Engaging Men From Blue-collar Industries in Weight Loss: Study 3- Evaluating the Acceptability of Weight Loss Treatments
Phase: NA
Conditions: Obesity
Sponsor: Rush University Medical Center

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
Version 1.000
Protocol 18013105-IRB01 
11 May 2022
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans – v4.0 2018-12-12 
1
Engaging men from blue-collar industries in weight loss: 
Study 3- Evaluating the Acceptability of Weight Loss 
Treatments 
Unique Protocol Identification Number: 18013105-IRB01 
National Clinical Trial (NCT) Identified Number: NCT05386238 
Principal Investigator: Melissa M. Crane 
Sponsor: Rush University Medical Center 
Grant Title: Engaging men from blue-collar industries in weight loss: Tailoring 
recruitment and treatment approaches 
Grant Number: K01DK119457 
Funded by: NIDDKD 
Version Number: v.1.000 
11 May 2022 
 
 
Title: 
Engaging men from blue-collar industries in weight loss  
Grant Number: 
K01DK119457  
Study Description: 
  
Objectives*: 
Primary Objective: Aim 1: Examine the acceptability of tailored 
behavioral weight loss program and a standard 
program in men working in blue-collar 
occupations.  
Aim 2: Compare recruitment approaches that 
vary on trust-based messaging to recruit men 
with overweight/obesity who work in blue-
collar occupations.  
Secondary 
Objectives: 
Determine the feasibility of retaining 
participants to a randomized trial over six 
months.   
Determine the reach of recruitment messages. 
Endpoints*: 
Primary Endpoint: Aim 1: Participant reported satisfaction at 3 
months.     
Aim 2: Proportion of participants who enroll in 
study by recruitment type. 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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Secondary 
Endpoints: 
Number of visits to recruitment websites by 
recruitment type.  
Participant reported satisfaction at 6 months. 
Percentage of participants who complete a 
weight assessment at the 6-month assessment 
timepoint.  
Study Population: 
Men working in blue-collar occupations with overweight or 
obesity. 
Phase* or Stage: 
Feasibility testing 
Description of Sites/Facilities 
Enrolling Participants: 
Single site 
Description of Study 
Intervention/Experimental 
Manipulation: 
This protocol is for a randomized pilot study that will test the 
acceptability of a novel weight loss program and a standard weight 
loss program in men with overweight or obesity who work in blue-
collar occupations. The secondary aim of the study is to test in a 
randomized comparison the effect of recruitment messages that 
enhance trust in two ways: researcher trust enhancement (Yes, No) x 
participant endorsement (Yes, No).  
Study Duration*: 
18 months 
Participant Duration: 
6 months 
 
 
 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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Protocol 18013105-IRB01 
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Table of Contents 
Statement of Compliance .............................................................................................................................................. 5 
Investigator's Signature ............................................................................................................................................. 5 
1 Protocol Summary ...................................................................................................................................................... 6 
1.1 Synopsis ............................................................................................................................................................... 6 
1.2 Schema ................................................................................................................................................................ 8 
1.3 Schedule of Activities ........................................................................................................................................... 9 
2 Introduction .............................................................................................................................................................. 11 
2.1 Study Rationale .................................................................................................................................................. 11 
2.2 Background ........................................................................................................................................................ 11 
2.3 Risk/Benefit Assessment.................................................................................................................................... 13 
2.3.1 Known Potential Risks ................................................................................................................................. 13 
2.3.2 Known Potential Benefits ........................................................................................................................... 13 
2.3.3 Assessment of Potential Risks and Benefits ............................................................................................... 13 
3 Objectives and Endpoints ......................................................................................................................................... 15 
4 Study Design ............................................................................................................................................................. 16 
4.1 Overall Design .................................................................................................................................................... 16 
4.2 Scientific Rationale for Study Design ................................................................................................................. 16 
4.3 Justification for Intervention ............................................................................................................................. 17 
4.4 End-of-Study Definition ..................................................................................................................................... 18 
5 Study Population ...................................................................................................................................................... 19 
5.1 Inclusion Criteria ................................................................................................................................................ 19 
5.2 Exclusion Criteria ............................................................................................................................................... 19 
5.3 Lifestyle Considerations ..................................................................................................................................... 20 
5.4 Screen Failures ................................................................................................................................................... 20 
5.5 Strategies for Recruitment and Retention ......................................................................................................... 20 
6 Study Intervention(s) or Experimental Manipulation(s) ........................................................................................... 22 
6.1 Study Intervention(s) or Experimental Manipulation(s) Administration ........................................................... 22 
6.1.1 Study Intervention or Experimental Manipulation Description ................................................................. 22 
6.1.2 Administration and/or Dosing .................................................................................................................... 26 
6.2 Fidelity ............................................................................................................................................................... 26 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING ............................................................................................ 26 
6.3 Measures to Minimize Bias: Randomization and Blinding ................................................................................. 27 
6.4 Study Intervention/Experimental Manipulation Adherence ............................................................................. 27 
6.5 Concomitant Therapy ........................................................................................................................................ 27 
6.5.1 Rescue Therapy ........................................................................................................................................... 27 
7 Study Intervention/Experimental Manipulation Discontinuation and Participant Discontinuation/Withdrawal .... 28 
7.1 Discontinuation of Study Intervention/Experimental Manipulation ................................................................. 28 
7.2 Participant Discontinuation/Withdrawal from the Study .................................................................................. 28 
7.3 Lost to Follow-Up ............................................................................................................................................... 29 
8 Study Assessments and Procedures ......................................................................................................................... 30 
8.1 Endpoint and Other Non-Safety Assessments ................................................................................................... 30 
8.2 Safety Assessments ............................................................................................................................................ 31 
8.3 Adverse Events and Serious Adverse Events ..................................................................................................... 31 
8.3.1 Definition of Adverse Events ...................................................................................................................... 31 

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8.3.2 Definition of Serious Adverse Events .......................................................................................................... 32 
8.3.3 Classification of an Adverse Event .............................................................................................................. 32 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up ............................................................ 33 
8.3.5 Adverse Event Reporting ............................................................................................................................ 33 
8.3.6 Serious Adverse Event Reporting................................................................................................................ 34 
8.3.7 Reporting Events to Participants ................................................................................................................ 34 
8.3.8 Events of Special Interest ........................................................................................................................... 34 
8.3.9 Reporting of Pregnancy .............................................................................................................................. 34 
8.4 Unanticipated Problems .................................................................................................................................... 34 
8.4.1 Definition of Unanticipated Problems ........................................................................................................ 34 
8.4.2 Unanticipated Problems Reporting ............................................................................................................ 34 
8.4.3 Reporting Unanticipated Problems to Participants .................................................................................... 35 
9 Statistical Considerations ......................................................................................................................................... 36 
9.1 Statistical Hypotheses ........................................................................................................................................ 36 
9.2 Sample Size Determination................................................................................................................................ 36 
9.3 Populations for Analyses ................................................................................................................................... 36 
9.4 Statistical Analyses............................................................................................................................................. 36 
9.4.1 General Approach ....................................................................................................................................... 36 
9.4.2 Analysis of the Primary Endpoint(s) ............................................................................................................ 36 
9.4.3 Analysis of the Secondary Endpoint(s) ....................................................................................................... 37 
9.4.4 Safety Analyses ........................................................................................................................................... 37 
9.4.5 Baseline Descriptive Statistics .................................................................................................................... 37 
9.4.6 Planned Interim Analyses ........................................................................................................................... 37 
9.4.7 Sub-Group Analyses .................................................................................................................................... 37 
9.4.8 Tabulation of Individual Participant Data ................................................................................................... 37 
9.4.9 Exploratory Analyses .................................................................................................................................. 37 
10 Supporting Documentation and Operational Considerations ................................................................................ 38 
10.1 Regulatory, Ethical, and Study Oversight Considerations ................................................................................ 38 
10.1.1 Informed Consent Process ........................................................................................................................ 38 
10.1.2 Study Discontinuation and Closure ........................................................................................................... 38 
10.1.3 Confidentiality and Privacy ....................................................................................................................... 39 
10.1.4 Future Use of Stored Specimens and Data ............................................................................................... 40 
10.1.5 Key Roles and Study Governance ................................................................ Error! Bookmark not defined. 
10.1.6 Safety Oversight ........................................................................................................................................ 40 
10.1.7 Clinical Monitoring .................................................................................................................................... 41 
10.1.8 Quality Assurance and Quality Control ..................................................................................................... 41 
10.1.9 Data Handling and Record Keeping .......................................................................................................... 42 
10.1.10 Protocol Deviations................................................................................................................................. 42 
10.1.11 Publication and Data Sharing Policy ....................................................................................................... 42 
10.1.12 Conflict of Interest Policy ........................................................................................................................ 43 
10.2 Additional Considerations ............................................................................................................................... 43 
10.3 Abbreviations and Special Terms ..................................................................................................................... 43 
10.4 Protocol Amendment History .......................................................................................................................... 45 
11 References .............................................................................................................................................................. 46 
References ........................................................................................................................................................... 46 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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Protocol 18013105-IRB01 
11 May 2022
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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following: 
o 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible 
for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) 
must be obtained before any participant is consented. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study. All changes to the 
consent form(s) will be IRB approved; a determination will be made regarding whether a new consent 
needs to be obtained from participants who provided consent, using a previously approved consent 
form. 
INVESTIGATOR'S SIGNATURE 
  
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
 
Date:05/11/22   
Name*:  
Melissa M. Crane, PhD 
Title*:  
Assistant Professor 
  
Investigator Contact Information: 
Affiliation*:  Rush University Medical Center 
Address:  
1700 W Van Buren, Suite 470, Chicago, IL 60612 
Telephone:  312-563-0269 
Email:  
melissa_m_crane@rush.edu 
 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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11 May 2022
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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
  
Title: 
Engaging men from blue-collar industries in weight loss  
Grant Number: 
K01DK119457  
Study Description: 
  
Objectives*: 
Primary Objective: 
Aim 1: Examine the acceptability of 
tailored behavioral weight loss program 
and a standard program in men working 
in blue-collar occupations.  
Aim 2: Compare recruitment approaches 
that vary on trust-based messaging to 
recruit men with overweight/obesity who 
work in blue-collar occupations.  
Secondary Objectives: 
Determine the feasibility of retaining 
participants to a randomized trial over six 
months.   
Determine the reach of recruitment 
messages. 
Endpoints*: 
Primary Endpoint: Aim 1: Participant reported satisfaction at 3 
months.     
Aim 2: Proportion of participants who enroll 
in study by recruitment type 
Secondary 
Endpoints: 
Number of visits to recruitment websites by 
recruitment type.  
Percentage of participants who complete a 
weight assessment at the 6-month assessment 
timepoint.  
Participant reported satisfaction at 6 months. 
Study Population: 
Men BMI>25 
Phase* or Stage: 
Feasibility testing 
Description of 
Sites/Facilities Enrolling 
Participants: 
Single site 
Description of Study 
Intervention/Experimenta
l Manipulation: 
This protocol is for a randomized pilot study that will test the 
acceptability of a novel weight loss program and a standard weight 
loss program in men with overweight or obesity who work in blue-
collar occupations. The secondary aim of the study is to test in a 
randomized comparison the effect of recruitment messages that 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
Version 1.000
Protocol 18013105-IRB01 
11 May 2022
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans – v4.0 2018-12-12 
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enhance trust in two ways: researcher trust enhancement (Yes, No) 
x endorsement (Yes, No).  
Study Duration*: 
18 months 
Participant Duration: 
6 months 
  
 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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1.2 SCHEMA 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
Version 1.000
Protocol 18013105-IRB01 
11 May 2022
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1.3 SCHEDULE OF ACTIVITIES 
  
Screening Baseline: 
Time 0 
Time 3: 
Week 12 
± 4 
Time 6: 
Week 24 ± 4 
Reference 
Measure 
type 
Contact information 
X 
  
  
  
  
SR 
Basic demographics 
X 
  
  
  
  
SR 
Occupational 
situation 
X 
  
X 
X 
  
SR 
Alcohol use 
X 
  
  
  
1 
SR 
Physical activity 
readiness 
questionnaire 
X 
  
  
  
2 
SR 
Weight 
  
X 
X 
X 
  
Physical 
measure 
Waist circumference 
  
X 
X 
X 
  
Physical 
measure 
Physical activity 
  
X 
X 
X 
3 . 
Staff 
interview 
Program satisfaction 
  
  
X 
X 
4 . 
SR 
Healthcare climate 
questionnaire 
  
  
X 
X 
5 . 
SR 
Program satisfaction 
interview 
  
  
  
X 
  
Interview 
Sugary beverage 
screener 
  
X 
X 
  
6 . 
SR 
Fast food screener 
  
X 
X 
  
7 . 
SR 
NCI Fruit and 
Vegetable Screener 
  
X 
X 
X 
8 . 
SR 
Weight loss strategies 
  
X 
X 
X 
9 . 
SR 
Self-weighing 
frequency 
  
X 
X 
X 
10 . 
SR 
Food shopping habits 
  
X 
X 
X 
11 . 
SR 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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Adverse Events 
Reporting 
  
  
X 
X 
  
SR 
Sessions attended 
  
  
X 
X 
  
Staff 
report 
Tracking submitted 
  
  
X 
X 
  
Staff 
report 
Demographics 
  
X 
  
  
  
SR 
Patient preference for 
treatment 
  
X 
  
  
  
SR 
Weight loss 
history/Motivations 
for weight loss 
  
X 
  
  
  
SR 
Tobacco use 
  
X 
  
  
  
SR 
Health literacy 
  
X 
  
  
12 . 
SR 
Delay discounting 
  
X 
  
  
13 . 
SR 
Medical conditions 
  
X 
  
  
  
SR 
 
 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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Protocol 18013105-IRB01 
11 May 2022
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans – v4.0 2018-12-12 
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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Men working in blue-collar occupations have a high prevalence of overweight and obesity and have high 
rates of comorbidities associated with obesity. Unfortunately, these men are unlikely to participate in 
evidenced-based weight loss interventions. Further, few efficacious interventions have been developed 
that target this population for weight control.  
  
The purpose of this study is to test the feasibility and acceptability of tailored recruitment messages and 
a novel, tailored behavioral weight loss intervention in the context of a randomized trial.   
 
 
2.2 BACKGROUND 
The prevalence of obesity has reached an all-time high in the United States,14 and the connection 
between obesity and numerous comorbidities and excess mortality has been well established.15 16 17 The 
combined prevalence of overweight and obesity is greater in men than women (79.2 vs. 76.8%), 18 and 
both genders experience various related conditions, including diabetes, heart disease and stroke, and 
some cancers.2 3 4 Despite these similar risks, men are significantly less likely than women to attempt 
weight loss,19 participate in behavioral weight loss research studies20 21 or commercial weight loss 
programs,22 or bariatric surgery23 . 
  
One subgroup of men with especially low participation rates in weight loss programs includes those 
working in blue-collar industries, which the U.S. Department of Labor defines as “precision production, 
craft, and repair occupations; machine operators and inspectors; transportation and moving 
occupations; handlers, equipment cleaners, helpers, and laborers.” 24 These industries are male-
dominated, and men who work in these industries are at increased risk for obesity and related 
comorbidities compared to the general population.25 .26 .27 For example, the prevalence of type 2 
diabetes is twice as high among truck drivers compared to the general population.26 Compared to other 
industries, overweight or obesity in blue-collar industries yields greater reduction in job performance 
and productivity, increases risk for injury, and generates higher indirect costs associated with obesity 
(e.g., costs due to absenteeism). 28 .29 .Together, these data indicate men from blue-collar industries 
would greatly benefit from participation in weight loss programs. 
  
Men-only weight loss programs that integrate men’s preferences have begun to be developed and 
evaluated. In a meta-analysis and a systematic review, these programs led to increased weight loss 
compared to no intervention. 30 .31 My prior work adds to this literature 32 . Collectively, growing 
evidence suggests this type of weight loss program has higher acceptability to men than traditional 
approaches. 

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A glaring limitation of the male-targeted weight loss studies conducted thus far is that they are 
comprised primarily of men with high levels of education. The exact occupational representation of 
these samples is difficult to quantify because occupational background is rarely assessed in health 
research.33 However, because only 7% of individuals working in blue-collar industries hold a Bachelor’s 
degree, 34 this educational threshold can be used as an indicator of an absence of individuals working in 
blue-collar industries. Like many other men-only weight loss programs, my previous intervention was 
applied to a highly educated sample in which 83% of participants had at least a college degree. Because 
research on men’s weight loss has predominately been conducted with a small, potentially non-
representative subgroup of men, we cannot assume these programs will work equally well among men 
from blue-collar industries. 
  
Tailoring interventions to occupational groups may be an effective way to reach underserved 
populations. Occupational groups have shared common experiences and social norms that 
promote/inhibit health behaviors. 33 35 Addressing these experiences and norms may be an effective way 
to tailor programs but the efficacy of this tailoring is not known. First, health promotion programs 
targeting blue-collar occupations may need to tailor content considering the masculine norms, including 
a drive towards independence and eating “masculine” foods, which are highly prevalent in this group.36 
.37  . Mahalik & Burns, 2011; Mahalik, Burns, & Syzdek, 2007; Roos, Prattala, & Koski, 2001) How to do 
this is not currently known. Second, workers in blue-collar occupations are at increased risk for injury, 
especially musculoskeletal injuries;(Charles, Ma, Burchfiel, & Dong, 2017; Dembe, Erickson, & Delbos, 
2004; Farnacio, Pratt, Marshall, & Graber, 2017; Ma et al., 2018) thus, inclusion of injury prevention 
strategies may be a key consideration. Research has demonstrated this is an effective strategy for 
smoking cession(Sorensen et al., 2002) but has not been tested for weight loss. Third, blue-collar 
occupations often, but not always, include high levels of physical activity. A common misperception 
among individuals in high-activity occupations is that they have a reduced need for leisure-time physical 
activity.(Caban-Martinez et al., 2014) However, multiple studies have shown that higher occupational 
physical activity is associated with increased all-cause mortality in men even when controlling for other 
health behaviors (e.g. smoking).(Clays et al., 2013; Coenen et al., 2018; Harari, Green, & Zelber-Sagi, 
2015; Wang, Arah, Kauhanen, & Krause, 2016) Leisure-time physical activity reduces this risk; (Clays et 
al., 2013; Harari et al., 2015; Wang et al., 2016) therefore, explicitly promoting the need for leisure-time 
physical activity, regardless of occupational activity may be needed. Finally, many workers in blue-collar 
industries report few options for healthy foods at work,(Nagler, Viswanath, Ebbeling, Stoddard, & 
Sorensen, 2013) which has been confirmed by objective assessments of work 
environments.(Apostolopoulos et al., 2011; Shimotsu, French, Gerlach, & Hannan, 2007) Providing 
guidance on selecting healthy foods in this challenging setting may be an important feature of a tailored 
intervention; but again, this has not been demonstrated. 
  
In preparation for this study, we have conducted formative studies that have focused on evaluating 
preferences men working in blue-collar occupations have for weight loss programs. These studies (Crane 
et al., under review and in preparation) have indicated that to reach this population, the intervention 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
Weight Loss Treatments 
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should be delivered online, easily incorporated into their daily lifestyles, and be presented in a 
trustworthy fashion. There was little support for programs conducted in worksites indicating a need to 
reach this population at home (versus work). As a result, this study will use a randomized design to test 
the acceptability of an intervention that incorporating these program features into a novel, tailored 
intervention. Additionally, this study will incorporate factors found to be important to participants into 
recruitment messages. 
 
 
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
The foreseeable physical, psychosocial, legal, and financial risks associated with participation in this 
study are minimal. There are minimal risks for individuals who receive the mailings as no personal health 
information will be included. The physical risks associated with participating in the intervention include 
an increased risk minor injury due to increasing leisure-time physical activity. This risk has been 
minimized by prescribing a gradual increase in physical activity, recommending walking as the primary 
form of physical activity, and repeated discussion of maintaining safety while exercising. Study 
assessments include widely used questionnaire measures. There is a very small chance that some items 
could be mildly distressing. In this event, subjects may postpone answering or opt out of distressing 
questions. 
  
There is a risk of loss of confidentiality of participant data. Steps will be taken to maximize 
confidentiality of data . Also, other participants who attend the group-based weight loss program may 
share information about their interactions with you outside of the group. The research team will ask all 
group members to respect each other’s privacy, but cannot guarantee they will do so. 
  
There are no foreseeable legal or financial risks associated with participation.  
2.3.2 KNOWN POTENTIAL BENEFITS 
Subjects may experience an improvement via weight loss. Subjects participating in the post-intervention 
interviews are not expected to directly benefit from that component of the study. The potential benefits 
to future participants are that this study may advance the knowledge of the development and 
promotion behavioral weight loss interventions to reach and engage men from blue-collar industries. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
There are minimal risks associated with this study and the potential benefits to both the participant and 
society outweigh the potential risks. This study has the potential to provide information on how to best 
reach and engage men working in blue-collar occupations in behavioral weight loss program. This is 
important due to the high rates of overweight and obesity in this population and the very low levels of 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
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participation in weight control efforts. 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
Aim 1: Examine the acceptability of 
tailored behavioral weight loss program 
and a standard program in men working 
in blue-collar occupations.  
Participant reported 
satisfaction with program 
at 3 months.   
Participant satisfaction is a proxy for 
acceptability. 
Aim 2: Compare recruitment approaches 
that vary on trust-based messaging to 
recruit men with overweight/obesity 
who work in blue-collar occupations.  
Proportion of participants 
who enroll in study by 
recruitment message 
type.  
The goal of recruitment is enrollment in the 
study. Using the proportion of participants 
who received the postcard as the endpoint 
provides an assessment of the effectiveness 
of the message.  
Secondary 
Determine the feasibility of retaining 
participants to a randomized trial over 
six months.   
Percentage of 
participants who 
complete a weight 
assessment at the 6-
month assessment 
timepoint.  
High retention to the study will indicate the 
study procedures are feasible for a fully 
powered trial.  
Determine the reach of recruitment 
messages.  
Number of visits to 
recruitment websites.  
 The website is the first indication of 
participant interest in the study. 
Determine the acceptablity of the 
intervention.  
Participant reported 
satisfaction with program 
at 6 months.   
  
Tertiary/Exploratory 
Determine percentage of participants 
who achieve a clinically significant 
weight reduction (5% of initial weight). 
Weight objectively 
assessed by study staff at 
baseline, 3 months, and 6 
months.  
5% weight loss is an established indicator of 
clinically significant weight loss.  
Evaluate participants perceptions of 
program components.  
Semi-structured 
interviews. 
We will conduct semi-structured interviews 
with participants to gain a deeper 
understanding of their perceptions of 
program components and their experiences 
in the program. 

Engaging men from blue-collar industries in weight loss: Study 3- Evaluating the Acceptability of 
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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
This study is a two-armed randomized controlled trial with assessments at baseline, 3 months after 
randomization, and 6 months after randomization. The objective is to assess the acceptability of the 
intervention to participants at 3 months and the feasibility of study procedures at 6 months with 
retention to the study as the outcome. This is a  single site, Stage 1 study. 
  
Participants will be randomly assigned to study groups by a biostatistician who is not involved with the 
study assessments or interventions using a random number generator. Individuals will be randomly 
assigned to study conditions in cohorts of approximately 30 individuals. Randomization will be 
concealed from participants until their first treatment session.  
  
Participants will be randomized to receive either the tailored BELT (Better Energy through Lifestyle for 
Tradesmen) treatment or a standard weight loss program (Diabetes Prevention Program Group Lifestyle 
Balance; DPP GLB). The groups will be matched on number of weeks of treatment, mode of delivery, and 
contact time. 
  
During recruitment for this study, we will conduct a randomized comparison of recruitment messages. 
This comparison will use a factorial design testing the effects of enhancing trust in the researchers (Trust 
Messaging: Yes, No)  and the effects of a participant endorsement (Endorsement: Yes, No). Names and 
addresses for individuals from a purchased marketing list will be randomly assigned to be sent a 
postcard with a recruitment message matching their assigned condition. Recruitment reach will be 
assessed through website visits and number of participants responding to each message. 
  
This is a feasibility study with no formal hypotheses to be tested.  
 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
This study will use a randomized design to test the feasibility of recruiting and retaining men working in 
blue collar occupations into a study of multiple weight loss programs. This study will use a previously 
tested, effective, publicly available program as the comparison group 38. The benefits of using the 
program include that all participants will receive an active intervention and we will have data on men's 
performance in a standard weight loss program as well as our tailored program at the end of this study. 
This will be key preliminary data for future grant applications. A potential problem associated with using 
this control group is that participants may not be interested in a non-tailored program if a tailored 
program is available. This may decrease both recruitment and retention to the study.  
  

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To enhance recruitment for this study and future studies, we will use a randomized, factorial design to 
test the efficacy of two components of recruitment messaging. By using this factorial design, no 
participants will be randomized to a true control group: all participants will receive a message we 
believe may be effective for recruitment of this population.  
 
 
4.3 JUSTIFICATION FOR INTERVENTION 
This protocol is a randomized feasibility trial where participants will be randomized to a standard, non-
targeted behavioral intervention (DPP GLB) or a novel tailored intervention (Better Energy through 
Lifestyle change for Tradesmen: BELT). The goal of the BELT intervention is to produce weight loss in via 
small but sustainable changes to eating and through an increase in leisure-time physical activity. The 
BELT intervention is a translation of our previously developed and tested intervention for men32 . This 
intervention, like the earlier iteration, targets Social Cognitive Theory emphasized building self-efficacy 
for behavior change through small changes to lifestyle patterns and self-monitoring. In the earlier 
intervention, men lost an average of 5% of their starting weight. The intervention has been modified 
based on formative studies targeting men working in blue-collar occupations. Most notably, the changes 
include 1) delivery via online video conferencing, 2) modification of physical activity goals, 3) change to 
the framing of the eating modification goals (from “making 6 100-calorie changes per day” to “use a tool 
at nearly every time you eat”: see Eating Goals below), 4) shift from written educational materials to 
videos, and 5) inclusion of more language and examples that tie to blue-collar works and culture. These 
translations are guided by our formative work and with input from our community advisory board. 
  
The comparison will be a group-based delivery of the Diabetes Prevention Program Group Lifestyle 
Balance (DPP GLB 2017). This is a manualized weight loss program designed to produce moderate 
weight changes through lifestyle change. The leader guides and handouts will be minimally modified for 
this study (e.g., changes appropriate for delivery via online group sessions vs. in-person) to provide a 
“standard” weight loss program comparison. The two interventions will be matched for number of 
group sessions and will be delivered by the same interventionist. 
  
One of the challenges for targeting men working in blue-collar occupation in this context is that many of 
these men do not consider themselves overweight 25 27 and avoid help-seeking behavior 39 40 . To 
overcome this, in this study, we will test recruitment messages that will not focus on weight per se and 
will instead focus on the target behaviors (eating and physical activity) and outcomes reported by 
participants in formative work as important to them (improved energy and feeling better). The 
messages will explicitly target the identity of tradesmen to increase the likelihood that men working in 
blue-collar populations will identify with the message. This tailoring of messages theoretically increases 
the effort recipients exert to process the messages, as described by the Elaboration Likelihood Model 41 . 
  

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In our experimental comparison, this study will focus on evaluating the effects of including information 
to increase trust in the program in two ways. First, trust will be enhanced by increasing the transparency 
of the intervention development and testing process. Transparency is key to building trust in medical 
research.42 "Effects of a methodological infographic on research participants’ knowledge, transparency, 
and trust." 40 41 In our formative work, participants nearly universally reported that they would join a 
program if someone personally recommended it to them. Unfortunately, relying on person 
recommendations is not possible in a large-scale study nor would the results be generalizable. Instead 
this study will test whether including an endorsement of the program by a former participant would be 
enough to increase interest in the program. 
  
  
 
 
4.4 END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he has completed the baseline assessment 
and the 6-month follow-up assessments. 
  
The end of the study is defined as completion of the 6-month follow-up assessment shown in the 
Schedule of Activities (SoA), Section 1.3. 
 
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Age 18  years and older 
2. Male 
3. Overweight or obesity (body mass index (BMI) > 25 kg/m2) 
4. Employed >20 hours per week in an occupation classified as blue collar 
5. Ability to communicate in English 
6. Provision of signed and dated informed consent form 
 
 
5.2 EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. History of bariatric surgery 
2. Diabetes managed with insulin 
3. Diagnosis of a serious mental illness 
4. Conditions contraindicated to exercise independently (determined using  four questions of Physical 
Activity Readiness Questionnaire)2 
5. Report of potentially hazardous alcohol use (ASSIST >27) 1 . 
6. Weight loss in the prior six months of 10 pounds or greater 
7. Body mass index ≥60 kg/m2, due to increased injury risk with exercise 
8. Diagnosis of an eating disorder 
9. Any major medical condition that could increase risk for injury or other contradictions for treatment (e.g., 
cancer treatment) or high likelihood of attrition (e.g., recent hospitalization for depression, psychosis) as 
determined by the study team 
 
 

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5.3 LIFESTYLE CONSIDERATIONS 
During this study, participants are asked to: 
• 
Refrain from starting medications or dietary supplements for weight or appetite control and 
• 
Refrain from participating in another weight loss program. 
 
 
5.4 SCREEN FAILURES 
During this study, participants are asked to: 
• 
Attend an in-person assessment visit and complete questionnaires online. 
• 
Attend at least one treatment session. 
Participants who do not complete the baseline assessment visit will not be randomized into the study.  
 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
Participants will be recruited via the postcards mailed to their homes. They will be directed to a study 
website where a brief description of the study will be presented. Participants recruited through the four 
recruitment messages will be sent to separate but identical websites. Participants who are interested 
will be asked to complete an online screening form. Those who appear initially eligible will be contacted 
to schedule a time to attend a study orientation. This orientation will allow participants the opportunity 
to gain information about the study and to experience the web conferencing platform (if they have not 
used it before). The session will describe the study and will use the motivational interviewing approach 
described by Kiernan and colleagues 44 .45 .46 to enhance engagement and retention to the study. 
Following this, participants will attend an in-person assessment visit where they will sign consent before 
completing the physical measures and self-report questionnaires. Participants who complete the 
baseline visit and measures will be randomized to receive either the tailored intervention or the generic 
intervention following a 1:1 randomization ratio. 
  
Recruitment will be supplemented by recruitment through flyers, notices on a hospital "on-hold" line, 
and online recruitment messages as needed. These potential participants will be encouraged to contact 
the study through the study website and will go through the recruitment process described above. 
  
All recruitment materials and plans will be reviewed and approved by the Rush University Institutional 
Review Board prior to implementation. 

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To maximize retention, we will collect multiple methods for contacting participants (e.g., email, 
telephone) at baseline. Participants will tentatively schedule their follow-up assessment during their 
initial treatment session, a method we have used in prior studies to increase retention rates. During the 
intervention, participants have not engaged with treatment for at least one anticipated sessions will be 
contacted directly by intervention staff to encourage reengagement with the program. 
  
Guidelines for attempting to schedule intervention visits. These general guidelines are intended only to 
set norms around how frequently attempts should be made to contact participants for intervention 
visits. Each attempted contact should be tracked in Research Electronic Data Capture (REDCap). Unlike 
scheduling outcomes assessments, clinical judgment can play a larger role in determining how 
“aggressively” interventionists should seek to communicate with participants. In general, it is likely most 
effective to adopt a non-judgmental tone, normalize the difficulty a participant may be having with 
engaging in the intervention, and invite participants to outline when and how we can stay in touch with 
them until they are hopefully able to reengage with the study. 
  
  
WHAT TO TRY 
WHEN TO TRY IT 
Call and/or email participants the day after missed session and 
encourage their return to group the following week. 
When first session is missed 
Increase variability and/or frequency of attempts to every 3-4 days, 
while trying to not overwhelm the participants using calling, text or 
email. 
After 1 week of no contact with study 
(e.g., no session attendance or self-
monitoring reported) 
Send a letter asking them to get in touch 
No contact for 3-4 weeks 
Call from Principal Investigator to probe for concerns or barriers to 
engagement 
When deemed appropriate, but no 
later than 5 weeks overdue 
 
 

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6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Recruitment substudy 
During recruitment for the trial, we will test the effects of recruitment messages using mailing postcards 
with four different recruitment messages to addresses of men believed to work in blue-collar 
occupations. The intervention exposure is the receipt of the postcards by potential participants. The four 
recruitment messages: 
• 
Standard recruitment message alone (e.g., “Tradesmen: Boost your energy and feel better through 
changes to eating and physical activity!”) 
• 
Standard message plus messages to enhance trust (e.g., “Join the BELT study: built for tradesmen with 
tradesmen” and “Why we are doing this: Our team wants to understand how to help men like you 
improve their health. We’ve developed a new program with input from men like you for men like you. It’s 
designed to fit into your life!”), 
• 
Standard message plus an endorsement from a prior participant (“This is a great program…safe, 
thoughtful, and effective.”) 
• 
A combined trust and endorsement message. 
An identical description of the program plus a call to action “Go to [study website] to see if you are 
eligible!] will be included in all postcards. Participants will be sent to separate but identical websites to 
allow us to track the reach of the messages via the number of independent website visits. The remaining 
recruitment process will be identical for all participants, regardless of recruitment message received. 
From the website, participants can choose to be screened for eligibility and will be randomized into the 
trial as appropriate. 
  
The BELT Intervention 
The BELT intervention will be delivered via 16- group session conducted via web-conferencing (i.e., 
Zoom) supported by short, educational videos hosted on the study website. Online groups sessions will 
allow participants to give and receive social support from peers while also minimizing disruption to 
lifestyle that would be needed for a face-to-face group session. Study staff will help troubleshoot any 
issues using this system during the intervention. Importantly, all participants will have chance to use the 
platform during the online orientation session for the study. Group sessions will be 60 minutes per 
session and will occur weekly for months 1-3, twice in month 4, and once a month in months 5 and 6. 
  
Group sessions will be accompanied by short videos that participants will view asynchronously that align 
with the topics discussed in the group sessions. These videos will be used in lieu of traditional printed 
handouts. Short videos can be an efficient way to convey the educational materials and is a familiar 
approach to participants who may have viewed educational on workplace safety in the past. Videos will 

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be short (maximum of 3 minutes) to encourage participants to view the videos regularly. Similar to 
previous men-only weight loss interventions, these will feature straight forward language, include 
humor, and will include a conversational style of speech. New videos will be posted at least once each 
week to encourage participation with the program throughout the 6-month study. Scripts for videos will 
be developed simultaneous to the leader guides for the groups sessions to ensure overlap between 
topics. The intervention guides and scripts will be developed to take an autonomous support approach 
(e.g., present multiple options for participants to choose from in making changes). 
  
The lessons in this study focus on target behaviors and skills that will aid participants in reducing their 
intake below their baseline levels (see topics in Table). The behaviors and skills align with what we used 
in our earlier study. These were identified by reviewing the literature and finding specific activities that 
have either been associated with weight loss in past studies—for example, reducing caloric beverages 
can produce weight loss over time47 or behaviors that have be targeted in other successful weight loss 
studies.48 49The goal of selecting these specific behaviors was to select behavioral targets that can be 
articulated to participants in a simple manner, monitored in a simple manner, and implemented with 
minimal lifestyle disruption. The behaviors that were expected to yield to greatest caloric reductions will 
be presented first. This is designed to help participants to begin to losing weight earlier in the 
intervention in order to prevent discouragement. Four additional lessons that focus on weight loss 
maintenance skills will be presented during months four through six. These lessons ("Relapse 
Prevention", “Eating in Social Situations”, “Slips, Slides, and Falls”, and “Maintaining Your Momentum”) 
are skill based versus focusing on specific eating behaviors. These topics were selected for use during 
the tapered contact period of the program because these are skills that support making long-term 
changes to eating and exercise behaviors. 
  
Eating behavior 
Participants will be encouraged to make several small changes to their diet throughout their day. Rather 
than providing calorie goals to stay beneath, participants will be encourage to use the “tools” (i.e., 
specific eating behaviors or change techniques) presented during group sessions and videos. Examples 
of these tools include: reducing portion sized, replacing with a lower calorie option, removing extras, 
skipping extra servings. Starting during the second group meeting, participants will be asked to identify 
aspects of their eating and physical activity habits that are not aligned with their desire to lose weight 
and that they were willing to change. Based on this self-evaluation, participants will be asked to set 
weekly goals for eating behaviors they wanted to change. As part of the self-evaluation, participants will 
be given an estimate of their daily caloric needs as well as the prescribed intake level to produce a one- 
to two-pound weight loss per week based on their weight and level of physical activity reported during 
their baseline assessment. Participants will be given a list of upcoming lesson topics and a description of 
the behaviors that indicate tools that may useful strategies to help them lose weight (see Table X). 
Taking an autonomy supportive approach, participants will be asked to consider which behaviors they 
would be most willing to change and which behaviors they are not ready to change, emphasizing their 
autonomy in the program 
  

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Physical activity 
Goals for leisure-time physical activity will be matched across interventions groups at 150 minutes of 
moderate-to-vigorous physical activity per week. In the BELT condition, participants will be given 
progressive exercise plans (starting at 0, 50, 100 minutes of activity per week) that encourage exercise 5 
days per week and will increase by 5 minutes per exercise session until the goal is reached. A distinction 
will be made between occupational activity and leisure-time physical activity with an emphasis on the 
health benefits associated with leisure-time activity. 
  
Goal setting  
At the end of each group session, participants will set a SMART goal (Specific, measurable, attainable, 
relevant, time-bound) that they will strive to achieve over the next week. Theses goals will be 
encouraged to focus on the behavior topic presented in the group session or another behavior of 
interest. 
  
Self-monitoring 
BELT will use a simplified approach to self-monitoring where participants will be encouraged to monitor 
(at a minimum) their daily weight, minutes of leisure-time physical activity, and the “tools” participants 
used to modify their eating that day. 
  
Participants will be encouraged to track this information using the diary section within the MyFitnessPal 
app. The study will create accounts within the app for participants that will give the intervention team 
access to the self-monitoring information. The team will log into the platform and email feedback on 
participant progress (e.g., monitoring completeness, weight loss, progress towards eating and activity 
goals). Participants will also use the MyFitnessPal app to closely monitor their intake during week 1 of 
the program. Continued detailed self-monitoring will be presented as a tool participants can use to help 
increase weight loss as needed but will not be required. 
  
BELT Lesson Topics 
Session 
Topic Title/Primary 
Video 
Secondary video 
Topics covered 
1 
Lifestyle change for 
weight control 
Self-monitoring 101 Energy balance, weight loss goals, self-
monitoring to increase nutrition 
knowledge 
2 
3RS: Replace, reduce, 
remove, skip seconds: 
Your everyday tools 
Self-weighing as a 
tool 
Self-regulation process;  introduction to 
tools for weight loss; motivation for 
weight loss 
3 
Balance your beverages SMART goals 
Beverages; goal setting for self-
regulation 
4 
Preventing snack attack Hungry, bored, or 
habit? 
Excess calories from snacks, choosing 
healthier snack options, evaluation of 
hunger as eating cue (vs. other cues) 

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5 
Move more!  
Do I have to 
exercise if I work all 
day? 
Exercise principles (FITT), exercise 
safety, goals, the importance of leisure-
time PA 
6 
Portion distortion 
Nutrition facts or 
fiction?  
Reading nutrition labels, estimates of 
portion sizes, how to reduce portions 
using stimulus control 
7 
Reduce in restaurants 
Quick and easy 
meals on the go* 
Eating in restaurants and on the go 
8 
Increase to decrease 
Plan your plate 
Tips for incorporating more fruits and 
vegetables into diet; introduce balanced 
plate with half fruits/vegetables 
9 
Cutting the fat 
Winning with water Reduce fat intake to reduce caloric 
density; cutting empty calories from fat; 
revisit beverage concepts and ways to 
increase water consumption 
10 
Start with breakfast 
Breakfast FAST!* 
Importance of maintaining regular 
eating patterns; suggestions for 
breakfast alternatives 
11 
Swap out sweets 
Grab and go at the 
gas station 
Reduce calories from sugar. Healthier 
alternatives when buying on the go 
12 
Fitness fights fatigue 
Round out your 
routine 
Reducing sedentary behavior to make 
time for PA; including stretching and 
resistance training to activity routine 
13 
Eating in social 
situations 
Get the help you 
need 
Social cues for eating and how to 
manage them;  Identifying places where 
social support can help with example 
scripts 
14 
Do you know your zone? Problem solving 
Self-regulation for relapse prevention; 
check in on concerns about transitions 
to independence; encourage problem 
solving around weight loss 
15 
Slips, Slides, and Falls 
Rework what's 
around you 
Relapse prevention; stimulus control 
16 
Maintaining  your 
momentum 
  
Maintaining motivation during 
maintenance 
*Written recipes will be provided instead of videos for these topics 
  
DPP GLB 
The Diabetes Prevention Program Group Lifestyle Balance program50 will be used as the comparator in 
this study. The first 16 lessons will be covered over 16, hour-long group sessions conducted online via 
Zoom. The intervention will be minimally modified from the published version except to make the 
program appropriate for online delivery (e.g., no supervised exercise sessions). The published behavior 
targets will be used (e.g., calorie and fat goals set by beginning weight). The lessons will be provided to 

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participants as PDF files. These lessons will be minimally modified (e.g., remove reference to 
pedometers). 
  
Comparison of BELT to the DPP GLB 
  
BELT 
DPP GLB 
Contact 
16 60-minute group sessions conducted 
over Zoom 
16 60-minute group sessions conducted 
over Zoom 
Educational materials 
Pocket guide + videos 
PDF handouts 
Dietary goals 
Small changes to eating behaviors 
Moderate changes to diet 
Physical activity 
150 minutes of leisure-time physical 
activity 
150 minutes of leisure-time physical 
activity* 
Self-monitoring 
Daily tracking of weight, physical activity, 
and tools used to change eating 
Daily tracking of weight, physical 
activity, and calories (after session 6) 
  
*Note. This is change from the DPP GLB as published due to the difficulties of providing pedometers 
during a remotely delivered program. 
6.1.2 ADMINISTRATION AND/OR DOSING 
  
Participants in both randomized groups will be encouraged to attend weekly group sessions months 1-3, 
two sessions in month 4, 1 session in month 5, and 1 session in month 6. All group sessions will be one 
hour in duration. 
  
 
 
6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
  
The program interventionist is an registered nurse with many years of experience delivering behavior 
change interventions. Prior to the intervention beginning, the PI and interventionist will develop (BELT) 
or review (DPP GBL) all group leader guides. The PI and interventionist will meet weekly to review the 
previous week's sessions and review the next sessions materials.  
  
A subset of group intervention sessions will be audio recorded and reviewed by the primary investigator 
using a treatment fidelity checklist. The investigator will monitor for contamination of the tailored 
program material appearing in the standard program but not vice versa. A subset of feedback provided 
to participants will also be reviewed for contamination and completeness.  
  

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6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Randomization to treatment conditions for the recruitment message substudy will be conducted by the 
study Principal  Investigator using a random number generator.  Participants will not be blind to the 
study condition but will be blind to hypotheses. Staff cannot be blinded to study arm as they will need to 
ask which recruitment message was received.  
  
In the main trial, randomization to treatment condition will be conducted by a statistician not involved 
with treatment delivery. Randomization will be revealed to participants at their first treatment session. 
Outcome assessors will be blind to treatment assignment.  
  
Though it is not possible to blind participants to the nature of the treatment they are receiving, both 
arms will be named and described as (and truly are) active treatments to eliminate expectancy effects. 
As both arms will receiving information remotely, risk of contamination is minimal. 
  
 
 
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
The interventionist will record attendance during each of the group sessions.  
 
 
6.5 CONCOMITANT THERAPY 
N/A 
6.5.1 RESCUE THERAPY 
N/A 
 
 

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7 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
When a subject discontinues from study intervention but not from the study, remaining study 
procedures will be completed as indicated by the study protocol.  If a clinically significant finding is 
identified  after enrollment, the investigator or qualified designee will determine if any change in 
participant management is needed. Any new clinically relevant finding will be reported as an adverse 
event (AE). 
The data to be collected at the time of study intervention discontinuation will include the following: 
• 
The reason(s) for discontinuing the participant from the intervention, and methods for determining the 
need to discontinue 
• 
The participant will be included in all future scheduled assessments, even though not participating in the 
intervention. 
 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
  
An investigator may discontinue a participant from the study for the following reasons: 
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up study data 
would not be in the best interest of the participant or might require an additional treatment that would 
confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded in the study 
record.  Subjects who sign the informed consent form, and are randomized and receive the study 
intervention, and subsequently withdraw, or are discontinued from the study, will not be replaced. 
 
 

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7.3 LOST TO FOLLOW-UP 
Participants will be considered lost to follow-up if they cannot be contacted for the 24-week study 
assessment within the assessment window. To minimize missing data, staff will attempt to follow up 
with all participants randomized into the study regardless of their level of participation in the 
intervention or completion of the 12-week assessment (i.e., those who fail to complete the 12-week 
assessment will be contacted to complete the 24-week assessment). Importantly, no subject is 
considered lost to follow up at any earlier point in the study, even if they miss other assessments. 
Retention efforts should continue throughout the entire duration of the study 
 
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Assessments will occur at baseline and 3 and 6 months post-randomization. Assessments will occur in 
three parts: in-person assessment, online questionnaires, and (optional) semi-structured interviews. 
  
In person assessment visits 
Participants will come to the study site for in-person assessments. Assessments will be conducted by 
study staff in private rooms. Measures include weight (measured in duplicate in street clothes with 
shoes removed and heavy objects removed from pockets), height (baseline only), and a physical activity 
interview. The physical activity interview is based on the Paffenbarger physical activity measure3 4 but 
will be conducted as an interview to allow follow up questions to correctly categorize physical activities 
reported. 
  
Online questionnaires 
Participants will be provided with a personalized link to an online survey where they will complete all of 
the self-report measures for each time point. 
  
Satisfaction with program (3 and 6 months): Satisfaction with the program questions are modeled after 
other weight control program evaluation questions51 .52 .and ask the participant to consider their 
satisfaction and their satisfaction given the effort they put into the program. The participants will also 
rate the likelihood they will continue to engage in the behaviors encouraged by the program. 
Participants in the BELT intervention will also be asked to evaluate specific program components. 
  
Eating behaviors: Vegetable intake will be assessed using the all-day Screener developed for the NCI 
Eating at America's Table Study (EATS). This 10-item questionnaire asks participants the frequency and 
amount of vegetables they consumed over the past month. Frequency of fast food consumption will be 
assessed using the questions from the CARDIA study Participants will be asked to report how frequently 
they eat fast food in a week and whether the meals are for breakfast, lunch, dinner or snacks. Beverage 
consumption will be assessed using the Family Life, Activity, Sun, Health and Eating (FLASHE) beverage 
screener. This screener assesses the frequency of drinking seven common beverages. 
  
Weight control behaviors: a 45-item questionnaire will assess how frequently participants engaged in 
specific weight control strategies 53 . These strategies include approaches to weight control encouraged 
by the program and strategies not included to assess the intervention effects. 
  
Healthcare climate questionnaire: The Healthcare climate questionnaire is an established scale54 .that 
asses the study team provided the level of autonomous support. 
  

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Substance use: Tobacco use will be asked via four yes or no questions taken from the Population 
Assessment of Tobacco and Health Study (PATH). This assesses current and lifetime smoking, use of 
electronic, smokeless, and other forms of tobacco. Alcohol consumption will be assessed using two 
questions including the number of days in the last month alcohol was consumed and the number of 
drinks consumed each time. Alcohol misuse will be assessed during screening only and will use the 
alcohol related items from the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) 
measure. 
  
Weight history questions: The survey will ask participants to report their highest, lowest, and ideal 
weight; the weight they would like to lose during the program, frequency of self-weighing, their number 
of prior weight loss attempts, their reasons for losing weight, and approaches to weight loss they have 
used before (e.g., commercial program). 
  
Demographic characteristics: Demographic characteristics as age, marital status, household members, 
income, education, occupational status, race, and ethnicity will be collected. Self-reported history of 
medical conditions will also be collected. 
  
Optional Semi-structured interviews 
Up to five participants in each treatment arm will be asked to complete a brief semi-structured 
interview about their experiences in the weight loss program they have received following the in-person 
assessment visits at 3 and 6 months. These interviews will focus on their motivation to join the program, 
their satisfaction and evaluation of the program components, and their suggestions for future changes 
to the program. 
  
 
 
8.2 SAFETY ASSESSMENTS 
Data on adverse events will be collected at each assessment point after baseline and documented as 
they arise. Unanticipated problems that are also deemed to be serious adverse events will be reported 
to the IRB immediately, and not later than 24 hours from the time the investigator becomes aware of 
the event. Any other unanticipated problem or adverse event will be reported to the IRB within 1 week. 
 
 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
The DHHS Office of Human Research Protections (OHRP) defines the following types of events in 
research involving human subjects:  Any untoward or unfavorable medical occurrence in a human 

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subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the subject’s participation in the research, whether or 
not considered related to the subject’s participation in the research. 
  
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 An adverse event that results in death; is life-threatening; results in inpatient hospitalization or 
prolongation of existing hospitalization; results in a persistent or significant disability/incapacity; results 
in a congenital anomaly/birth defect; or may jeopardize the subject’s health and may require medical or 
surgical intervention. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
  
8.3.3.1 SEVERITY OF EVENT 
The following guidelines will be used to describe the severity of an adverse event: 
Mild: Events require minimal or no treatment and do not interfere with the participant’s daily activities. 
Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
Severe: Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, the 
term "severe" does not necessarily equate to "serious". 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. 
• 
Definitely Related: There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test result, 
occurs in a plausible time relationship to study procedures administration and cannot be explained by 
concurrent disease or other drugs or chemicals. The response to withdrawal of the study procedures 
should be clinically plausible. The event must be pharmacologically or phenomenologically definitive. 
• 
Probably Related: There is evidence to suggest a causal relationship, and the influence of other factors is 
unlikely. The clinical event, including an abnormal laboratory test result, occurs within a reasonable time 
after administration of the study procedures, is unlikely to be attributed to concurrent disease or other 
drugs or chemicals, and follows a clinically reasonable response on withdrawal. 
• 
Potentially Related: There is some evidence to suggest a causal relationship (e.g., the event occurred 
within a reasonable time after administration of study procedures). However, other factors may have 
contributed to the event (e.g., the participant? clinical condition, other concomitant events). Although an 
AE may rate only as "possibly related" soon after discovery, it can be flagged as requiring more 
information and later be upgraded to "probably related" or "definitely related", as appropriate. 

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• 
Unlikely to be related: A clinical event, including an abnormal laboratory test result, whose temporal 
relationship to study procedures administration makes a causal relationship improbable (e.g., the event 
did not occur within a reasonable time after administration of the study procedures) and in which other 
drugs or chemicals or underlying disease provides plausible explanations (e.g., the participant? clinical 
condition, other concomitant treatments). 
• 
Not Related: The AE is completely independent of study procedures administration, and/or evidence 
exists that the event is definitely related to another etiology. There must be an alternative, definitive 
etiology documented by the clinician. 
8.3.3.3 EXPECTEDNESS 
 A clinician with appropriate expertise in will be responsible for determining whether an adverse event 
(AE) is expected or unexpected. An AE will be considered unexpected if the nature, severity, or 
frequency of the event is not consistent with the risk information previously described for the study 
procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and treatment sessions of a study participant. 
All AEs will be captured on the appropriate case report form (CRF). Information to be collected includes 
event description, time of onset, clinician assessment of severity, relationship to study procedures 
(assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study will be documented appropriately 
regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE. 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
Study staff will record events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study 
visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be 
followed for outcome information until resolution or stabilization. 
8.3.5 ADVERSE EVENT REPORTING 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of an adverse event and shall report the results of such evaluation to the NIH and the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working 
days after the investigator first learns of the event. 

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8.3.6 SERIOUS ADVERSE EVENT REPORTING 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of an adverse event and shall report the results of such evaluation to the NIH and the 
reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working 
days after the investigator first learns of the event. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
N/A 
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY 
N/A 
 
 
8.4 UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following 
criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved 
research protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in 
the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI's name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome 

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• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the funding agency within 24 
hours of the investigator becoming aware of the event 
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 7 days of 
the investigator becoming aware of the problem 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
N/A 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
The primary aims of this study are to examine the acceptability of tailored behavioral weight loss 
program to a standard program in men working in blue-collar occupations and to compare recruitment 
approaches that vary on trust-based messaging to recruit men with overweight/obesity who work in 
blue-collar occupations. There are no formal hypotheses to be tested.  
  
 
 
9.2 SAMPLE SIZE DETERMINATION 
This is a feasibility study. No formal sample size estimations were conducted. Instead the sample size 
was selected to produce appropriate size treatment groups (n = 15) for two interventions across two 
cohorts (N = 60). 
 
 
9.3 POPULATIONS FOR ANALYSES 
We will use an intention-to-treat analysis population where we will include all participants randomized 
to the study. Similarly, the population for the recruitment substudy includes the 4000 addressees that 
sent the postcards minus those addresses who’s postcards are returned. 
 
 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
General presentation of data will be dependent on the distributions of the final data. The majority of 
outcomes reported will be descriptive in nature.  
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
The primary outcome is acceptability of the interventions. These will be presented descriptively and will 
be reported as continuous data unless data is highly skewed in which case, the proportion of 
participants that reported that the treatment is acceptable will be reported. We will compare 
differences in the portion of participants randomized into the study by recruitment message type using 
chi-square analysis.  

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9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
  
The proportion of participant who complete the 6-month assessment visit will be compared across study 
arms descriptively. We will use binomial proportion tests to compare the number of website visits by 
recruitment message type.  
9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
N/A 
9.4.6 PLANNED INTERIM ANALYSES 
N/A 
9.4.7 SUB-GROUP ANALYSES 
N/A 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
None 
9.4.9 EXPLORATORY ANALYSES 
We will explore effect sizes for differences in proportion of participants achieving a 5% weight loss 
between groups.  
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  A copy of the consent form and consent process 
documentation form are submitted with this protocol. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
During the online screening, participants will be asked to read a brief statement about the screening 
process before they submit their contact information and complete the online screening form. This brief 
consent will cover only the screening process and associated data. Participants who are eligible to 
participate in trial will be required to attend an online orientation meeting where the study will be 
described in detail (described above). Following this, participants will meet with a study staff member 
individually, in-person to review the consent document. Participants will have time to consider their 
participation in the study between the orientation session and the consent session. Participants will be 
given the opportunity to ask questions about the study and will receive answers before the consent is 
signed. A written signature from the participant will be obtained. Participants will be given a copy of the 
consent form for their records.  
  
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants, the IRB, and sponsor and will provide the reason(s) for the termination or 
suspension. Study participants will be contacted, as applicable, and be informed of changes to study visit 
schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 

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• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other 
relevant regulatory or oversight bodies (OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY 
 Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the safety and oversight monitor(s), and the sponsor and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written 
approval of the sponsor/funding agency. 
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), or regulatory agencies may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) 
and pharmacy records for the participants in this study. The clinical study site will permit access to such 
records. 
Data management support for this project will be provided by the Data Management Center (DMC) 
within the Rush Department of Preventive Medicine. The DMC has extensive experience in the 
acquisition, maintenance, and analysis of both large and small clinical trial databases. Risks to privacy 
and confidentiality will be minimized by following a strict data management protocol. All data will be 
stored in a de-identified format. Only members of the research team will have access to identifiable 
private information. All interviewer-administered and self-report questionnaire data will be collected via 
Snap© survey (Portsmouth, NH) online data capture or REDCap (Research Electronic Data Capture; 
Nashville, TN) via laptop computers using mobile internet connections/WiFi or paper case report forms. 
Both Snap and REDCap are fully HIPPA compliant web data collection tools. Both websites and 
databases are hosted by the Rush Information Services Group. 
All Rush issued laptops and tablets are encrypted using Advanced Encryption Standard (AES) algorithm 
by TrendMicro. No data stored in an encrypted volume can be read without using the correct password. 
The DMC Server is supported by Rush Information Services. Rush servers are maintained and secured as 
follows: Rush University has two data centers in Chicago, with one located at 1700 W. Van Buren St. and 
the other at 711 S. Paulina St. All servers are located in locked data centers with access limited via a 
biometrics access system to authorized personnel. The data network is segmented and protected from 
the internet by a Palo Alto firewall. Access to the network from the internet requires multi-factor 
authentication. All network users are required to have unique logins and passwords. Complex passwords 
are required, and passwords must be changed every 180 days. Systems are backed up nightly and the 
data is duplicated and sent to an offsite storage facility. 
  

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After the study investigators have had a reasonable period of time to prepare manuscripts, study data 
sets will be stripped of all PHI to allow sharing of data without compromising participant confidentiality, 
privacy, and safety. All identification covered under HIPAA will be removed. All remaining variables not 
covered under HIPAA will be evaluated in terms of risk for deductive disclosure of identity, and 
appropriate measures will be taken to protect confidentiality. 
  
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies It is NIH 
policy that the results and accomplishments of the activities that it funds should be made available to 
the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate. 
  
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), 
has issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, 
clinical or other human subjects research funded wholly or in part by the federal government. Recipients 
of NIH funding for human subjects research are required to protect identifiable research information 
from forced disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). 
As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported 
research covered by this Policy are required to establish and maintain effective internal controls (e.g., 
policies and procedures) that provide reasonable assurance that the award is managed in compliance 
with Federal statutes, regulations, and the terms and conditions of award. It is the NIH policy that 
investigators and others who have access to research records will not disclose identifying information 
except when the participant consents or in certain instances when federal, state, or local law or 
regulation requires disclosure. NIH expects investigators to inform research participants of the 
protections and the limits to protections provided by a Certificate issued by this Policy. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
Data collected for this study will be analyzed and stored at the Rush Department of Preventive 
Medicine. After the study is completed, the de-identified, archived data will stored with Rush 
Information Services, for use by other researchers including those outside of the study. 
  
No biological data will be collected in this study. 
  
10.1.6 SAFETY OVERSIGHT 
Subject safety will be closely monitored by the investigators in conjunction with a Data and Safety 
Officer (DSO). The DSO for this study will be Lisa Ravindra, MD, an internal medicine physician who is 
familiar with the procedures for monitoring and reporting events related to safety in the context of 
research. 

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During the study startup period, Dr. Ravindra will review and approve a detailed study protocol prior to 
its implementation. She will approve the content and format of safety, accrual, and retention reports 
that will be generated by the research team. These reports will be issued every 3 months during 
intervention delivery. 
  
Dr. Ravindra’s role will also include reviewing all Adverse Events, Serious Adverse Events, and 
Unanticipated Problems, and verifying that these have been correctly adjudicated. It is within the scope 
of the DSO’s role to request additional information on any AE, and to view events in an unblinded 
fashion. The DSO will assist the PI in reporting all adverse events to the appropriate regulatory bodies in 
a timely fashion (see below). Any feedback or concerns raised by the DSO will be reported, in writing, to 
the investigators, the Rush University Medical Center IRB, and the NIH program officer. 
10.1.7 CLINICAL MONITORING 
See Section 10.1.8, Quality Assurance and Quality Control 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
The site will perform internal quality management of study conduct, data collection, documentation and 
completion. All sites will follow a common quality management plan. 
Quality control (QC) procedures will be implemented as follows: 
  
Informed consent - Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents. This review will evaluate compliance with GCP, 
accuracy, and completeness. Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
  
Source documents and the electronic data - Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database. To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. 
  
Intervention Fidelity - Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking. 
  
Protocol Deviations - The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
  
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 

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10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
 Study documents will be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Council on Harmonisation (ICH) region and until there are no pending or 
contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor/funding agency, if applicable. It is the responsibility of the 
sponsor/funding agency to inform the investigator when these documents no longer need to be 
retained. 
10.1.9.2 STUDY RECORDS RETENTION 
  
10.1.10 PROTOCOL DEVIATIONS 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, 
or the study site staff. As a result of deviations, corrective actions will be developed by the site and 
implemented promptly. 
These practices are consistent with ICH GCP: 
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
It will be the responsibility of the investigator to use continuous vigilance to identify and report 
deviations.  Within 10 working days of identification of the protocol deviation.  Protocol deviations must 
be sent to the reviewing IRB per their policies. The site investigator is responsible for knowing and 
adhering to the reviewing IRB requirements. 
  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 

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This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 4 years after the 
completion of the primary endpoint by contacting Melissa Crane, PhD. Considerations for ensuring 
confidentiality of these shared data are described in Section 10.1.3. 
10.1.12 CONFLICT OF INTEREST POLICY 
 The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.  The study 
leadership in conjunction with the NIDDK has established policies and procedures for all study group 
members to disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest. 
 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 

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FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator's Brochure 
ICH 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
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