. A digital smart scale will also be provided to TECH participants. The smart
scale (Withings®, Inc.) transmits objective measures of body weight directly to a smart phone
application which also interfaces with the Jawbone UP3 System. All technology tools (UP3
system in combination with the smart scale) will allow for self-monitoring of energy
expenditure, energy balance, physical activity, dietary intake, and body weight to occur in
real-time and within an integrated system. Participants will attend one introductory session
in which a tutorial of the components of the Jawbone UP3 System and smart scale will be
provided. Individuals will be given confidential login codes which will provide access to the
websites and smart phone applications. Login procedures as well as uploading data and
Bluetooth® syncing of the technology components will be demonstrated. Detailed written
instructions will also be given illustrating these procedures. Additionally, a follow-up call
within 1 week of the initial meeting will occur to make sure that all technology components
are working properly.

TECH will also initially receive a one-hour lesson on basic guidelines of the weight
management intervention. At this time, caloric goals and weekly physical activity
recommendations will be explained. To support weight loss behaviors, participants will be
encouraged to use the Jawbone UP3 System and smart scale to self-monitor dietary intake,
physical activity, and body weight.

Participants in TECH will also receive a scheduled intervention telephone call from a study
coach on the following schedule:

-Month 1: One call per week for the first 4 weeks of the study. This will support the
participants with making changes to their lifestyle behaviors as a part of the intervention.
Additionally, this call will be used to ensure that the technology is functioning properly
and that it is being used as intended by the study.

Months 2-6: One call per month. This call will be used to provide continued intervention
support in addition.

These telephone calls will take approximately 10-15 minutes and will be completed by a member
of the intervention staff that is experienced using the Jawbone UP3 System and smart scale
and is trained in delivering behavioral telephone interventions. Strategies to overcome
weight-loss barriers will be primarily discussed, and a standardized script will serve as a
guide to address technical difficulties using the UP3 System and smart scale, frequency of
technology usage, participant goals, barriers to diet and physical activity, and monitoring
of body weight. Interventionists will have access to the information uploaded to the
web-interfaces from the UP3 System and smart scale, and this will allow the interventionist
to review this information prior to facilitating interactions with participants during the
telephone calls. The length of each telephone intervention will be recorded.

Inclusion Criteria:

- Between the ages of 18-60 years.

- 1-year post-bariatric surgery.

- Able to walk at 3 miles per hour during a cardiorespiratory fitness test.

Exclusion Criteria:

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

- Reports not having a smart phone device that is compatible with the Jawbone UP3 System
that will be examined in this study.

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

- Reports being treated for a current medical condition that could affect body weigh
(diabetes mellitus, cancer, chronic renal insufficiency, hyperthyroidism,
hypothyroidism, chronic liver disease).

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

- Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure
of ≥100 mmHg or taking medication to control blood pressure that affects heart rate.

- Reports being treated for a psychological issue (i.e., depression, bipolar disorder,
etc).

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

- Currently participating in an exercise or weight control study or a current
participant in a commercial weight reduction program.

- 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 6 months.

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