Promoting Lifestyle Change Via Tailored mHealth Feedback to Improve Health

This study includes the following activities:

1. Screening:

Phase I: it will be conducted online. Respondents to recruitment solicitations will be
provided an online Uniform Resource Locator (URL) with a hyperlink to a study flier that
describes the essential elements of the study. It will also include a choice of URL or
Quick Response (QR) code to access a Qualtrics online survey that will provide more
details about the study. The investigator will also ask preliminary questions about
eligibility (age, height and weight to calculate BMI), and consent to have the research
team review the participant's answers.

Phase II: it will be conducted online. Those who meet these criteria in Phase I will be
notified via a second email with a link to another survey online and consent for
providing more in-depth health history, including diagnosis of major medical conditions.
After completing an online consent, the participants will provide personal information
in the Sociodemographic and Lifestyle Questionnaire and health and medical conditions in
the General Health History questionnaire.

Individuals who remain eligible will be invited to a screening appointment where the
investigators measure the participant's height/weight for BMI, and explain the aims of
the study and the 2 group conditions. If interested in participating, attendees will be
asked to sign a consent form for the baseline data collection. At this visit, the
participants will be asked to complete the Eating Habits Checklist (EHC) to screen for
eating disorders; a one-page questionnaire (Quick WAVE140) that assesses current diet
and PA habits, and the CES-D.

Run-in period: to minimize attrition and ensure that potential subjects are appropriate
for the intervention, investigators will teach all eligible individuals how to download
and complete a 5-day Self-Monitoring diary using the My Food Diary (Fitbit)
Self-Monitoring program on the participant's phone or other computer. After review of
the diary, investigators will contact the potential participant to schedule the baseline
assessment. Individuals need to record at least 700 kcal/day of food intake to be
eligible for the study. Each user will have a username and password and also have the
ability to manage the participant'sown privacy settings.

2. Randomization:

At the end of the baseline assessment when eligibility is confirmed, the research staff
will use a computer software program on a laptop to determine to which group the
individual will be randomized. (Prior to this time, the randomization scheme will be
implemented via a computerized program (Visual Basic 6.0) using minimization method,
which will be overseen by a statistician (Co-PI: S Sereika). Each of the 2
conditions(Self-Monitoring alone or Self-Monitoring plus Feedback) will be assigned a
total of 265 subjects with randomization stratified by gender and race. After
randomization, all participants will receive instructions on using the Fitbit Charge 2™
for physical activity and the Withings scale for self-weighing.

3. Intervention:

The intervention will consist of the Self-Monitoring and Feedback program and remote guidance
to a lifestyle program for weight loss. All participants will be subscribed to My Food Diary
an online Self-Monitoring program that can be accessed via the participant's smartphone or
any computer. The interventionists will have access to the diaries so the participants can
contact a participant if there is any safety concern about the reported eating behaviors. The
study will provide all participants a wrist-worn FitBit Charge 2™ to self-monitor the
participant's physical activity which synchs with the participant's phone or computer. The
study will also provide all participants a Bluetooth-enabled scale (Withings) for
self-monitoring the participant's weight. The scale will transmit the weight values to the
smartphone, LoseIt! and server, so the research team will know the weight status of
participants. The subject registers as the primary scale user and is subsequently recognized
and distinguished from other household users. The scale displays the weight accurately to the
10th decimal. The data are converted to graphs for easy review. Batteries have a 6-12 month
life. The scale measures weights between 5 and 180 kg. participants will weigh themselves
with device daily; participants will be able to view the participant's weight data on the
participant's smartphone. The Fitbit will provide data on daily steps and distance walked,
which will be used to inform the selection of message that the investigators will provide
participants in the Self-Monitoring plus Feedback group feedback messages related to physical
activity. The data that will be transmitted between the Fitbit and Pitt servers will not
contain any identifying personal information nor will Fitbit store any identifying
information for the participants except the participant's usernames and email addresses,
which are necessary to create a user account.

1. Self-Monitoring group: Individuals in this condition will not receive Feedback messages.
All subjects will use a smartphone to self-monitor diet (LoseIt!), Fitbit Charge HR to
monitor PA, and a Withings digital scale for weight. Both LoseIt! and Fitbit app are
publically available. At the baseline visit following randomization, participants will
be oriented to Self-Monitoring and the various Self-Monitoring devices and apps, and
provided a tutorial with images shown on the laptop and devices as well as printed
materials showing the screen shots. At this baseline session, each participant will have
a one-on-one session with the project interventionist which covers the core principles
of behavioral weight loss to ensure all understand basic recommendations for safe and
effective weight loss. The participants also will be given personalized fat, calorie,
and physical activity goals for weight loss and information about how to access the
intervention materials from the Diabetes Prevention Program (DPP) online which is
publically available(https://www.diabetesprevention.pitt.edu/).

2. Self-Monitoring+Feedback -This group will receive up to 4 Feedback messages per day
(messages will be delivered between the hours set by the participants on the
participant's phone, e.g., 8 AM and 9:30 PM). Messages will be delivered automatically,
remotely and in real-time. it will be tailored to each participant's progress based on
standardized algorithms. At the baseline visit following randomization, participants
will be oriented to Self-Monitoring and the various Self-Monitoring devices and apps,
and provided a tutorial with images shown on the laptop and devices as well as printed
materials showing the screen shots. In addition, the Feedback program will be explained
to them and how this is responsive to information entered on the Self-Monitoring
diaries. Also, the participants will be given a brief handout on fat, calorie, physical
activity and weight goals for weight loss and information about how to access the
intervention materials from the Diabetes Prevention Program (DPP) online.

Research team are able to review the Self-Monitoring data, and will check the data weekly. As
long as any indication of rapid weight loss or periods of inactivity occurs, research staff
will contact the subject.

(4) Measurements used in this study:

1. baseline. Medical and Weight History Form, Sociodemographic Form, Binge Eating Scale
(Eating Habits Checklist), Center for Epidemiologic Studies-Depression (CES-D), Quick
WAVE Screener;

2. baseline, 6 and 12 months. Weight (Withings scale, smartphone), blood pressure, waist
circumference, Self-Regulation of Eating Behavior Questionnaire, Barriers to Healthy
Eating, Weight Efficacy Lifestyle (WEL), Self-Efficacy and Eating Habits Survey,
Self-Efficacy and Exercise Habits Survey, diet (24-Hour Dietary Recall & smartphone), PA
(The FitBit Charge 2™, smartphone), Intervention Satisfaction Questionnaire.

Inclusion Criteria:

1. currently own and regularly use a smartphone

2. age ≥18 years;

3. BMI > 27 and < 43; and

4. successful completion of a 5-day electronic diary of food intake during a run-in
period.

Exclusion Criteria:

1. presence of an unstable condition requiring physician-supervised diet and exercise
(e.g., recent myocardial infarction);

2. physical limitations precluding ability to engage in moderate-intensity physical
activity;

3. pregnancy or intention to become pregnant during study;

4. current treatment for a serious mental illness (e.g. schizophrenia);

5. reported alcohol intake > 4 drinks/day;

6. participation in a formal weight loss program, loss of ≥ 5% weight in past 6 month, or
current use of weight loss medication18;

7. history of bariatric surgery in <5 years,

8. planned extended vacations, absences, or relocation during study;

9. a score >16 on the Center for Epidemiologic Studies Depression Scale (CES-D) or

10. score >32 on the Eating Habits Checklist, an eating disorder scale administered at
baseline. For those who have an elevated BDI score (>22) or EHC (>32), we offer
referral for counseling.