Adaptation of a Digital Weight Loss Intervention Promoting Self-regulation for Use in Type 2 Diabetes
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Overweight and Obesity
Sponsor: University of North Carolina, Chapel Hill

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T2 Connect: Adaptation of a Digital Weight Loss 
Intervention Promoting Self-regulation for Use in Type 2 
Diabetes 
 
Unique Protocol Identification Number: UNCWR18-2805 
National Clinical Trial (NCT) Identified Number: 03650088 
Principal Investigator: Deborah Tate 
IND/IDE Sponsor: n/a 
Funded by: Michigan Center for Diabetes Translational Research 
Version Number: 3.0 
28 May 2020 
  
 
Table of Contents 
Statement of Compliance ............................................................................................................................. 4 
1 Protocol Summary...................................................................................................................................... 5 
1.1 Synopsis ............................................................................................................................................... 5 
1.2 Schema ................................................................................................................................................ 6 
1.3 Schedule of Activities (SoA) ................................................................................................................. 8 
2 Introduction ............................................................................................................................................... 9 
2.1 Study Rationale ................................................................................................................................... 9 
2.2 Background ........................................................................................................................................ 10 
2.3 Risk/Benefit Assessment ................................................................................................................... 13 
2.3.1 Known Potential Risks................................................................................................................. 13 
2.3.2 Known Potential Benefits ........................................................................................................... 15 
2.3.3 Assessment of Potential Risks and Benefits ............................................................................... 15 
3 Objectives and Endpoints ........................................................................................................................ 17 
4 Study Design ............................................................................................................................................. 19 
4.1 Overall Design .................................................................................................................................... 19 
4.2 Scientific Rationale for Study Design ................................................................................................. 19 
4.3 Justification for INTERVENTIOn ......................................................................................................... 19 
.4 End of Study Definition ........................................................................................................................ 20 
5 Study Population ...................................................................................................................................... 21 
5.1 Inclusion Criteria ................................................................................................................................ 21 
5.2 EXCLUSION CRITERIA ......................................................................................................................... 21 
5.3 Lifestyle Considerations .................................................................................................................... 22 
5.4 Screen Failures .................................................................................................................................. 22 

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5.5 Strategies for Recruitment and Retention ........................................................................................ 22 
6 Study Intervention ................................................................................................................................... 24 
6.1 Study Intervention(s) Administration ................................................................................................ 24 
6.1.1 Study Intervention Description ................................................................................................... 24 
6.1.2 Dosing and Administration ......................................................................................................... 27 
6.2 FIDELITY ............................................................................................................................................. 27 
6.2.1 Interventionist Training and Tracking ......................................................................................... 27 
6.3 Measures to Minimize Bias: Randomization and Blinding ................................................................ 27 
6.4 Study Intervention Compliance ......................................................................................................... 27 
6.5 Concomitant Therapy ........................................................................................................................ 27 
6.5.1 Rescue Medicine ......................................................................................................................... 28 
7 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal ................................ 29 
7.1 Discontinuation of Study Intervention .............................................................................................. 29 
7.2 Participant Discontinuation/Withdrawal from the Study ................................................................. 29 
7.3 Lost to Follow-Up .............................................................................................................................. 30 
8 Study Assessments and Procedures ......................................................................................................... 31 
8.1 Efficacy Assessments ......................................................................................................................... 31 
8.2 Safety and Other Assessments .......................................................................................................... 32 
8.3 Adverse Events and Serious Adverse Events ..................................................................................... 33 
8.3.1 Definition of Adverse Events (AE) ............................................................................................... 33 
8.3.2 Definition of Serious Adverse Events (SAE) ................................................................................ 33 
8.3.3 Classification of an Adverse Event .............................................................................................. 34 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up ............................................ 34 
8.3.5 Adverse Event Reporting ............................................................................................................ 35 
8.3.6 Serious Adverse Event Reporting ............................................................................................... 35 
8.3.7 Reporting Events to Participants ................................................................................................ 35 
8.3.8 Events of Special Interest ........................................................................................................... 35 
8.3.9 Reporting of Pregnancy .............................................................................................................. 35 
8.4 Unanticipated Problems .................................................................................................................... 36 
8.4.1 Definition of Unanticipated Problems (UP) ................................................................................ 36 
8.4.2 Unanticipated Problem Reporting .............................................................................................. 36 
8.4.3 Reporting Unanticipated Problems to Participants .................................................................... 37 
9 Statistical Considerations ......................................................................................................................... 38 
9.1 Statistical Hypotheses ....................................................................................................................... 38 
9.2 Sample Size Determination ............................................................................................................... 38 
9.3 Populations for Analyses ................................................................................................................... 38 
9.4 Statistical Analyses ............................................................................................................................ 38 
9.4.1 General Approach ....................................................................................................................... 38 
9.4.2 Analysis of the Primary Efficacy Endpoint(s) .............................................................................. 38 
9.4.3 Analysis of the Secondary Endpoint(s) ....................................................................................... 38 
9.4.4 Safety Analyses ........................................................................................................................... 38 
9.4.5 Baseline Descriptive Statistics .................................................................................................... 39 

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9.4.6 Planned Interim Analyses ........................................................................................................... 39 
9.4.7 Sub-Group Analyses .................................................................................................................... 39 
9.4.8 Tabulation of Individual Participant Data ................................................................................... 39 
9.4.9 Exploratory Analyses .................................................................................................................. 39 
10 Supporting Documentation and Operational Considerations ............................................................... 40 
10.1 Regulatory, Ethical, and Study Oversight Considerations ............................................................... 40 
10.1.1 Informed Consent Process ........................................................................................................ 40 
10.1.2 Study Discontinuation and Closure .......................................................................................... 40 
10.1.3 Confidentiality and Privacy ....................................................................................................... 40 
10.1.4 Future Use of Stored Specimens and Data ............................................................................... 41 
10.1.5 Key Roles and Study Governance ............................................................................................. 41 
10.1.6 Safety Oversight ........................................................................................................................ 42 
10.1.7 Clinical Monitoring .................................................................................................................... 42 
10.1.8 Quality Assurance and Quality Control..................................................................................... 42 
10.1.9 Data Handling and Record Keeping .......................................................................................... 42 
10.1.10 Protocol Deviations ................................................................................................................ 43 
10.1.11 Publication and Data Sharing Policy ....................................................................................... 43 
10.1.12 Conflict of Interest Policy ........................................................................................................ 43 
10.2 Additional Considerations ............................................................................................................... 44 
10.3 Abbreviations .................................................................................................................................. 44 
10.4 Protocol Amendment History ......................................................................................................... 44 
11 References ............................................................................................................................................. 46 
12 Appendix ................................................................................................................................................ 50 
 
 
 

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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. 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
T2 Connect: Adaptation of a Digital Weight Loss Intervention Promoting Self-
regulation for Use in Type 2 Diabetes 
Study 
Description: 
The purpose of this study is to adapt a previously developed weight loss app  
implementation with a study population living with impaired glucose (pre-
diabetes or type 2 Diabetes (T2DM)), integrating daily monitoring of blood 
glucose (BG) using continuous monitoring (CGM) into the intervention) and 
to conduct a pilot and feasibility study on the short-term impacts of the 12-
week intervention in overweight adult patients with pre-diabetes or T2DM 
not being treated with medications to gather preliminary data in preparation 
for an R01 submission. 
Objectives: 
Primary Objective: 
The primary objectives of the study are to 1) review 
previously developed weight loss intervention features 
and adapt them to the needs and perspectives of those 
with impaired glucose or type 2 diabetes in a new 
modified intervention, 2) conduct a pilot and feasibility 
study on short-term impacts of the intervention in 
overweight adult patients with T2D not treated with 
medication (n=20) in preparation for an R01 submission. 
Secondary Objectives: To explore the effect of the intervention on short-term 
blood glucose control, perceived self-control, and 
perceived quality of life. 
 
Endpoints: 
Primary Endpoint: 
• 
Change in body weight (kg) from baseline to 12 
weeks. 
Secondary Endpoints: • 
Change in Body Mass Index from baseline to 12 weeks. 
• 
Change in HbA1c from baseline to 12 weeks. 
• 
Change in compliance behavior and efforts at diabetes 
self-control from baseline to 12 weeks as measured by 
the Diabetes Locus of Control Scale 
• 
Change in Diabetes-related Quality of Life from 
baseline to 12 weeks as measured by the Diabetes 
Obstacles Questionnaire. 
Study 
Population: 
Adults 18-65 years old with BMI 25-40 kg/m2 who meet the criteria for pre-
diabetes or  type 2 diabetes and who do not take medication to manage their 
blood glucose. 
Phase: 
Pilot 

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1.2 SCHEMA 
Pre-Screening 
<Time Point, 
e.g., Day -30 to  
Description of 
Sites/Facilities 
Enrolling 
Participants: 
Participants will be recruited and enrolled at the UNC Weight Research 
Center in Chapel Hill, NC. 
Description of 
Study 
Intervention: 
The intervention will be delivered through weekly in-person or virtual individual 
sessions; a mobile iphone app that integrates diet, weight, and physical activity; and 
continuous blood glucose data, to support self-regulatory behaviors. In the first 
weekly session, participants will be oriented to the intervention and provided with 
their self-monitoring tools. They will be encouraged to weigh and track physical 
activity with a wearable activity monitor, “Red” foods (using a simplified dietary self-
monitoring approach that classifies foods in a “Traffic Light approach”, weight using 
a wifi-enabled digital scale, and blood glucose daily (Abbot Freestyle Libre 
Continuous Glucose Monitor). They will be taught to use self-regulatory techniques 
for weight management and glycemic control. Similar to blood glucose self-
regulation, participants are taught to compare the number on the scale each day to 
a standard or goal (weight loss goal) and, depending upon the comparison, make 
changes to their diet (i.e., Green foods or Red foods) and physical activity (i.e., 
moderate to vigorous physical activity (MVPA) or sedentary behavior (SB)) as 
needed. All participants will be given an initial weight loss goal of 5%. 
Study Duration: Approximately 12 months – participants will be accrued on a rolling basis.   
Participant 
Duration: 
Up to 4 months (screening and enrollment + 12-week intervention + follow-up 
assessment).  
Pre-screen potential participants by inclusion and exclusion criteria. 

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Day 1> 
<Day -30 to  
Day 1> 
 
<Day -30 to  
Day 1> 
 
 
<Day -30 to  
Day 1> 
 
<Day -30 to  
Day 1> 
 
 
In Person  
Visit 1 
 
<Day 1> 
In-person/ 
Virtual Visits  
1-12 
<Days 7- 91> 
 
 
In Person/Virtual  
Visit 2 
<Day 91 +/-7> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-screen 
Pre-Consent 
Pre-In-
person 
Visit 1 
In-person 
Visit 1 
Day 1 
Pre-In-
person 
Visit 2 
Day 91  
+/-7 
In-person 
Visit 2 
Day 91 +/-
7 
Administer study intervention individual coaching sessions 1-12 
Final Assessments 
< refer to Section 1.3, Schedule of 
Activities> 
Conduct in person or virtual orientation. Refer to Section 1.3, Schedule of Activities 
Conduct informed and physician consent process. Refer to Section 1.3, Schedule of Activities 
Complete assessment questionnaires. Refer to Section 1.3, Schedule of Activities 
Complete Kickoff Session 
Perform baseline assessments to determine eligibility. Refer to Section 1.3, Schedule of Activities 

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1.3 SCHEDULE OF ACTIVITIES (SOA) 
 
 
Web Screening 
 
X 
 
 
 
 
Phone Screening  
 
X 
 
 
 
 
Orientation 
(In-person/Virtual) 
X 
 
 
 
 
Informed Consent 
 
 
X 
 
 
 
Physician Consent 
 
 
X 
 
 
 
Demographics 
 
 
X 
 
 
 
Contact Information 
 
X 
 
 
 
 
iPhone Information 
 
 
X 
 
 
 
Height 
 
 
 
X 
 
X 
Weight 
 
 
 
X 
 
X 
BMI 
 
 
 
X 
 
X 
HBA1c 
 
 
 
X 
 
X 
Diabetes-Specific Locus of 
Control 
 
X 
 
X 
 
Diabetes Obstacles 
Questionnaire 
 
X 
 
X 
 
Technology Acceptance 
Model-Continuous Glucose 
Monitoring 
 
X 
 
X 
 
Glucose Monitoring 
Satisfaction Survey 
 
X 
 
X 
 
Technology Acceptance 
Model-CGM-Follow-up 
 
 
 
X 
 
Program Evaluation 
 
 
 
X 
 
 
Medical Events 
 
 
 
 
 
X 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
 
Type 2 diabetes (T2D) represents a global public health crisis and is associated with increased rates of 
morbidity, mortality, and medical expenditures (1). Despite advances in prevention and treatment, rates 
do not appear to be subsiding (2,3). Of those living with T2D in the U.S., nearly 90% are overweight or 
obese (NIDDK). Modest reductions in weight (> 5%) have been shown to reduce symptoms, improve 
glycemic control, and reduce or eliminate pharmacotherapy regimens (4-6). Rates of conversion from 
prediabetes (impaired glucose) to diagnosed type 2 diabetes are of particular concern. It is estimated 
that 425 million adults worldwide are living with diabetes, representing a pronounced increase over the 
past few decades (7,8). In the United States, approximately 84 million adults (more than 1 out of 3) have 
prediabetes; however, 90% of people with prediabetes don’t know they have it. Risk factors for 
prediabetes include overweight and lack of physical activity. While not everyone who is obese develops 
type 2 diabetes, obesity greatly increases the risk of developing type 2 diabetes.  
 
In a 2017 Consensus Statement by the American Association of Clinical Endocrinologists and the 
American College of Endocrinology, the authors recommend weight loss of 5-10% for those with T2D 
whose BMI is > 25 kg/m2 through comprehensive lifestyle intervention (9). Comprehensive lifestyle 
interventions are the gold standard in the behavioral treatment of obesity and diabetes (10). These 
evidence-based interventions include diet and physical activity prescriptions to reduce energy intake 
and increase expenditure; employ a variety of behavioral techniques to support these changes; and 
include in-person support from a multi-disciplinary team of interventionists. Changes in diet and activity 
as well as weight loss are essential for glycemic control in T2D. Lack of glycemic control leads to cardio- 
and micro-vascular complications that can significantly contribute to morbidity and mortality.  
 
Glycemic control is generally measured using glycosylated hemoglobin (HbA1c), which evaluates longer-
term (~over 3 months) management of blood glucose (BG) with a goal of <7% (11). More intensive daily 
monitoring of BG is associated with better glycemic control; however, few individuals with T2D not 
taking insulin follow a structured self-monitoring blood glucose (SMBG) regimen. Studies show that 
patients with T2D often lack the knowledge and skills to interpret BG information to make the necessary 
behavior changes to improve glycemic control (12,13). Use of SMBG has mixed results in the limited 
trials that have been conducted (14); however, there is evidence that it can be effective when patients 
monitor multiple times daily and are taught how to use the information (15). Therefore, optimizing 
SMBG with state-of-the-art knowledge of how it may be enhanced by and incorporated within effective 
behavior change may identify previously unrecognized benefits. In particular, incorporating SMBG in a 
lifestyle intervention may contextualize glucose levels more specifically, provide relevance to self-
regulatory behaviors, increase feelings of self-control, and, thereby, improve ongoing self-management 
of T2D. 

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This pilot and feasibility study of an intervention called T2 Connect, will serve several aims toward 
applying for future NIH funding. The study will establish the feasibility of recruiting this population, 
integrating blood glucose self-monitoring data into the weight loss intervention and adaptation of the 
Traffic Light monitoring approach for weight loss in adults living with impaired glucose. These data and 
experiences, if promising, combined with data from prior studies, will position the team to apply for an 
R01 to demonstrate the initial efficacy of the intervention in a larger study population.  
2.2 BACKGROUND 
  
Comprehensive lifestyle interventions are intensive and typically result in average weight losses of 8-
10% (11). Despite their overall efficacy, 30% or more of participants do not respond to treatment (i.e., 
lose 5% of initial body weight, which has been shown to confer clinically significant improvements in 
disease risk and outcomes) (16). There are many hypothesized reasons for non-response to treatment, 
including non-adherence to diet and exercise prescriptions and poor self-monitoring. Self-monitoring is 
a cornerstone in behavior change interventions (17) that, while effective, can be burdensome. Non-
adherence may be due to psychological factors such as lack of feelings of control over disease 
management, low self-efficacy for change, or feelings of deprivation; cognitive factors such as 
intervention complexity and burden; and physical factors such as hunger or discomfort with physical 
activity. Effective interventions must promote sustainable changes in behavior which are reinforced by 
an individual’s self-efficacy for engaging in the behaviors and positive reinforcement for attaining 
desired outcomes.  
 
Self-regulation of behavior is an intervention approach to manage weight and to control blood glucose. 
Self-regulation involves having a goal, having access to information about whether the goal is being 
achieved, and if not, taking steps to restore equilibrium. Self-regulation has been widely applied to type 
1 diabetes, where an individual must be knowledgeable about the level of blood glucose they are trying 
to achieve, monitor their glucose to see if there are discrepancies between their goal and their actual 
blood sugar, and then if there are discrepancies, they must adjust their diet, exercise, or insulin dose to 
reduce the discrepancy. Self-monitoring of blood glucose has been achieved by serial finger sticks 
throughout the day, although emerging technologies including continuous self-monitoring and flash self-
monitoring are becoming more widespread and associated with tighter control (18).  
 
Those who can adhere to self-monitoring are more likely to master self-regulation. In one study, 
patients with diabetes reported a fairly high willingness to self-monitor, which authors relate to the 
controllability of the disease (19). Being able to see the impact of one’s behaviors on outcomes of 
interest (i.e., weight and glucose) may increase feelings of control and self-efficacy and provide the 
internal rewards that will sustain the behavior changes desired. We have successfully applied self-
regulation in the context of weight loss and weight gain prevention interventions with the use of daily 
weighing to regularly assess outcome to inform diet and physical activity behaviors. Across the 
interventions, there was a high acceptability of daily weighing as a behavior change tool (20-23).  

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Diet self-monitoring is consistently associated with weight loss success across behavioral interventions 
(17), however, self-monitoring decreases over time. Diet self-monitoring traditionally consists of 
recording the types, amounts and nutritional content (typically calories and fat content) of all foods and 
beverages consumed daily for the duration of intervention. In a six-month weight loss study, self-
monitoring adherence peaked at week 2 and dropped significantly after week 3. Other studies have 
shown adherence decline by 5 weeks (24-28). While mobile technologies introduced in the past 15 years 
have improved adherence, there remains a high percentage of program participants who are unable to 
monitor all foods eaten and meet a reduced calorie goal over an extended period of time, resulting in 
suboptimal weight outcomes.  
 
Adherence to physical activity recommendations for weight management and diabetes control among 
individuals with T2D is also modest with the majority of patients generally sedentary (29,30). 
Interventions that use trackers (i.e., pedometers and accelerometers) to self-monitor physical activity 
have been effective in increasing physical activity in patients with T2D. However, comprehensive 
lifestyle interventions have similar rates of non-adherence to physical activity recommendations as 
dietary recommendations with only a subset of participants reaching recommended levels of MVPA 
(31). Emerging research suggests that reducing sedentary behavior in T2D also benefits glycemic control 
(32,33).  
 
Self-monitoring blood glucose (SMBG) is an established treatment protocol in type 1 diabetes and in T2D 
treated with insulin. However, in those with T2D controlled through oral medications, SMBG is not 
common and, if implemented, is often not the structured regimen that is recommended for insulin-
treated diabetes. A recent meta-analysis of SMBG with non-insulin treated T2D estimated modest 
reductions in HbA1c of 0.17% compared to no SMBG and a 0.27% reduction with structured compared 
to non-structured SMBG (15). Given the effectiveness of structured monitoring, the International 
Diabetes Federation recently supported structured monitoring for patients with non-insulin treated T2D 
as key component of care (34). Despite recommendations, clinical practice suggests that even if patients 
are monitoring BG, many do not use the information to modify their lifestyle or medications due to lack 
of knowledge or skills around self-management (13,35). Given the value of self-monitoring not only BG 
but also diet, physical activity and weight, an intervention that teaches the skills to self-regulate 
behaviors based on glucose and weight measurements could enhance improvements in glycemic 
control. 
 
Diet, physical activity and weight loss directly affect blood sugar and vascular outcomes and the 2017 
Consensus statement has specific recommendations for the diet and exercise prescription in T2D. It 
recommends weight management through a diet that is primarily plant-based, high in polyunsaturated 
and monounsaturated fatty acids, limited in saturated fatty acids and avoidance of trans fats, and 
limited sucrose-containing or high-glycemic index foods. Achievement of at least 150 minutes of 
moderate to vigorous physical activity (MVPA) (preferably > 175 minutes which has been significantly 
associated with weight loss in Look AHEAD (6) is also recommended. 
 

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Our research team has been conducting comprehensive behavioral lifestyle interventions for prevention 
of type 2 diabetes for over 15 years. Studies have used in-person, group and individual behavioral 
counseling with particular emphasis on uses of digital technology to support behavior change.  We have 
published trials using daily weighing for weight loss (22) and for long term weight gain prevention (21). 
Both of these trials demonstrated significant benefit from the daily weighing interventions compared to 
controls.  
 
We have also piloted a Red foods monitoring approach using mobile phones in mothers of preschool 
children. The Smart Moms study was a 6-month randomized controlled trial that tested the efficacy of a 
smartphone delivered intervention to reduce sugar-sweetened beverage and juice consumption among 
children ages 3-5 and maternal weight compared to a waitlist control group. The primary focus of the 
study was on limiting children’s sugar-sweetened beverages, but mothers were also given dietary goals 
to help them lose weight, which included limiting caloric beverages to 8 fl. oz. per day and limiting “red 
foods” from the Traffic Light Diet to half of their baseline level of intake. To encourage adherence 
throughout the study, they engaged in a simplified form of self-monitoring that consisted of tracking 
their beverages, the number of times (not servings or calories) they consumed a “Red” food from the 
Traffic Light diet, and their weight daily in a small paper diary. They submitted their weekly totals via 
text message at the end of each week, which were used to create personalized feedback on their 
progress. Mothers also accessed lessons on a mobile-optimized website and received 3-4 text messages 
throughout the week. At 6 months, mothers in the Smart Moms group lost 2.4 kg at 6 months compared 
to a 0.9-kg gain in the control group (p < .01) (36). This Red foods monitoring approach was well 
received and will be adapted to the needs of type 2 diabetes in this study.  
 
Another pilot successfully used daily weights from wireless scales along with objectively measured PA 
data using Fitbits. The WELL Body study evaluated the feasibility and efficacy of two 6-month 
interventions that used wireless scales, with or without activity trackers, and focused on daily self-
weighing (DSW) to promote weight gain prevention among African American breast cancer survivors. 
African American women (n=35) were randomized to one of three groups: 1) DSW + activity tracking 
(INT+); 2) DSW (INT); or 3) delayed intervention control (CON). Intervention participants received a 
wireless scale and activity tracker (INT+ only) that transferred objective data to a mobile app and 
website, email lessons on weight control, and tailored feedback on objective weight (and activity data). 
The intervention encouraged use of DSW as the primary self-monitoring strategy to prevent weight gain. 
Participants in the INT+ group additionally were encouraged to track their physical activity daily. At 6 
months, 62.5% of intervention participants were at/below baseline weight; those who weighed 6-7 
days/week (n=10; 42%) lost more weight than those who weighed <6 days/week (-4.9±6.3% vs. -
0.3±2.6%, p=0.02). Intervention groups maintained weighing frequency over the study period,  
with no decreases from week 1 to 24 (INT+, p=0.41; INT, p=0.14). Both intervention groups endorsed 
being very likely to continue DSW after the program and had favorable experiences with the scales, 
trackers and DSW (easy to do, easy to remember, helpful, positive) (20).  
 
In this study, we will explore the feasibility of daily monitoring of BG and weight, self-monitoring of 
diet using the simplified Traffic Light system, self-monitoring of physical activity using a Fitbit 

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tracker, and appropriate displays of data in the app to facilitate comprehension and decision making 
to meet the needs of this patient population. It is hypothesized that the positive feedback achieved 
through the self-regulation loop results in improvements in feelings of control and goal attainment, 
which reinforce behaviors over time, resulting in sustainable behavior change and weight loss. 
  
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
Emotional distress or Embarrassment (infrequent). We believe that potential psychological risks to 
participants are small. It is possible that some participants may find questions included in the 
questionnaires to be slightly emotionally distressing or embarrassing. Additionally, a participant may be 
embarrassed if friends, family, or acquaintances find out that the person is participating in or not 
successful in the program. However, these instances should be mild and rare to infrequent as they have 
the right to refuse to answer any questions. Participants will be encouraged to contact the Principal 
Investigator if they feel they have incurred any emotional distress as a result of study participation. As 
this is a voluntary study, a participant is free to exit the study at any point if they feel uncomfortable or 
do not want to continue. 
  
Breach of confidentiality (infrequent). We expect a breach of confidentiality to be rare or infrequent. 
Most communication during the study period will take place via telephone, direct emails, or through the 
smartphone app either to deliver questions, conduct assessments, or remind participants to complete 
questionnaires. We do not anticipate any risks of harm as a result of these communications, however 
there is always a possibility that their scale data, tracker data, or activity in the app will be intercepted. 
  
Steps to Ensure Confidentiality of Participants: All data records related to a participant’s involvement in 
this research study will be stored in a locked file cabinet and/or in encrypted files on servers that adhere 
to the University policy on storage and transmission of sensitive data. Participant identity on these 
records will be indicated by an ID number, and the information linking these numbers with participant 
identity will be kept separate from the research records. In addition, all research databases will have 
password-controlled access, and this will be controlled by critical staff.  
  
The Fitbit API will be used to access data from participants' scale, activity tracker, and Fitbit app. During 
the consent process, participants will consent for the data from their specific device IDs to be accessed 
by our study. They will need to enter their Fitbit username and password during the app setup process 
to allow Fitbit data to be sent to our study server. The study smartphone app uses a Standard OAuth 2.0 
security model for logging in to Fitbit. The study uses temporary access tokens that are stored only on 
the user's device and is not stored on our servers. Therefore, Fitbit usernames and passwords will not be 
stored in any way with this study. Instead, the weight and tracker data will be connected to participants 
by their unique study ID that they will also enter during the app setup process. Data are transmitted on 
secure servers that adhere to the University of North Carolina at Chapel Hill policy on Sensitive Data. The 
risk of breach of confidentiality over the Fitbit websites will be partly subject to each individual’s 

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comfort in sharing information in their individual profile. To further minimize the risk of breach of 
confidentiality, all participant activities on the Fitbit websites will be voluntary. Consent forms will also 
clearly communicate the risk of this type of disclosure to participants. 
  
There are no major physical risks associated with participation in the study, which involves using a smart 
scale, activity tracker and glucose monitor, or the data collection visits. 
  
1. Risks of physical activity: Infrequent risk. It is possible that participants may increase their physical 
activity in response to data and feedback viewed on the activity tracker. There may be some risk to 
increasing physical activity, including, but not limited to, injuries to the muscles, ligaments, tendons, and 
joints of the body. Other risks include abnormal blood pressure, fainting, dizziness, disorders of heart 
rhythm, exacerbation of exercise-induced asthma symptoms, and very rare instances of heart attack, 
stroke, or even death. To help ensure safety, information on exercise safety will be provided to all 
participants. 
  
Minimization of risks: To ensure medical readiness to begin physical activity, participants will complete a 
physical activity readiness questionnaire (PAR-Q). The PAR-Q assesses for the following medical 
conditions: heart problems, chest pains, faintness or dizzy spells, high blood pressure, bone, or joint 
problems such as arthritis that has been or could be aggravated by exercise, prescription medication 
use, and other medical reasons why exercise would not be advisable. Participants endorsing yes to any 
items on the PAR-Q (experience of heart problems, frequent chest pains, faintness or dizziness, bone or 
joint problems, on prescription medications for blood pressure or a heart condition) will be excluded 
from the study.  
 
We also will monitor any major musculoskeletal problems that develop during the intervention (e.g., 
broken bones) using a medical events questionnaire at 3 months and determine whether these appear 
related to our study. Participants who develop musculoskeletal problems or other health problems that 
may affect safe participation will be instructed to stop exercising until the problem resolves and their 
physician approves resumption of physical activity. 
  
Participation is fully voluntary, and we will ask participants to report any problems to the study 
researchers. 
  
2. Risk of wearable devices: There is also the possibility of minor skin irritation associated with wearable 
devices. 
 
Minimization of risk: We will recommend taking the device off occasionally, not wearing it too tightly, 
and keeping it clean and dry. If participants experience skin irritation, we will suggest that they contact a 
member of the study team to discuss the issue and determine whether they would like to continue 
participating in the study. 
  

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3. Risk of using a phone while driving: It is dangerous to pay attention to a cellular phone while driving, 
walking, or doing any activity that requires attention. 
  
Minimization of risk: We will strongly recommend that participants exercise good judgment on this 
while participating in this study and will ask that they not open the application or view any notifications 
or messages while they are driving. 
  
4. Risk of CGM: There is a small risk that the adhesive used to attach the sensor to the arm will cause 
skin irritation. 
 
Minimization of risk: Through instructions on usage of the CGM will be provided to the participant at the 
beginning of the study. Proper placement and care will be emphasized and, if irritation does occur, 
participants will be instructed to discontinue use of the sensor and alert the study staff. 
  
5. Risk of finger stick: Approximately 3 drops of blood will be removed by finger stick. This is a standard 
method used to obtain blood for routine hospital laboratory tests. The participant may experience pain 
when the lancet goes into their finger. Other than this momentary pain, the discomfort of finger stick 
should be minimal. However, in about 10% of the cases a small amount of bleeding under the skin will 
produce a bruise (hematoma). A small scar may persist for several weeks. The risk of local infection is 
less than 1 in 1,000. 
  
Minimization of risk: Staff are trained in the sanitary collection of blood using gloves, prepping the area 
with an alcohol swab, having the participant apply pressure to the finger after the finger stick and 
application of a bandage if needed. 
  
2.3.2 KNOWN POTENTIAL BENEFITS 
This study may help researchers understand the acceptability of CGM in a pre-diabetes and T2D 
population and determine if incorporating daily monitoring of BG within the context of a behavioral 
weight loss intervention promotes self-regulation and adherence to lifestyle changes necessary for 
weight loss. Given the widespread prevalence of T2D and obesity, this study could inform larger trials 
that could lead to clinical recommendations. 
 
The benefits of participation in a short-term program that includes weighing, increasing physical activity, 
and dietary changes may include weight loss and short-term improvements in activity and eating. 
Increased physical activity and healthier eating can also lead to other improvements in health, such as 
improved cardiovascular outcomes. Better glucose control (over time) could result in fewer vascular 
complications. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during weekly individual coaching sessions. 

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All AEs, not otherwise precluded per the protocol, will be captured on the appropriate adverse events 
form.  
 
A Medical Events questionnaire will be administered at the 12-week follow up assessment. To capture 
any adverse events not reported during the individual coaching sessions. 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
Change in weight (kg).  
Weight change at 12 weeks 
The primary goal of the 
intervention is weight loss, thus 
change in weight is appropriate 
Secondary 
1. Change in Body Mass Index 
(BMI)  
 
2. Change in HbA1c from 
baseline to 12 weeks. 
 
 
 
 
 
3. Change in compliance 
behavior and efforts at 
diabetes self-control from 
baseline to 12 weeks as 
measured by the Diabetes 
Locus of Control Scale 
 
4. Change in Diabetes-related 
Quality of Life from baseline to 
12 weeks as measured by the 
Diabetes Obstacles 
Questionnaire. 
Change in measures at 12 weeks 1. BMI is commonly used to 
assess level of overweight. 
 
2. Change in HBA1c is a valuable 
diagnostic clinical measure for 
glucose management over the 
past 3 months and is 
responsive to changes in diet, 
physical activity and weight. 
 
3. Change in compliance 
behavior and efforts at 
diabetes self-control may 
moderate weight loss and 
HbA1c outcomes. 
 
 
4. Change in obstacles to adhere 
to diabetes treatment 
recommendations may 
moderate weight loss and 
HbA1c outcomes. 
Tertiary/Exploratory 
To examine the feasibility of using 
Continuous Glucose Monitoring in 
overweight individuals as an 
indicator of response to diet and 
physical activity behavior 
modification to promote weight 
loss. 
 
Acceptability and effectiveness of 
the Traffic Light diet Red food 
monitoring 
1. Responses to Glucose 
Monitoring System 
Satisfaction Survey and 
Technology Acceptance 
Model-Continuous Glucose 
Monitoring at 12 weeks. 
2. Adherence to Blood Glucose 
monitoring 
 
1. Adherence to Traffic Light 
diet monitoring across the 
12-week intervention 
  

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Association between adherence 
to Red food goals and change in 
weight  

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
This project will test a weight loss intervention delivered through a mobile app for use in non-
medication treated type 2 diabetics and pre-diabetics. The app is designed to integrate self-monitoring 
data from wireless scales and physical activity trackers, allow self-monitoring of foods through a Traffic 
Light diet approach, serve as a portal for feedback on behaviors and outcomes, and provide a platform 
for behavioral lessons. We will use the app coupled with in-person support to inform future versions.  
 
We propose a single arm pilot trial testing the feasibility of a behavioral weight loss intervention for 
adults with type 2 diabetes or prediabetes. Participants will be instructed to decrease intake of Red 
foods, weigh daily, monitor BG using a CGM system, and gradually increase minutes of physical activity. 
This 12-week intervention is aimed at promoting improvements in diet quality consistent with 
recommendations for T2D, a decrease in energy intake, an increase in energy expenditure, and modest 
weight loss with a goal of improving glycemic control. Participants will meet weekly with a lifestyle 
counselor (interventionist) to review data on all behaviors, weight, and BG. The session will include 
feedback on progress, discussion of core content, problem solving and goal setting.  
 
Participants will be given activity trackers (Fitbit Inspire) and wireless digital scales (Withings) to use for 
the duration of the study. Dietary behaviors will be monitored using an app that our research team has 
developed to track foods using the Traffic Light system. Assessments will occur at baseline and 12-
weeks. Weight will be collected in the clinic on calibrated digital scales (Tanita) during in-person 
counseling sessions. Adherence measures will include self-monitoring and activity tracking, attendance 
at individual sessions and achievement of weekly diet and activity goals.  
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
This study is specifically designed to test the feasibility of conducting the intervention as well as to 
collect preliminary data to be used to develop and propose a larger randomized controlled trial. The 
proposed research is funded under a pilot/feasibility research program with limited funding. Therefore, 
a single group design with a limited number of participants is acceptable. 
 
4.3 JUSTIFICATION FOR INTERVENTION 
Weight loss is recommended for individuals with overweight or obesity and impaired glucose. Behavior 
change interventions are the first line of treatment and are effective at reducing weight and improving 
glycemic control. Weight loss of 5-10% is associated with clinical improvements. 
 
Digital weight loss interventions that integrate behavior change techniques and supports including diet, 
physical activity, and weight self-monitoring have been shown to be effective for weight loss in adults. 

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Expert support is also a key component of behavioral weight loss interventions. In this study, we will use 
human counseling rather than automated feedback in order to best gather feedback and impressions on 
the feasibility of implementing this intervention given the exploratory nature of using the Traffic Light 
approach for diet monitoring and CGM for this non-insulin dependent population. 
 
.4 END OF STUDY DEFINITION 
The end of the study is defined as completion of the 12-week 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: 
• 
Currently age 20-65 years 
• 
Diagnosed with type 2 diabetes or pre-diabetes  
• 
Poor glycemic control (HbA1c > 5.7%)  
• 
BMI 25-40 kg/m2  
• 
Own an iPhone with a data and text messaging plan  
• 
Have home Wi-Fi access  
• 
Have the ability to read, write, and speak English  
• 
Not meeting the American College of Sports Medicine recommendation of 150 minutes of 
Moderate to Vigorous Physical Activity each week  
• 
Ability to attend weekly visits at the UNC Weight Research Program clinic  
• 
Can obtain primary care provider consent that appropriation is appropriate 
5.2 EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
• 
Lost more than 10 pounds in the last 6 months  
• 
History of weight loss surgery  
• 
Currently participating in another physical activity or weight loss program or research study that 
may interfere with participation in this study  
• 
Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous 
physical activity  
• 
Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within 
the next 4 months  
• 
Planning to relocate in the next 4 months  
• 
Cannot attend weekly visits at the UNC Weight Research Program clinic  
• 
Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, 
as determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire) 
• 
Treatment of diabetes with insulin or oral medications  
• 
Report taking prescription or over the counter medication with a known impact on metabolism 
or weight  
• 
Current treatment for cancer  
• 
History of clinically diagnosed eating disorder  
• 
Diagnosis of schizophrenia or bipolar disorder  
• 
Hospitalization for a psychiatric diagnosis within the last year  
• 
Report a past diagnosis of or current symptoms of alcohol or substance dependence  
• 
Unwilling or unable to wear the CGM device continuously for the duration of the study  
• 
On dialysis  
• 
Have an implanted medical device such as a pacemaker 

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All participants will be required to obtain consent from their primary care provider in order to 
participate. 
5.3 LIFESTYLE CONSIDERATIONS 
During this study, participants are asked to: 
• 
Refrain from using over-the-counter medications, dietary supplements, and prescribed 
medications for the purposes of weight loss; however, they will not be withdrawn if use is 
reported. Medication usage will be assessed at the pre-enrollment screening and change in 
medications, as well as adverse medical events, will be assessed at the 12-week study visit and 
documented in the Medical Events questionnaire.  
 
5.4 SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study.  An example of a screen failure 
would be a participant who comes for the baseline assessment and does not meet the eligibility criteria 
(such as a BMI or HbA1c that is out of eligible range).  
If the participant does not meet inclusion criteria, staff will inform the individual that they do not meet 
criteria for this particular study and ask if they would be interested in being contacted about future 
studies. 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment 
Participants meeting diagnostic criteria for Type 2 diabetes (not treated by medication) and prediabetes 
will be recruited from the community through informational listservs, as well as through the UNC Health 
Care system using lists generated by the Carolina Data Warehouse. 
  
If needed, we will use the UNC Informational listserv and boosted Facebook posts to advertise as well. 
Interested participants will be directed to a web page with study information. If they wish to determine 
their eligibility, they will complete an online REDCap screening questionnaire. Participants initially 
eligible on the web screen will be contacted by phone to complete screening. 
 
All recruitment advertisements will encourage potential participants to visit a website with study 
information (purpose, eligibility criteria, time commitment, and incentives). The recruitment website 
will also have a link to a preliminary online screening questionnaire, which directs participants to a 
secure REDCap survey. Initial screening of basic eligibility and demographics will be done online, 
including questions on age, race/ethnicity, height, weight, basic health history, type 2 diabetes 
diagnosis, access to technology and availability to participate. If the individual is initially eligible, study 

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staff will contact the individual by phone for complete screening. Individuals who are ineligible will be 
notified via email. 
  
All individuals who respond to our advertising will be eligible for enrollment independent of gender and 
race/ethnicity. As women are generally over-represented in weight control studies, we do not anticipate 
having inadequate representation by women. Also, given the diversity of the patient population in the 
UNC system and similar (if not higher) rates of overweight among minorities, access to participation will 
not be limited for these groups. 
  
Enrollment 
Once an individual has been deemed potentially eligible to participate, they will be invited to the clinic 
for an orientation to the study where study staff will provide further information about the study and 
allow the potential participants to ask questions. This procedure, whereby potential participants have a 
chance to determine if the study is a good fit for them, has been effective in our past studies for high 
rates of retention. If the individual decides to participate, they will provide informed consent for 
participation. They will have their height, weight, and HbA1c measured and complete questionnaires. 
After completion of the baseline assessments, the in-person individual sessions will begin.  
 
COVID-19 Modifications: 
Orientation sessions were delivered via Zoom after March 15, 2020. If the individual decides to 
participate, study staff will send an email link to the Informed Consent Form for the study participant to 
review and electronically sign in REDCap. Once the consent is signed, the online study questionnaires 
will be deployed to the participant. Once questionnaires are complete, the participant will be scheduled 
to attend the baseline assessment visit at the clinic and to attend the kickoff session. 
  
Incentives 
Participants will receive $15 for completing the baseline assessment and $25 for completing the 12-
week assessment. Participants who complete the 12-week assessment will be allowed to keep the Fitbit 
and scale.  
 
The small incentives are meant to offset the time for completing the study questionnaires, 
transportation costs for coming to clinic for assessments, and to ensure that we get adequate follow-up 
data once the study has been completed by the participant. The Fitbit and scale are relatively affordable 
devices that are widely available to the general public. 
  
 
 

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6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
  
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
Intervention. The intervention is delivered through weekly in-person individual sessions and a mobile 
iphone app that integrates diet, weight, and physical activity data to support self-regulatory behaviors. 
Additionally, participants use a Continuous Glucose Monitoring system to track and manage blood 
glucose. In the first weekly session, participants are oriented to the intervention and provided with their 
self-monitoring tools. They are encouraged to weigh and track PA, Red foods and BG daily and taught to 
use self-regulatory techniques for weight management and glycemic control. Similar to blood glucose 
self-regulation, participants are taught to compare the number on the scale each day to a standard or 
goal (weight loss goal) and, depending upon the comparison, make changes to their diet (i.e., Green 
foods or Red foods) or physical activity (i.e., moderate to vigorous physical activity (MVPA) or sedentary 
behavior (SB)) as needed. All participants are given an initial weight loss goal of 5%.  
 
Dietary Intervention  
Participants are guided to follow a Traffic Light Diet approach where foods are categorized into Green, 
Yellow, and Red categories. Users are encouraged to increase Green foods, moderate Yellow foods, and 
limit Red foods. Foods in the Green category include fruits, vegetables and certain very lean proteins. 
They are low in calories, fat, and sugar, and rich in nutrients. The high volume, water content and fiber 
in fruits and vegetables and the protein from the lean meats and egg whites in this category help 
promote satiety while consuming fewer calories. The Yellow category includes moderately lean proteins, 
legumes, low fat dairy, whole grains, starchy vegetables, and low fat dressings. These foods are higher in 
calories than green food but are still a good source of nutrients. Red foods are high in calories, fat, 
and/or sugar and are not a good source of nutrients. The goal in the Traffic Light Diet is to increase 
Green foods and to limit Red foods. This emphasis on increasing healthful eating has been hypothesized 
to reduce feelings of deprivation and hunger (37,38). In the Traffic Light approach followed in this study, 
users are allowed unlimited Green foods and are not given a specific target for Yellow food servings. 
 
Each participant is given a personalized Red foods limit, which is determined by baseline weight. The 
intent of the goal is to result in a caloric reduction of 500-1000 per day. Participants are asked to 
monitor all of their foods for the first two weeks in order to orient them to the Traffic Light Diet system 
and to give them and their counselor a good idea of their overall intake pattern. After the first two 
weeks, they have the option to only monitor Red foods. During individual counseling sessions, 
interventionists have the option to set a goal for Green and/or Yellow foods and have the participant 
monitor those in the app, and/or to reduce the participant’s Red Food limit if weight loss is not 

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progressing as desired. Lesson content encourages building healthy meals around green foods and 
participants are provided with meal plans and recipes that models this meal pattern. 
 
Baseline Weight 
Red Food 
Limit 
< 200 lbs 
3 
200 - < 250 lbs 
4 
250+ lbs 
5 
 
Physical Activity Intervention  
The physical activity goal for the study is to progress the participant to at least 150 minutes of moderate 
to vigorous physical activity per week. An initial goal is  based on baseline levels of PA as reported by the 
participant. Progression will occur each week based on individual progress of the participant.  
 
Baseline Weekly 
MVPA 
Active Minutes Goal 
< 50 
10 min/day 
50-75 
15 min/day 
76-100 
20 min/day 
101-125 
25 min/day 
126-149 
30 min/day 
Maximum 
60 min/day 
 
 
PA GOAL PROGRESSION 
When total active minutes for the week is equal to or above [AM Goal*5], then increase daily 
goal for the next week by 5 minutes 
Otherwise, active minutes daily goal remains the same the next week 
Example, if goal is 15 min/day, the 5-day equivalent would be 75. If participant gets 80 min, 
then daily goal increases by 5, to 20 min/day. But if participant only got 60 min, then their daily 
goal for the new week would stay at 15 min/day 
 
Intervention app  
During the first individual session, the interventionist will work with the participant to download the app 
onto the participant’s smartphone, familiarize them with the app, and set personal goals for weight, diet 
and physical activity, and BG monitoring.  
• 
Weight Goal and Monitoring: Participants will be provided a Withings Wi-Fi Smart Scale digital 
scale and instructed on setup and procedures for daily weighing.  
• 
Dietary Goal and Monitoring: Interventionists instruct on the Red foods list and monitoring of 
Red foods in the app. They will be instructed on portion size estimation and self-monitoring best 
practices (timing proximal to consumption). During the first week, participants will be advised to 
monitor all of their foods and work towards meeting their daily Red food goal.  
• 
Physical Activity Goal and Monitoring: Participants will be provided with a Fitbit Inspire and will 
set up the device and the app to allow for data transfer. They will receive a weekly physical 

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activity goal based on baseline physical activity reported on the online screener. Participants will 
also be advised on using the Fitbit to monitor sedentary time and to target sedentary behavior 
throughout the day.  
• 
BG Goals and Monitoring: Participants will be provided with an Abbott Freestyle Libre device, 
which is a Continuous Glucose Monitoring (CGM) unit. Recent advances in technology have 
made CGM much less invasive and simplified, thereby allowing for a better picture of glucose 
control given the number of data points available without the burden that previous CGM units 
presented. The interventionist will work with the participant to set goals for monitoring and 
ensure comprehension of CGM procedures. Study participants will be instructed on placement 
of the CGM sensor on the back of the arm. The sensor is worn for 14 days continuously, and 
then replaced. The participant will scan the sensor using a handheld device or iPhone at 
different points throughout the day (upon waking, before meals, 1 ½ - 2 hours after meals, but 
no less than every 8 hours) and to “mark” eating and activity events in the scanning device or 
iPhone app. The data will be uploaded to the Freestyle Libre system. The study interventionist 
will have access to the data through a web-based portal and will review this information with 
the participant at weekly coaching sessions. Participants will be taught to interpret their blood 
glucose information and to use it to inform diet and physical activity behaviors.  
• 
Feedback: The app provides graphical feedback comparing goals to behaviors and a weekly 
feedback message from the counselor that encourages adherence to the goals of daily weighing, 
monitoring and meeting Red foods and physical activity goals. For the purposes of this study, 
more rigorous intervention feedback will be delivered by the interventionist at weekly sessions.  
 
Behavioral Lessons  
A standard behavioral intervention based on the DPP (used by Dr. Tate effectively in both face to 
face and Internet formats) will be adapted for this protocol. Behavioral weight control approaches 
are founded on teaching skills and providing the support necessary to enable participants to adhere 
to the diet and physical activity prescription in their intervention. For the dietary intervention, 
materials will be adapted to reflect the Traffic Light Diet focus and modules for decreasing sedentary 
behavior will be added to those for increasing MVPA. Materials will be adapted with a focus on T2D. 
Additional materials and activities will be added specifically on self-regulation of weight and BG in 
relation to diet and physical activity behaviors. Lessons will be presented within the app. Brief 
review of the content will be done during individual sessions to assess comprehension and to 
explore personal applications. 
 
Coaching Support  
Individual counseling sessions will be semi-structured and led by Master’s level or higher 
interventionists trained in behavioral weight control. Sessions will occur weekly (12 sessions) and 
typically last 30-45 minutes. For the first 4 weeks of the study, all sessions will be conducted at the 
UNC Weight Research Program clinic. Participants will be encouraged to attend in-person sessions 
for the duration of the study, however they will be given the option to complete the remaining 8 
sessions through phone or video chat (Zoom) if desired. (Note: the remote mode of delivery became 
the primary delivery mode due to COVID-19 restrictions.)   

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6.1.2 DOSING AND ADMINISTRATION 
Described in section above 6.1.1 
 
6.2 FIDELITY 
  
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
To ensure intervention fidelity, study meetings will be held weekly. At these meetings, the research 
team will discuss issues relevant to study progress, including enrollment, participant safety (adverse 
events), participant retention, and protocol compliance. Summaries of the team meeting minutes will be 
available for inspection when requested by any of the regulatory bodies charged with the safety of 
human subjects and the integrity of data including, but not limited to, the oversight of the Office of 
Human Research Ethics (OHRE) Biomedical IRB, or the North Carolina TraCS Institute Data Safety 
Monitoring Board (DSMB). 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING  
This is a single arm study. Therefore, randomization is not applicable. 
 
Due to the size of this pilot study and staffing limitations during the COVID-19 pandemic, study staff will 
not be blinded for the assessments. Assessment staff will be trained and strictly adhere to assessment 
protocol. 
6.4 STUDY INTERVENTION COMPLIANCE 
Interventionists will review food, weight, and activity progress through an administrative web portal 
prior to individual sessions. During the weekly session, the interventionist will review self-monitoring 
records with the participant, set weekly goals, review behavioral lesson content introduced in the app, 
facilitate problem solving of any barriers the participant is having, and adapt treatment 
recommendations based on the needs of the participant. 
  
6.5 CONCOMITANT THERAPY 
For this protocol, participants will be discouraged from using over-the-counter medications and dietary 
supplements, and prescribed medications for the purposes of weight loss; however, they will not be 
withdrawn if use is reported. Medication usage will be assessed at the pre-enrollment screening and 
change in medications, as well as adverse medical events, will be assessed at the 12-week study visit and 
documented in the Medical Events questionnaire. 

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6.5.1 RESCUE MEDICINE 
N/A 
 
 

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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
Discontinuation of the study intervention without withdrawal from the study will only occur at the 
request of the participant if they are no longer willing or able to adhere to the study intervention for 
personal (not medical or safety) reasons. When a subject discontinues from the study intervention but 
not from the study, final assessment measures will be completed as indicated by the study protocol 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. Participants 
will be withdrawn from the study should they experience greater than minimal risk as described in 
section 2.3. 
In addition, an investigator may discontinue a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the 
study objectives  
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Participants who become pregnant during the study, as weight loss is contraindicated. 
• 
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 on the Case 
Report Form (CRF). Subjects who sign the informed consent form and are randomized but do not receive 
the study intervention may be replaced.  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. 
The research team will provide continuous monitoring of participant safety and periodic reporting to the 
UNC IRB as required, including any Unanticipated Problems/Severe Adverse Events that may have 
occurred during the study. Data safety and monitoring activities continue until all participants have 
completed trials and until all participants have been followed to the point at which study-related 
adverse events would likely no longer be encountered. 

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 7.3 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they fail to return for the 12-week follow up 
assessment visit and study staff are unable to contact the participant after at least 3 attempts.  
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant, reschedule the missed visit within 4 weeks of 
the scheduled time frame, counsel the participant on the importance of maintaining the 
assigned visit schedule, and ascertain if the participant wishes to and/or should continue in the 
study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up 
 
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 EFFICACY ASSESSMENTS 
Note: Refer to the Schedule of Activities 1.3 for the timing and frequency of assessments. 
  
Screening and Orientation 
Screening, orientation, and enrollment procedures are described in section 5.5. At each point, study 
staff will confirm eligibility, as described. The participant has the choice to discontinue participation at 
any point. If participation is discontinued by staff or the participant, screening information will be held 
for the duration of the study and identifiers will be destroyed after the study is complete. Reasons for 
ineligibility will be retained for descriptive purposes. 
 
Physical Measurements 
Weight (kg) (primary outcome): Participants will be weighed wearing shorts and without shoes using a 
calibrated digital Tanita scale. Trained study staff will conduct these measurements following a 
standardized protocol. Two measures will be completed and the average of the two will be used. If the 
difference between the two measures exceeds 0.2 kg, a third measure will be taken. 
  
Height (cm): Height will be measured at baseline using a wall-mounted stadiometer (Country 
Technology Inc, WI). Two measures of height will be taken and the average of the two will be used. If the 
two measures are not within 0.5 cm, a third measurement will be taken 
  
BMI: Height and weight will be used to calculate BMI. 
  
HbA1c will be measured with a fingerstick and analyzed on a point of care unit (Afinion Alere). 
   
REDCap questionnaires: 
Demographics. Participants will provide demographic information at baseline. They will provide age, 
gender, race/ethnicity, weight, and smoking history. (Baseline only)  
 
Diabetes Specific Locus of Control.  
We will administer an 18-item questionnaire consisting of three domains measuring diabetes-specific 
internal locus of control, powerful other locus of control, and chance locus of control (39). 
 
Diabetes Obstacles Questionnaire. This is a diabetes-related quality of life questionnaire consisting of 
30 items using a 5-point Likert-scale addressing social, psychological, cognitive, and behavioral obstacles 
(40).  
 

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Glucose Monitoring System Satisfaction Survey. This is a 15-item survey consisting of four scales 
including Emotional Burden, Behavioral Burden, Openness, and Trust. The survey is validated in Type 1 
and Type 2 diabetes patient populations and assesses satisfaction with the device and its impact on 
quality of life. We have slightly modified four items to replace "diabetes" with "blood sugar" to better 
align with our population and research aims (41).  
 
Personal Diabetes Questionnaire. This questionnaire will be used both as a secondary outcome to test 
the effect of the intervention as well as an assessment tool to inform the counselor at baseline in order 
to personalize the intervention. The following scales will be used: Weight Change Readiness Dietary 
Knowledge and Skills, Diet Decision Making, Eating Problems. Diet Barriers, Physical Activity, and 
Exercise Barriers. This is a validated measure of diabetes self-care behaviors, perceptions and barriers 
(42).  
 
Technology Acceptance Model-Continuous Glucose Monitoring. This survey assesses usability and 
predictors of adherence to using the CGM device. Subscales include perceived reliability, information 
overload, technology-related self-efficacy, usefulness, ease of use, attitude, visibility of body change, 
and intention. We have added an item to assess helpfulness with weight management (in addition to 
blood sugar control) (43). 
  
Program Satisfaction. Participants will be asked to complete a post-treatment program evaluation. 
Questions will ask about participants’ perceptions and experiences with the intervention and may 
provide valuable information about how to modify the programs for future use in this population. 
Participants will be asked to report their overall satisfaction with the intervention they received. 
Additional satisfaction questions will assess specific treatment components including the topics of the 
weekly lessons and use of the app and activity tracker for self-monitoring. Post-intervention only. 
  
Feasibility Measures. Adherence to digital scale use; activity tracking and physical activity patterns 
captured by the Fitbit; Blood Glucose monitoring and outcomes; Red food monitoring; and attendance 
at individual counseling sessions will be tracked. 
 
Medical Events. Adverse medical events and changes to medications will be assessed at 12 weeks (staff 
administered). 
8.2 SAFETY AND OTHER ASSESSMENTS 
Safety management in this study is intended to achieve 4 objectives: 1) to minimize the occurrence of 
adverse effects; 2) to effectively manage adverse events as they relate to the study; 3) to identify when 
the intervention should be suspended because of concerns for participant safety; and 4) to determine 
when the intervention may be resumed after having been suspended. 
  
Should any concerns arise during data collection, they will be addressed immediately by study personnel 
and the PI will be notified as soon as possible. Though unlikely, should any concerns arise after data 

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collection, subjects will be given the study coordinator's contact information to share their concerns and 
the PI will address concerns directly or through appropriate referrals. Any concerns that arise over the 
course of the study will be recorded and aggregated as part of the feasibility data and shared with the 
research team and the IRB as necessary. 
 
We do not anticipate that any questions, anthropometric measurements, observations will cause 
discomfort or embarrassment, but participants may stop or refuse collection of data at any time. 
Participants will be informed of potential safety risks in the informed consent. 
 
The research team will provide continuous monitoring of participant safety and periodic reporting to the 
UNC IRB as required, including any Unanticipated Problems/Severe Adverse Events that may have 
occurred during the study. Data safety and monitoring activities continue until all participants have 
completed trials and until all participants have been followed to the point at which study-related 
adverse events would likely no longer be encountered. 
  
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered 
intervention-related. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
A possible SAE is any event that may meet the following criteria (complete one SAE form for each 
event): 
a. An event that was life threatening, or placed the participant at immediate risk of death 
b. An event that caused persistent or significant disability or incapacity (lasted at least one month 
and changed the participant’s life) 
c. An event that required or prolonged a hospitalization 
d. A pregnancy that resulted in a congenital anomaly or birth defect 
e. Death 
f. An event that caused other significant hazards or potentially serious harm to research subjects 
or others 

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8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
  
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity.  
• 
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 
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.  
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a 
causal relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an 
alternate etiology has been established. 
8.3.3.3 EXPECTEDNESS 
A clinician with appropriate expertise in behavior and physiological adaptation 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 assessment visits and individual coaching sessions. 
 

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All AEs, not otherwise precluded per the protocol, will be captured on the appropriate adverse events 
form. Information to be collected includes event description, time of onset, clinician’s 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. 
 
Kristen Polzien 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 study team 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 
The research team will report to the UNC IRB as required, including any Unanticipated Problems/Severe 
Adverse Events that may have occurred during the study. Data safety and monitoring activities continue 
until all participants have completed the trial and until all participants have been followed to the point 
at which study-related adverse events would likely no longer be encountered. 
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 a serious adverse event and shall report the results of such evaluation to 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 
NA 
8.3.8 EVENTS OF SPECIAL INTEREST 
NA 
8.3.9 REPORTING OF PREGNANCY 
Participants who become pregnant during the study will be withdrawn and the intervention will be 
withdrawn as weight loss is contraindicated. Pregnancies will be reported on the Medical Events form, 
should they occur. 

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8.4 UNANTICIPATED PROBLEMS 
  
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
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 PROBLEM REPORTING 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the lead principal investigator (PI). 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  
• 
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 DCC/study 
sponsor/funding agency within <insert timeline in accordance with policy> 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 
<insert timeline in accordance with policy> of the investigator becoming aware of the problem  

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• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within <insert timeline in accordance with policy> of the 
IRB’s receipt of the report of the problem from the investigator 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
NA 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
• 
Primary Efficacy Endpoint(s): n/a 
• 
Secondary Efficacy Endpoint(s): n/a 
9.2 SAMPLE SIZE DETERMINATION 
Sample size was not determined using statistical methods. This was a pilot and feasibility study and the 
sample size was determined based on funding and logistics.  
9.3 POPULATIONS FOR ANALYSES 
The analysis population will be Intention-to-Treat (ITT) (i.e. all randomized participants) 
9.4 STATISTICAL ANALYSES 
  
9.4.1 GENERAL APPROACH 
App utilization will be explored using descriptive statistics examining sums of weighing days, tracker 
wear, days of BG monitoring, and days tracking Red foods. Preliminary analysis of change over time in 
weight and A1c will be conducted using paired t-tests. Estimates of change on physiologic and 
psychologic variables, along with others in the literature, will be used to estimate effect sizes for the 
R01.  
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
See 9.4.1 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 See 9.4.1 
 
9.4.4 SAFETY ANALYSES 
Safety endpoints will be analyzed as summary statistics during treatment and/or as change scores from 
baseline. 
Each AE will be counted once only for a given participant), presented (e.g., expectedness, severity, 
frequency, and relationship of AEs to study intervention will be presented by System Organ Class (SOC) 
and preferred term groupings.  

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AE start date, stop date, severity, relationship, expectedness, outcome, and duration will be reported. 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
See 9.4.1 
9.4.6 PLANNED INTERIM ANALYSES 
NA 
9.4.7 SUB-GROUP ANALYSES 
 NA 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 NA 
9.4.9 EXPLORATORY ANALYSES 
  
 
 

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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 details of the study intervention, study procedures, and risks will be given to 
the participant and written documentation of informed consent will be completed prior to starting the 
study intervention.   
The following consent materials are submitted with this protocol: 
• 
Participant informed consent 
• 
Physician's consent 
• 
Online screener 
• 
Telephone screener 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
If the participant is deemed eligible and decides to participate, the participant will complete the consent 
form on-site or the study staff will send a link to the study participant to read and electronically sign the 
consent in REDCap. 
  
All participants are required to obtain consent to participate from their Primary Care Provider. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study has no pre-specified criteria for discontinuation or closure. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
Assessment data will be collected and managed by study staff. Online data collection will be done 
through RedCap, and paper forms will be entered by study staff into a RedCap form. Data will be stored 
without identifiers. After all study activities are completed, data will be de-identified. Longitudinal 
measurements will undergo consistency and outlier checks, be compared with raw data, and edited as 
required. Audit trails will be used to document any database changes. 
  

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To ensure confidentiality of participants, all survey data and scale/tracker/dietary records related to a 
participant’s involvement in this research study will be stored in encrypted files on servers that adhere 
to the University policy on storage and transmission of sensitive data. Participant identity on these 
records will be indicated by an ID number, and the information linking these numbers with participant 
identity will be kept separate from the research records. In addition, all research databases will have 
password-controlled access, and this will be controlled by critical staff. 
  
All data records related to a participant’s involvement in this research study will be stored in a locked 
file cabinet and/or in encrypted files on servers that adhere to the University policy on storage and 
transmission of sensitive data. Participant identity on these records will be indicated by an ID number, 
and the information linking these numbers with participant identity will be kept separate from the 
research records. In addition, all research databases will have password-controlled access, and this will 
be controlled by critical staff.  
 
The Fitbit API will be used to access data from participants' scale, activity tracker, and Fitbit app. During 
the consent process, participants will consent for the data from their specific device IDs to be accessed 
by our study. They will need to enter their Fitbit username and password during the app setup process 
to allow Fitbit data to be sent to our study server. The study smartphone app uses a Standard Auth 2.0 
security model for logging in to Fitbit. The study uses temporary access tokens that are stored only on 
the user's device and is not stored on our servers. Therefore, Fitbit usernames and passwords will not be 
stored in any way with this study. Instead, the weight and tracker data will be connected to participants 
by their unique study ID that they will also enter during the app setup process. Data are transmitted on 
secure servers that adhere to University policy on Sensitive Data. The risk of breach of confidentiality 
over the Fitbit websites will be partly subject to each individual’s comfort in sharing information in their 
individual profile. To further minimize the risk of breach of confidentiality, all participant activities on 
the Fitbit websites will be voluntary. Consent forms will also clearly communicate the risk of this type of 
disclosure to participants 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Questionnaire data as well as physical measurements including height, weight, and HbA1c  data 
collected for this study will be analyzed and stored on password-protected encrypted file servers at the 
University of North Carolina at Chapel Hill. No specimens will be stored. 
   
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Medical Monitor 
Deborah Tate, Ph.D., Professor 
NA 
University of North Carolina, Chapel Hill 
  
1700 Martin Luther King Jr. Blvd. Suite 
136, Chapel Hill, NC 27514 
  
919-966-5853 
  

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dtate@unc.edu 
  
  
10.1.6 SAFETY OVERSIGHT 
Safety oversight will be under the direction of the Office of Human Research Ethics (OHRE) Biomedical 
IRB and the Principal Investigator. 
  
10.1.7 CLINICAL MONITORING 
NA 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
  
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 all of the completed consent documents.  This review will evaluate compliance with GCP, accuracy, 
and completeness.   
  
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.   
  
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. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. 
 

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Assessment data will be collected and managed by study staff. Online data collection will be done 
through RedCap, and paper forms will be entered by study staff into a RedCap form. Data will be stored 
without identifiers. After all study activities are completed, data will be de-identified. Longitudinal 
measurements will undergo consistency and outlier checks, be compared with raw data, and edited as 
required. Audit trails will be used to document any database changes. 
  
To ensure confidentiality of participants, all survey data and scale/tracker/dietary records related to a 
participant’s involvement in this research study will be stored in encrypted files on servers that adhere 
to the University policy on storage and transmission of sensitive data. Participant identity on these 
records will be indicated by an ID number, and the information linking these numbers with participant 
identity will be kept separate from the research records. In addition, all research databases will have 
password-controlled access, and this will be controlled by critical staff. 
10.1.9.2 STUDY RECORDS RETENTION 
Study documents will be retained until data analysis is completed.  At this point, any materials with 
identifiers will be destroyed. 
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). 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 site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator will be responsible for knowing and adhering 
to the reviewing IRB requirements.  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
NA 
10.1.12 CONFLICT OF INTEREST POLICY 
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 

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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 
University of North Carolina 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 
During the 12-week study, participants will monitor their blood glucose using the Abbott Freestyle Libre 
Continuous Glucose Monitoring system. For the CGM, a representative of the device manufacturer 
(Abbott) will train research staff to instruct study participants on the use of the device. The device is 
commercially available and measures blood sugar without the need for finger sticks. It involves 
placement of a sensor on the upper arm and use of a scanning device to "read" the sensor. Use of the 
device is considered ‘off-label’ for individuals without diabetes. 
  
The study interventionists in this study are trained in behavioral weight control, have served this role in 
weight control interventions in the lab for 5 – 15 years, and are Master’s or PhD level in Health Behavior, 
Nutrition (and Registered Dietitian), or Exercise Physiology. 
10.3 ABBREVIATIONS 
  
API 
Application Programming Interface 
BMI 
Body Mass Index 
CDC 
Centers for Disease Control 
CGM 
Continuous Glucose Monitor 
DPP 
Diabetes Prevention Program 
HBA1c 
Glycated Hemoglobin  
IRB 
Institutional Review Board 
NC TraCS North Carolina Translational and Clinical Sciences Institute 
OHRE 
Office of Human Research Ethics 
PAR-Q 
Physical Activity Readiness Questionnaire 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
  
10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
1 
1/16/2019 
Initial 
NA 
2 
3/15/2020 
In-person orientation, assessments, 
COVID-19 restrictions 

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counseling sessions suspended. Some 
final weights had to be done using 
remote weighing protocol (stepping on 
the Withings smart scale three times in 
a row, first thing in the morning). 
3 
5/28/2020 
Resume in-person assessments with the 
re-opening of the University effective 
June 1 for Human Subjects Research, 
following the guidelines of the Office of 
Research and the IRB.  Transitioned to 
online consent to reduce the number of 
in-person visits necessary to conduct 
this study. We moved to conducting 
Orientation sessions via a Zoom call and 
send a link for the Informed Consent 
following the Orientation.  The consent 
form will be deployed through REDCap 
and we will obtain an electronic 
signature. We will provide the study 
participant with a paper copy of the 
signed Informed Consent at the Baseline 
Assessment (which will take place in 
person). 
COVID-19 restrictions 
  
  
  
  
 
 

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10. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic 
JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, 
Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini 
MG, Wnek J,   Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, 
Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC, Jr., Tomaselli GF. 
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of the American College of Cardiology/American Heart Association Task Force on Practice 
Guidelines and The Obesity Society. Circulation 2014; 129:S102-138. 
 
11. Standards of medical care in diabetes--2008. Diabetes care 2008; 31 Suppl 1:S12-54. 
12. Guerci B, Benhamou PY, Durain D, Bahloul A, Jeanbat V, Detournay B. [Self-monitoring of blood 
glucose in France: data from a national survey]. Sante publique (Vandoeuvre-les-Nancy, France) 
2017; 29:229-240. 
  
13. Franciosi M, Pellegrini F, De Berardis G, Belfiglio M, Cavaliere D, Di Nardo B, Greenfield S, Kaplan 
SH, Sacco M, Tognoni G, Valentini M, Nicolucci A. The impact of blood glucose self-monitoring 
on metabolic control and quality of life in type 2 diabetic patients: an urgent need for better 
educational strategies. Diabetes care 2001; 24:1870-1877. 
 
14. Young LA, Buse JB, Weaver MA, Vu MB, Mitchell CM, Blakeney T, Grimm K, Rees J, Niblock F, 
Donahue KE. Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in 
Primary Care Settings: A Randomized Trial. JAMA internal medicine 2017; 177:920-929. 
 
15. Mannucci E, Antenore A, Giorgino F, Scavini M. Effects of Structured Versus Unstructured Self-
Monitoring of Blood Glucose on Glucose Control in Patients With Non-insulin-treated Type 2 
Diabetes: A Meta-Analysis of Randomized Controlled Trials. Journal of diabetes science and 
technology 2017:1932296817719290. 
 
16. Unick JL, Hogan PE, Neiberg RH, Cheskin LJ, Dutton GR, Evans-Hudnall G, Jeffery R, Kitabchi AE, 
Nelson JA, Pi-Sunyer FX, West DS, Wing RR. Evaluation of early weight loss thresholds for 
identifying nonresponders to an intensive lifestyle intervention. Obesity (Silver Spring, Md) 
2014; 22:1608-1616. 
 
17. Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating 
and physical activity interventions: a meta-regression. Health psychology : official journal of the 
Division of Health Psychology, American Psychological Association 2009; 28:690-701. 
 
18. Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price 
D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R. Continuous Glucose Monitoring 
Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A 
Randomized Trial. Annals of internal medicine 2017; 167(6):365-374. 
 
19. Huygens MW, Swinkels IC, de Jong JD, Heijmans MJ, Friele RD, van Schayck OC, de Witte LP. Self-
monitoring of health data by patients with a chronic disease: does disease controllability 
matter? BMC family practice 2017; 18:40.  
 
20. Valle CG, Deal AM, Tate DF. Preventing weight gain in African American breast cancer survivors 
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survivorship : research and practice 2017; 11:133-148.  
 

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21. Wing RR, Tate DF, Espeland MA, Lewis CE, LaRose JG, Gorin AA, Bahnson J, Perdue LH, Hatley KE, 
Ferguson E, Garcia KR, Lang W. Innovative Self-Regulation Strategies to Reduce Weight Gain in 
Young Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized 
Clinical Trial. JAMA internal medicine 2016; 176:755-762. 
 
22. Steinberg DM, Tate DF, Bennett GG, Ennett S, Samuel-Hodge C, Ward DS. The efficacy of a daily 
self-weighing weight loss intervention using smart scales and e-mail. Obesity (Silver Spring, Md) 
2013; 21:1789-1797 25. 
 
23. Steinberg DM, Tate DF, Bennett GG, Ennett S, Samuel-Hodge C, Ward DS. Daily self-weighing 
and adverse psychological outcomes: a randomized controlled trial. American journal of 
preventive medicine 2014; 46:24-29. 
 
24. Bartfield JK, Stevens VJ, Jerome GJ, Batch BC, Kennedy BM, Vollmer WM, Harsha D, Appel LJ, 
Desmond R, Ard JD. Behavioral transitions and weight change patterns within the PREMIER trial. 
Obesity (Silver Spring, Md) 2011; 19:1609-1615. 
 
25. Burke LE, Conroy MB, Sereika SM, Elci OU, Styn MA, Acharya SD, Sevick MA, Ewing LJ, Glanz K. 
The effect of electronic self-monitoring on weight loss and dietary intake: a randomized 
behavioral weight loss trial. Obesity (Silver Spring, Md) 2011; 19:338-344. 
 
26. Carter MC, Burley VJ, Nykjaer C, Cade JE. Adherence to a smartphone application for weight loss 
compared to website and paper diary: pilot randomized controlled trial. Journal of medical 
Internet research 2013; 15:e32. 
  
27. Shay LE, Seibert D, Watts D, Sbrocco T, Pagliara C. Adherence and weight loss outcomes 
associated with food-exercise diary preference in a military weight management program. 
Eating behaviors 2009; 10:220-227. 
 
28. Yu Z, Sealey-Potts C, Rodriguez J. Dietary Self-Monitoring in Weight Management: Current 
Evidence on Efficacy and Adherence. Journal of the Academy of Nutrition and Dietetics 2015; 
115:1931-1938. 
 
29. Cooper AR, Sebire S, Montgomery AA, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Dayan CM, 
Andrews RC. Sedentary time, breaks in sedentary time and metabolic variables in people with 
newly diagnosed type 2 diabetes. Diabetologia 2012; 55:589-599. 
 
30. Cichosz SL, Fleischer J, Hoeyem P, Laugesen E, Poulsen PL, Christiansen JS, Ejskjaer N, Hansen TK. 
Objective measurements of activity patterns in people with newly diagnosed Type 2 diabetes 
demonstrate a sedentary lifestyle. Diabetic medicine : a journal of the British Diabetic 
Association 2013; 30:1063-1066. 
 
31. Burgess E, Hassmen P, Pumpa KL. Determinants of adherence to lifestyle intervention in adults 
with obesity: a systematic review. Clinical obesity 2017; 7:123-135.  
 

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32. Sardinha LB, Magalhaes JP, Santos DA, Judice PB. Sedentary Patterns, Physical Activity, and 
Cardiorespiratory Fitness in Association to Glycemic Control in Type 2 Diabetes Patients. 
Frontiers in physiology 2017; 8:262. 
33. Garcia JM, Cox D, Rice DJ. Association of physiological and psychological health outcomes with 
physical activity and sedentary behavior in adults with type 2 diabetes. BMJ open diabetes 
research & care 2017; 5:e000306.   
 
34. International Diabetes Federation. Global Guide for Type 2 Diabetes  https://www.idf.org/our-
activities/advocacy-awareness/resources-and-tools/79:global-guideline-for-type-2-
diabetes.html. Accessed August 20, 2017.        
 
35. Parsons S, Luzio S, Bain S, Harvey J, McKenna J, Khan A, Rice S, Watkins A, Owens DR. Self-
monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes (The SMBG Study): study 
protocol for a randomised controlled trial. BMC endocrine disorders 2017; 17:4. 
 
36. Nezami BT, Lytle LA, Tate DF. A randomized trial to reduce sugar-sweetened beverage and juice 
intake in preschool-aged children: description of the Smart Moms intervention trial. BMC public 
health 2016; 16:837. 
 
37. Epstein LH, Gordy CC, Raynor HA, Beddome M, Kilanowski CK, Paluch R. Increasing fruit and 
vegetable intake and decreasing fat and sugar intake in families at risk for childhood obesity. 
Obesity research 2001; 9:171-178. 
 
38. Epstein LH, Paluch RA, Beecher MD, Roemmich JN. Increasing healthy eating vs. reducing high 
energy-dense foods to treat pediatric obesity. Obesity (Silver Spring, Md) 2008; 16:318-326. 
 
39. Peyrot M and Rubin RR.  Structure and correlates of diabetes-specific locus of control. 
(1994). Diabetes Care 17 (9): 994-1001. 
 
40. Pily L at al. Development and validation of the short version of 
the diabetes obstacles questionnaire (DOQ-30) in six European countries. (2016). 22(1): 16-22. 
 
41. Polonsky WH, Fisher L, Hessler D, Edelman SV. Development of a New Measure for Assessing 
Glucose Monitoring Device-Related Treatment Satisfaction and Quality of Life. Diabetes Technol 
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42. Stetson B, Schlundt D, Rothschild C, Floyd JE, Rogers W, Mokshagundam SP. Development and 
validation of The Personal Diabetes Questionnaire (PDQ): A measure of diabetes self-care 
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2016;10(3):633-639. doi:10.1177/1932296816634736 
 

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12 APPENDIX 
12.1 PARTICIPANT INFORMED CONSENT 
 
University of North Carolina at Chapel Hill 
Consent to Participate in a Research Study 
Adult Participants  
 
Consent Form Version Date: 7/8/2020 
IRB Study # 18-2805 
Title of Study: Adaptation of a digital weight loss intervention promoting self-regulation for use 
in type 2 diabetes 
Principal Investigator Department: Health Behavior Operations 
Principal Investigator Phone number: (919) 966-7546 
Principal Investigator Email Address: dtate@unc.edu  
Study Contact Telephone Number: (919) 966-5853 
Study Contact Email: KEERICKS@email.unc.edu 
 
CONCISE SUMMARY 
This is a research study to test the effectiveness of a weight loss program that uses digital tools to 
help adults with type 2 diabetes or prediabetes lose a modest amount of weight and manage their 
blood sugar.   
 
Participants will have their height, weight and HbA1c measured.  They will complete 
questionnaires about their health and lifestyle at the beginning of the study and again at the end 
of the study (after 3 months).  These procedures will take approximately 30 minutes.  
Participants will visit the clinic to get their digital tools (study app, a digital scale, an activity 
tracker and a Continuous Glucose Monitor, which is a small sensor worn on the back of the arm 
continuously and replaced every 14 days) and meet with a study coach who will teach them how 
to use the tools and to get started making changes to their physical activity and diet.  This first 
visit will take 2 hours.  Participants will use the tools for 12 weeks.  Each week, participants will 
meet (remotely) with the study coach who will review their progress and set goals for the coming 
week.  These visits will take 30-45 minutes.   
 
Some participants will be invited to complete a 1-1 1/2 hour interview at the end of the study to 
give the research staff feedback about their experience. 
 
There greatest risks of this study include the possibility of injury when increasing physical 
activity as part of the weight loss program, discomfort from the HbA1c fingerstick, and skin 
irritation from wearing the Continuous Glucose monitor on the arm.   

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What are some general things you should know about research studies? 
You are being asked to take part in a research study.  To join the study is voluntary. 
You may choose not to participate, or you may withdraw your consent to be in the study, for any 
reason, without penalty. 
 
Research studies are designed to obtain new knowledge. This new information may help people 
in the future.   You may not receive any direct benefit from being in the research study. There 
also may be risks to being in research studies. Deciding not to be in the study or leaving the 
study before it is done will not affect your relationship with the researcher, your health care 
provider, or the University of North Carolina-Chapel Hill. If you are a patient with an illness, 
you do not have to be in the research study in order to receive health care. 
 
Details about this study are discussed below.  It is important that you understand this information 
so that you can make an informed choice about being in this research study.  
 
You will be given a copy of this consent form.  You should ask the researchers named above, or 
staff members who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to test a comprehensive lifestyle intervention that uses 
digital tools to support behavior change.  This novel intervention uses a smartphone app that 
combines a simplified diet monitoring system, a connected scale, physical activity tracker and 
blood glucose monitoring along with coaching to promote weight loss and diabetes management. 
 
You are being asked to be in the study because you meet the following criteria: 1) age 20 – 65; 2) 
diagnosed with type 2 diabetes or pre-diabetes and not taking medication used to treat diabetes; 
3) have poor glycemic control (HbA1c > 5.7%); 4) are overweight with a Body Mass Index 
(BMI) of 25-40 kg/m2; 5) speak and write English; 6) not meeting the American College of 
Sports Medicine recommendation of 150 minutes of Moderate to Vigorous Physical Activity  
each week; 7) have an iPhone with a data and text messaging plan; 8) have home wi-fi access; 9) 
ability to attend weekly remote visits with staff from the UNC Weight Research Program; and 
10) your primary care provider will provide written approval that participation in this study is 
appropriate for you.   
 
Are there any reasons you should not be in this study? 
You should not be in this study if you: 
• Are currently participating in another physical activity or weight control program or 
research study that would interfere with this study;  
• Have lost and kept off 10 or more pounds in the past 6 months or have ever had weight 
loss surgery; 
• Take a prescription medication (e.g., insulin, metformin, other oral agents) to manage 
your diabetes; 
• Regularly meet the American College of Sports Medicine recommendation of getting 150 
minutes or more of moderate to vigorous physical activity each week; 
• Take a medication that has a known effect on your metabolism or weight; 

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• Have a heart condition, chest pain during periods of activity or rest, loss of consciousness 
or any other reason you cannot participate in unsupervised exercise; 
• Have an implanted medical device such as a pacemaker; 
• Are currently being treated for cancer; 
• Are on dialysis; 
• Have substance abuse or mental health problems that would make it difficult to follow 
the recommendations of the program; 
• Are moving out of the area within the next 4 months; 
• Are unable to attend weekly sessions (either by phone or in-person at the clinic in Chapel 
Hill); 
• Have been diagnosed with an eating disorder such as bulimia or anorexia; 
• Are currently pregnant, have been pregnant within the past 6 months, or you are planning 
to become pregnant within the next 4 months; 
• Are unwilling or unable to wear the Continuous Glucose Monitoring device for the 
duration of the study.  
 
How many people will take part in this study? 
There will be approximately 20 people in this research study. 
 
How long will your part in this study last? 
If you participate, your part in this study will last up to 4 months.  
 
What will happen if you take part in the study? 
If you choose to participate in this study, the following will take place: 
 
Baseline Assessment and Kick-Off Session: After you consent to participate, you will complete 
a set of online questionnaires that will take you approximately 30 minutes. These questionnaires 
will include demographics and questions specific to your experience with diabetes.  After 
completing the questionnaires, you will attend an in-person visit to have your height, weight, and 
HbA1c measured.  For the HbA1c, you will have a finger stick and approximately 3 drops of 
blood drawn.  Your sample will be analyzed on a point-of-care analyzer immediately after it is 
drawn.  None of your blood will be stored.  These measures will take approximately 15 minutes. 
 
After completing the assessment measures, you will have a kick-off session with a study 
interventionist.  You will receive a Study smartphone app, a Withings Wi-Fi-enabled bathroom 
scale, a Fitbit Alta activity tracker, and a Freestyle Libre CGM (Continuous Glucose Monitoring) 
system, all for your use during the study. The Freestyle Libre is a continuous glucose monitoring 
system that uses a sensor that is continually worn on the upper arm and a handheld reader, and 
does not require any finger sticks.   
 
The Study smartphone app, Withings scale, and Fitbit activity tracker all require you to 
download an app onto your phone and set up a username and password for each.  The Freestyle 
Libre also requires you to set up an account which can be accessed either through a smartphone 
app or from a computer.  For each of these devices, you will give permission for the research 
study staff to have access to your data.     
 

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Study staff will help you set up the Fitbit, install the study’s smartphone app on your iPhone, and 
will give you instructions on how to set up the scale at home. They will also instruct you on 
using your glucose monitoring system.  In addition, staff will give you instructions on making 
changes to your diet and physical activity to help you lose weight and manage your blood sugar.   
12-week Study Period: During the 12 weeks following your group session you will be asked to 
weigh yourself on the Wi-Fi scale in the morning, wear your Fitbit, track some of your foods in 
the study smartphone app, and wear your CGM sensor. For the purposes of the research study, it 
is important that you are the only person in your household who uses the scale and the Fitbit 
during the study. The data from your app, Fitbit, scale and Freestyle Libre will be transmitted to 
your study interventionist.  It is anticipated that you will spend no more than 10-15 minutes per 
day tracking your foods and using the study app. You may receive text messages throughout the 
study for various reasons, which may include reminding you to sync your Fitbit, track your 
foods, or return to the study app if you haven’t used it in a few days. You will receive no more 
than 3 text messages per week.  
Once per week, you will meet with the study interventionist to review your data and progress, 
receive lesson materials that will help you to make healthy diet and activity changes in your daily 
life and set goals for the coming week.  These meetings will take place remotely (video 
conference “zoom” or phone call).  There will be a total of 12 sessions.  Sessions will typically 
last 30 – 45 minutes.   
Final Assessment:  After the 12 weeks of the weight loss program, you will repeat the measures 
you completed at the beginning of the study.  This will include a set of online questionnaires that 
will take approximately 30 minutes to complete and a final weight and HbA1c measurement. 
The measurements will take no more than 15 minutes.  If you complete your final assessment, 
you will be able to keep your Fitbit and scale.  You will be asked to return the CGM scanner. 
You may be invited to complete a 60-90 minute interview about your experience during the 
study.  If you decide to participate in the interview, you will sign an additional consent form and 
will receive an additional incentive. 
What are the possible benefits from being in this study?  
Research is designed to benefit society by gaining new knowledge. You may also expect to 
benefit by participating in this study by receiving accurate and important information about 
weight loss and health. Your participation may help you lose weight, and could experience 
improvements in physical health associated with weight loss and making healthier choices. 
However, there is no guarantee that any or all of these changes will occur as a result of you 
participating in this study.   
 
What are the possible risks or discomforts involved from being in this study? 
There may be uncommon or previously unknown risks. You should report any problems to the 
researcher. 
 
Risks of Increasing Physical Activity. 
There may risks associated with increasing physical activity, including, but not limited to, 
injuries to the muscles or joints of the body. Other risks include abnormal blood pressure, 
fainting, dizziness, disorders of heart rhythm, exacerbation of exercise-induced asthma 
symptoms, and very rare instances of heart attack, stroke, or even death. To help ensure your 
safety, the study will follow guidelines and safety recommendations for physical activity set 
forth by the American College of Sports Medicine. The study will provide you with information 

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and recommendations for safely starting an exercise program and increasing your physical 
activity and will make modifications to your program if you experience any of the above 
problems. The safest way to start becoming more physically active is to begin slowly and build 
up gradually. During this study, you will receive information on exercise safety. These are not 
intended to be a substitute for consultation with your personal physician and/or health care 
provider. You may want to talk with your doctor by phone or in person before you start 
becoming much more physically active. You should report any problems to the researchers. 
 
Risks associated with Questionnaires 
As part of the study, you will be asked about personal factors related to your weight related 
behaviors and health. You may feel uncomfortable while completing the surveys, because of the 
personal nature some of the questions. You can elect not to share this private information. You 
should contact researchers if you feel that you have experienced any emotional distress as a 
result of study participation. 
 
Risk of Breach in Confidentiality 
This would mean that a person or persons outside the study team will find out that you are 
participating in this study and/or access the information you share with the study. This is a very 
rare possibility. In-person assessments will take place in our study offices. The only study data 
stored on your phone will be foods you have tracked in your food log that have not yet been 
transferred to the study server (i.e. your food log is stored on your phone when you do not have 
an internet connection, but is transferred to the server as soon as you receive access to an internet 
connection and then deleted from your phone). Though the likelihood is very rare, it is possible 
that your data could be accessed by others should you lose your mobile device or lend the device 
to other people. In addition, there is a possibility that others may see your smartphone 
communications, including notifications or messages when the application is open, or see an 
open webpage while you are completing online questionnaires. If you would like, you may set up 
a passcode on your mobile phone to help prevent unauthorized access to your device, text 
messages, and research data. Additional information on how your study records will be kept 
private is written below. 
 
Fitbit: You will also receive a Fitbit activity tracker. This device requires use of the companion 
Fitbit website and smartphone app. This is protected by a unique user login and password. 
Though you will need to enter your Fitbit username and password as part of the setup process for 
the study, we will not store your Fitbit username or password on our servers. In your Fitbit 
account settings, you will give permission for your Withings scale data to sync to your Fitbit 
account.  All website information on your activity and weight data that are accessed by study 
staff will be kept confidential.  
 
The risk of breach of confidentiality over the Fitbit website will be partly subject to your comfort 
with sharing information on your individual profile. Fitbit will have access to the data that you 
choose to track within the Fitbit app/website and the information you choose to include on your 
individual Fitbit profile, but they will not have access to any other information about you that is 
collected as part of the research study.    
 

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Freestyle LibreView. When you scan your Freestyle Libre sensor, your CGM data will be stored 
in the web-based LibreView software.  Within your account settings, you will share this data 
with the research study staff.  The study staff will not have access to your username or password.  
All website information on your blood glucose data that are accessed by study staff will be kept 
confidential.  
 
The risk of breach of confidentiality over the LibreView website will be partly subject to your 
comfort with sharing information on your individual profile. LibreView will have access to the 
data that you choose to track within the app/website and the information you choose to include 
on your individual profile, but they will not have access to any other information about you that 
is collected as part of the research study.    
 
Risk of Wearing Fitbit Activity Tracker  
There is also the possibility of minor skin irritation associated with wearable devices. We 
recommend taking it off occasionally, not wearing it too tightly, and keeping it clean and dry. 
You should regularly clean your wearable device—especially after working out or sweating. 
Rinse the wearable device with water or wipe it with a small amount of rubbing alcohol. Do 
NOT use hand soap, body soap, dish soap, or household cleaners which could get trapped 
beneath the band and irritate skin. Always dry the wearable device well before putting it back on. 
If you start to experience skin irritation on your wrist, we suggest you remove the device and 
contact a member of the study team to discuss the issue and determine whether you would like to 
continue participating in the study. 
 
Risk of CGM: There is a small risk that the adhesive used to attach the sensor to the arm will 
cause skin irritation.    You will be provided with instructions on how to properly place the 
sensor.  If excessive irritation does occur, you should remove the sensor and contact study staff.   
Risk of finger stick:  When you complete your baseline and follow-up assessment, you will have 
your HbA1c measured.  Approximately 3 drops of blood will be removed by finger stick. This is 
a standard method used to obtain blood for routine hospital laboratory tests. You may experience 
a small amount of pain when the lancet goes in to your finger.  Other than this momentary pain, 
the discomfort of finger stick should be minimal. However, in about 10% of the cases a small 
amount of bleeding under the skin will produce a bruise (hematoma). A small scar may persist 
for several weeks. The risk of local infection is less than 1 in 1,000.  The site will be cleaned 
with an alcohol wipe prior to the finger stick to minimize this risk. 
There may be uncommon or previously unknown risks. You should report any problems to the 
researcher. 
 
What if you are a UNC employee? 
Taking part in this research is not a part of your University duties, and refusing will not affect 
your job.  You will not be offered or receive any special job-related consideration if you take part 
in this research. 

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Will it cost you anything to be in this study? 
It will not cost you anything to be in this study. 
What if we learn about new findings or information during the study?  
You will be given any new information gained during the course of the study that might affect 
your willingness to continue your participation. While you are continuously tracking your blood 
sugar, you may see previously unknown high or low blood sugar episodes.  Both you and your 
coach will have access to this information on a daily basis. This information could benefit you so 
that you can work with the study coach and/or your primary care provider to better manage your 
blood sugar. 
Will I receive any other clinical results?  
Other clinically relevant results of this research will be communicated with you.  You will 
receive a report of your weight and HbA1c (which measures longer-term blood sugar 
management) at the beginning of the study and at the end.  
 
How will information about you be protected? 
The study team will store any personal information you provide, your Wi-Fi scale and tracker 
data, and your location data in secure databases that comply with the University of North 
Carolina’s policies on sensitive information storing and transmission.  This means that there are 
very strong protections in place to keep your information from being accessed by individuals not 
authorized to access it. Any information that you share on paper forms will be stored with an ID 
that does not identify you personally and will be kept in locked file cabinets only accessible to 
study staff.  Information you share through online questionnaires uses a secure server that 
complies with the University security policies.  You will be asked to voluntarily allow the study 
team to access your Fitbit data through the Fitbit website by entering your Fitbit username and 
password. The study staff member who helps set up your devices will allow you to create and 
enter your Fitbit username and password on your own and will not need to see this information. 
Your usernames and passwords will not be stored by the study in any manner.  
 
You will not be identified in any report or publication about this study. We may use de-identified 
data from this study in future research without additional consent  
 
Although every effort will be made to keep research records private, there may be times when 
federal or state law requires the disclosure of such records, including personal information.  This 
is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by 
law to protect the privacy of personal information.  In some cases, your information in this 
research study could be reviewed by representatives of the University, research sponsors, or 
government agencies (for example, the FDA) for purposes such as quality control or safety. 
 
Will you receive results from research involving your specimens? 
You will receive the results of your HbA1c tests.  The use of your samples may result in 
commercial profit.  You will not be compensated for the use of your samples other than what is 
described in this consent form. 
 
What will happen if you are injured by this research? 
All research involves a chance that something bad might happen to you.  This may include the 

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risk of personal injury. In spite of all safety measures, you might develop a reaction or injury 
from being in this study. If such problems occur, the researchers will help you get medical care, 
but any costs for the medical care will be billed to you and/or your insurance company. The 
University of North Carolina at Chapel Hill has not set aside funds to pay you for any such 
reactions or injuries, or for the related medical care. You do not give up any of your legal rights 
by signing this form. 
 
What if you want to stop before your part in the study is complete? 
You can withdraw from this study at any time, without penalty.    
 
Will you receive anything for being in this study? 
You will receive $15 after you complete the baseline assessment and $25 after you complete the 
12-week follow-up assessment. You must complete the measures and questionnaires in order to 
receive the payment.  If you complete the 12-week assessment, you will also be able to keep the 
Fitbit activity tracker and scale that you will use during the study. If you decide to withdraw 
from the study or do not complete all of the study assessments, we will ask you to return the Wi-
Fi scale and Fitbit to the UNC Weight Research Program.  You will receive CGM sensors and a 
scanner to read the CGM data.  You will return the scanner to the study once the study 
procedures are complete.  In the event that any device is lost or damaged, you will not be 
responsible for the cost, however, please alert study staff immediately so that the device can be 
replaced.  As the devices used are costly to the researchers, care should be taken with them. 
 
Who is sponsoring this study? 
This research is funded by the University of Michigan Board of Regents.  This means that the 
research team is being paid by the sponsor for doing the study.  The researchers do not, however, 
have a direct financial interest with the sponsor or in the final results of the study. 
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research. If 
you have questions about the study (including payments), complaints, concerns, or if a research-
related injury occurs, you should contact the researchers listed on the first page of this form. 
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
What if you have questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights 
and welfare.  If you have questions or concerns about your rights as a research subject, or if you 
would like to obtain information or offer input, you may contact the Institutional Review Board 
at 919-966-3113 or by email to IRB_subjects@unc.edu. 
 
Participants will be shown a link that says “Next.” 
Thank you for reviewing the Informed Consent document.  Please choose one of the following: 

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• I have read the information and voluntarily agree to participate in this research study. 
NOTE: A copy of this electronically signed informed consent will be provided to you at 
the baseline assessment visit, and signature of receipt will be collected at that time. 
• I do not wish to participate in this research study. 
SUBMIT 
 
If the person picks yes, provide a message that says “You have indicated that you will participate 
in this research study.  By signing below, you are granting consent to participate in this study.” 
(provide box and submit button).  After submit, get text that says “Congratulations on enrolling in 
this research study.”   
 
If the person picks no, say, “Thank you for your time. You have chosen not to participate in this 
research study.  If you have any questions, please contact the UNC Weight Research Program.”  
 
 
 
 
 
12.2 PHYSICIAN CONSENT  
 
PHYSICIAN CONSENT TO PARTICIPATE IN A DIET AND EXERCISE  
PROGRAM AT UNC-CHAPEL HILL 
 
 
TO: 
 
RETURN TO: 
 
Physician’s Name 
 
Karen Hatley, MPH 
 
 
UNC Weight Research Program 
 
 
Lineberger Comprehensive Cancer Center 
 
 
1700 Martin Luther King Jr. Blvd., CB 7294 
 
Address 
Chapel Hill, NC 27514 
 
 
 
 
 
 
Telephone: (919) 966-5853 
 
City 
State 
Zip 
FAX:           (919) 843-6663 
 
 
 
 
(          ) 
*please give form to study participant to  
 
Telephone Number 
  return to study staff or send directly 
 
Your patient ______________________________ has asked to participate in a weight loss program for 
adults with type 2 diabetes or pre-diabetes who are not being treated with insulin or other medications 
at the University of North Carolina at Chapel Hill.  This is a 3 month research study designed to help 
patients to change their eating and exercise habits and to examine the impact that this will have on 
short-term weight loss and glycemic control.  This will involve the following: 

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A diet program that will reduce energy intake by focusing on tracking and reducing ‘red’ foods (higher 
calorie and/or fat foods) and increasing ‘green’ foods (plants and very lean protein). 
A physical activity program that will be primarily home-based.  The exercise will gradually be progressed 
from 50 minutes per week to 150 minutes per week with activities akin to brisk walking.   
Continuous glucose monitoring (CGM), using a device that does not require calibration, used as a tool to 
interpret diet and activity changes and their impact on blood glucose and weight loss. 
Behavioral modification techniques for changing eating and exercise behaviors plus weekly sessions with 
study staff to review self-monitoring records, set goals and review progress. 
Digital tools including an iphone app, wifi connected digital scale, Fitbit activity tracker and Freestyle 
Libre CGM. 
 
Please indicate below if this program seems appropriate for your patient or if you see any 
contraindications for his/her participation (please check the appropriate box below). 
 
I know of no contraindications to this patient participating in any of the above components of 
the program. 
 
I feel that this program would not be appropriate for this patient for the following reason(s): 
 
________________________________________________________________________________ 
 
________________________________________________________________________________ 
 
 
 
 
Signature of Physician 
 
Inclusion Criteria: 
1. Currently age 20-65 
2. BMI 25-50 kg/m2 
3. Normal or impaired glucose as determined by HbA1c fingerstick (<6.5%) 
4. Own an iPhone with a data and text messaging plan 
5. Have home Wi-Fi access 
6. Have the ability to read, write, and speak English 
7. Not meeting the American College of Sports Medicine recommendation of 150 minutes of Moderate 
to Vigorous Physical Activity each week 
8. Ability to attend weekly visits at the UNC Weight Research Program clinic for one month and weekly 
in-person, phone, or video call for an additional two months 
9. Can obtain primary care provider consent that participation is appropriate 
 
Exclusion Criteria: 
1. Lost more than 10 pounds in the last 6 months 
2. History of weight loss surgery 
3. Currently participating in another physical activity or weight loss program or research study that 
may interfere with participation in this study 
4. Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous 
physical activity 
5. Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the 
next 4 months 
6. Planning to relocate in the next 4 months 

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7. Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as 
determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire) 
8. Diagnosis of diabetes  
9. Taking medications to treat prediabetes 
10. Report taking prescription or over the counter medication with a known impact on metabolism or 
weight 
11. Current treatment for cancer 
12. History of clinically diagnosed eating disorder 
13. Diagnosis of schizophrenia or bipolar disorder 
14. Hospitalization for a psychiatric diagnosis within the last year 
15. Report a past diagnosis of or current symptoms of alcohol or substance dependence 
16. Unwilling or unable to wear the CGM device continuously for the duration of the study 
17. On dialysis 
No exclusion criteria shall be based on race, ethnicity, or gender.  
12.3 ONLINE SCREENER 
 
Welcome to the T2 Connect Research Study screening questionnaire. These questions will take 
you approximately 5-10 minutes to complete. Once you complete the screener and submit your 
responses, you will be contacted by a study staff member by phone or by email. If you continue 
with the screening questions, your responses to the questions will be kept for the duration of 
the study for descriptive purposes. 
 
Do you give your permission to continue with the online questionnaire and to be contacted by study 
staff if you are determined to be eligible for this study? 
 Yes 
 
 No 
• 
If yes, continue screener 
• 
If no, have message that says “Thank you for your interest in our program.  If you wish to be 
informed of future studies, click here.”  Link to www.uncweightresearch.org/participate_cap.asp 
 
 
1. Do you read, write and speak English? 
 Yes 
 No (INELIGIBLE) 
 
2. How did you hear about this program? 
  Facebook post (sponsored)  
  Facebook post by friend, family, co-worker, etc.  
  Tweet by friend, family, co-worker, etc. 
  Email from friend, family, co-worker, etc. 
  Website 
  Listserv: If so, which one: _____________ 
  Word of mouth (friend, relative, co-worker, etc.) 
  Another study participant. Name_______________ 
  Flyer 
  Other (please specify): ______________  
 
3. What is your gender? 
 Male 
 
 Female 

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WOMEN ONLY COMPLETE THE NEXT 3 QUESTIONS  
 
4. Are you currently pregnant or breastfeeding? 
 
 Yes (INELIGIBLE) 
 No 
 
5. Have you been pregnant in the last 6 months? 
 
 Yes (INELIGIBLE) 
 No 
6. Do you plan on becoming pregnant in the next 4 months? 
 Yes (INELIGIBLE) 
 No 
 
 
7. What is your age? ______________ 
 
break 
 
The information gathered on this page is collected for descriptive purposes and does not influence your 
eligibility to participate. 
 
8. Are you of Hispanic or Latino or origin? 
 Yes 
 No 
 
9. Which race to do consider yourself to be? (you may choose more than one category): 
  Black or African-American  
  Asian 
  American Indian or Alaska Native  
  Hispanic, Latino, or Cape Verdean 
  Native Hawaiian or Other Pacific Islander 
  White 
  Other (Specify):__________________ 
 
break 
 
10. What is your current weight? _______ lbs. 
 
11. What is your height? ____ ft _____ inches   
 
[BMI automatically calculated] 
The formula to calculate BMI is (weight in pounds * 703)/(height in inches * height in inches) 
 
12. Have you lost weight in the past 6 months?  
 
 No     
Yes   If yes, how much have you kept off? ______ lbs. (> 10 lbs = INELIGIBLE) 
 
13. Have you ever had weight loss surgery? 
 
 
 No     
Yes    (INELIGIBLE) 
 
14. In a typical week, how many days do you do any physical activity or exercise of at least moderate 
intensity, such as brisk walking, bicycling at a regular pace, and swimming at a regular pace?  
 None  
 1 day per week 

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 2 days per week 
 3 days per week  
 4 days per week  
 5 days per week 
 6 days per week  
 7 days per week  
 
 
15. On the days that you do any physical activity or exercise of at least moderate intensity, how long do 
you typically do these activities?  
 
 
__________Minutes 
________Hours 
 
16. Have you ever had or are you currently receiving treatment for any of the following? 
 
a. Pre-Diabetes or Diabetes 
 Yes  
 No (INELIGIBLE) 
 
If yes, how is it controlled?  ________________________ 
Diet and exercise 
Prescription medication (INELIGIBLE) 
Insulin (INELIGIBLE) 
Other  (describe) 
 
 
b. Hospitalization in the past year for  
 Yes (INELIGIBLE) 
 
 No 
      depression or other psychiatric disorder 
 
 
 
 
 
c. Schizophrenia or bipolar disorder?  
 Yes  (INELIGIBLE) 
 
 No 
 
d. Alcohol or substance abuse? 
 
 Yes (INELIGIBLE) 
 
 No 
 
e. Anorexia or bulimia? 
 
 
 Yes (INELIGIBLE) 
 
 No 
 
f. Cancer 
 
 
 Yes  (Current treatment = INELIGIBLE)              
 No  
____________________________________________________________________ 
 
break 
 
1. Has a doctor ever said that you have a heart condition AND that you should only do physical activity 
recommended by a doctor?  
 
 No  
 Yes (INELIGIBLE) 
 
2. Do you feel pain in your chest when you do physical activity?  
 No  
 Yes 
(INELIGIBLE) 
 
3. In the past month, have you had chest pain when you WERE NOT doing physical activity? 
 No   
Yes (INELIGIBLE) 

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4. Do you ever lose your balance because of dizziness or do you ever lose consciousness? 
 No  
 Yes  (INELIGIBLE) 
 
5. Do you have a bone or joint problem that could be made worse by a change in your physical 
activity? 
 No  
 Yes  
 
6. Is your doctor currently prescribing drugs for your blood pressure, cholesterol, or a heart condition? 
 No  
 Yes  
 
 

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7. Do you know of any other reason why you should NOT do physical activity? 
 NO  
 YES  
 
8. Are you currently on dialysis? 
 NO  
 YES (INELIGIBLE) 
 
9. Do you have an implanted medical device (for example, a pacemaker)? 
 NO  
 YES (INELIGIBLE) 
 
If yes, please describe: _______________________ 
 
Break 
 
 
25. Are you taking any prescription medications? 
 
 NO 
 Yes  
 
26.  Are you taking any non-prescription over the counter dietary supplements? 
 NO 
 Yes  
 
 
Break 
 
27. Do you have access to the Internet at home? 
Yes  
No (INELIGIBLE) 
If yes, How do you access the Internet at home (Check all that apply)? 
 
 
 Computer (desktop or laptop)  
 Smartphone or cell phone  
 Tablet 
 
 
 
 
 
 
 
 
 
 
If yes, do you connect to the Internet using home Wi-Fi, or another method such as mobile 
wireless (smartphone hotspot, USB key, etc.)? 
 Home Wi-Fi (wireless connection) (INELIGIBLE if not selected) 
 Smartphone hotspot 
 Other (please specify): ______________  
 
 
28. What kind of smartphone or cell phone do you have (Check all that apply)? 
 Traditional cell phone (not a smartphone) 
 iPhone (INELIGIBLE if not selected) 
 Android  
 Other smartphone   
 
 
 I do not have a cell phone or smartphone  

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29. (If iPhone) Do you have a data plan to access the Internet and receive text messages on your 
iPhone? 
 Yes, unlimited 
 Yes, but in limited amounts 
 No, I only access the Internet on my smartphone when connected to Wi-Fi 
 Other (please specify): _____________ 
 
 
30. Are you planning on moving out of the area within the next 4 months? 
 Yes (INELIGIBLE) 
 No 
 
31. Would you be willing to come for weekly study visits at the UNC Weight Research Program in Chapel 
Hill? 
 Yes 
 
 No (INELIGIBLE) 
 
 
32. Thank you for completing these questions. In order to complete your eligibility screening, a study 
staff member will need to contact you by phone. Please enter your contact information below. 
First Name:  
Last Name:  
Contact phone number: 
Email address: 
 
33. What is the best time to reach you (select all that apply)?   
 Mornings 
 Afternoons 
 Evenings 
 
 
34. If we call you to follow up about your eligibility, may we leave a message? 
 
 Yes 
 No 
 
Please click "next" to complete the survey. 
After Next, this message will appear: Thank you for completing the T2Connect research study screening 
questions.  You will be contacted by a member of the study staff with information about your eligibility. 
Depending on the number of people interested in participating, it may take a few days for us to contact 
you. If you do not receive a call within 3-4 business days, please call our research center at 919-966-
5852. 
 
 
12.3 TELEPHONE SCREENER 
1. When you filled out the online screening questions, you reported that your weight is _____ lbs. and 
your height is _____.  Is this accurate to the best of your knowledge?  

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If BMI calc on edges of eligibility (25-27 or 38-40), “If you are eligible after we finish these screening 
questions and you decide you would like to participate, we will confirm your height and weight at 
your first study visit at our center.” 
 
2. If Yes to Cancer question 17.  
 
In the online screener, you reported having been diagnosed with cancer in the past. Can you tell me 
when that was?  Are you currently being treated for Cancer?  (If current treatment, INELIGIBLE) 
 
3. If yes to Question 23 on web screen: Do you know of any other reason why you should not do 
physical activity? 
 
In the online screener, you answered yes to the question “Do you know of any other reason why you 
should not do physical activity?”  Can you explain?  (INELIGIBLE if they can’t do activity akin to 
walking and progress to 150 minutes of Moderate to Vigorous PA per week over time) 
 
4. If Yes to Question 25 on web screen: Are you taking any other prescription medications? 
 
You reported that you are taking prescription medications.  Can you tell me the names of them?  (Also 
ask what it is used to treat) 
If Yes, specify: _______________________________________________________ 
 (NOTE: look for meds with known effects on appetite or weight, oral steroids, diabetes meds--
INELIGIBLE) 
 
6. If Yes to Question 26 on web screen:  Are you taking any non-prescription over the counter dietary 
supplements? 
 
You reported that you are taking non-prescription over the counter dietary supplements.  Can you tell 
me the names of them?   
 
If yes, specify:  _____________________________________________________________  
 
If other than vitamin/mineral supplement:  Would you be willing to stop taking this supplement during 
the study period?  
 NO  (INELIGIBLE)    
 Yes   
 
7.  Are you currently participating in any other weight loss of physical activity program? 
 
8. Are you currently a member of any other research studies? 
 
 NO 
 Yes   
BMI = _____________ MUST BE 25 – 40; 

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If yes, describe _______________________________________________ 
(If other study would interfere with following study protocol, INELIGIBLE) 
 
Thanks for taking the time to answer my questions.   
 
You submitted the following contact information on the website (read their info. from the web report).  
Has any of this changed?  [If so, note below].   
 
Name: ________________________________________________________________ 
 
Street Address: _________________________________________________________ 
 
City: _______________________ State: _____ Zip Code: _______________________ 
  
Home Phone: _____________Work Phone: ____________ Cell Phone: ____________ 
 
Email Address: _________________________________________________________  
 
Staff note:  ensure that participant is residing within a reasonable distance of the assessment site. 
 
The information you’ve given me will be reviewed by the project coordinator to determine your eligibility 
for the study.   If you are eligible, we will ask you to come in to our center for an orientation session so that 
you can hear more about the program, meet the staff, and ask questions before deciding whether or not to 
participate.  If you decide to participate, you will sign an Informed Consent document and schedule your 
baseline assessment visit.  This visit will take approximately one hour.  You will be notified of the date and 
time of the orientation either by phone or by email.   
 
[If you think they are definitely eligible, schedule them for an orientation visit.  Tell them that the 
appointment will be confirmed by email.]  
 
Do you have any last questions?  Thank you for your time today.   
 
OFFICE USE ONLY:  
 
Eligible:  
 
 
  Yes  
  No
 
Reason______________________________ 
 
 
Scheduled orientation visit: 
 
  Yes  
  No  
 
Date:____/____/____ and Time 
 
Verify BMI:  
 
 
  Yes  
  No