A Randomized, Controlled, 3-Arm Clinical Trial to Assess Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet
Phase: NA
Conditions: Overweight, Obesity
Sponsor: Medifast, Inc.

Study Title: 
 
A Randomized, Controlled, 3‐Arm Clinical Trial to Assess Weight Loss using the Take Shape For Life 
Program or the Medifast Direct Program Versus a Self‐Directed Diet 
 
 
 
ClinicalTrials.gov Identifier: 
NCT02835092 
 
 
Document Date: 
 
21 June 2016 

 
 
 
 
 
TITLE 
 
 
A Randomized, Controlled, 3-Arm  Clinical  Trial  to Assess Weight  Loss 
using the Take Shape  For Life Program or the Medifast Direct  Program 
Versus  a Self-Directed Diet 
 
 
 
 
 
 
 
 
 
 
Protocol BI0-1607 (MED 019) 
 
 
 
 
 
 
Sponsor: 
Jason  Pharmaceuticals, Inc. 
(a wholly owned subsidiary of Medifast, Inc.) 
3600 Crondall Lane 
Owings Mills, MD 21117 
Trial  Managed by: Biofortis 
Innovation Services 
211 East Lake Street 
Addison, IL  601 01 
630-617-2000 (Tel) 
630-617-2001  (Fax) 
 
 
 
CONFIDENTIAL 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BJ0-1607 (MED 019) 
21 June 2016; Version 1.7 
Co11f1dential 

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/ 
1J I I' 
/!(.! J /I 'r/  ')11..1.\
INVESTIGATOR PROTOCOL SIGNATURE SHEET 
 
 
Protocol BI0-1607 (MED 019) 
 
 
A Randomized, Controlled, 3-Arm Clinical Trial to Assess 
Weight Loss using the Take Shape For Life Program or the 
Medifast Direct Program Versus a Self-Directed  Diet 
 
 
By my signature below, I attest that I have read, understood, and agree to abide by all conditions, 
instructions, and restrictions contained in this protocol (including appendices). I will not initiate 
this study without approval from the appropriate Institutional Review Board (IRB) and I 
understand that any changes to the protocol must be approved in writing by the Sponsor  and the 
IRB before they can be implemented, except where necessary to eliminate immediate hazards to 
the participant. 
 
 
Approval Signatures: 
 
,/(j 'ff.A.Aj!AA,,_ 
/0• t.AAr 
.l 
 
Investigator Signature  
() 
;<af/Lia._t_l<_;e_!_le-'"'{-'t_·'  _;:J  
 
 
 
 
 
 
Date 
Name 
 
 
 
Name of Facility 
 
2 II  f  Laid   st 
  
 
Address 
 
 
 
Address 
 
 
 
City, State, Zip Code 
 
----------- & ic   6 -IL1L· 2 ooo   
 
Tel Number 
 
-----"- ""H.._·-"I'CL 17L._   2"-0'1.0
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Fax Number  
E-mail Address 

21 June 2016; Version 1.7 
 
 
SPONSOR  PROTOCOL SIGNATURE  SHEET 
 
 
 
Protocol BI0-1607 (MED 019) 
 
A Randomized, Controlled, 3-Arm Clinical Trial  to Assess 
Weight Loss using the Take Shape For Life Program or the 
Medifast  Direct Program Versus a Self-Directed  Diet 
 
 
 
 
 
 
 
 
By my signature  below, I approve of this protocol. 
 
 
 
 
 
 
 
 
Sponsor Company:  £ Jn 
Signature 
 
;(_/  (..L d 0/ 
Date 
 
Linda Atierburn, PhD 
Vice President, Scientific and Clinical Affairs 
Medifast, Inc. 
3600 Crondall Lane 
Owings Mills, MD 21117 
Tel:  (443) 379-5191 
Cell:  (301) 648-4284 
Linda.Arterburn@choosemedifast.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
810-1 607 (MED 019) 
Confidential 
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Table of Contents 
I.  
List of Abbreviations ...............................................................................................................6 
2. 
Key Roles and Contact Information ........................................................................................7 
3. 
Background/Rationale .............................................................................................................8 
4. 
Objectives ................................................................................................................................ 9 
5. 
StudySample ........................................................................................................................... 9 
6. 
Study Design and Procedures ..................................................................................................9 
6.1. 
Study Design .....................................................................................................................9 
6.2. 
Flow Chart.......................................................................................................................l3 
6.3. 
Study Sample ..................................................................................................................14 
6.3.1. 
Inclusion Criteria ..................................................................................................... l4 
6.3.2. 
Exclusion Criteria ....................................................................................................15 
6.3.3. 
Excluded Medications and Products........................................................................ l6 
6.3.4. 
Randomization Procedures ......................................................................................16 
6.4. 
Study Programs and Foods .............................................................................................16 
6.4.1. 
Description of Study Programs................................................................................ l6 
6.4.2. 
Labeling and Packaging of Study Foods .................................................................21 
6.4.3. 
Storage and Use of Study Foods..............................................................................21 
6.5. 
Clinical Measurements....................................................................................................21 
6.5.1. 
Clinic Visits .............................................................................................................21 
6.5.2. 
Laboratory Measurements .......................................................................................22 
6.5.3. 
Gown Body Weight Assessment .............................................................................22 
6.5.4. 
Anthropometric Measurements ...............................................................................23 
6.5.5. 
Dual-Energy X-ray Absorptiometry ........................................................................23 
6.5.6. 
Impact of Weight on Quality of Life-Lite Questionnaire ........................................23 
6.5.7. 
RAND-36 Questionnaire .........................................................................................23 
6.5.8. 
Program Questionnaire ............................................................................................23 
6.5.9. 
Satisfaction and Health/Well-being Questionnaire .................................................24 
6.6. 
Procedures at Each Clinic Visit ......................................................................................24 
6.6.1. 
Screening (Visit I, week -I) (-2 weeks to -I day) ...................................................24 
6.6.2. 
Baseline (Visit 2, week 0) (I to 14 days after Visit I) ............................................24 
6.6.3. 
Clinic visit (Visit 3, week 2 ± 2 d)...........................................................................25 
6.6.4. 
Clinic visit (Visit 4, week 4 ± 3 d)...........................................................................25 
6.6.5. 
Clinic visit (Visit 5, week 8 ± 3 d)...........................................................................25 
6.6.6. 
Clinic visit (Visit 6, week 12 ± 3 d).........................................................................26 
6.6.7. 
Clinic visit (Visit 7, week 16 ± 3 d).........................................................................26 
6.7. 
Early Termination Procedures ........................................................................................27 
6.8. 
Procedure for Participants that Reach a Low BMI .........................................................27 
7. 
Assessment of Outcomes .......................................................................................................27 
7.1. 
Primary Outcome Variable .............................................................................................27 
7.2. 
Secondary Outcome Variables ........................................................................................28 
8. 
Data Analysis and Statistical Methods ..................................................................................29 
8.1. 
Sample Size.....................................................................................................................29 
8.2. 
Statistical Analysis ..........................................................................................................29 
8.2.1. 
Analysis Populations ...............................................................................................29 
8.2.2. 
Outcome Analysis....................................................................................................29 

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8.2.3. 
Safety and Tolerability Analysis .............................................................................30 
8.2.4. 
Missing or Incomplete Data.....................................................................................30 
9. 
Study Monitoring ...................................................................................................................30 
9.1. 
Concomitant Medications/Supplements .........................................................................30 
9.2. 
Adverse Event Monitoring..............................................................................................31 
9.2.1.  
Grading and Severity ............................................................................................... 3 I 
9.2.2. 
Relationship .............................................................................................................31 
9.2.3. 
Serious Adverse Event Definition/Qualification .....................................................32 
9.2.4. 
Serious Ad verse Event Reporting Instructions ........................................................32 
9.2.5. 
Electronic CRF Recording of Adverse Events ........................................................33 
9.2.6.  
Serious Adverse Event Follow-Up ..........................................................................33 
9.2.7.  
Pregnancy ................................................................................................................33 
1 0. 
Conduct of the Study .........................................................................................................34 
10.1. 
Ethics and Regulatory Considerations  ........................................................................34 
I 0.2. 
Institutional  Review Board ..........................................................................................34 
I 0.3. 
Informed Consent and Protected Health Information .................................................34 
I 0.4. 
Participant Confidentiality  ..........................................................................................35 
10.5. 
Withdrawal of Participants from the Study .................................................................35 
II. 
Administrative  Matters ......................................................................................................35 
II. I.  
Changes to the Protocol...............................................................................................36 
11.2. 
Protocol Deviations and Violations.............................................................................36 
11.3. 
Electronic Case Report Forms.....................................................................................36 
11.4. 
Clinical Monitoring .....................................................................................................36 
11.5. 
Auditing Procedures .................................................................................................... 37 
11.6. 
Records Retention .......................................................................................................37 
II.7. 
Termination  of Study...................................................................................................38 
11.8. 
Final Report/Publications ............................................................................................38 
12. 
Study Foods .......................................................................................................................38 
13. 
Disci osure ..........................................................................................................................38 
14. 
References..........................................................................................................................39 
Appendix 1: Exclusionary  Medications/Supplements ...................................................................41 
Appendix 2: Body Circumference  Measurements.........................................................................46 
Appendix 3. Impact of Weight on Quality of Life (IWQOL)-Lite  Questionnaire ........................47 
Appendix 4. RAND-36 Questionnaire  ..........................................................................................49 
Appendix 5. Program Questionnaire ..........................................................................,..................56 
Appendix 6. Satisfaction and Health/Well-being Questionnaire* .................................................59 

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1.   List of Abbreviations 
AE 
ALP 
ALT 
ANCOVA 
ANOVA 
AST 
BMI 
BUN 
C02 
CFR 
DXA 
cCRF 
FDA 
HIPAA 
hs-CRP 
ITT 
ICH 
IWQOL 
IRB kg 
LOCF 
MEDD 
m 
m2 
mg mL 
mmHg 
PAL 
QoL 
SEM 
SOP 
TSFL 
tel 
us 
USDA 
VAS 
 
 
adverse event alkaline 
phosphatase  alanine 
aminotransferase analysis 
of covariance analysis of 
variance aspartate 
aminotransferase body 
mass index 
blood urea nitrogen 
carbon dioxide 
Code of Federal Regulations 
dual energy x-ray absorptiometry 
electronic case report form 
Food and Drug Administration 
Health Insurance Portability and Accountability Act 
high-sensitivity C-reactive protein 
intent-to-treat 
International  Conference  on Harmonization 
Impact of Weight on Quality of Life 
Institutional Review Board 
kilogram 
last observation  carried forward 
Medifast Direct 
meter 
meter squared 
milligram 
milliliter 
millimeters of mercury 
physical activity level 
quality of life 
standard error of the mean 
standard operating procedure 
Take Shape For Life 
telephone 
United States 
United States Department  of Agriculture 
visual analog scale 

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2.   Key Roles and Contact Information 
 
Principal Scientific 
Investigator 
 
 
 
 
 
 
 
Co-Principal  Scientific 
Investigator 
 
-·- 
·--··· 
Chad Cook, PhD 
Senior Scientist, Nutrition & Metabolism 
Biofortis Innovation Services 
211 East Lake Street 
Addison, IL 60101 
Tel: (630) 516-3883 
E-mail: chad.cook@mxns.com 
DeAnn Liska, PhD 
Senior Director of Nutrition and Scientific Affairs 
Biofortis Innovation Services 
211 East Lake Street 
Addison, IL  601 01 
Tel: (630) 516-3882 
E-mail: deann.liska@mxns.com 
Principal Clinical 
Kathy Kelley-Garvin,  MD 
Investigator  
Biofortis Innovation Services 
211 East Lake Street 
Addison, IL 60101 
Tel: (630) 617-2004 
Fax: (630) 617-2001 
E-mail: kathy.kelley-garvin@mxns.com 
Pt·oject Manager  
Kristen Sanoshy, MPH 
Project Manager 
Biofortis Innovation Services 
211 East Lake Street 
Addison, IL  601 0 I 
Tel: (630) 516-3990 
Email: kristen.sanoshy@mxns.com 
Sponsor  
Linda Arterburn, PhD 
Vice President, Scientific and Clinical Affairs 
Medifast 
3600 Crandall Lane 
Owings Mills, MD 21117 
Tel: (443) 379-5191 
Cell: (301) 648-4284 
E-mail:  Linda.Arterburn@choosemedifast.com 
Laboratory  
Scott Jenkins, MT (ASCRP) 
Elmhurst Memorial Reference Laboratory 
!55  E. Brush Hill Road 
Elmhurst, IL 60126 
Tel: (331) 221-0342 
Fax: (331) 221-3735 
E-mail: sjenkin@emhc.org 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3.   Background/Rationale 
Recent advances in the understanding of the etiology of obesity, along with development of novel 
pharmaceutical  and surgical treatment options have yet to contribute to a reduction  in the obesity 
prevalence in the US population.  Improving diet and physical activity are still the foundation of 
current obesity treatments.   One approach shown to be useful in modulating energy intake to 
support weight loss in overweight/obese individuals is provision of pre-portioned  foods and 
beverages (i.e., meal replacements; Cheskin 2008, Hannum 2004 and 2006, 1-Ieymsfield 
2003).  Indeed, a group of obesity experts has considered the evidence behind this strategy as 
sufficiently strong and consistent to be considered empirically proven compared to more 
conventional  dietary advice, such as food choices based on general concepts like balance, 
variety, and moderation  (Casazza 2013).  Some commercially available weight loss programs 
utilize this approach; however, data from randomized clinical trials documenting the degree of 
weight loss achievable with these programs is often lacking. 
 
In this context, the role of commercially-available weight loss programs has received increased 
attention by the scientific community  (Gudzune 2015, Jensen 2014).  In 2013, joint guidelines 
issued by the American Heart Association, the American College of Cardiology  and The Obesity 
Society for the management  of overweight and obesity in adults (Jensen 2014) examined  the use 
of some commercial programs.  The general recommendation  was that some commercially 
available programs that promote a comprehensive lifestyle intervention  can be prescribed  as an 
option for weight loss provided there is peer-reviewed  published evidence of their safety and 
efficacy.  Yet, well designed, randomized, controlled trials directly testing efficacy of many 
programs have not been conducted.  Thus, a need exists to identify evidence-based, 
commercially  available weight management  programs. 
 
Two such commercially  available weight loss programs are the Take Shape For Life (TSFL) 
Optimal Weight 5 & 1 PlanTM and the Medifast AchieveTM Plan (also known as the 4 & 2 & 1 
Plan® offered by Medifast Direct).  Both programs utilize portion-controlled, nutritionally 
balanced meal plans combined  with various levels of programmatic  support.  The meal plans 
consist of either four or five Medifast meal replacements  per day supplemented  with purchased 
healthy foods (lean protein, vegetables and healthy fats) to create self-prepared  lean and green 
meals (one or two per day, depending  on the specific plan).  Preparation  of the lean and green 
meals helps teach portion control and life-long healthy eating habits.  The Medifast meal 
replacements  are nutrient dense and fortified with 24 vitamins and minerals to ensure adequate 
micronutrient  nutrition while on a calorie restricted, reduced energy meal plan. 
 
Both programs offer programmatic  support, with varying degrees of personal support.  TSFL 
takes a holistic approach to optimal health (and weight loss for those who need it) and provides a 
skilled and caring personal TSFL coach to help people restore their health and improve their 
quality of life (QoL).  TSFL is based on the Habits of Health system (Andersen  2008) which 
emphasizes the importance of being physically healthy, free of stress, and poised for a more 
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MediJ'ast Direct (MEDD) focuses on individuals who want less support with a self-guided 
program that offers a variety of tools to assist in weight loss, including written and online 
resources, program guides, and a self-help workbook, among other items.  MEDD users also 
have access to the optional services of the Medifast Nutrition Support Team, a group of 
professionals with expertise in the Medifast programs, products, and more generally, in nutrition, 
exercise and behavioral change. This team is available by phone or e-mail to answer 
programmatic, weight loss and exercise questions for both MEDD and TSFL users, as well as 
TSFL coaches. 
 
The interventions in this study are designed to mimic the TSFL and MEDD user experiences and 
will utilize the meal plans, Medifast products, and support options available for each of these 
programs. The TSFL and MEDD groups will be compared to a control group following a self- 
directed, food-based, reduced-calorie diet consistent with the 2015 Dietary Guidelines for 
Americans and based on the United States Department of Agriculture (USDA) ChooseMyPlate 
program. 
 
4.   Objectives 
The primary objective of this study is to evaluate the effects of two commercially available 
weight loss programs, the TSFL and the MEDD programs, each compared to a self-directed 
control diet, on changes in body weight over a 16-week weight loss phase, in apparently healthy 
overweight and obese men and women. 
 
Secondary objectives include, examining effects of each weight loss program compared to the 
seli directed control diet on changes in body composition, body circumference parameters, QoL, 
and biomarkers of inflammation over a 16-week weight loss phase.  Relationships between 
changes in body weight with self-reported adherence and QoL assessments will also be 
examined. Additionally, participant perspectives on program satisfaction and sense of 
health/well-being will be assessed at the end of the study. 
 
5.   Study Sample 
Participants will be apparently healthy men and women, 18-65 years of age, inclusive, each with 
a body mass index (BMI) of27.0  to 42.0 kg/m2 , inclusive. No more than 10% of participants 
will be enrolled with a BMI 27.0 kg/m2  and <30.0 kg/nl and no more than 25% of participants 
will be males. 
 
6.   Study Design and Procedures 
 
6.1. Study Design 
The study will utilize a randomized, controlled, 16-week parallel study design with one screening 
visit (Visit I; week -I); one baseline visit (Visit 2; week 0); and five clinic visits (Visits 3, 4, 5, 6, 
and 7; weeks 2, 4, 8, 12, and 16). 
 
Screening {Visit 1; week -1) 
At the screening visit (Visit I; week -I), after providing informed consent, participants will 
undergo screening visit procedures (evaluations of demographics, medical history, inclusion and 
exclusion criteria, prior and current medication/supplement use, height, vital signs, and BMI 

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calculation).   Additionally, a gown body weight (fasted 12 ± 2 h, water only, anchored to the 
time of gown body weight measurement)  will be measured.  Fasting blood samples will be 
collected for a chemistry profile and hematology panel.  Female participants  <60 years of age 
will also undergo an in-clinic urine pregnancy test. 
 
Baseline (Visit 2; week 0) 
At Visit 2 (week 0), participants  will arrive at the clinic fasted (12 ± 2 h, water only, anchored  to 
time of gown body weight measurement)  to undergo clinic visit procedures  [evaluations  of 
inclusion/exclusion criteria, concomitant medication/supplement use, vital signs, BMI calculation, 
and adverse events (AE)].   Gown body weight and body circumferences [waist, hip, chest, upper 
arm (dominant arm), and thigh (dominant leg)] will be measured.  Additionally, female 
participants <60 years of age will undergo an in-clinic urine pregnancy test.  Blood samples will 
be collected for analysis of high-sensitivity C-rcactive  protein (hs-CRP),  with additional blood 
samples collected and archived for possible future analysis of non-genetic  indicators of 
inflammation and metabolism.   A dual energy x-ray absorptiometry  (DXA) scan will be 
performed (female participants  <60 years of age must have a negative pregnancy  test before the 
DXA scan is initiated).    Participants will then be administered  the Impact of Weight on Quality 
of Life (IWQOL)-Lite and the RAND-36 Questionnaires (Appendices  3 and 4). Additionally,  all 
participants will be administered  the Program Questionnaire  (questions  I and 2 only; Appendix 
5). Participants that complete all baseline testing will be randomized  before 
12:00 h to one of three study groups (Control, TSFL, or MEDD), as follows: 
 
Control Group 
 
The Control group will follow a self-directed diet, which is a food-based,  reduced-caloric diet, 
consistent with the 2015 Dietary Guidelines for Americans (See Supplementary Materials).  The 
Control group will receive a one-on-one personal instruction session (10-15 min) with a trained 
member of the study staff at the Visit 2 (week 0) clinic visit.  A personalized  daily energy intake 
level will be determined for each participant based on a targeted weight loss goal of 7% over the 
16-week weight loss phase.  Participants will receive publicly available information  from the 
USDA Choose MyPlate program.  Participants will be instructed to start their weight loss 
program the day following randomization  (day I). No weekly check-ins will occur.  More 
details on the self-directed  control diet can be found in Section 6.4.1. 
 
TSFL Group 
Participants randomized  to the TSFL group will follow Medifast's TSFL Optimal Weight 5 & I 
Plan'".   At Visit 2 (week 0), participants will be dispensed  study-specific printed materials 
(including the "Getting  Started Instructions"), along with a starter meal kit containing 
approximately  one week's  worth of study foods (see Supplementary  Materials).  Participants will 
place an order for the following four weeks' worth of study foods with additional study foods 
ordered throughout the study.  Following Visit 2 (week 0), participants  randomized  to this group 
will receive TSFL coaching with an assigned research assistant trained to function as a TSFL 
coach.  Coaching,  for the purpose of this study, will take place via telephone.   The initial session 
(45 min in length) will occur the day of Visit 2 (week 0) as participants  will be instructed to start 
their weight loss program on the day following the randomization  visit (day I). Coaching sessions 
(i.e., phone consults) will occur at additional  times throughout  the 16 weeks. 
Participants  in the TSFL group will be encouraged  to track weight and food intake, discuss their 

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progress with their coach during the coaching sessions, and access TSFL written, online, and 
virtual support tools, to use at their discretion.  To be consistent with the commercially  available 
program, participants with questions that the TSFL coach cannot address will be referred to the 
Medifast Nutrition Support Team. More details on the TSFL program can be found in Section 
6.4.1. 
 
MEDDGroup 
Participants randomized to the MEDD group will be assigned to the Medifast AchieveTM Plan (4 
& 2 &  l Plan"') for weight loss.  Study-specific  printed materials (including the "Getting Started 
Instructions"),  will be dispensed at Visit 2 (week 0) along with a starter meal kit containing 
approximately one week's  worth of study foods (see Supplementary  Materials).  Participants  will 
place an order for the following four weeks' worth of study foods with additional study foods 
ordered throughout the study.  Following the clinic visit, participants randomized to this group 
will be instructed to contact the Medifast Nutrition Support Team by telephone prior to 17:00 h 
EST to receive an overview of the weight loss program.  This telephone call (l0-15 min in 
length) will take place the day of Visit 2 (week 0) as participants will be instructed to start their 
weight loss program on the day following the randomization  visit (day l ).  Participants will also 
have telephone and e-mail access to the Medifast Nutrition Support Team (at the participants' 
discretion) and Medifast online tools throughout the study. Participants in the MEDD group will 
be encouraged to track weight and food intake and access MEDD written, online, and virtual 
support tools to use at their discretion.  More details on the MEDD program can be found in 
Section 6.4.1. 
 
Clinic Visits (Visit 3, 4, 5, 6 and 7; weeks 2, 4, 8, 12, and 16) 
At Visit 3 (week 2), participants  will arrive at the clinic fasted (12 ± 2 h, water only, anchored to 
time of gown body weight measurement)  to undergo clinic visit procedures (evaluations of 
inclusion/exclusion criteria, concomitant  medication/supplement use, vital signs, and AEs). Gown 
body weight will be measured. 
 
At Visit 4 (week 4), participants  will arrive at the clinic fasted (12 ± 2 h, water only, anchored to 
time of gown body weight measurement)  to undergo clinic visit procedures (evaluations  of 
inclusion/exclusion criteria, concomitant  medication/supplement use, vital signs, and AEs). Gown 
body weight and body circumferences [waist, hip, chest, upper arm (dominant arm), and thigh 
(dominant leg)] will be measured.   Additionally, female participants  <60 years of age will 
undergo an in-clinic urine pregnancy test.  A DXA scan will be performed (female participants 
<60 years of age must have a negative pregnancy test before the DXA scan is initiated).   All 
participants will then be administered  the Program Questionnaire  (Appendix  5), and TSFL and 
MEDD participants will place an order for the following four weeks'  worth of study foods. 
 
At Visit 5 (week 8), participants  will arrive at the clinic fasted (12 ± 2 h, water only, anchored to 
time of gown body weight measurement)  to undergo clinic visit procedures (evaluations of 
inclusion/exclusion criteria, concomitant  medication/supplement use, vital signs, and AEs). 
Gown body weight and body circumferences [waist, hip, chest, upper arm (dominant arm), and 
thigh (dominant leg)] will be measured.   Additionally, female participants  <60 years of age will 
undergo an in-clinic urine pregnancy  test.  A DXA scan will be performed (female participants 
<60 years of age must have a negative pregnancy test before the DXA scan is initiated). 
Participants will then be administered  the IWQOL-Lite  and the RAND-36 Questionnaires.   All 

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participants will then be administered the Program Questionnaire, and TSFL and MEDD 
participants will place an order for the following four weeks' worth of study foods. 
 
At Visit 6 (week 12), participants will arrive at the clinic fasted (12 ± 2 h, water only, anchored 
to time of gown body weight measurement) to undergo clinic visit procedures (evaluations of 
inclusion/exclusion criteria, concomitant medication/supplement use, vital signs, and AEs). 
Gown body weight and body circumferences [waist, hip, chest, upper arm (dominant arm), and 
thigh (dominant leg)] will be measured. Additionally, female participants <60 years of age will 
undergo an in-clinic urine pregnancy test.  A DXA scan will be performed (female participants 
<60 years of age must have a negative pregnancy test before the DXA scan is initiated).   All 
participants will then be administered the Program Questionnaire, and TSFL and MEDD 
participants will place an order for the following four weeks' worth of study foods. 
 
At Visit 7 (week 16), participants will arrive at the clinic fasted (12 ± 2 h, water only, anchored 
to time of gown body weight measurement) to undergo clinic visit procedures (evaluations of 
inclusion/exclusion criteria, concomitant medication/supplement use, vital signs, and AEs). 
Blood samples will be collected for analysis ofhs-CRP,  with additional blood samples collected 
and archived for possible future analysis of non-genetic indicators of inflammation and 
metabolism. Gown body weight and body circumferences [waist, hip, chest, upper arm 
(dominant arm), and thigh (dominant leg)] will be measured.  Additionally, female participants 
<60 years of age will undergo an in-clinic urine pregnancy test.  A DXA scan will be performed 
(female participants <60 years of age must have a negative pregnancy test before the DXA scan 
is initiated).   Participants will then be administered the IWQOL-Lite, the RAND-36, the 
Program Questionnaire, and the Satisfaction and Health/Well-being Questionnaire (Appendices 
3, 4, 5, and 6).  All study participants will be dispensed maintenance handouts and guides prior 
to discharge from the clinic (see Supplementary Materials).  Additionally, eligible Control group 
participants will be given instructions for placing orders for study food upon completion of all 
study visits. 

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-
-
 
 
6.2. Flow Chart 
- 
""" 
--- 
- 
. ·····---·- 
Screening/ 
Clinic Visits 
Baseline 
 
lvisit' 
"   ..------·· 
 
1 
2 
3 
4 
5  
6 
7 
""  
""    ·-·- 
Week  
-1 
0 
2 
4 
8  
12 
16 
"" 
-·-- 
--··- 
Infon;  ed Consent/I-iiPAA2 
X 
Demographics/Medical History                                                  X 
Clinic  Visit'                                                                       X           X           X            X            X            X            X 
Gown  Body  Weight                                                                      X           X           X            X            X            X            X 
Anthropometries'                                                                               X                           X            X            X            X 
In-clinic Urine Pregnancy T st5                                                                      X           X                           X            X            X            X     II 
Chemistry Profile6                                                                                                      X 
"" 
Hematology Pane17 
X 
-h,;-:CRP8  
X 
X 
----- 
Archive Blood  Samples9 
X 
X 
Randomization  
X 
--- 
Dual  Energy  X-ray  Absorptiometry 
X 
X 
X 
X 
X 
··-- ·--···-- ------- 
IWQOL-Lite Questionnaire'" 
X 
X 
X 
-RAND-36" 
X 
X 
X 
)iet  Education"                                                                                   X 
Dispense Educational Material "                                                            X 
Dispense Study  Food 14                                                                                                                 X 
- 
- 
--- 
Order  Study  Food 15 
X 
X 
X 
X 
X 
program QuestJ" Onna.tre 16 
Dispense Maintenance Guidc 17 
-- 
X 
X 
X 
X 
X 
--·· 
X 
Satisfaction and Health/Well-being Questionnaire" 
X 
. ·-- -  " 
 
Footnotes: 
1 A window of 1-14 d will be allowed  between  Visits  I  and 2.  A window  of± 2 d will  be allowed  between 
clinic  visits 2 and 3.  All other  clinic  visits  will have a± 3 day window (Visit  3 through  7). 
'Health Insurance Portability and  Accountability Act (HIPAA).  The signed  document authorizes the use 
and disclosure of the participant's Protected Health  Information by the Clinical Investigator and staff 
solely  for the purposes of the study. 
3 Clinic  visit procedures include evaluations of height  (Visit  I, week -I  only),  BMI  calculation (Visit  1 
and 2, weeks  -1 and 0 only), vital signs,  inclusion/exclusion criteria  (for eligibility at Visit 1 and for 
potential  protocol  deviations at subsequent visits), concomitant medication/supplement use, and AEs, 
where  appropriate. 
4 Body circumference measurements (waist, hip, chest,  dominant thigh,  and dominant upper arm; 
Appendix 2). 
5Urine  pregnancy tests  will be completed for all women< 60 years of age. 
6The following will  be performed as a part of the fasting ( 12 h ± 2 h, water only)  chemistry panel: 
glucose, calcium, albumin, total  protein,  sodium, potassium, carbon  dioxide (C02 ), chloride, blood urea 

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nitrogen (BUN), creatinine, alkaline phosphatase (ALP), aminotransferase (AST), alanine 
aminotransferase (ALT), total bilirubin, and osmolality. 
7 The following will be performed as part of the fasting (12 h ± 2 h, water only) hematology 
measurements:  white blood cell count/automated  differential,  red blood cell count, hemoglobin, 
hematocrit,  platelet count, mean corpuscular  volume, mean corpuscular  hemoglobin, and mean 
corpuscular  hemoglobin concentration. 
8Blood will be collected for analysisofhs-CRP. 
9 Blood will be collected and archived for possible future analysis of non-genetic  indicators of 
inflammation  and metabolism. 
10Appendix 3. 
"Appendix 4. 
12AII three groups will receive diet instructions at Visit 2 (week 0).  See Section 6.4.1 for details. 
JJAII three groups will receive educational  materials at Visit 2 (week 0). See Section 6.4.1 for details. 
14The TSFL group and the MEDD group will receive study food as part of the study program.  See 
Section 6.4.1 for details. 
15The TSFL group and the MEDD group will place orders for additional study foods with the study staff 
at visits 2, 4, 5, and 6 (weeks 0, 4, 8, and 12); these will be shipped directly from Medifast. Orders must 
be submitted on the visit days.  Participants who are assigned to the Control group and complete  all study 
visits will be provided instructions for placing orders for study food at Visit 7 (week 16). 
"'Appendix  5. 
17All study groups will receive handouts with guidance for weight maintenance. 
18Appendix 6. 
 
6.3. 
Study Sample 
Each participant must meet all of the following inclusion criteria and none of the exclusion 
criteria at baseline (Visit 2, week 0) in order to participate in this study. 
 
6.3.1.   Inclusion Criteria 
I.   Participant is judged by the Clinical Investigator to be in good health on the basis of medical 
history and screening laboratory assessments. 
2.   Participant is male or female, 18-65 years, inclusive 
3.   Participant has a BMI of27.0  to 42.0 kg/m2 at Visit 2 (week 0). 
4.   Participant has no plans to change smoking habits during the study period. 
5.   Participant is willing and able to comply with the visit schedule. 
6.   Participant is willing to modify their physical activity level in accordance with 
recommendations provided with each group. 
7.   In the Clinical Investigator's opinion, participant has interest in losing weight, and is ready 
and willing to do so. 
8.   Participant is willing/able to follow assigned plan and adhere to food and beverage 
consumption guidelines for the duration of the study period. 
9.   Participant has access to the internet via a computer, tablet, and/or smart phone. 
10. Participant understands the study procedures and signs forms providing informed consent to 
participate in the study and authorization for release of relevant protected health information 
to the study Clinical Investigators. 
 
 
 
 
 
 
 
 

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6.3.2.   Exclusion Criteria 
1.   Participant has an abnormal laboratory test result of clinical significance,  at Visit 1 (week -1), 
at the discretion of the Clinical Investigator.  One re-test will be allowed on a separate  day 
prior to Visit 2 (week 0), for participants with abnormal laboratory test results. 
2.   Participant has had a weight loss or gain >5% in the 6 months prior to the screening  visit 
(Visit 1; week -1) except in the case of post-partum weight loss. 
3.   Participant has extreme dietary habits, including vegetarianism,  in the judgment of the 
Clinical Investigator. 
4.   Participant has used medications, products, supplements,  and/or programs/diets intended  to 
alter body weight within 6months of Visit I  (week -I). 
5.   Participant has used medications which are known to stimulate or suppress appetite,  and/or 
alter body weight but which are taken for other indications, will be allowed as long as the 
dose has remained stable for the past 6 months. 
6.   Participant has used thyroid hormones, except stable-dose replacement therapy for ::0:2 months 
prim· to Visit I  (week -I). 
7.   Participant has used Coumadin@ (warfarin), and/or medications that may influence  lipids 
and/or blood pressure, except stable-dose medications  for 1 month prior to Visit I (week -I). 
8.   Participant has used medications that may influence carbohydrate metabolism,  including  but 
not limited to hypoglycemic  medications and systemic (intravenous,  intramuscular, or oral) 
corticosteroids  within Imonth of Visit I(week -1). 
9.   Participant has used lithium within I month of Visit 1 (week -1). 
10. Participant has a history of any surgery or liposuction for weight reducing purposes. 
11. Participant has a history or presence of clinically important gout, cardiac, renal, hepatic, 
endocrine (type 1 diabetes mellitus or type 2 diabetes mellitus that requires medication), 
pulmonary, biliary, pancreatic, or neurologic disorders. 
12. Participant has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa or 
binge eating) diagnosed  by a health professional. 
13. Participant has uncontrolled  hypertension  (systolic blood pressure ::0:160 mm Hg or diastolic 
blood pressure ::0:100 mm 1-Ig) as defined by the blood pressure measured at Visit 1. Onere- 
test will be allowed on a separate day prior to Visit 2 (week 0) for participants  whose blood 
pressure exceeds either ofthese cut points at Visit 1  (week -1). 
14. Participant has a history or presence of cancer in the prior 2 years, except for non-melanoma 
skin cancer. 
15. Participant has elective hospitalizations planned (e.g., elective cosmetic procedures) during 
the study period. 
16. Participant is a female who is pregnant, planning to be pregnant during the study period, 
lactating, or is of childbearing  potential and is unwilling to commit to the use of a medically 
approved form of contraception  throughout the study period. 
17. Participant  has a recent history of (within 12 months of Visit 1; week -1) or strong potential 
for alcohol or substance  abuse.  Alcohol abuse defined as>14 drinks/week  (1 drink= 12 oz 
beer, 5 oz wine, or 1 y, oz distilled spirits). 
18. Participant  has a known allergy, sensitivity,  or intolerance to the study foods or any 
ingredient(s)  of the study diets (e.g., soy, gluten, wheat, lactose). 
19. Exposure to any non-registered  drug product within 1 month prior to the screening visit 
(Visit 1; week -1 ). 
 
 
 
 

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20. Participant has a condition the Clinical Investigator believes would interfere with his or her 
ability to provide informed consent, comply with the study protocol, or which might 
confound the interpretation of the study results or put the person at undue risk. 
 
6.3.3.   Excluded Medications and Products 
Medications which are known to stimulate or suppress appetite, but which are taken for other 
indications, will be allowed as long as the dose has remained stable for the past six months prior 
to Visit I  (week -1).  Use of medications, products, supplements, and/or programs/diets intended 
to alter body weight are not allowed within six months prior to Visit I (week -1).  Unstable use of 
thyroid hormones within 2 months of Visit I  (week -I)  is not allowed. The use of other 
medications that may affect carbohydrate metabolism, including but not limited to hypoglycemic 
medications and systemic (intravenous, intramuscular, or oral) corticosteroids is not allowed 
within one month of Visit 1 (week -I).  Use ofCoumadin (warfarin) and/or medications known 
to influence lipids and/or blood pressure, except stable-dose medications within one month of 
Visit 1 (week -1), is not allowed.  Additionally, lithium is excluded within one month of Visit I 
(week -1).  A list of exclusionary medications/supplements and products can be found in 
Appendix I. 
 
Should a participant require any of these medications or supplements, the study staff should 
consult with the Project Manager or Principal Scientific Investigator to discuss the participant's 
participation in the trial. 
 
6.3.4.   Randomization  Procedures 
Stratified block randomization will be utilized. Participants will be randomized to one of three 
groups (1:I:1 ratio) stratified by sex to ensure each group is allocated a maximum of 25% male 
participants.  Additionally, the total study sample will be limited to :SI 0% of participants with a 
BMI between 2:27.0 and <30.0 kg/m2, but randomization will not be stratified by BMI. 
 
If a participant meets all inclusion and none of the exclusion criteria, a staff member will select 
the next sealed sequential randomization envelope, derived fi·om a computer generated 
randomization list, containing randomization number and group assignment for the participant. 
The randomization number will be recorded with the participant's source documentation. The 
participant randomization envelope should be maintained with the participant's source 
documents. 
 
6.4.  Study ]>mgrams and Foods 
 
6.4.1.   Description of Study Programs 
Control Group:  The Control group will follow a self-directed diet, which is a food-based, 
reduced-calorie diet, consistent with the 2015 Dietary Guidelines for Americans (See 
Supplementary Materials).  This group will receive a one-on-one personal instruction session 
(10-15 min) with a trained member of the study staff at the Visit 2 (week 0) clinic visit.  During 
this session, daily energy intake targets will be determined for each participant using the 
National Institutes of Health body weight planner (www.niddk.nih.gov/health- 
information/health-topics/weight-control!body-weight-planner/Pages/bwp.aspx).  The 
personalized daily energy intake level will be specific to each participant's 16-week weight loss 

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goal, targeting 7% weight loss over the 16-week weight loss period, consistent with recent obesity 
treatment guidelines (Jensen 2014).  Participants will receive publicly available information from 
the USDA Choose MyPlate program, including a handout with a meal plan from the website to 
match their target energy intake, as well as instruction to utilize the www.choosemyplate.gov 
website.  Participants with target energy intakes of <1600 kcal per day will be instructed to take a 
multi-vitamin  of their choosing (not marketed to enhance or benefit weight loss, energy, 
metabolism, etc.) to ensure adequate intake of micronutrients.   Participants  will be instructed to 
start their weight loss program on the day following randomization  (day l ). In keeping with the 
self-directed  nature of this control group, participants  will not receive further instructions or 
personal support during the weight loss period. 
 
Control  Group-Specific Procedures 
 
-   ---·- 
.. 
 
 
- 
- 
Weight  Los_s_Phase 
  
-·  
 
[week 
···-··· 
1 
3  
4 5 
6
---···-   ·7--. 
 
8 
9 
10 ]] 
12 
 
..1. 3 14 15 16 
Dispense Educational Material sa 
X 
X 
--- -· 
In-Clinic Instruction Session" 
X 
 
 
--·-·- -- 
Provide Instructions for 
X 
Ordering Study Fo()dc 
-·· 
....... 
.. 
 
Footnotes: 
'At Visit 2 (week 0), participants will receive a SuperTracker Profile, SuperTracker handouts, and meal 
plan handouts specific to their targeted calorie level (see Supplementary Materials). Participants will be 
instructed to set up and use the Super Tracker profile at home. At Visit 7 (week 16), participants will 
receive maintenance handouts and guides tailored to this control group (see Supplementary Materials). 
bThe instruction session will be conducted in-clinic by a trained study staff member  in a one-on-one 
format. 
'Participants who are assigned to the control group and complete all study visits are eligible to receive 
study food and will receive instructions on how to place orders at Visit 7 (week 16). 
 
Take Shape For Life Group:   The TSFL Program group will be assigned to the Optimal 
Weight 5 & I Plan'M for weight loss.  This is a portion-controlled, nutritionally  balanced, low 
calorie weight loss meal plan (800-1 000 kcal/day) that consists of five Medifast meal 
replacements,  one lean and green meal, and one optional snack each day. The Medifast meal 
replacements  are nutrient dense and fortified with 24 vitamins and minerals to ensure adequate 
micronutrient  nutrition while on a calorie restricted meal plan. All Medifast meal replacements 
share a similar nutritional profile, allowing them to be used interchangeably.  All Medifast meal 
replacements  required for the meal plan will be provided to the TSFL Group participants 
throughout the 16-week weight loss period of the study.  The lean and green meal is a self- 
prepared meal consisting of a specified amount of lean protein, non-starchy  vegetables, and 
healthy fats.  Participants  will purchase and prepare foods used for the lean and green meals on 
their own.  Additionally, the Medifast Flavors of Home@ products offer a "heat and serve" 
alternative to the self-prepared  lean and green meal for occasional  use.  TSFL participants will 
receive up to six Flavors of Home products per month during the study.   TSFL participants will 
receive a list of self-selected  foods (purchased  by the participants)  that can be used for the 

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optional  snack.   In addition, participants will also be provided  with up to two boxes (i.e.,  14 
individual packets)  of Medifasl snacks  which can serve as a portable,  pre-portioned, ready-to-eat 
alternate snack  option. 
 
This TSFL group  will have regularly  scheduled coaching sessions starling  at Visit 2 (week  0) with 
an assigned  research assistant trained  to function as a TSFL coach  (hereinafter referred to as the 
TSFL Coach)  for the duration  of the study.   The TSFL coach  training  will take place  before the 
study  and will utilize a training protocol  mimetic  of current  training received  by new TSFL 
Coaches. The coaching schedules and content  will meet the TSFL coaching standards of 
practice. Coaching, for the purpose of this study,  will take place via telephone.  The initial 
coaching session  (45 min in length)  will occur  the day of Visit 2 (week  0) as participants will be 
instructed to start their weight  loss program  on the day following the randomization visit (day  I). 
If the coaching session  does not take place,  participants will be instructed to start their  weight 
loss program  on day  I regardless (a protocol  deviation form  must be submitted).  Participants 
will have access  to TSFL  written  support tools and monthly e-mailed  newsletters throughout the 
study to assist  with weight  loss. Participants will also have limited  telephone and e-mail  access 
during  the study to the Medifast Nutrition Support Team (available when a question exceeds the 
scope of the TSFL Coach  training), which is consistent with the commercially available 
program. 
 
TSFL Group-Specific t>roccdm·cs 
- 
•..   .. 
··-- 
·---  - " 
····-···-- 
-·-· 
. .. 
.. 
Weight Loss Phase 
"''Ck 
0 
1 
2 
3  
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 14 IS 16 
L .opense Educational Materials"  
X 
X 
-·--  ·------    -. - -- ---· ·--·---·-·-  ···-·- ... ····--···· ·-·· ···-  -····· ··   ------    -- - 
""felephone  Coaching' 
X x4 xz xz xz X 
X  X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
TSFL  Monthly  eNewsletter' 
X 
X 
X 
X 
 
Dispense Study  Fooda 
X 
 
Order Study  Foodc 
X 
X 
X 
X 
   
 
 
Footnotes: 
"At Visit 2 (week 0), participants will receive a packet of study-specific TSFL printed materials [includes 
one of each of the following: The Optimal Weight 5 & I  Plan™ Quick Start guide; Dining Out guide; 
Healthy Celebrations guide; TSFL Optimal Weight 5 & I   Plan™ food journal; Dr. A's Habits of Health 
book; Living a Longer, Healthier Life: The Companion Guide to Dr. A's Habits of Health; Dr. A's 
Discover Your Optimal Health book; Fit & Festive recipe cards (5 sets); Condiment Recommendations 
handout; TSFL shaker jar] and  the "Getting Started Instructions" for the TSFL Group; see 
Supplementary Materials) during the clinic visit.  The TSFL coach will review key concepts during the 
initial coaching contact. At Visit 7 (week 16), participants will receive TSFL maintenance handouts and 
guides (see Supplementary Materials). 
"Coaching sessions will be conducted one-on-one by telephone with an assigned TSFL coach trained in 
the TSFL Habits of Health coaching model.  Coaching sessions will take place at baseline and 4 times 

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during the first week, twice in each of weeks 2, 3 and 4, and weekly thereafter through week 16.  Week I 
coaching will occur Monday through Friday (i.e., no weekend calls), with subsequent sessions taking place 
at any point during those weeks.  The initial intake session at baseline will be approximately 45 min in 
length.  Subsequent check-ins will be approximately 5-10 min, and the final session will be approximately 
30 min. Pmticipants in the TSFL group will be encouraged to track weight and food intake, discuss their 
progress with their coach during the coaching sessions, and access TSFL written, online, and virtual 
support tools to use at their discretion. These participants will also have limited access to the Medifast 
Nutrition Support Team. 
'The TSFL group will receive monthly newsletters (each calendar month) via email that contain general 
health information and links to the TSFL Stop, Challenge, Choose e-book, and archived TSFL support 
calls (doctors and nurse support calls). 
d At baseline (Visit 2, week 0), the TSFL group will be dispensed a starter meal kit containing a I 0-d 
supply of study foods for the assigned meal plan (i.e., the 5 & I   Plan) to ensure they have adequate study 
foods until they receive their first order. This kit will contain 7 boxes of Medifast meal replacements (i.e., 
49 individual meal replacements). Participants will start the Optimal Weight 5 & 1  Plan™, including 
consumption of the assigned study food, the day following the randomization visit (day 1 ), regardless of 
whether the coaching session has occurred (a protocol deviation form must be submitted). 
'Participants will order enough study food to ensure their supply will last until the next food ordering 
timepoint: each order will include 20 boxes ofMedifast  meal replacements (i.e., 140 individual meal 
replacements), and up to 2 boxes ofMedifast  Snacks (i.e., 14 individual snacks),  and up to 6 
individual Flavors of Home products. The study foods will be participant-selected from among those 
offered on the TSFL order form (see Supplementary Materials), and the orders will be placed with study 
staff during clinic visits. 
 
Medifast Direct (MEDD) Program Group:  Participants randomized to the MEDD group  will 
be assigned  to the Medifast Achieve™ Plan (4 & 2 & I  Plan@)  for weight  loss.  The Achieve 
Plan is a portion-controlled, nutritionally balanced, reduced  energy  (II 00-1300 kcal/day) meal 
plan that consists of four Medifast  meal replacements, two lean and green meals,  and one healthy 
snack.  The Medifast meal replacements and the lean and green meals  are the same as those 
described above  for the TSFL  Group.   Briefly,  Medifast meal replacements are portion- 
controlled, nutrient  dense,  and fortified  with 24 vitamins and minerals. All Medifast meal 
replacements share a similar  nutritional profile,  allowing them to be used interchangeably. 
Medifast meal replacements required  for the program  will be provided  to the MEDD  Group 
participants throughout the study.   The lean and green  meal  is a self-prepared meal consisting of 
a specified amount  of lean protein,  non-starchy vegetables, and healthy  fats.  Participants will 
purchase and prepare  foods  used for the lean and green meals on their own.   Additionally, the 
Medifast Flavors of Home@ products offer a "heat  and serve" alternative to the self-prepared lean 
and green  meal for occasional use.  MEDD  participants will receive  up to twelve  Flavors  of Home 
products per month  during the study.   The healthy  snack  will consist of a self-selected serving  of 
fruit, dairy,  or grain purchased by the participant, or one ofMedifast's portable,  pre- portioned, 
ready-to-eat Medifast snacks  can be used as a healthy  snack.   Participants will receive up to two 
boxes (i.e., 14 individual packets)  ofMedifast snacks  per month. 
 
Participants will be dispensed study-specific printed  materials (including the "Getting Started 
Instructions") at Visit 2 (week  0) and will have one telephone call with a Medifast Nutrition 
Support Team  member  prior to 17:00  h EST at Visit 2 (week  0) to receive  instruction on the 
meal plan and support materials as participants will be instructed to start their weight  loss 
program  on the day following the randomization visit (day  I).  If the telephone call does not take 

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- 
-- 
place, participants will be instructed to start their weight  loss program  on day  I regardless (a 
protocol  deviation form must be submitted). Participants will also have telephone and e-mail 
access  to the Medifast Nutrition Support Team and Medifast  online  tools throughout the study. 
Participants in the MEDD  group  will be encouraged to track weight and food intake  and access 
MEDD  written,  online,  and virtual  support  tools to use at their discretion. 
 
MEDD-Spccific  Procedures 
_j 
-Week- 
 
 
 
··- . 
 
·-  ··-··--  ··-· 
 
 
Weight Loss Phase 
-· 
 
Dispense  Educational Materialsa 
0 I 2 
 
X 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 
14 
15 
16 
····-· 
X 
 
Program  Instruction Session" 
X 
-· 
Dispense  Study  Foodc 
X 
 
Order Study  Food"  
X 
X 
X 
X 
-····    ·-··· 
·- 
··-· 
-" 
-·-· . 
 
Footnotes: 
'At Visit 2 (week 0), participants will receive a packet of study-specific MEDD printed materials 
[includes one of each of the following: The Medifast AchieveTM Plan guide; The Dining Out guide; the 4 
& 2 & I  Plan"' food journal; Healthy Celebrations guide; Your Self-Directed Healthy Living workbook; 
Simply Well: An Everyday, Healthy Cookbook; Fit & Festive recipe cards (5 sets); Condiment 
Recommendations handout; Medifast shaker jar] and the "Getting Started Instructions" for the MEDD 
Group.  At Visit 7 (week I 6), participants will receive MEDD group maintenance handouts and guides 
(see Supplementary Materials). 
bThe MEDD group will be instructed to call the Medifast Nutrition Support Team to receive a one-on-one 
introduction to their assigned weight loss program with a Nutrition Support Team member prior to I 7:00 h 
EST.  This telephone call (I 0-15 min in length) will take place the day of Visit 2 (week 0) as participants 
will be instructed to start their weight Joss program the day following the randomization visit (day I).  If 
the telephone call does not take place, participants will be instructed to start their weight Joss 
program on day I  (a protocol deviation form must be submitted).  These participants will also have access 
to the Nutrition Suppmi Team (to use at their discretion) and all online and written Medifast Direct 
materials throughout the study. 
'At  baseline (Visit 2, week 0), the MEDD group will be dispensed a Starter Meal Kit containing a I 0-d 
supply of study foods for the assigned meal plan (i.e., the 4 & 2 & I   Plan) to ensure participants have an 
adequate supply of study food until they receive their first order.  This kit will contain 6 boxes of 
Medifast meal replacements (i.e., 42 individual meal replacements).  Participants will stmt the 4 & 2 & I 
Plan"', including consuming the assigned study food the day following randomization (day I), regardless 
of whether the telephone call with the Medifast Nutrition Support Team member has occurred. 
'Participants will order enough study food to ensure their supply will last until the next food ordering 
timepoint: each order will include 16 boxes ofMedifast  meal replacements (i.e., I 12 individual meal 
replacements), and up to 2 boxes ofMedifast  Snacks (i.e., 14 individual snacks), and up to 12 individual 
Flavors ofl·Iome products.  The study foods will be participant-selected from among those offered on the 
MEDD order form (see Supplementary Materials), and the orders will be placed with study staff during 
clinic visits. 

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6.4.2.   Labeling and Packaging of Study Foods 
The Sponsor will provide a total of approximately 17 weeks' worth of study foods for each 
participant in the TSFL and MEDD groups to cover the 16-week weight loss phase and additional 
study food to account for shipping time and ensure participants do not run out of food 
between orders.  Foods dispensed at the clinic (Visit 2; week 0) will be supplied in pre-packaged 
kits (starter meal kits) containing multiple boxes of pre-selected study foods packaged in their 
original commercial packaging. The outer box of each starter meal kit will list the group kit type 
(TSFL or MEDD) and will have a space to write the participant's randomization number. 
Subsequent study foods will be home-delivered to participants, consistent with Medifast's 
commercial programs.  Study foods will be supplied in their original commercial packaging. 
Medifast meal replacements and Medifast snacks come in boxes of 7 meals or snacks each; 
Flavors ofl-Iome are individually packaged. 
 
6.4.3.   Storage and Usc of Study Foods 
The site will maintain an inventory of study foods to include (I) pre-packaged starter meal kits 
for the TSFL and MEDD groups, and (2) an inventory of individual boxes ofMedifast  meal 
replacements for participant foods that might need to be exchanged (e.g., the participant does not 
like a food or particular flavor supplied in the starter meal kit).  The Site will complete a Master 
Study Food Log, which is a list of all study Starter Meal Kits received at the site, as well as any 
individual boxes of study food items received.  A Study Food Accountability Log for study 
Starter Meal Kits and any individual boxes of food items dispensed by the clinic should also be 
completed individually for each participant and maintained with the participant's chart.  The 
date, participant's initials, randomization number should be recorded on this log. 
 
The study foods will be stored in a dry secure location at ambient temperature. Study foods are 
to be used only in accordance with this protocol and under the supervision of the Clinical 
Investigator. All records must be available for inspection by the Sponsor and for regulatory 
agency inspection at any time. Copies of the records will be provided to the Sponsor at the 
conclusion of the study.  A written explanation from the study staff will be required for any 
missing study food. 
 
6.5. Clinical Measurements 
 
6.5.1.   Clinic Visits 
Clinic visits will include evaluations of height (Visit I only), BMI calculation (Visit I  and 2 
only), vital signs, prior and concomitant medication/supplement use, and inclusion/exclusion 
criteria (for eligibility at visit I  and for potential protocol deviations at subsequent visits).  In 
order to calculate BMI, height will be measured at the screening visit (Visit I, week -I) using a 
wall-mounted stadiometer.  Participants will remove shoes prior to height measurement. 
 
Standardized vital signs measurements will include resting blood pressure and heart rate 
measured using an automated blood pressure measurement device.  Blood pressure will be 
obtained after the participant has been sitting for at least five min. Systolic and diastolic 
pressures will be measured once using an appropriate sized cuff (bladder within the cuff must 
encircle 2:80% of the arm).  Clinic staff may take a second blood pressure and heart rate, if 
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in the eCRF.  Should elevated blood pressure (see Section 6.3.2, criterion 13) be present at the 
screening visit (Visit 1, week -1 ), one retest will be allowed on a separate day, prior to Visit 2 
(week 0). 
 
Additionally, AEs will be assessed at each post-randomization  visit (Visits 2, 3, 4, 5, 6, and 7; 
weeks 0, 2, 4, 8, 12, and 16).  Inquiring about AEs will occur with an open-ended question.   This 
study is a dietary intervention  and does not include an investigational  study drug or product. 
However, for safety purposes, assessment of AEs will be conducted in a manner consistent  with 
clinical trials on investigational  study drugs or products. Participants will be asked an open- 
ended question (e.g. "Have there been in any changes in your health or medications since you 
were last asked?"). 
 
6.5.2.   Laboratory  Measurements 
The procedures for all clinical laboratory measurements  will be described in detail in a 
laboratory manual.  Laboratory parameters that are missing or have not been obtained must be 
entered in the eCRF as "not done." 
 
The following will be performed as a part of the fasting (12 ± 2 h) chemistry profile at Visit I 
(week -I):  glucose, calcium, albumin, total protein, sodium, potassium, C02, chloride, BUN, 
creatinine, ALP, AST, ALT, total bilirubin, and osmolality.  Analytes will be assessed by 
Elmhurst Memorial Reference Laboratory (Elmhurst, IL). 
 
The following will be performed as part of the fasting (12 ± 2 h) hematology measurements at 
Visit I (week -1): white blood cell count/automated  differential,  red blood cell count, 
hemoglobin, hematocrit,  platelet count, mean corpuscular  volume, mean corpuscular 
hemoglobin, and mean corpuscular  hemoglobin concentration.   Analytes will be assessed by 
Elmhurst Memorial Reference Laboratory (Elmhurst, IL). 
 
At Visits 2 and 7 (weeks 0 and 16) samples will be collected for the assessment  ofhs-CRP.  hs- 
CRP will be assessed by Elmhurst Memorial Reference Laboratory (Elmhurst, IL).  Additional 
samples will be collected and stored and archived for possible future analysis of non-genetic 
indicators of inflammation  and metabolism. 
 
An in-clinic urine pregnancy test will be performed at Visits I, 2, 4, 5, 6, and 7 (weeks -1, 0, 4, 8, 
12, and 16) for females < 60 years of age. 
 
6.5.3.   Gown Body Weight Assessment 
Body weight will be measured at all visits (Visits  I  through 7; weeks -1 through 16) following a 
fast (12 ± 2 h, water only).  Participants will be asked to change into a gown and remove their 
shoes before their weight is obtained.  Weight will be recorded on a medical quality digital scale 
(Health 0 Meter 349KLX) to the nearest tenth pound (one decimal place).  The same digital scale 
will be used to measure body weight at each clinic visit.  The scale will be calibrated at least 
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6.5.4.   Anthropometric Measurements 
Measurements of waist, hip, chest, dominant upper arm, and dominant thigh circumferences will 
be conducted at Visits 2, 4, 5, 6, and 7 (weeks 0, 4, 8, 12, and 16; Appendix 2). A stretch- resistant 
anthropometric tape (Gulick 11 model #67020, Gays Mills, WI) with an indicator buckle to denote 
proper amount of tension applied to the tape will be used for body circumference 
measurements.  These measurements  will be used for calculation of total body circumference and 
waist-to-hip ratio. 
 
6.5.5.   Dual-Energy X-ray Absorptiometry 
DXA scans (GE Lunar Prodigy, enCORE software version 16, Madison, WI) will be performed 
on Visits 2, 4, 5, 6, and 7 (weeks 0, 4, 8, 12, and 16) to assess body composition.   The DXA scan 
will provide estimates of total body fat mass, total body fat-free mass, trunk fat, and non-trunk fat.  
Female participants <60 years of age must have a negative pregnancy test before the DXA scan is 
initiated. 
 
6.5.6.   Impact of Weight on Quality of Life-Lite Questionnaire 
Participants will be administered  the electronic IWQOL-Lite Questionnaire  at Visits 2, 5, and 7 
(weeks 0, 8, and 1 6; Appendix 3) to assess obesity specific QoL domains (physical function, selt 
esteem,  sexual life, public distress and work). 
 
6.5.7.   RAND-36 Questionnaire 
Participants will be administered  the electronic RAND-36 Questionnaire  at Visits 2, 5, and 7 
(weeks 0, 8, and 16; Appendix 4).  This widely used 36-item test requires participants to assess 
eight health concepts: physical functioning,  role limitations caused by physical health problems, 
role limitations caused by emotional problems, social functioning, emotional well-being, 
energy/fatigue, pain, and general health perceptions. 
 
6.5.8.   l'rogram Questionnaire 
Participants will be administered the electronic  Program Questionnaire  at Visits 2, 4, 5, 6, and 7 
(weeks 0, 4, 8, 12, and 16; Appendix 5).  The questionnaire  will include questions about activity 
level only (Question  Iand 2) at Visit 2 (week 0). 
 
Based on the answers to Iand 2, the Physical Activity Level (PAL = ratio of total energy 
expenditure I resting metabolic rate) can be determined  as shown in each cell for each 
combination  of work/school and leisure time activity estimates.  This value can then be recorded 
for each participant at each time point during the study to track physical activity. 

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Leisure Time Activity 
Very Light 
Light 
Moderate  
Active  
Very 
.. 
0 
Very Light 
.?0:· 
()  •H 
Light 
r:/;la
.t
::)
:: 
:::-< 
Moderate 
15 
Heavy 
1.4 
•.. 
1.5 
1.5 
··--- 
1.6 
1.7 
1.9 
1.6 
1.7 
1.8 
2.0 
1.6 
1.7 
1.8 
1.9 
2.2 
1.7 
1.8 
1.9 
2.1 
2.3 
 
 
-·  
·--·- 
 
 
Active ·-- 
 
 
 
 
 
 
 
 
 
 
At Visits 4, 5, 6, and 7 (weeks 4, 8, I 2, and I 6), participants in all groups will be asked to 
document their adherence to the weight loss plan and activity level over the previous 4-week 
period (Questions 3, 4 and 5), and participants in the TSFL and MEDD groups will also be asked 
to assess their adherence to study meal replacement intake (Question 6). 
 
6.5.9.   Satisfaction  and Health/Well-being Questionnaire 
Participants  will complete the electronic Satisfaction and Health/Well-Being Questionnaire  at 
Visit 7 (week 16; Appendix 6).  The Satisfaction and Health/Well-Being Questionnaire  is a 20- 
item questionnaire assessing participant satisfaction with the assigned diet program and general 
health/well-being.   Question order will be randomized. 
 
6.6. Procedures at Each Clinic Visit 
 
6.6.1.   Screening (Visit I, week -1) (-2 weeks to -1 day) 
• Informed consent/HIPAA 
• Demographics/medical history 
• Clinic visit 
• Height 
• BMI calculation 
• Vital signs 
• Review inclusion/exclusion criteria 
• Assess prior and current medication/supplement use 
• Gown body weight 
• In-clinic urine pregnancy test, where applicable 
• Chemistry profile 
• Hematology  panel 
 
6.6.2.   Baseline (Visit 2, week 0) (1 to I 4 days alter Visit 1) 
• Clinic visit 
• 
BMI Calculation 
• 
Vital signs 
• 
Assess AEs 
• 
Review inclusion/exclusion criteria 

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• 
Assess concomitant  medication/supplement use 
• Randomization 
• hs-CRP 
• Archived blood samples 
• Gown body weight 
• Anthropometric  measurements 
• In-clinic urine pregnancy test, where applicable 
• DXA 
• Program Questionnaire 
• IWQOL-Lite Questionnaire 
• RAND-36 Questionnaire 
• Diet education and handouts (Control group) 
• Dispense packet of educational  materials (TSFL and MEDD groups) 
• Dispense starter meal kits (TSFL and MEDD groups) 
• 
Schedule initial TSFL coaching session (TSFL group only) 
• Reminder to call Nutrition Support Team (MEDD group only) 
• Order study foods (TSFL and MEDD groups) 
 
6.6.3.   Clinic visit (Visit 3, week 2 ± 2 d) 
• Clinic visit 
• Vital signs 
• Assess AEs 
• Review inclusion/exclusion criteria 
• Assess concomitant  medication/supplement use 
• Gown body weight 
 
6.6.4.   Clinic visit (Visit 4, week 4 ± 3 d) 
• Clinic visit 
• Vital signs 
• Assess AEs 
• Review inclusion/exclusion criteria 
• Assess concomitant  medication/supplement use 
• Gown body weight 
• Anthropometric  measurements 
• In-clinic urine pregnancy test, where applicable 
• DXA 
• Program Questionnaire 
• Order study foods (TSFL and MEDD groups) 
 
6.6.5.   Clinic visit (Visit 5, week 8 ± 3 d) 
• Clinic visit 
• Vital signs 
• Assess AEs 
• Review inclusion/exclusion criteria 
• Assess concomitant  medication/supplement use 

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• Gown body weight 
• Anthropometric measurements 
• In-clinic urine pregnancy test, where applicable 
• DXA 
• Program Questionnaire 
• IWQOL-Lite Questionnaire 
• RAND-36 Questionnaire 
• Order study foods (TSFL and MEDD groups) 
 
6.6.6.   Clinic visit (Visit 6, week 12 ± 3 d) 
• Clinic visit 
• 
Vital signs 
• 
Assess AEs 
• 
Review inclusion/exclusion criteria 
• 
Assess concomitant medication/supplement usc 
• Gown body weight 
• Anthropometric measurements 
• In-clinic urine pregnancy test, where applicable 
• DXA 
• Program Questionnaire 
• Order study foods (TSFL and MEDD groups) 
 
6.6.7.   Clinic visit (Visit 7, week 16 ±3d) 
• Clinic visit 
• Vital signs 
• 
Assess AEs 
• 
Review inclusion/exclusion criteria 
• 
Assess concomitant medication/supplement use 
• Gown body weight 
• Anthropometric measurements 
• In-clinic urine pregnancy test, where applicable 
• hs-CRP 
• Archived blood samples 
• DXA 
• Program Questionnaire 
• IWQOL-Lite Questionnaire 
• RAND-36 Questionnaire 
• Satisfaction and Health/Well-being Questionnaire 
• Provide instructions for placing study food orders (control group completers only) 
• Dispense Group-specific Maintenance Materials and Guides 
 
In addition to (and outside o1) the regularly scheduled clinic visits described above, the 
TSFL Group will receive telephone coaching sessions per the schedule outlined in the 
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6.7. Early Termination  Procedures 
The term "Early Termination" refers to a participant's non-completion of the study. Should a 
participant decide to withdraw, all efforts will be made to complete and report observations as 
thoroughly as possible. In the event that a participant is withdrawn from the study, the reason for 
the withdrawal and the party who initiated the withdrawal (participant or Clinical Investigator) 
will be documented.  Should the participant decide to withdraw, documentation of the early 
termination will be made and an attempt to conduct an early termination visit (which will occur 
at week 16 and include the clinic visit procedures for Visit 7). 
 
The primary reason for a participant withdrawing prematurely should be selected fi·om the 
following standard categories: 
 
 
Adverse Event- event which results in discontinuation of the study food by the 
participant or that in the judgment of the Clinical Investigator for the best interest of the 
participant requires discontinuation of study food (includes all categories of study food 
relatedness; Not Related, Unlikely, Possibly, Probably, and Definitely). 
 
 
Death -death of the participant. 
 
 
Withdrawal of Consent- participant desires to withdraw from further participation in the 
study in the absence of a medical need to withdraw determined by the Clinical Investigator. 
 
 
Lost to Follow-Up- participant did not return for one or more follow-up visit(s) 
following dispensing of test product and could not be contacted thereafter.  The reason 
for withdrawal was unknown and could not be documented. 
 
 
Other- causes of premature termination from the study other than the above, such as 
theft or loss of study foods, pregnancy, termination of study by Sponsor, etc. 
 
6.8. Procedure for Participants  that Reach a Low BMI 
Participants who achieve a BMI of 19.0 kg/m2 or below will discontinue their assigned weight 
loss diet and this will be noted in source documents.  Participants will receive maintenance 
materials and guides (appropriate to their assigned study group) and will be asked to follow a 
weight maintenance plan for the duration of the study.  The participant will continue in the study 
and be asked to return for remaining clinic visits. 
 
7.   Assessment of Outcomes 
 
7.1. Primary Outcome Variable 
The primary endpoint is body weight and the primary outcome is change (percent and absolute 
change) from baseline (Visit 2; week 0) body weight to Visit 7 (week 16).  Body weight change 
(percent and absolute change) at Visits 3, 4, 5, and 6 (weeks 2, 4, 8, and 12) will also be 
evaluated. 
 
 
 

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7.2. Secondary Outcome Variables 
Secondary outcome variables will include the following: 
•  Proportion of participants achieving 2:5% and 2: I 0% loss of baseline body weight at each 
post-randomization visit (Visits 3, 4, 5, 6, and 7; weeks 2, 4, 8, 12, and 16) 
•  Percent and absolute change in body composition  parameters (measured via DXA) from 
baseline to Visits 4, 5, 6, and 7 (weeks 4, 8, 12, and 16). 
o Total fat mass 
o Total lean mass (non-bone fat free mass) 
o Percent body fat (expressed as a percentage of total body mass) 
o Percent lean mass (expressed as a percentage of total body mass) 
o Android fat and lean mass 
o Gynoid fat and lean mass 
o Abdominal visceral fat mass and volume 
• Absolute change in body circumference  parameters from baseline to Visits 4, 5, 6, and 7 
(weeks 4, 8, 12, and 16). 
o Waist circumference 
o Hip circumference 
o Chest circumference 
o Dominant upper ann circumference 
o Dominant thigh circumference 
o Total body circumference  (sum of all 5 measures) 
o Waist:hip ratio 
• Absolute change in QoL questionnaire  outcomes (total and domain scores) from baseline 
to Visits 5 and 7 (weeks 8 and 16).  QoL will be measured using both the RAND-36 
Questionnaire  [which uses the same questions as the Short Form (36) Health Survey 
Questionnaire  (Ware JE, eta!.  1992)] and the IWQOL-Lite  Questionnaire. 
o  The IWQOL-Lite  Questionnaire  (Kolotkin RL, eta!. 2001) is a 31-question  self- 
report instrument to assess obesity specific quality of life and consists of five 
domains:  Physical Function (11 questions), SelfEsteem (7 questions), Sexual 
Life (4 questions), Public Distress (5 questions), and Work (4 questions). 
o  The RAND 36-ltem Health Survey Questionnaire  assesses eight health domains: 
physical functioning  (10 questions),  role limitations due to physical health 
problems (4 questions), bodily pain (2 questions),  general health perceptions (5 
questions),  vitality (4 questions), social functioning  (2 questions),  role limitations 
due to emotional  problems (3 questions), and emotional  well-being (5 questions) 
(RAND HEALTH, 2009). 
• Weight loss program adherence assessed at Visits 4, 5, 6, and 7 (weeks 4, 8, 12, and 16) 
based on the Program Questionnaire. 
o Adherence will be calculated  based on self-reported  TSFL/MEDD  meal 
replacement  product consumption, participation  at assigned coaching sessions 
(TSFL only), utilization of Nutrition Support (TSFL/MEDD), and a single question 
VAS rating adherence to their assigned weight loss program (all groups). 
• Participant satisfaction  and health/well-being assessed via the Satisfaction  and 
Health/Well-being Questionnaire at Visit 7 (week 16). 
• Absolute change in hs-CRP from baseline (Visit 2; week 0) to Visit 7 (week 1 6). 
 
 
 

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8.   Data Analysis and Statistical Methods 
 
8.1. Sample Size 
A standard deviation of 15.0 lb for change in body weight over 16 weeks was derived from the 
largest variability observed in a previous study by Davis et al. (20 I 0) that compared weight  loss 
over 16 weeks on the Mcdifast 5 & I  Plan@  (-29.8 ± 13.0 lb) vs. a food-based isocaloric control 
diet (-14.3 ± 15.0 lb).  Using this estimate of expected variability and accounting for a more 
conservative mean difference in weight loss between groups over a similar timefi'ame, an 
evaluable sample of 55 participants in each group (165 total) will provide 80% power to detect a 
difference of9.0 pounds (an effect sized of 0.60). This assumes a nominal a= 0.025 (two-sided) 
accounting for two primary comparisons, each Medifast group compared to the control group, in 
order to maintain an overall type I error of a= 0.05.  To account for possible attrition, a total 
sample of 198 participants (n = 66 I group) will be randomized. 
 
8.2. Statistical Analysis 
 
8.2.1.   Analysis Populations 
An intent-to-treat (ITT) population will include all participants who were randomized  into the 
study. A complete case population (i.e., completers) will include the subset of participants  that 
completed the study on their assigned intervention.  A modified ITT population will include all 
randomized participants that had a least one post-baseline weight measurement. 
 
All decisions regarding exclusion from the outcome populations will be documented  prior to 
database lock. 
 
8.2.2.   Outcome Analysis 
Descriptive statistics [number of participants, mean, standard error of the mean (SEM), standard 
deviation, median, interquartile limits, minimum and maximum] will be presented for continuous 
variables. Ratings for categorical variables will be presented as counts and percentages. 
 
Baseline comparisons for demographic  characteristics  between control and active groups will be 
completed with the Chi-Square test, Fisher's exact (two-tail) tests, or analysis ofvarianee 
(ANOVA), as appropriate. 
 
A mixed model repeated measures analysis of covariance (ANCOVA) will be used to assess 
differences between study groups in continuous outcome variables. Initial ANCOVA models will 
contain terms for intervention,  week, intervention  by week interaction, and sex, with baseline 
measures (where applicable) as covariatcs.   Models will be reduced using a backward selection 
method until only significant terms and/or intervention  and baseline measures (where applicable) 
remain in the model.  Pairwise comparisons  between groups at each post-randomization visit will 
be conducted  from the final ANCOVA model, with Dunnett's correction for multiple comparisons 
between each Medifast group vs. control.  Assumptions of normality of residuals will be 
investigated  for each response measurement.   If the normality assumption  is rejected at 
the I% level with the Shapiro-Wilk  test (Shapiro 1965), then an analysis using ranks or other 
transformation  will be performed. 

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Counts and percentages of participants who experience weight loss of :0:5% or :0: I 0% between 
baseline and each post-randomization visit will be presented.  Differences between control  and 
each active group participants with weight loss :0:5% or :0:10% will be assessed using a 
generalized  linear model with a logit link and binomial distribution specified. Initial repeated 
measures models will contain terms for intervention, week, intervention  by week interaction, and 
sex.  Models will be reduced using a backward selection method until only significant terms or 
intervention  remains in the model.  Pairwise comparisons  at each post-randomization visit will 
be conducted using Dunnett's correction for multiple comparisons  between each Medifast  group 
vs. control. 
 
Counts and percentages for questionnaire responses will be presented by intervention  group for 
ordinal outcomes (e.g. Likert scales). Differences  between control and each active group will be 
assessed using a generalized linear model with a cumulative  logit link and multinomial distribution 
specified. Initial repeated measures models will contain terms for intervention, week, intervention  
by week interaction, and sex.  Models will be reduced using a backward selection method until 
only significant terms or intervention  remains in the model.  Pairwise comparisons between control 
and each active group at each post-randomization visit will be conducted  using Dunnett's 
correction for multiple comparisons  between each Medifast group vs. control. 
 
8.2.3.   Safety and Tolerability  Analysis 
Safety assessments  will be determined from intervention-emergent AEs that occur after 
randomization  at Visit 2 (week 0).  Possible differences in the number of participants with at 
least one AE will be assessed with Chi-Square  or Fisher's  exact test. 
 
Participants who achieve a BMI of 19.0 kg/m 2 or below will discontinue the weight loss diet and 
begin a maintenance diet and will be asked to return for remaining clinic visits.  These 
participants will be noted in the safety analysis. 
 
Vitals (blood pressure, pulse rate) will be summarized  by group with descriptive statistics. 
 
8.2.4.   Missing or Incomplete  Data 
Analysis with and without imputation will be conducted in the ITT population.   For the analysis 
with imputation,  single (e.g., last observation  carried forward (LOCF)], and/or multiple 
imputation  will be considered, as appropriate  (Elobeid, 2009; Peng 2015; George 2016). 
 
9.   Study Monitoring 
 
9.1. Concomitant  Medications/Supplements 
All concomitant  medications/supplements used for six months prior to Visit Iand during the 
study will be reported to the study personnel for assessment  and recorded in the participant's 
cCRF. 
 
Use of the medications/supplements described  in the "Exclusion Criteria" section and Appendix 
1  is not allowed during this study. If a participant  requires any ofthese medications,  the 
participant may not enter the study. 

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9.2. Adverse Event Monitoring 
In a consensus view of guidelines for the design, conduct and reporting of human intervention 
studies to evaluate the health benefits of foods, an International Life Sciences Institute Europe 
Expert Group defines an AE as "any  untoward medical occurrence or undesirable clinical 
experience in a participant in a clinical trial, whether or not considered related to the 
intervention" (Welch 2011).  This includes any occurrence that is new in onset or aggravated in 
severity or frequency from the baseline condition, or abnormal results of diagnostic procedures 
(including laboratory test abnormalities where applicable).  Therefore, clinical observations, 
including responses to the question, "Have there been in any changes in your health or 
medications since you were last asked?" will be collected post randomization.  These observations 
will be reviewed for assessment of AE, including severity and potential relationship 
to the dietary intervention as determined by the study physician. 
 
Events should be considered AEs if they: 
 
 
• Result in discontinuation from the study, 
• Require treatment or any other therapeutic intervention, 
• Require further diagnostic evaluation (excluding a repetition of the same procedure to 
confirm the abnormality), 
• Are associated with clinical signs or symptoms judged by the Clinical Investigator to 
have a significant clinical impact. 
 
9.2.1.   Grading and Severity 
The Clinicallnvestigator will evaluate all AEs with respect to their severity, and record the 
outcome and action taken on the AE eCRF. AEs will be graded as: 
 
Mild: 
Moderate: 
Severe: 
 
Awareness of symptoms but easily tolerated 
Discomfort enough to interfere with but not prevent daily activity 
Unable to perform usual activity 
 
9.2.2.   Relationship 
The Clinical Investigator will also judge the likelihood that the AE was related to the diet plan 
administered and document this on the appropriate eCRF as: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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NOT RELATED 
This category applies to those adverse experiences which, after careful consideration, 
are clearly and incontrovertibly due to extraneous causes (disease,  environment,  etc.). 
UNLIKELY 
In general, this category can be considered applicable  to those experiences  that after 
careful medical consideration  at the time they are evaluated, arc judged to be, unlikely 
rclated to the study foods administered. 
POSSIBLY 
This category applies to those adverse experiences for which, after careful medical 
consideration  at the time they are evaluated,  a connection  with the study foods 
administration appears possible but cannot be ruled out with certainty. 
PROBABLY 
This category applies to those adverse experiences  that, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to 
be related to the study foods. 
DEFINITELY 
This category applies to those adverse experiences  which, the Clinical Investigator 
feels are incontrovertibly related to the study foods. 
 
Appropriate therapeutic action and follow-up measures will be performed by the Clinical 
Investigator in accordance with good medical practice. 
 
9.2.3.  Serious Adverse Event Definition/Qualification 
A SAE is defined as an AE that results in any of the following outcomes: 
 
 
o 
Death (note that death is the outcome of a SAE and the cause of death should be listed as 
the AE) 
o 
Life-threatening event 
o 
In-patient hospitalization  or prolongation of existing hospitalization 
o 
A persistent or significant  disability/incapacity 
o 
Congenital  anomaly or birth defect 
o 
 Any other important medical event that may not result in death, be life-threatening, or 
require hospitalization, may be considered a SAE when, based upon appropriate  medical 
judgment, the event may jeopardize the pm1icipant and may require medical or surgical 
intervention  to prevent one of the outcomes listed above.  Examples of such medical 
events include allergic bronchospasm  requiring intensive treatment in an emergency room 
or at home, blood dyscrasias or convulsions  that do not result in in-patient hospitalization, 
or the development  of drug dependency  or drug abuse. 
 
In the event of a SAE, the participant may be dropped from the study if the Clinical Investigator 
deems it necessary. 
 
9.2.4.   Serious Adverse Event Reporting Instructions 
If in the opinion of the Clinical Investigator  the event meets the criteria of a SAE the following 
procedures will be followed: 
 
o 
The Clinical Investigator  will report the SAE by telephone to Biofortis Innovation 
Services immediately  upon becoming aware of the event. 

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• In addition, the initial SAE report should be submitted with other applicable information 
(such as medical history, concomitant medications, AEs) to Biofortis Innovation Services 
within 24 h of reporting the event to the attention of the Project Manager. 
• The Clinical Investigator will also notify the Institutional Review Board (IRB) of the 
event within the parameters and timeframe specified under the IRB Standard Operating 
Procedures (SOP) after becoming aware of the SAE. An initial report followed promptly 
by a complete report will be forwarded to the IRB. 
• Follow-up information relating to a SAE must be submitted to Biofortis Innovation 
Services by telephone, fax, or overnight courier as soon as additional data related to the 
event are available. 
• If a subject is hospitalized or hospitalization is prolonged due to the SAE, the hospital 
discharge summary will be obtained if possible when it becomes available. 
• If a death occurs and an autopsy is performed, a copy of the autopsy report will be 
obtained if possible when it becomes available. All efforts must be undertaken to obtain 
follow-up information promptly. 
• Biofortis Innovation Services will report SAEs to the Sponsor per the terms of the Master 
Service Agreement. 
 
9.2.5.   Electronic CRF Recording of Adverse Events 
All AEs will be recorded on the AE eCRF page. For participants who have an ongoing AE at 
their final study visit, a follow-up AE eCRF page will be collected after 30 d.  Participants will be 
instructed to notify Biofortis Innovation Services immediately should new AEs emerge for an 
additional 30 d following their last day on the study diet.  All SAEs must be recorded on the AE 
and SAE eCRF page. 
 
9.2.6.   Serious Adverse Event Follow-Up 
For all SAEs occurring during the study or within 30 d of the study diet, the Clinical Investigator 
must submit follow-up reports to Biofortis Innovation Services regarding the participant's 
subsequent course. All SAEs that are ongoing at the end of the study or upon discontinuation of 
the participant's participation must be followed until either: 
 
• The event resolves, or 
• The event/condition has stabilized (e.g., in the case of persistent impairment), or 
• The event returns to baseline, if a baseline value is available, or 
• The participant dies, or 
• The event can be attributed to other than the study treatment, or to other than the study 
conduct. 
 
9.2.7.   Pregnancy 
The study foods being dispensed for consumption in this study are commercially available 
ingredients, safe for consumption by pregnant or lactating women.  However, the outcome 
variables measured would be expected to be affected by pregnancy and lactation, and the caloric 
levels of the study meal plans are not appropriate for pregnant women.  Additionally, the DXA 
scan involves a very small dose of radiation, which makes the test unsuitable for women who 
arc, or might be, pregnant. All female participants <60 years of age will undergo in-clinic urine 
pregnancy testing prior to every DXA scan. Pregnant or lactating women will be excluded from 
 
 

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the study and women of childbearing  potential will be required to use appropriate contraceptive 
methods to avoid pregnancy.  Documentation  of contraception  method must be recorded in the 
source chart. 
 
Although pregnancy is not a SAE, all pregnancies occurring in mndomized participants 
will be reported within 24 h of notification.  The Clinical Investigator will immediately  notify 
the Principal Scientific Investigator and the IRB about the pregnancy.  Should a female 
participant become pregnant at any time after randomization, the participant should be 
withdrawn from the study, and the Clinical Investigator will be required to follow the participant 
through the pregnancy term and report to Biofortis Innovation Services the course of the 
pregnancy including perinatal and neonatal outcomes. 
 
10. Conduct of the Study 
 
10.1.  Ethics and Regulatory Considerations 
This study will be conducted according to Good Clinical Practice Guidelines, the Declaration  of 
Helsinki (2000), and US 21 CFR. Signed written informed consent for participation  in the study 
will be obtained from all participants  before protocol-specific  procedures are carried out. 
Participants will be informed of their right to withdraw from the study at any time. 
 
1 0.2. 
Institutional  Review Board 
The Clinical Investigator  will ensure that an appropriately  constituted  IRB, in compliance  with 
the requirements of21 CFR 56, reviews and approves the clinical study.  Before the study is 
started, the Clinical Investigator  will forward copies of the protocol and consent form for this 
study to the IRB for review and approval.  IRB approval must refer to the study by exact 
protocol title and number, identify the documents  reviewed, and state the date of review.  The 
IRB must be informed of all subsequent  protocol amendments.   No alterations, modifications to 
IRB-approved documents,  including the protocol, protocol summary, consent form, recruitment 
materials and questionnaires  will be allowed.  The IRB must also be informed of all SAEs and of 
unexpected AEs that meet the IRB's  reporting guidelines as outlined in the IRB's  SOPs.  In 
addition, the Clinical Investigator  will immediately forward copies of all correspondence with 
the IRB to Biofortis Innovation Services. 
 
10.3. 
Informed Consent and Protected Health Information 
The study will be explained verbally as well as on the informed consent document.   Each 
participant will be given ample opportunity to inquire about details of the study and to read and 
understand the consent form before signing it. 
 
Consent must be documented  by the dated signature of the participant.   Each participant's signed 
informed consent document  must be kept on file by the Clinical Investigator for possible 
inspection by regulatory authorities or by the Sponsor.  The participant should receive a copy of 
the written informed consent document once he/she bas signed it. 
 
The Sponsor recognizes the importance of protecting the privacy of participant data.  Therefore, 
for study sites within the United States, the informed consent form will incorporate, or be 
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participants authorize the usc and disclosure of their Protected Health Information by the Clinical 
Investigator and by those persons who need that information for the purposes of this study. 
 
A participant may not be admitted to the study unless informed consent of the participant (or her 
legally authorized representative) has been obtained. 
 
10.4. Participant Confidentiality 
The Clinical Investigator is responsible for ensuring that participants' anonymity will be 
maintained.  Electronic CRFs or other documents will identify participants by initials, number, or 
code, and not by name. The Clinical Investigator will keep a separate log showing codes, names, 
and addresses.  All documents showing the participants' identity will be kept in strict confidence 
by the Clinical Investigator. However, the Clinical Investigator agrees that the Sponsor, its 
employees or agents, the IRB, as well as representatives of the FDA, will have the right to audit 
and review pertinent medical records relating to this clinical trial and that the participants will 
provide written informed consent to this effect. Sponsor will also receive name and contact 
information for participants for the purpose of fulfilling study food orders (which are sent 
directly to the homes of participants) and for interactions with the Medifast Nutrition Support 
Team. Sponsor will ensure that participant information will be kept confidential and will not be 
used for any commercial purposes. 
 
l 0.5. Withdrawal of Participants from the Study 
Participants may be removed from the study for any of the following reasons: 
 
• A participant requests discontinuation; 
• The Clinical Investigator initiates removal for medical or compliance reasons; 
• Occurrence of any AE or condition that could, in the Clinical Investigator's opinion, 
interfere with the evaluation of the treatment effect of the study food or put the 
participant at undue risk. 
 
It is understood by all concerned that an excessive rate of withdrawals can render the study 
uninterpretablc, therefore, unnecessary withdrawal of participants should be avoided. Should a 
participant decide to withdraw, all efforts will be made to complete and report observations as 
thoroughly as possible. In the event that a participant is withdrawn from the study, the reason for 
the withdrawal will be documented in the eCRF. Prior to a participant's withdrawal from the 
study, an attempt will be made to conduct an early termination visit, which will occur at week 16 
and include the clinic visit procedures for Visit 7. 
 
Note that any participant who achieves a BMI of <:19 kg/m2 will be placed on a weight 
maintenance diet and should not be withdrawn from the study. 
 
ll. Administrative Matters 
All references to the Sponsor in this section include all designees e.g., Contract Research 
Organizations or Consultants acting on behalf of the Sponsor. 
 
 
 
 
 
 
 

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11.1. Changes to the Protocol 
All changes to the protocol must be documented by amendments to the protocol signed by the 
Sponsor and the Clinical Investigator.  The amended protocol and a revised informed consent 
form will be submitted for approval to the lRB.  A copy of the approval will be provided to 
Biofortis Innovation Services.  Where the local IRB regulations regarding protocol amendments 
differ from this policy, the local regulations will apply. 
 
The above-mentioned requirements do not preclude any immediate action from being taken in 
the interests of participants' safety. 
 
11.2. Protocol Deviations and Violations 
A protocol deviation is a minor departure from the protocol that is approved by the Principal 
Scientific Investigator or authorized designee prior to implementation and does not compromise 
participant safety or the integrity of the data.  Any deviation from the inclusion/exclusion criteria 
requires an approved waiver from the Principal Scientific Investigator or designee prior to 
randomization in order to enroll that participant into the study. The site should accurately 
document the deviation and approval in the source document and complete the protocol 
deviation/violation eCRF. 
 
A protocol violation is a divergence from the IRB-approved protocol that is not approved by the 
Principal Scientific Investigator or authorized designee prior to implementation.  A violation can 
be classified as major or minor.  A major violation compromises the safety of the participant or 
the integrity of the data collected.  A minor violation is a less-significant departure from the 
protocol that, though not pre-approved, does not compromise the safety of the participant or the 
integrity of the data collected.  The site should accurately document the violation in the source 
document.  Violations that could significantly influence participant safety will be reported to the 
IRB. 
 
11.3. Electronic Case Report Forms 
Data collected in the eCRF will be documented in an anonymous fashion (e.g., the participant 
will be identified only by a stndy number and their initials).  Each evaluation recorded in the 
eCRF will be performed at the time specified in the protocol. 
 
All information required by the protocol should be documented in the source records and 
provided in the eCRF.  The Clinical Investigator must agree to complete and maintain source 
documents for each participant in the study.  An explanation must be given for any omissions. 
All eCRFs must be completed as soon as possible after the participant's visit, in order that the 
monitor may verify the validity and completeness of the data. The Clinical Investigator should 
review and sign (as required) all eCRFs for completeness and accuracy prior to and during 
monitoring visits, as changes to the eCRF may be made during the monitoring visits by the site 
staff.  All information on the eCRFs must be traceable back to the source documents. 
 
11.4. Clinical Monitoring 
An initiation meeting will be conducted by the Sponsor or an approved representative.  At this 
meeting the protocol, eCRFs, and pertinent aspects of the CFR will be reviewed with the Clinical 
Investigator and all study staff. 
 
 
 
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Remote and on-site monitoring visits will be conducted during the study, focusing on human 
participant protection and data integrity risks of the trial.  A clinical monitoring plan will be 
developed which identifies specific risk-based monitoring  focal points.  These may include: 
• Informed consent 
• Eligibility criteria 
• Randomization/blinding 
• SAEs 
• 
Serious protocol violations 
• Endpoints 
• Test article administration 
• Accountability 
 
No data disclosing the identity of participants  will leave the study center, except, as described  in 
section 10.4, to the Sponsor for the purposes of food ordering and Medifast Nutrition Support 
Team interactions.  Biofortis Innovation Services and any designees will maintain confidentiality 
of all participant records. 
 
The Clinical Investigator  must ensure that access to the CRF is secured and that other study 
documentation is stored in a secure location.  During the conrsc of the study, the responsible 
Biofortis Innovation Services staff will be available to discuss any matters relating to the conduct 
of the study. 
 
11.5. Auditing J>rocedures 
In addition to the monitoring visits outlined above, an investigational  site may undergo a quality 
assurance audit. The Sponsor representatives or a regulatory agency such as the FDA may 
conduct the audit.  If a regulatory agency requests an audit of the study site, the Clinical 
Investigator is required to inform the Sponsor and Biofortis Innovation  Services immediately. 
 
11.6. Records Retention 
All study documentation generated in connection  with this study will be retained for at least five 
years after the last approval of a marketing application  in an International  Conference on 
Harmonization (ICI-1)-region and until there arc no pending or contemplated  marketing 
applications in an ICH-region or at least 5 years have elapsed since the formal discontinuation of 
clinical development  of the investigational  product.  These documents  should be retained for a 
longer period, however, if required by the applicable regulatory  requirements  or by an agreement 
with the Sponsor.  It is the responsibility  of the Sponsor  to inform the Clinical 
Investigator/institution as to when these documents  no longer need be retained. The study 
documents  include IRB approvals for the study protocol and all amendments,  all source 
documents and laboratory records, eCRF records, signed participant informed consent forms, and 
any other pertinent study document. The Clinical Investigator  agrees to supply Biofortis 
Innovation Services with a written confirmation  that these procedures are in place and will be 
adhered to. 
 
 
 
 
 
 
 
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11.7. Termination  of Study 
The Sponsor and the Clinical Investigator reserve the right to terminate the study at any time. In 
terminating the study, the Sponsor and the Clinical Investigator will assure that adequate 
consideration is given to the protection of each participant's interest. 
 
11.8. 
Final Rcportfl>ublications 
Any formal presentation or publication of data collected as a direct or indirect result of this trial 
will be considered as a joint publication by the Clinical lnvestigator(s), where applicable, and the 
Sponsor. 
 
12. Study Foods 
All study foods will be supplied to the Clinical Investigator. Product supplies must be kept in an 
appropriate, secure area (see Section 6.4.3) and maintained under the storage conditions 
specified in the protocol. 
 
 
The Clinical Investigator will oversee that an accurate record regarding the shipment and 
dispensing of the study food is maintained, using a product accountability log.  An accurate 
product disposition record will be kept specifying the date and amount dispensed to each 
participant and any supplies either destroyed or returned to the Sponsor.  This inventory record 
must be available for inspection by and is subject to regulatory inspection at any time.  Copies of 
this record will be provided to the Sponsor by the Clinical Investigator at the conclusion of the 
study. 
 
 
Product supplies are to be used only in accordance with this protocol and under the supervision 
of the Clinical Investigator.  The Clinical Investigator agrees not to destroy any unused product 
supply. 
 
 
At the conclusion of the study, and, if appropriate, during the course of the study, the Clinical 
Investigator will ship all unused product containers and a copy of the completed Master Study 
Food Log to the Sponsor. 
 
13. Disclosure 
By conducting this study, the Clinical lnvestigator(s) agrees that all information provided will be 
maintained by the Clinical Investigator and his/her staff in strict confidence.  Such information 
may be communicated to the Scientific Committee and/or IRB/Ethics Committee under a 
similar, appropriate understanding of the confidential nature of the information.  Study 
documents provided (protocols, investigators' brochures, and other material) will be stored 
appropriately to ensure their confidentiality.  It is understood that the confidential information 
provided to the Clinical Investigator will not be disclosed to others without written authorization, 
except to the extent necessary to obtain informed consent from those participants who are 
eligible and choose to participate in the study.  Such information will not be provided to potential 
participants or participants by telephone or to any other individual. 
 
 
 
 
 
 
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14. References 
 
 
Andersen, WS. Dr. A's Habits of Health: The Path to Permanent Weight Control and Optimal 
Health. Habits of Health  Press,  Annapolis, MD. 
 
Casazza  K, Fontaine  KR, Astrup  A, et al. Myths,  presumptions, and facts about obesity. N Eng! J 
Med 2013;368(5):446-54. 
 
Cheskin  LJ, Mitchell  AM, Jhaveri  AD, et al. Efficacy  of meal replacements versus a standard 
food-based diet for weight  loss in type 2 diabetes: a controlled clinical  trial. Diabetes Educ 
2008;34(1):118-27. 
 
Elobeid  MA, Padilla MA, McVie  T, Thomas 0, Brock DW, Musser  B, et al. Missing data  in 
Randomised Clinical  Trials for weight  loss: scope of the problem, state ofthe field, and 
performance of statistical methods. PLOS ONE 2009;4:e6624 
 
George  B.J, Beasley  TM, Brown  AW, Dawson  J, Dimova  R, Divers .J, et al. Common scientific 
and statistical errors  in obesity  research. Obesity 2016; 24(4):781-790. 
 
Gudzune KA, Doshi  RS, Mehta  AK, et al. Efficacy  of commercial weight-loss programs: an 
updated  systematic review. Ann Intern Med 2015;162(7):501-12. 
 
Hannum  SM, Carson  L, Evans EM, et al. Use of portion-controlled entrees  enhances weight  loss 
in women.  Obes Res 2004;12(3):538-46. 
 
Hannum  SM, Carson  LA, Evans  EM, et al. Use of packaged entrees  as part of a weight-loss diet in 
overweight men: an 8-week  randomized clinical  trial.  Diabetes Obes Metab 2006;8(2):146-55. 
 
Heymsfield SB, van Mierlo  CA, van der Knaap  HC, Heo M, Frier HI. Weight  management using 
a meal replacement strategy: meta and pooling analysis from six studies. Jnt JObes Relat Metab 
Disord 2003;27(5):537-49. 
 
Jensen  MD, Ryan DH, Apovian CM, et al. 2013  AHA/ACC/TOS guideline for the management 
of overweight and obesity  in adults:  a report of the American College of Cardiology/American 
Heart Association Task Force on Practice  Guidelines and The Obesity  Society. JAm Col! 
Cardio/2014;63(25 Pt B):2985-3023. 
 
Kolotkin RL, Crosby  RD, Kosloski KD, et al. Development of a brief measure  to assess quality 
oflife in obesity.  Obesity  Research. 2001; 9 (2): 102-111. 
 
Peng L, Stuart  EA, Allison  DB. Multiple imputation: a flexible tool for handling missing  data. 
JAMA 2015; 314(18)1966-7. 
 
 
RAND HEALTH. 2009.  Medical  Outcomes Study: 36-ltem Short  Form Survey  Scoring 
Instructions. http://www.rand.org/health/surveys_tools/mos/mos_core_36item_scoring.html 
 
 
 
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Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). 
Biometrika. 1965; 52(3/4): 591-611. 
 
 
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): conceptual 
framework and item selection. Med Care 1992;30: 473-483. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 1: Exclusionary  Medications/Supplements 
This list is not intended to be comprehensive. 
 
CLASS OF DRUG/PRODUCT  
GENERIC/BRAND NAME 
. 
Unstable  use ofthefollowihg within 6tttontbs of Visit 1 (week -1; "unstable'' indicat!'sa changin 
dose/regimen) . 
. 
..· 
.  ..    >  
. ·... ...  ·.. 
.·..· 
..· ·.•· ..••. .. . . . 
... 
Medications  known to stimulate 
or suppress appetite, but which 
are taken for other indications 
(including,  but not limited to: 
benzod iazepenes, anti-anxiety, 
antidepressants, anti-psychotics) 
Alprazolam (Niravam,  Xanax, 
Xanax XR) 
Amitriptyline  (Eiavil, Endcp) 
Amoxapine (Asendin) 
Amphetamine  (Adderall) 
Aripiprazole (Abilify) 
Buproprion (Wellbutrin) 
Buspirone (BuS par) 
Carbamazepine (Tcgretol) 
Chlordiazepoxide (Librium) 
Chlorpromazine (Thorazine) 
Citalopram  hydrobromide 
(Celexa) 
Clomipramine (Anafranil) 
Clonazepam  (Kionopin) 
Clorazepatc  (Tranxene) 
Cloazpine (Clorazil) 
Desipramine (Norpramin) 
Dextroamphetamine (Adderall, 
Dexedrine) 
Diazepam (Valium) 
Divalproex  sodium (Depakote) 
Doxepin (Adapin, Sinequan) 
Duloxetine (Cymbalta) 
Escitalopram  (Lexapro) 
Fluoxetine (Prozac) 
Fluphenazine (Prolixin) 
Fluvoxamine  (Luvox, Luvox CR) 
Haloperidol  (Haldol) 
Hydroxyzine  pamoatc (Vistaril) 
Imipramine (Tofranil) 
Lithium citrate (Cibalith  S) 
Lorazepam (Ativan) 
Loxapine (Loxitane) 
Maprotiline (Ludiomil) 
Mesoridazine  (Serentil) 
Methylphenidate (Ritalin) 
Mirtazapine  (Remeron) 
Molindone (Moban) 
Nefazodone  (Serzone) 
Nortriptyline (Pamelor) 
Olanzapine (Zyprexa) 
Oxazepam (Serax) 
Paroxetine (Paxil,  Paxil CR) 
Pemoline (Cylert) 
Perphenazine (Trilafon) 
Phenelzine (Nardi!) 
Prazepam (Centrax) 
Prochlorperazine (Compazine) 
Protriptylinc  (Vivactil) 
Quetiapine (Seroquel) 
Risperidone  (Risperdal) 
Sertraline (Zoloft) 
Thioridazine (Mellaril) 
Thiothixene  (Navane) 
Tranylcypromine sulfate (Prarnate) 
Trazodone (Desyrel) 
Trifluoperazine (Stelazine, Vesprin) 
'l'rimipramine (Surmontil) Valproic 
acid (Depakcnc) Venlafaxine  
(Effexor, Effexor XR) 
 
 
 
 
 
 
 
 
 
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Excluded within 6montbs prior to Visit l(week -1) and thronghouttltestudy  period 
. . 
. 
Weight loss medications, 
products, supplements  taken by 
the participant with the explicit 
intent to alter body weight, 
appetite, and/or satiety, and/or 
programs/diets 
Bcnzphetamine HCI (Didrex) 
Naltrexone and bupropion 
(Contrave) 
Diethylpropion  HCl 
(Tenuate,Tenuate Dospan) 
Mazindol (Sanorex) 
Orlistat (Xenical, Alii) 
Phendimetrazine tartrate (Adipost, 
Anorex-SR, Appecon, Bontril, 
Bontril SR, Melfiat, Obesine, 
Phendiet, Plegine, Prelu-2, 
Statobex) 
Phentermine (Adipex-P,  lonamin, 
Obenix, Oby-Cap, Pro Fast-SA, 
Teramine, Zantryl) 
Sibutramine  (Meridia) 
Phentermine and topiramate 
(Qsymia) 
Lorcaserin (Belviq) 
SlimFast (or similar product) meal 
replacement  bars, shakes, and 
snacks 
Any over-the-counter weight loss 
medications/products 
Programs (such as Weight 
Watchers, NutriSystem, Jenny 
Craig) 
Any dietary supplement,  including, 
but not limited to: 
Chromium  picolinate 
Cinnamon (as a supplement) 
Ginseng 
Bitter orange 
Chitosan 
Chromium 
Conjugated  linoleic acid (CLA) 
Country mallow 
Fiber supplements 
Green tea extract, kola nut, guarana, 
guaranine, or yerba mate 
5-Hydroxytryptophan 
Starch blockers (or similar  products 
such as Carb Away, Carb Cutter, 
Carb Eliminator, CarboLock, 
Ultimate Carb Phaser 1000, Ultra 
Carb Blocker, Detrine, Trimspa) 
Guggul Lipid 
Guar gum 
Gymnema 
Glucomannan 
Hoodia 
Pyruvate 
Any other weight loss supplement 
JJilstabluse or the following withi112 months orvisit.l(weell. -t; ''u stabte" indicates a chang"   ii•• -·--  ---. ••_• ----•- 
dose/regtml'n)  .   .__        .   _-  _       . 
_- 
_      . _ 
.-._   . --.-..... -.-..• ••--    _.---  _-_. 
_           < 
-.. 
_. 
_     _ 
. 
>  
> 
••- •• _ 
Thyroid hormones 
Levothyroxine  (Leva-T,  Levothroid, Levoxyl 
Synthroid, Unithroid) 
Liothyronine (Cytomel,  Triostat) 
Liotrix (Thyrolar) 
Thyroglobulin 
Thyroid (Armour Thyroid, Thyrar, Thyroid Strong, Westhroid) 
.· 
Excluded within 1 month prior to Visit 1 (week -1) and.throughoutthestudy period 
••
-·- 
Psychoactive drugs 
Lithium  
. -·  -·   ·--·--···--- 
Alpha-glucosidase Inhibitors 
Glyset (Miglitol) 
Precosc {Acarbose) 
-- 
Biguanidcs and Biguanide 
combinations 
Actoplus Met (Pioglitazone + 
metform in) 
Glucovancc  (Glyburide + 
metformin) 
._ .. · ._·     .  
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
- 
 
 
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------- 
Avandamet (Roziglitazone  +          Janumct (Sitagliptin + metformin) 
metformin)  
Metaglip (Giipizide + metformin) 
Fortamet (Metformin)  
Prandimet (Repaglinide + 
G lumetza,G Jucophage, 
metformin) 
Glucophage  XR (Metformin) 
 
Bile acid sequestrant  
Welchol (Colescvelam)  as hypoglycemic 
--- 
Thiazolidinedioncs 
Actos (Pioglitazone)  
Avandia (Rosiglitazone) 
- 
Dipeptidyl Pcptidase-4  Inhibitors  
Januvia (Sitagliptin)  
Onglyza (Sexagliptin) 
Injectable hypoglycemic  
Apidra, Exubera, Humalog, Humolog Mix, 1-lumulin N, Humulin  R, 
medications  
Lantus, Levemir, Novolin, Novo log, Novolog Mix (Insulin) 
Byetta  (Exenatide) 
Symlin (Pramlintide acetate) 
Victoza (Liraglutide) 
Meglitinides  
Prandimct (Repaglinide + 
Prandin (Repaglinide) 
metformin)                                            Starlix (Nateglinide) 
 
Sulfonylurcas and Combination  
Amaryl (Glimepiride)  
Glynase PresTab (Giipizide) 
Sulfonylureas  
 Avandaryl (Posiglitazone  + 
Glucovance   (Giyburide + 
glimepiridc)                                           metfonnin) 
Diabinese (Chlorpropamide) 
Metaglip (Glipizide + mctfomin) 
DiaBeta (Giyburide)  
Micronase (Giyburide) 
Duetact (Pioglitazone +                 Orinase (Tolbutamide) 
glimepiride)                                           Tolinase (Tolazamide) 
Dymelor (Acetohexamide) 
Glucotrol, Glucotrol XL 
(Giipizide) 
Corticosteroids  
Oral or systemic use of: 
Prednisolone 
Betamethasone  
Prednisone 
Budcsonide  
 Triamcinolone 
Cortisone  
 Systemic  use of: 
Dexamethasone                                  Fludrocortisone acetate (Florinef) 
Hydrocortisone 
Methylprednisolone 
Unstable use oftheJoii  \Ving within 1month ofVisifl- (week -l; ''un t ble" indicates aeltange in  
.-... 
 
dose/•·egimen) 
.....-  
-•.-_._.   .·. ....·-· 
·.· 
_  .. _.-._.. 
._  ......_ ...      .... ·.--·     ·•.·· 
.. · 
 
 
-·-·- 
 
·_._ 
Lipid-altering  medications  
Atorvastatin  calcium (Lipitor)  
Fluvastatin (Lcscol) 
Dual amlodipinc/atorvastatin 
Gemfibrozil  (Lopid) 
(Caduct)  
Lovastatin (Ad vicor, Mevacor, 
Cholestyramine (Prevalite,  
Altoprev) 
Questran or Ques!ran Light)  
Niacin (Niaspan,  Advicor, Simcor) 
Clofibrate (Atromid-S)  
Pravastatin  sodium (Pravachol) 
Colesevelam  HCI (WelChol)  
Aspirin + pravastatin (Pravigard 
Colestipol HCJ (Colestid)  
PAC) 
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·------- 
---------· 
··- 
Ezetimibe (Zelia)  
Rosuvastatin Calcium (Crestor) 
Fenoftbrate (Tricor, Antm·a, 
Simvastatin (Simcor, Vytorin,  Zocor) 
Lofibra, Triglide, Fenoglide and 
Trilipix) 
 
 
Antihypertensive  medications 
·-·-----·- 
-- 
 
Aldosterone antagonists  
lnspra (Eplerenone) 
Spironolactone 
Alpha Adrenergic blockers 
Cm·dura (Doxazosin) 
 Phenoxybenzamine 
Flomaxtra/Flomax (Tamsulosin) 
 Phentolamine (Rogitine)  
Hytrin (Terazosin)  
Uroxatral (Aifuzosin)  
Minipress (Prazosin) 
Alpha-2 agonists  
Catapres, Catapres TTS (clonidine) 
-· -· 
Angiotensin-converting enzyme  
Accupril (Quinipril)  
Prinivil (Lisinopril) 
inhibitors  
Accuretic (Quinipril + 
Prinzide (Lisinopril + 
hydrocholorothiazide) 
hydrocholorothiazide) 
Aceon (Perinodopril  erbumine)  
Tarim (Trandolapril  + verapamil) 
Altace(Ramapril) 
Uniretic (Moexipril + 
Capoten (Captopril)  
hydrocholoroth iazide) 
Capozide (Captopril + 
Univasc (Moexipril) 
hydrocholorthiazide) 
Vaseretic (Enalopril + 
Lotensin (Benazapril) 
hydorcholorithiazide) 
Lotensin HCT (Benazapril  + 
Vasotec (Enalopril) 
hydrochlorothiazide) 
Zestoretic (Lisinopril + 
Mavik (Trandolapril) 
hydrocholorothiazide) 
Monopril (Fosinopril)  
Zestril (Lisinopril) 
 
Angiotensin II receptor  
Atacand, Atacand  HCT 
Hyzaar (Losartan + 
antagonists  
(Candesattan) 
hydrocholothiazide) 
Aval ide (Irbesartan  + 
Micardis, Micardis HCT 
hydrocholorthiazide) 
(Telmisartan) 
Avapro (Irbesartan)  
Teveten (Eprosartan) 
Benicar (Oimesmtan) 
 Teveten HCT (Eprosartan  + 
Beniear HCT (Olmesmtan + 
hydrocholorothiazide) 
hydrocholorothiazide) 
Tribenzor (Olmesartan  + amlodipine 
Cozaar (Losartan)  
+thiazide diuretic) 
Diovan, Diovan HCT (Valsartan)  
 Twynsta (Telmisartan  + amlodipine) 
Edarbi (Azilsartanmedoxomil) 
Valturna (Valsartan  + aliskiren) 
---·-· 
Beta-adrenergic blockers  
Betapace (Sotalol)  
Lopressor HCT (Metroprolol  + 
Brevibloc (Esmolol)  
hydrocholorothiazide) 
Blocadren (Timolol)  
Normodyne (Labetalol) 
Systolic (Nebivolol) 
Sectral (Acebutolol) 

45 
Jason Pharmaceuticals,  Inc. 
BIO- J 607 (MED 0 19) 
21 June 2016; Version  1.7 
Cm?fldential 
 
-- 
...  ·-- 
Cartrol (Carteolol)  
Tenoretic (Atenolol + chlorthialidone) 
Corgard (Nadolol)  
Tenormin (Atenolol) 
Corcg CR (Carvedilol)  
Timololmaleate 
lnderal, lnnopran XL 
Toprol XL (Metoprolol) 
(Propranolol) 
Trandate (Labetalol) 
lnderide (Propranolol  + 
Viskcn (Pindolol) 
hydrochlorothiazide) 
Zebeta (Bisoprolol) 
Kerlone (Betaxolol)  
Ziac (Bisoprolol  + 
Levatol (Penbutolol)  
hydrochl01ihiazide) 
Lopressor (Metoprolol) 
 
Calcium Channel Blockers  
Adalat CC (Nifedipinc)  
N imotop (Nimodipine)Norvasc 
Afeditab CR (Nifedipine) 
(Amlodipine) 
Amturnide (Aliskiren, amlodipine  
 Plendil (Felodipine) 
and hydrochlorothiazide) 
Procardia, Procardia XL (Nifedipinc) 
Azor (Amlodipine + olmesartan)  
Sular (Nisoldipine) 
Calan, Calan SR (Verapamil)  
Tekamlo (Aliskiren  +amlodipine) 
Jsoptin, lsoptin SR (Verapamil)  
Tiazac (Diltiazem) 
Exforge (Amlodipine + valsartan)  
Tribenzor  (Oimesartan  + amlodipine 
Lotrel (Amlodipine  + benazcpril)  
+thiazide diuretic) 
Nicardipine  
Twynsta (Telmisartan  + amlodipine) 
Nifcdiac CC, Nifedical XL, 
Vascor (Bepridil) 
Nifedical  XR (Nifedipinc)  
Verelan PM (Verapamil) 
- 
- 
Central Alpha-Agonist  
Aldoril (Methyldopa+ hydrocholorthiazide) 
Catapres (Cionidine) 
Tenex (Guanfacine) 
Direct Renin Inhibitor  
Tekamlo (Aiiskiren +amlodipine) 
Tekturna (Aiiskiren) 
Tekturna HCT (Aiiskerin + hydrocholorthiazide) 
Aldosterone antagonists  
Inspra (Eplerenone) 
Spironolactone (See Diuretics for trade names) 
 
 
Alpha Adrenergic blockers  
Cm-dura (Doxazosin) 
Phenoxybenzamine 
Flomaxtra/Fiomax (Tamsulosin) 
Phentolamine (Rogitine) 
Hytrin (Terazosin)  
Uroxatral (Aifuzosin) 
Minipress (Prazosin) 
 
 
 
 
 
 
 
 
 
 
 

46 
Jason Pharmaceuticals, Inc. 
BI0-1607  (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
Appendix 2: Body Circumference Measurements 
 
 
Measurements of waist, hip, chest, upper arm, and thigh circumferences will be performed using 
a stretch-resistant anthropometric tape.  To ensure accuracy and reliability, each site will be 
carefully determined as explained below: 
 
 
• Participants should sJand straight with weight equally distributed over both legs and breathe 
normally. 
 
• All measurements will be taken in order as listed below. For all measurements, a stretch- 
resistant tape that provides a constant amount of tension and a special indicator buckle to 
identify the proper amount of tension applied will be used. 
 
• Two measurements will be obtained for each site with the measuring tape removed between 
measurements. All measurements will be recorded to the nearest 0.1 em. If the two 
measurements are different by>1.0 em, a third measurement will be obtained and recorded. 
 
1st  measurement- mid-upper arm (dominant arm)  circumference 
The upper arm is measured at the midpoint between the shoulder and the elbow, with the ann 
hanging down the side of the body in a relaxed position. The upper arm measurement should be 
made without any clothing between the measuring tape and the skin. 
 
2"d measurement - chest circumference 
The chest is measured over light clothing worn at each visit with the tape measure wrapped 
around the upper body on a horizontal plan at the level of the nipples.  The measurement should 
be obtained between the center of both nipples at the end of a normal expiration with the arms 
down at the participant's sides. 
 
3rd measurement -waist circumference 
The iliac crest will be palpated and the waist measured on a horizontal plane at the level of the 
iliac crest at the end of a normal expiration.  The waist circumference measurement should be 
made without any clothing between the measuring tape and the skin. 
 
4th  measurement- h1' p c.ircum".erence 
The hip is measured on a horizontal plane at the widest portion of the buttocks over light 
clothing worn at each visit. 
 
5
111  measurement- thigh (dominant leg) circumference 
The thigh is measured on a horizontal plane at the widest portion of the thigh, which is typically 
the midpoint between the lower buttocks and the back of the knee.  The thigh measurement may 
be taken over the same light clothing worn at each visit. 

21 June 2016; Version 1.7 
 
•
5. 
,.
•
,
' 
•
•  
" 
hB
•
r'l'P
Physical F!tDctjon 
•
• 
' 
2
.,
•
• 
' 
.. 
Appendix 3. Impact of Weight  on Quality of Life (JWQOL)-Lite Questionnaire 
 
 
Participant Initials - 
Visit No. -- 
Participant Randomization  No.--- - 
Date   
_ 
 
 
 
 
 
 
Impact of Weight on Quallty of Lifo Questlonnaire-Uto Version (IWQOL-Llto} 
 
Please answet the following staternents by circling the number that best applies 
to you in the past \>\leek Be as open as possible. There are no right or wrong 
answers. 
 
A'..WAYS 
US.l.lJ\LLY 
S.O\lLTU/..f'S 
RARELY 
MCVER 
TRL'E 
 TRUE 
 lR!J£  
 iRUE 
 HHJG 
l.  Becaif:.e c.f my weigh! I haw:-lf&Jl 
5 
3 
2 
1 
plO<.Ing ti? obj.:>.cl . 
2. 
Because  of m" weight 1   hew:tr-.Yill:t)•ing 
 5  
3 
2 
my shoes.. 
f!ecavse of rr.y WJ?Ight I ha« dirficclty· 
5 
3 
2 
get1lng u;::- !Jo.-'11 chairs. 
4. 
Becau5e c.f roy weight  l have II&lli::42- us;,ng 
5 
2 
slmrs. 
Bec.<hr:;e of my weigh! I    \I"e' dif11ccliy 
5 
3 
2 
pul:1ing oo or taldng oil  f  clolhfng. 
6. 
Becac;;se of my •Ne-Igh! I hiW€ lro<>t"M;- \W1h 
5 
:; 
2 
mf>I'.Y.M\c 
1. 
Sec:.;use cln1'/ weight I ha t!. tro,.Jte- 
5 
• 
2 
UOSSi.r.;;J Jn)'  QS. 
e. 
;!128 s..>'tOO c-1 blf.<alh \'>ith only mild e-xNh!X1. ' 
• 
3 
2 
9.  
t am truJNe<f by painful or eWt joints.  
5 
• 
:l 
2 
\0.    f,fy SJJ; ;Ies and low€r legs. are S<.\Xl!ier,al 
-5 
• 
3 
2 
end ofille day. 
H.   Iam .....ort.,;;-0  about my· heallll.  
5  
• 
" 
2
 
Self-es1oom  
A'..WAYS 
US·UAlLY  
SO tETIIJ£S  
RARELY 
t,EvER 
"TRUE 
TR'-Jf  
1RU£  
lRlJ.E 
TRUC 
!. 
Because ol my weigh! I am sel-ronsC\0'--"!>. 
5 
:; 
2 
1 
 
2. 
Beca•;;se ol my wejghl  my selt es!eem rs 
5 
2 
not Whllt i1 could be. 
3. 
Becae o!my \".'eight! feel uns:ure o! 
5 
4  
3 
2 
 
/Y(,•S2ff. 
f:Jecs;..'Se ot my weight I flon't like myseft.  
5 
• 
5. 
8ecs1.1:.e of m't' weight I am akil!;:l ot being  
5 
• 
3 
2 
rejecled. 
6.  
Secss:.e of m· weight I avoid loo k'?-J In 
5  
3 
2 
rrt\rrors m s.eeffig myself In photographs. 
7. 
Seca;:,:.e ol my weight! am erno-auassed to  
5  
3 
be seen b public places. 
 
 
 
 
 
 
 
 
i\ (',;'l"'t yh2\KifL !Jub:  t illln l ll;.' l\k l1l C<:ntc-1. Du-n:lall  .;un· pl•::Hk'ili:k> ltm:<: l(' !" 1-:.t>lo>lklll, l'h.D,,Oll<' ll) 
"'ml 0\l:thl)· or!.if>' C<:>."W:lfht :,::, ('li9J41)}.1NiJ.>; }""'": {'il'.f,)493·99:!5 (cm:;o.1l .Wdr•· -;: rl'ilk1Un-'{i\'O!hP, •..:n.'1l\ 
l\I!)OlAck- >:,,!;hit ;0 ). 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BJ0-1607 (MED 0 19) 
Confidential 
47 

21 June 2016; Version 1.7 
 
Participant's Initials---·-··---- 
Date   
 
 
 
 
Sexual Life 
I>LV
TR
«AYS 
U iJ/ LLY  
SOMGT!tl£S 
RARELY 
G'i: 
THUE 
1RlJ£  
TRUE 
5 
•  
-:1- 
2 
5  
4 
3  
2 
!:> 
4 
3 
2 
t\'LVER 
TRUE 
1 
t. 
88cause ot my welgt1! I do no!€:!''}{})' sext>a 
acti '-<'lY. 
2. 
3. 
Becau:.e o1 rHJ' wetgt11 ! t1ave Hlth? or no 
s.;::o:ual dEsire. 
Eleca,.,"Se ot m·WBlghl ! ha\<'e- dtt1iD",.¢iy v.1'ih 
wmal perlonnaru:e, 
4. 
Becs<.t:;e cf my w ghl! ava;.j sexual 
enc:x,.;niers ;,<Jhenever possible. 
5 
• 
3 
2 
 
Public Distress 
AL'/,IAYS 
TRUE 
USLMLL"f 
TlhJE 
S.::tM£TlM.£S 
TRL'£ 
Rt..RELY 
mu:: 
t>'EVGH 
TfWC 
L 
Because ot mt• weighl  r  expe.:.::nce r.ok:ule, 
tes-;;ir1g,or t.WI.Vantfill attention. 
5 
• 
3 
2 
\ 
2. 
Because ot' my we-Ight I wany sOOi.t1ii!1mg 
Into sea1s ln public places. {e.{t tt>,.;;.st&rs, 
res1auranth cars, or airplanes) 
5 
4 
3 
2 
1 
3. 
Because ol my weJghtl \'.'Orry at<hl11WJng 
lhfW;Jll ai t.es or turnstiles. 
5 
• 
3 
2 
1 
4. 
Because of my weight I Vo'Orry atxr.. finding 
chaKs lhat  are strong enough  to hOld my 
...1-i":ight 
5 
< 
-3. 
2 
1 
5. 
Beca:;;:>e of my weight I ei:perf.i::w...e 
div.::rhnP.E!ion b!{ others. 
5 
• 
3 
2 
1 
(Note: For homemakers and 
retirees. anS\'ler with respect 
to your dally activities.) 
AL".VAYS 
lRUL 
U:SIJ.<\LLY 
TRUE 
SO\iETJil£S 
lRUL 
R..\RELY 
"TRUE 
1-;'£\lCH 
THUC 
L 
f3eca;:.:_s;e of my weight 1 have tro--..DJ.s gf'!Hing 
ttmas acoomph$hed or rneetlng rn 
res.po!',sibiltl"ie'S.. 
5 
4 
3 
2 
1 
2. 
Becawe ot· m:r·weight I amless p-rc.ctmti:".•e 
tt Ell t oo·:.-4:1 be. 
5 
4 
" 
2 
1 
3. 
8o?Ci!!llS.e of my weight[  don't rerewe 
appropriate rals.e.s,promotions or 
rec  Mion s1 work. 
5 
4 
3 
2 
1 
4. 
Secau:.e of m'l welghl. I s:m afraid logo on 
job b,1er.'ie'oNS.. 
5 
• 
' 
2 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
> C >:IJ I'Igh1::•non. n-akc UJ w<:t l:> M-d ,,."! t\•ntn. D1r<.'o:t  <Jfl '''lf"  w:t:kll;;-"' t...·1 l 'w..:·<k !.. Kok•tli m, l'h.D ,, Oh:stt. · 
"-m!{)u:Jbt:• nfL  fr Ctm 1.llbt)!; (9\9.1 .t i-J.\19'.<5; F -.;;{ 1J!i.}) 49::..99:25 (..::m<:il  i!o:!..llt<:.!';: rh,JMI;it1:·,, <: hr}.;l.n'tll!) 
!'.\ I}OL·Ll.<- hq;),;J,(LI!>f_, 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
Confidential 
48 
BI0-1607 (MED 0 19) 

21 June 2016; Version 1.7 
 
 
 
 
Appendix 4. RAND-36 Questionnaire 
 
 
Participant Initials   
_ 
Visit No. 
Participant Randomization  No. -- 
Date   
_ 
 
 
1. In general,  would  you 
say 
your health  is: 
Excellent 
Very good 
 
I Good 
' 
Fair 
4 
 
 
 
 
2. Compared to one year  ago, 
how would  you rate  your health  in general 
now? 
' 
I Much better now than  one year ago 
1 
 
Somewhat  better  now than one year ago  
2 
 
3 
i 
I Somewhat worse now than  one year ago 
4 
'r 
I Much worse now than one year ago 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
Confidential 
49 
BI0-1607 (MED 0 19) 

21 June 2016; Version 1.7 
 
Participant's Initials   
_ 
Date   
_ 
 
The following items are about activities you might do during a typical day. Does your 
health  now limit you in these activities? If so, how much? 
 
(Circle  One  Number on Each  Line) 
 
 
Yes, 
Yes, 
No, Not 
Limited a 
Limited a 
limited at 
Lot 
Little 
All 
 
3. Vigorous activities, such  as 
[1] 
[2] 
[3] 
running, lifting heavy  objects, 
participating in strenuous sports 
 
 
4. Moderate activities, such  as 
[1] 
[2] 
[3] 
moving a table, pushing a vacuum 
cleaner, bowling, or playing golf 
 
 
5. Lifting or carrying groceries 
[1] 
[2] 
[3] 
 
 
6. Climbing several flights of  
[1] 
[2] 
[3] 
stairs 
 
 
7. Climbing one  flight of stairs 
[1] 
[2] 
[3] 
 
 
8. Bending, kneeling, or stooping 
[1] 
[2] 
 
 
9. Walking more than a mile  
[1] 
[2] 
 
 
10.  Walking several blocks  
[1] 
[2] 
 
 
11.  Walking one  block  
[1] 
 
 
12.  Bathing or dressing yourself 
[1] 
[3] 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BIO-I 607 (MED 0 I 9) 
Cm?fldential  
50 

 
 
Participant's  Initials--- 
Date   
_ 
 
During  the past  4 weeks, have you had any of the following problems 
with your  work or other  regular  daily activities as a result of your 
physical health? 
 
(Circle One Number on Each Line) 
 
 
Yes 
No 
 
 
13. Cut down the amount of time  you spent on work  or 
1 
2 
other activities 
 
14. Accomplished less than  you would  like  
   1 
2 
15. Were limited  in the kind  of work  or other  activities 
1 
2 
 
 
16. Had difficulty performing the work or other  activities 
1 
2 
(for  example, it took  extra  effort) 
 
 
During  the past  4 weeks, have you had any of the following problems 
with  your  work or other  regular daily  activities as a result of any 
emotional problems (such  as feeling  depressed  or anxious)? 
 
(Circle One Number on Each Line) 
 
 
No 
 
 
17. Cut down the amount of time you spent on work  or 
1 
2 
other  activities 
 
 
18. Accomplished less than  you would  like  
1 
 
 
19. Didn't  do work or other  activities as carefully as usual  
1 
 
 
 
 
 
 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 019) 
21 June 2016; Version 1.7 
Confldenfia! 
51 

 
 
Participant's Initials   
_ 
Date ------- 
 
20.  During the  past  4 weeks, to  what  extent has your  physical health 
or emotional problems interfered with  your  normal social  activities with 
family, friends, neighbors, or groups? 
 
(Circle One Number) 
 
Not at all  1 
 
 
Slightly 2 
 
 
Moderately  3 
 
 
Quite  a bit  4 
 
Extremely 5 
 
 
 
 
21.  How  much  bodily pain  have  you  had  during the  past  4 weeks? 
(Circle One Number) 
None  1 
 
Very  mild  2 
 
 
Mild  3 
 
 
Moderate 4 
 
Severe 5 
 
 
Very  severe 6 
 
 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BI0-1607  (MED 019) 
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COI?fidentiaf 
52 

 
22. During  the past  4 weeks, how much did pain  interfere with  your 
normal  work (including both  work  outside  the home and housework)? 
 
(Circle One Number) 
 
Not at all 1 
 
A little bit  2 
 
Moderately  3 
 
Quite a bit 4 
 
Extremely 5 
 
These questions  are about  how you feel and how things  have been 
with you during the  past  4 weeks. For each question, please  give 
the one answer  that  comes closest  to the  way you have been feeling. 
 
How much of the time  during  the past  4 weeks ... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BI0-1607  (MED 019) 
21 June2016;  Version!.? 
Confidemial 
53 

21 June 2016; Version  1.7 
 
Participant's Initials 
Date 
  
 
 
(Circle One  Number on Each  Line) 
 
 
 
A 
A 
Most  
Good  
  
 Little 
 None 
All of  
 of  
 Bit of  
 Some  
 of 
 of 
the  
the  
the  
of the  
the  
the 
Time  
Time  
Time  
  Time  
Time  
Time 
 
 
23.  Did you  feel  full  of  
1 
2 
3 
4 
5 
6 
pep? 
 
 
24.  Have  you  been  a 
1 
2 
3 
4 
5 
6 
very  nervous person? 
 
 
25.  Have  you  felt  so 
1 
2 
3 
4 
5 
6 
down in the  dumps 
that  nothing could 
cheer  you  up? 
 
 
26. Have  you  felt  calm  
4 
5 
6 
and  peaceful? 
 
 
27. Did  you  have  a lot  
4 
6 
of energy? 
 
 
28. Have  you  felt  
4 
6 
downhearted and 
blue? 
 
 
29.  Did you  feel  worn  
4 
out? 
 
 
30. Have  you  been  a 
4 
happy  person? 
 
 
31.  Did you  feel  tired? 
1 
2 
3 
4 
5 
6 
 
 
 
 
Jason Pharmaceuticals, Inc. 
BJ0-1607 (MED 019) 
Confidential 
54 

21 June 2016; Version  1.7 
 
Participant's Initials   
_ 
Dale   
_ 
 
32. During  the past  4 weeks, how much  of the time  has your 
physical health or emotional problems interfered with  your  social 
activities (like  visiting with  friends,  relatives, etc.)? 
 
(Circle One Number) 
 
All of the  time 1 
 
Most  of the  time  2 
 
 
Some  of the  time 3 
 
A little of the  time 4 
 
 
None  of the  time 5 
 
How TRUE or FALSE is each of the following statements for you. 
 
(Circle One Number on Each Line) 
 
 
Definitely 
True 
Mostly 
True 
Don't 
Know 
Mostly 
False 
Definitely 
False 
 
 
33. Iseem to get  
1 
2 
5 
sick a little easier 
than other  people 
 
 
34. Iam as 
1 
2 
5 
healthy  as 
anybody  I know 
 
 
35. Iexpect my  
1 
health  to get worse 
 
 
36. My health  is 
1 
2 
excellent 
 
Adapted fi·om: Ware JE Jrl, Sherbourne  CD. The MOS 36-item short-form  health survey (SF-36).!. 
Conceptual  framework  and item selection.  Med Care.  1992; 30:473-83. 
 
 
 
 
Jason Pharmaceuticals)  Inc. 
BI0-1607 (MED 0 19) 
Cm?fidential  
55 

21 June 2016; Version  1.7 
 
Appendix 5. l'rogram Questionnaire 
 
 
Participant's Initials  
Date   
_ 
Randomization no  
_ 
Circle Visit number: 
 
Visit 2 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
 
 
 
 
 
 
 
 
Questions  1 and 2 for All Groups at Visit 2 only: 
 
 
 
I.   Describe your physical activity at work or school, on average, over the last 4 weeks? 
0 Very Light (sitting at your computer or desk most of the day) 
0 Light (light industrial work, sales or office work that comprises light activity) 
0 Moderate (cleaning, kitchen stan:or delivering mail on foot or by bicycle) 
0 Heavy (heavy industrial work, construction  work or farming) 
 
 
 
2.   Describe your physical activity at leisure time, on average, over the last 4 weeks? 
0 Very Light (almost no activity at all) 
0 Light (walking, non-strenuous  cycling or gardening approximately  once a week) 
0 Moderate (regular activity at least once a week, e.g., walking, bicycling (including 
to work) or gardening) 
0 Active (regular activities more than once a week, e.g., intense walking, bicycling 
or sports) 
0 Very Active (strenuous activities several times a week) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jason Pharmaceuticals,  Inc. 
BIO-I 607 (MED 0 19) 
Confidential  
56 

57 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
 
Questions 3, 4, and 5 for All Groups to be answered at Visits 4, 5, 6, and 7: 
 
 
DIRECTIONS:   Please draw a single, verticaL_ straight, mark along the line to indicate your 
response.  The vetiiealline must intersect with the horizontal line.  Please do not circle any 
words.  Your response should indicate how you are feeling at this moment. 
 
 
 
 
 
3. 
Over the last 4 weeks, how well did you follow your assigned 
weight loss plan? 
 
 
 
Not at all 
Perfectly 
 
 
VAS measurement (mm):                                         
 
 
 
 
 
4.  Describe your physical activity at work or school, on average, over the last 4 weeks? 
 
0 Very Light (sitting at your computer or desk most of the day) 
0 Light (light industrial work, sales or office work that comprises light activity) 
0 Moderate (cleaning, kitchen staff, or delivering mail on foot or by bicycle) 
0 Heavy (heavy industrial work, construction work or farming) 
 
 
 
5.   Describe your physical activity at leisure time, on average, over the last 4 weeks? 
0 Very Light (almost no activity at all) 
0 Light (walking, non-strenuous cycling or gardening approximately once a week) 
0 Moderate (regular activity at least once a week, e.g., walking, bicycling (including 
to work) or gardening) 
0 Active (regular activities more than once a week, e.g., intense walking, bicycling 
or sports) 
0 Very Active (strenuous activities several times a week) 

58 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
 
 
Question 6:  MEDD and TSFL groups only to be answered at Visits 4, 5, 6, and 7: 
 
6.   Over the last 4 weeks, how many Medifast meal replacement products did you 
consume on MOST DAYS? (Do not count Flavors of Home meals or Medifast 
Snacks in your count.) 
 
Please circle response (limit to one answer). 
 
• 0 
• 
• 2 
• 3 
• 4 
• 5 
• 6 
• >6 

59 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
 
 
 
Appendix 6. Satisfaction and Health/Well-being Questionnaire* 
 
 
 
 
 
 
 
 
 
Based on your experience throughout the study with the weight loss plan you were assigned, how much would you 
agree/disagree  with the following statements? 
 
 
 
 
 
 
 
 
 
I. I  would  recommend this 
weight  loss plan.  
0 
0  
0  
0  
0 
 
 
 
 
3. I feel my sleep has 
improved. 
0 
0 
0 
0 
0 
 
 
 
5. The weight loss plan fit 
my lifestyle. 
0 
0 
0 
0 
0 
 
 
 
 
 
 
 
 
 
0 
0 
0 
0  
0 

60 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
 
8. I have more energy 
 
0  
0 
0  
0  
0 
 
 
 
 
 
10. I felt my hunger  was 
under control  on the weight 
loss plan. 
0  
0  
0  
0  
0 
 
 
 
 
 
 
 
 

61 
Jason Pharmaceuticals,  Inc. 
BI0-1607 (MED 0 19) 
21 June 2016; Version 1.7 
Confidential 
 
 
 
16. I feel  more confident 
0  
0  
0 
0  
0 
 
 
 
 
 
 
 
 
program tools 
were easy to use. 
0 
0 
0 
0  
0 
 
 
 
 
 
 
 
*The order of the above questions will be randomly presented to the participants.