Study of an International Commercial Program on Weight Loss and Health Outcomes

The purpose of this study is to compare the effectiveness of the Weight Watchers program
delivered in the community to a DIY approach for weight loss.

Potential participants will be recruited through a variety of advertisement methods. Those
individuals responding to these advertisements will undergo web-based preliminary screening.
Initially eligible individuals will be contacted by phone to receive more detailed
information and to complete screening. Eligible and interested participants will be consented
in person and complete screening assessments that will be used to confirm eligibility (height
and weight to determine body mass index, resting blood pressure. For participants deemed to
be eligible and randomized to participate in this study, these measures will also be used as
their baseline data from analysis. Additional data collection will be collected at the
baseline assessment visit, with assessments repeated at 3 months and after the intervention
at 12 months. Assessments will include the following:

Height and Weight Resting Blood Pressure and Heart Rate Aerobic Stamina Flexibility Waist
Circumference Dietary Intake Additional Questionnaires to assess demographics, sleep, food
cravings, hunger and satiety, weight control strategies, affect, lifestyle activities

Group assignment will be revealed to study participants in a separate visit/contact after all
assessment procedures and randomization is completed. The contact will last 15-30 minutes and
participants will be provided with the resources they need to either follow the Weight
Watchers program or the DIY approach. The Weight Watchers orientation and DIY intervention
will not be provided by staff who collect measurements in order to preserve the blinding of
the measurement staff. Following randomization reveal, the staff will maintain communication
in order to promote retention (e.g., birthday card or small token reinforcer such as a water
bottle sent to all participants).

WEIGHT WATCHERS FREESTYLE (FLEX) GROUP Intervention Description Participants randomized to
the WW Freestyle (Flex) treatment arm will be referred to their local WW Meetings + Online
Plus program delivered at a WW center / meeting convenient to them. At the randomization
visit, they will be provided with a code to sign up for the Weight Watchers program free of
charge for 12 months. They will also be guided to download the smartphone app on their phone,
provided with a list of local meetings, and instructed on how to start the Weight Watchers
intervention.

The following describes the weight loss intervention that is delivered solely through the
commercially available Weight Watchers program. Measurement staff will not be involved in
delivery of this intervention.

Program type. Participants will receive a program with a structured, lifestyle modification,
weight-loss methodology. Specifically, it will include 1) a food plan, which is based on
balanced diet and healthy eating, 2) an activity plan, designed to promote progressive
physical activity increase, 3) group support, and 4) cognitive behavior modification.
Participants will determine their weight goal and will be encouraged to utilize all
intervention components.

Beyond the Scale. This holistic and personalized program focuses on multiple ways for
participants to define success, on and off the scale. The three main components are: eating
healthier, moving more, and finding and shifting the study subject's mindset.

Weekly meetings. Weight Watchers members attend weekly Weight Watchers meetings conducted in
local commercial centers with a group Leader and a receptionist and last30-60 minutes.
Meetings consist of lesson delivery of a new behavioral skill or knowledge transfer on
healthy habits, check-ins with each participant on their previous week, and group discussions
on the week's topic and application of that skill in their own lives. The discussions are led
by Weight Watchers Leaders, who are Lifetime members who have successfully achieved and
maintained a healthier body weight through the Weight Watchers program, and have successfully
completed a leader skills training course and ongoing professional development and quality
assurance (QA). WW participants have their weight measured at each meeting on regularly
calibrated scales.

Intervention materials. Weight Watchers participants receive: 1) access to an app for food
and activity tracking, 2) welcome packet a menu of 'how to's' and inspiration to get started
and weekly lesson plans delivered by the Meeting Leader, 3) weekly take-home skill builder
worksheet and content within the app 4) Weight Watchers emails, and 4) access to social
support from other WW Leaders and WW members through on online support portal.

Dietary goals. Dietary plan. The core of the Food Program is the SmartPoints® weight loss
system, which is a method of self-monitoring dietary intake. The SmartPoints system assigns
each food and beverage a SmartPoints value per portion based on its nutrition, factoring in
four components: calories, sugar, saturated fat, and protein. SmartPoints encourages a
healthier pattern of eating. This is translated into the following general guidelines:
certain foods have a SmartPoints value of zero which includes plant-based proteins, skinless
chicken and turkey breast, eggs, non-fat yogurt, skinless fish, fruits and most vegetables
(excludes starchy vegetables). For foods outside these categories, foods higher in lean
protein, such as lean cuts of steak and ham, have lower SmartPoints values while foods higher
in unhealthy saturated fats and sugar have higher Smartpoints values

SmartPoints Budget. Based on the Mifflin St-Jeor formula, which factors in age, gender,
height, and weight, participants will get a personalized SmartPoints Budget. The SmartPoints
budget consists of: a daily SmartPoints Target plus an extra bank of Weekly SmartPoints for
flexibility. Participants are free to spend their SmartPoints however they wish and can 'roll
over' up to 4 SmartPoints a day into their weeklies for added flexibility.

Food Log. Participants will be encouraged to track their SmartPoints each day on the Weight
Watchers app provided to them. Within the app there is a wealth of tools to help find and
track food choices, which includes; a barcode scanner to quickly identify foods, recipes,
restaurant and grocery store items in a database.

Activity goals. FitPoints. A large part of the Beyond the Scale program is the FitPoints™
system, which is a method of self-monitoring physical activity. The FitPoints system assigns
each activity a FitPoint value based on its duration (minutes) and intensity based on a
participant's current weight and FitPoints emphasizes activity because it feels good, not
solely as a means to swap for SmartPoints. FitPoints highlights that all activity counts and
adds up; "some is better than none".

FitPoints goal. Participants will receive a personalized daily FitPoints goal based on their
fitness level and goals.

Activity Log Participants will be encouraged to track their FitPoints each day on the Weight
Watchers app provided to them.

Mindset Approach. The Weight Watchers Freestyle/Flex program promotes the adoption of skills
and techniques to adopt a positive mindset in order to support lifestyle change and healthy
weight Participants receive digital and print materials around these topics and in person
support in the meetings.

DO-IT-YOURSELF GROUP Participants randomized to the DIY group will be provided with a brief
resource guide with basic information about a variety of healthful behavioral weight loss
approaches (meal plans, apps for calorie tracking, meal replacements, dietary approaches to
reduce calories healthfully such as following a low fat or low carb diet, and moderate
physical activity) and encouraged to choose an approach that would fit with their lifestyle.
The resource guide will provide model "profiles" of lifestyle factors that may help the
individual choose the approach that would work best for them. These approaches are consistent
with information that can be found in the general press and will be limited to approaches
that are deemed healthful by weight loss and medical professionals. Participants will be
informed that many people follow a DIY approach and can be successful (will reference the
National Weight Control Registry which is a research-based registry of individuals who have
lost weight and kept is off successfully; 50% of whom followed a DIY approach). For
retention, participants in the DIY group will be notified that if they choose to utilize WW
after the completion of the study, they will be offered free vouchers for 12 months of the WW
program.

Inclusion Criteria:

- Male or female ages 18-75 years

- With or without previous WW experience

- Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 45 (will be
confirmed at the Baseline Assessment visit).

- Self report that he/she feels the need to lose weight.

- Willing to discontinue any current over-the-counter (OTC) supplements not
recommended/prescribed by physician, with the exception of multivitamins or other
vitamin supplement.

- Willing to be randomized to one of two groups and follow recommendations according to
study protocol.

- Willing to include demographic information (e.g., ethnicity, income and education).

- Use of a personal smartphone (iOS 9.0 or Android 4.1)

- The willingness and ability to download, navigate and use applications on their
smartphone on a daily basis (minimum training will be provided)

- Ability to commit to attending study assessment visits at 0, 3 and 12 months

- Residing within 30 miles of a study assessment location

- Read, write and speak English

Exclusion Criteria:

- Participants that were a member of Weight Watchers within the past 12 months.

- Unwilling to refrain from using Weight Watchers if assigned to the DIY group.

- Participants that are involved in any other research studies at this time (also,
cannot join other research studies while in this study, over the next 12 months) that
would interfere with their ability to adhere to the protocol (i.e., attend assessment
visits, attend WW meetings).

- Given birth past six months, currently pregnant, or planning on becoming pregnant over
the next 12 months.

- Weight loss of ≥ 5 kg in the previous 6 months (and kept > 5 kg off).

- Ever been diagnosed with an eating disorder (anorexia nervosa, bulimia).

- Reported health problems that make weight loss or unsupervised exercise unsafe or
unreasonable (e.g., orthopedic limitations, heart problems)

- Untreated thyroid disease or any changes (type or dose) in thyroid medication in last
6 months.

- Taking any prescription medication with known effects on appetite or weight (e.g.,
oral steroids, weight loss medications such as Qsymia, Contrave, etc.) with the
exception of subjects on a stable dose of Selective serotonin reuptake inhibitors
(SSRIs) for 6 months

- Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel
syndrome acceptable).

- History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.)
within previous 6 months.

- Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100
mmHg (confirmed at baseline visit)

- Currently have type 1 or type 2 diabetes

- Ever had surgical procedure for weight loss.

- Major surgery within the previous 6 months that would interfere with consuming a
regular diet and performing physical activity such as walking.

- Presence of implanted cardiac defibrillator or pacemaker.

- History of cancer within past 5 years or current treatment for cancer (completely
resected basal or squamous cell carcinoma acceptable if treatment completed more than
6 months prior to enrollment).

- Hospitalization for psychiatric problems during the past 12 months

- Planning to relocate in the next 12 months

- Another member of the household is participating in this research study