Delay Discounting as a Target for Self-Regulation in Prediabetes
Phase: NA
Conditions: PreDiabetes
Sponsor: State University of New York at Buffalo

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Weight Loss for Prediabetes Using Episodic Future 
Thinking (MINDD4) 
 
NCT Number: NCT03670602 
 
Document Date: 1/15/2021 
 

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Protocol and Statistical Analysis Plan 
 
Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Hypotheses ............................................................................................................... 3 
3.0 
Scientific Endpoints ................................................................................................. 3 
4.0 
Background & Significance ..................................................................................... 3 
5.0 
Study Design ............................................................................................................ 4 
6.0 
Local Number of Subjects ....................................................................................... 4 
7.0 
Inclusion and Exclusion Criteria .............................................................................. 5 
8.0 
Vulnerable Populations ............................................................................................ 6 
9.0 
Eligibility Screening ................................................................................................ 6 
10.0 Recruitment Methods ............................................................................................... 8 
11.0 Procedures Involved................................................................................................. 9 
12.0 Measurements ........................................................................................................ 13 
13.0 Setting .................................................................................................................... 17 
14.0 Statistical Analysis Plan ......................................................................................... 17 
15.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 17 
16.0 Withdrawal of Subjects .......................................................................................... 18 
17.0 Risks to Subjects .................................................................................................... 18 
18.0 Potential Benefits to Subjects ................................................................................ 20 
19.0 Compensation for Participation ............................................................................. 20 
20.0 Consent Process ..................................................................................................... 20 
21.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 21 
22.0 References. ............................................................................................................. 22 
 
 
 

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PROTOCOL TITLE: 
MINDD 4: Prediabetes, Delay Discounting and Weight Control 
1.0 
Objectives 
Assess the effectiveness of adding episodic future thinking (EFT) to our standard 
behavioral weight control program to improve weight loss, DD, working memory, 
glycemic control (HbA1c) and behavioral and/or medication adherence over a 6 
month period in persons with prediabetes. 
2.0 
Hypotheses 
Specific Aim 1: To determine whether change in weight loss is superior for those 
with prediabetes randomized to behavioral treatment for obesity + EFT (BT-EFT) 
versus behavioral obesity treatment (BT. We hypothesize that weight loss for BT-
EFT will be superior to BT after 6 months of treatment.  
Specific Aim 2: To determine whether change in HbA1c is superior for those 
with prediabetes randomized to behavioral treatment for obesity + EFT (BT-EFT) 
versus behavioral treatment (BT). We hypothesize that reductions in HbA1c for 
BT-EFT will be superior to BT after 6 months of treatment.  
Specific Aim 3: To determine whether change in DD is superior for those with 
prediabetes randomized to behavioral treatment for obesity + EFT (BT-EFT) 
versus behavioral treatment (BT). We hypothesize that reductions in DD for BT-
EFT will be superior to BT after 6 months of treatment.  
Secondary Aim 1: To determine whether change in medication and behavioral 
adherence for hypertension and/or hyperlipidemia medications is superior for 
those with prediabetes randomized to behavioral treatment for obesity + EFT 
(BT-EFT) versus behavioral treatment (BT). We hypothesize that medication and 
behavioral adherence for BT-EFT will be superior to BT after 6 months of 
treatment.  
Secondary Aim 2: To determine whether improvements in working memory are 
superior for those with prediabetes randomized to behavioral treatment for obesity 
+ EFT (BT-EFT) versus behavioral treatment (BT). We hypothesize that working 
memory improvements for BT-EFT will be superior to BT after 6 months of 
treatment.  
Exploratory Aim 1: To examine the relationship between baseline DD and DD 
change with weight loss, improvements in HbA1c and medication adherence. We 
hypothesize that baseline DD and DD change will predict weight loss, 
improvements in HbA1c and medication adherence. 
3.0 
Scientific Endpoints 
The primary endpoint is the reduction of discounting of the future, weight loss, 
and improved glycemic control. 
4.0 
Background & Significance 

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DD has been related to several adverse health behaviors including smoking 
(Bickel et al., 1999) and obesity (Rollins et al., 2010). Our laboratories have 
extensive experience collecting information about DD and these various health 
outcome behaviors. 
Initial research on Type 2 diabetes (T2D) using a brief monetary choice 
questionnaire showed T2D individuals who discount the future have worse 
metabolic control than those who delay gratification (Reach et al., 2011). To our 
knowledge, there has been no research on the effects of EFT on DD among 
patients with prediabetes.  
Adults with greater DD is associated with obesity (Appelhans et al., 2012), and 
low activation of brain sites critical for self-control in DD predicts longitudinal 
weight gain in adults (Kishinevsky et al., 2012). Likewise, inability to delay 
gratification predicts greater subsequent weight gain in young children (Francis 
and Susman, 2009) and poorer response to evidence-based pediatric weight 
control programs (Seeyave et al., 2009).  
In turn, the prevalence of T2D is associated with obesity (Kahn et al., 2006). 
Moreover, T2D (Vanhanen et al., 1997, Kanaya et al., 2004, Yaffe et al., 2004) 
and risk for T2D (Vanhanen et al., 1997) are associated with increased risk of 
executive dysfunction. This association suggests one of two possibilities: (1) 
diabetes causes a decline in executive function, or (2) inadequate executive 
function contributes to obesity and then diabetes. In either case, the relationship 
between executive function and both obesity and diabetes can present challenges 
in adhering to behavioral and medical therapies (Smith et al., 2011, Primožič et 
al., 2012). Poor planning, low working memory, cognitive inflexibility, poor 
attention to detail in combination with excessive DD can lead to weight gain and 
poor metabolic outcomes.  
Research supports Episodic Future Thinking (EFT), self-projection into the future 
to pre-experience an event (Atance & O'Neill, 2001), as an effective approach to 
reduce bias towards immediate gratification (Daniel & Epstein, 2013; Daniel, 
Stanton, & Epstein, 2013). However, little is known about EFT’s effect in 
individuals at risk for Type 2 Diabetes. Understanding the effect of EFT in 
prediabetics can be efficacious in translating this technique into an efficacious 
health intervention.   
5.0 
Study Design 
This study is an experimental between-subjects design; subjects will be 
randomized to Behavioral Treatment for obesity + Episodic Future Thinking (BT-
EFT) or control group Behavioral Treatment for obesity (BT). 
6.0 
Local Number of Subjects 
Up to 200 subjects will be enrolled at the University at Buffalo (up to 400 
nationally). The second site is located at Virginia Tech Carillon Instutite, local PI, 
Warren Bickel, PhD. We expect about 25% of participants to meet our in-lab 
screening criteria, 20% of those participants subjects to drop out and about 80 
subjects will complete the study. In addition, a small sample (approximately 4-6 

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subjects) will be assigned to be pilot participants to help with quality assurance 
and data validity procedures. Participants will be informed if they are a pilot 
participant at the time of consent. 
7.0 
Inclusion and Exclusion Criteria 
Inclusion: 
Participants must be 18 years of age or older to participate. 
Prediabetes: Participants must have a diagnosis of prediabetes within the 
last 2 years or meet criteria for prediabetes. The American Diabetes 
Association guidelines (Group, 2003) defines prediabetes as Fasting 
Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after 
Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) 
approximately 5.4-6.7%.  
Exclusion: 
Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes.  
Pregnancy: Women who are pregnant or lactating will be excluded from 
participation. 
Substance use, abuse, or dependence: Individuals that currently have problems 
with substance dependence, addiction, or problematic substance use that would 
limit participation (e.g., binge drinkers, alcoholics, daily stimulant/opiate users) 
will be excluded. 
Conditions that affect adherence: Participants should not have a condition that 
would limit participation which include medical conditions that would affect 
individuals’ ability to use the computer for prolonged period of time; leave the 
individual unable to ambulate; or current diagnoses of an eating disorder other 
than binge-eating disorder (anorexia, bulimia), unmanaged psychiatric disorder 
(depression, anxiety, attention deficit hyperactivity disorder (ADHD), 
schizophrenia), or an intellectual impairment that would impact study adherence. 
Additionally, participants should be able to attend to all or most group and 
individual sessions. If a participant is not able to make most sessions (e.g. 
participant is out of town for several days or weeks during the study (e.g. work or 
vacation travel)) they may be excluded from the study 
Abnormal glucose related to medications: Participants should not be taking 
medications that would limit participation and cause abnormal glucose levels (e.g. 
atypical antipsychotic medications or glucocorticoids) including diabetic drugs 
such as Metformin. 
Prior participation in similar studies:  Individuals who have recently participated 
in a laboratory study using similar methods may also be excluded. 
Recent changes in weight: Individuals should not have had any significant 
changes in weight (e.g. 10% change) prior to starting this study.  
 

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8.0 
Vulnerable Populations 
☒ 
N/A:  This research does not involve pregnant women. 
☒ 
 N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
☒ 
N/A:  This research does not involve prisoners. 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.0 
Eligibility Screening  
Interested participants will have the opportunity to complete an initial screening 
by phone, online, or paper upon their preference to determine if they meet the 
inclusion criteria as previously described. Information about the study will be 
provided and consent will be obtained to prescreen for eligibility purposes. 
Additionally, we may send the person a link to a video that explains what the 
purpose of the study is and what can be expected.  
During the prescreen, along with other screening questionnaires participants will 
also complete the PHQ-2, a shorter version of the PHQ-9, which measures current 
(within the past two weeks) feelings of depression or loss of interest in activities. 
Those that score a 3 or above on the PHQ-2, will be contacted for follow-up via 
phone or in person at the screening session by a trained research staff member and 
be given the remainder of the PHQ-9. The PHQ-9 is a validated measure that 
looks not only at feelings of depression and associated symptoms, but also 
assesses for thoughts of self-harm. Given the concern for having a participant 
indicate thoughts of self-harm, this procedure would allow for a real-time 
conversation with that participant to monitor responses and also provide them 
with appropriate resources. Additionally, if the participant appears to be 
extremely upset and/or emotional, we may ask them to fill out the Beck 
Depression Inventory (BDI), a reliable measure of assessing depression (Sprinkle 
et. al. 2002). 
As part of the prescreen survey, prospective participants will also complete the 
Three Factor Eating Questionnaire (TFEQ) (Stunkard & Messick, 1985), a 
validated instrument to detect dietary restraint (Allison, Kalinsky, & Gorman, 
1992) with three subscales that assess dietary restraint, hunger, and disinhibition. 
A short revised version, the Three factor eating questionnaire-R18 (TFEQ-R18), 
measures 3 aspects of eating behavior: cognitive restraint, uncontrolled eating, 
and emotional eating (Karlsson, Persson, Sjöström, & Sullivan, 2000). After 
completing the prescreen survey, responses will be reviewed by research staff to 
assess eligibility. Participants will be called, emailed, or mailed a letter 
(depending on their preferred method of contact provided in the prescreen survey) 
regarding their eligibility. Those who are eligible will be scheduled to come into 
our lab for an in person screening visit (session 1). 
At the in person session 1 screening appointment, all participants will be given the 
Eating Disorder Examination (EDE) Questionnaire which is a well-established 

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and valid measure for eating disorders (J.M Mond et. al. 2004). If it is determined 
that they may have an eating disorder other than binge-eating disorder, the 
participant will not be eligible to continue with the study, and their physician may 
be notified. Binge-eating disorder or binge-eating disorder symptomology will not 
be considered exclusionary as behavioral weight loss treatment is both safe and 
effective for individuals with binge-eating disorder and binge-eating disorder 
symptomology (Grilo et al., 2011; Munsch et al., 2007). All participants who 
complete the EDE will be provided with a list of resources. 
At the in person screening visit (session 1) documented consent will be obtained 
from potential participants. During the screening procedure, participants will be 
asked to sign a medical release form allowing the primary care physician to 
provide us with the information regarding eligibility and also allow us to send any 
pertinent medical information to their primary care physician (i.e. diagnoses of 
obesity, prediabetes, hypertension, dyslipidemia, depression score assessed by the 
BDI). If we do not receive the form within about 5 business days we will call to 
follow up with the primary care physician. Participants will also be asked to sign 
a release form for relevant pharmaceutical records (e.g. refill history of 
medications used to treat pre-diabetes, diabetes, and/or hyperlipidemia and 
hypertension) from their current pharmacy. Release of pharmaceutical records 
may be attained through the end of study participation if not attained at screening 
and will cover the period from about 90 days prior to screening to about the end 
of study participation. At the screening visit, participants will have their HbA1c 
levels measured by finger stick to obtain a drop of blood. If subjects meet 
eligibility criterion based on HbA1c levels (approximately 5.4% - 6.7%) at the 
initial screening visit, they may be eligible to participate regardless of 
confirmatory PCP diagnosis. Additionally, participants will be assessed for 
hyperlipidemia by finger stick and blood testing as well as for hypertension using 
an automated blood pressure machine.  
Additionally at the first visit, participants may provide us with a urine sample to 
check for recent substance use and for pregnancy status for females. If the 
pregnancy results are positive the participant will be informed and they will not 
be eligible to continue with study. If throughout the study there is reason to 
believe a participant has become pregnant (i.e. the participant expresses that is 
their belief), we will provide pregnancy testing. If the pregnancy results are 
positive, the participant will be informed and they will not be eligible to continue 
with the study. 
Finally, at the in person screening visit (session 1), participants will have their 
responses to the prescreen eligibility survey reviewed with a research team 
member to follow up on any items or any new discoveries that may affect 
adherence to the study program. At the completion of the screening visit, 
participants will not know if they are eligible to continue, and all of the 
information gathered from the participant will be reviewed with all study team 
members to make a mutual decision if the participant will likely be able to 
successfully adhere to all study procedures (e.g. attend all study sessions). After 
that decision is made by the research team, the participant will be followed up 

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with by phone or email (or participant’s preferred method of contact) within one 
week regarding their eligibility. If eligible to continue, participants will then be 
scheduled for the baseline assessment session. 
Study personnel will inform participants that this information will be used to 
communicate with them about study eligibility and that this information will be 
kept confidential and not shared with anyone outside of the study team. 
The information assessed during screening is recorded in a secure database that 
requires a password to enter. The database is used by all members of the Division 
of Behavioral Medicine and has been approved for use by previous IRB 
committees. Information is retained in the database only if the subject gives 
consent. 
10.0 Recruitment Methods 
The Project Coordinator will oversee all study recruitment and enrollment 
activities. Participants will be recruited through recruitment materials (e.g., flyers, 
letters, and handouts/postcards), the Buffalo Research Registry, and web-based 
recruitment (e.g., departmental website, Facebook, Twitter, Craigslist, 
ResearchMatch, ClinicalTrials) disseminated through the local community, 
university campuses, and medical clinics including UB-MD, the university 
physician network, Urban Family Practice, and the Upstate New York Practice 
Based Research Network which is engaged in multiple research projects to 
improve patient care in Western New York.  
We may also use the i2b2 database through UB’s Institute for Healthcare 
Informatics (IHI) to recruit participants from the UBMD medical data base 
The study team may also utilize the University at Buffalo’s Clinical and 
Translational Science Institute (CTSI) for recruitment assistance and consultation. 
The CTSI’s Recruitment Team provides resources, guidance on appropriate 
recruitment strategies, and assistance in linking out study team with partners to 
effectively reach recruitment goals and target populations. We may also work 
with CTSI Community Engagement Team (CET) to create awareness of the study 
through their professional and community contacts. The tools they have available 
may include the Buffalo Research Registry (BRR), the Patients Voices Network 
(PVN), the Conventus CTSI/PVN Research Table, and conducting outreach at 
various community events. The BRR is a voluntary registry which can connect us 
to community members who have completed a health profile and are interested in 
participating in research. These community members have agreed to be contacted 
about potential research opportunities based on their self-reported information.  
These tools are method by which the CET distributes IRB-approved recruitment 
information to community members.  
The CET also tables at many events in the community throughout the year and 
may display the IRB approved flyer for this project at their table at community 
events. Examples of events the CET attends include Good for the Neighborhood 
hosted by Independent Health Foundation, UB on the Green, Juneteenth, 
Elmwood Arts Festival and many others. 

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The CET also hosts a standing table at the Conventus Building on the 4th floor of 
UBMD where the IRB approved flyer can be made available to community 
members and patients. This will occur only after agreement between the CRL and 
UBMD Conventus partners that the study is appropriate for the Conventus space. 
Additionally, a database of participants that have been involved in previous 
studies at the University at Buffalo Behavioral Medicine laboratory that expressed 
interest in future studies will be used. Participants who have indicated interest in 
contact for future studies will be contacted by email or phone with the study 
advertisement and survey link.  
In addition, several other IRB-approved projects in our lab are recruiting 
participants who are also pre-diabetic. To minimize the likelihood participants 
screen for multiple projects in our lab, and in order to efficiently direct 
participants to the study that might suit them, a shared online (Qualtrics) 
questionnaire will be used that asks participants questions about their height and 
weight, diabetes/prediabetes status, if they are taking medications for blood 
glucose management, hypertension, or high cholesterol, if they are interested in 
weight loss, if they shop at local grocery stores, and if they are on public 
assistance. 
11.0 Procedures Involved 
Upon arrival to the Division of Behavioral Medicine (G56 Farber Hall), 
participants will be greeted and escorted to a private interview room where they 
will be given a verbal explanation about the study and provide documented 
consent. After signing the consent forms, participants will have their blood 
HbA1c, blood pressure, cholesterol, height and weight measured to calculate 
BMI, complete measures of delay discounting and study questionnaires including 
demographics, consumption, alcohol, tobacco, substance use, and executive 
function such as time perspective and memory. In addition, participants may sign 
forms for release of their relevant medical records to confirm their eligibility (e.g., 
diagnosis with prediabetes). Participants will be given a choice as to whether they 
would like their screening results shared with them and/or with their physician. If 
participants have values at a certain critical level (e.g. critically high blood 
pressure) they may be automatically notified. Participants may also complete a 
urine drug screen to confirm non-substance abuse and female participants may 
complete a urine pregnancy test to ensure eligibility. If throughout the study there 
is reason to believe a participant has become pregnant (i.e. the participant 
expresses that is their belief), we will provide pregnancy testing. If the pregnancy 
results are positive, the participant will be informed and they will not be eligible 
to continue with the study. Following the screening session, participants will be 
reviewed by members of the study team to make a decision if the participant is 
eligible. 
Participants will also be given a choice as to whether they would like to be re-
contacted after the conclusion of their 6-month involvement in study treatment in 
order to complete in a longer-term follow-up assessment that would occur at 
about 6 months after study completion, or at about 12 months after their initial 

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baseline session and would be conducted virtually via video conference. 
Participants will be informed that their decision about being re-contacted for the 
longer-term follow-up will in no way preclude them from being involved in the 
study over the initial 6-month period.  
If participants are determined to be eligible (e.g., have an HbA1c measurement in 
the prediabetes range, are not pregnant, do not report alcohol or substance misuse, 
are able to adhere to all study procedures, etc.) they will be followed up by phone 
call or email (or preferred method of contact) within one week and scheduled for 
a baseline appointment. They will also be given a detailed orientation of what will 
be expected of them during the study, including tasks they need to complete, 
recording food consumption and activity levels, and frequency of visits to our lab. 
At the baseline assessment session, eligible participants may also be provided 
with an Actigraph WGT3X-BT accelerometer to measure physical activity. They 
will be instructed how to properly wear the accelerometer and asked to record a 
diary of its wear-time. After wearing the accelerometer for about 7 days, 
participants may be asked to visit the lab to return it. At the baseline session 
participants will also be instructed on how to complete a food recall, complete 
measures of delay discounting, behavioral economic demand, demographics, 
working memory, medication adherence, and physiological measures (e.g. 
HbA1c, cholesterol, weight, etc). 
After the first several weeks of treatment (about 6 weeks), eligible participants 
will be randomized to one of two groups, BT-EFT or BT. Participants in both 
groups will first attend weekly group meetings followed by bi-weekly group 
meetings, and then monthly group meetings for up to 6 months. Group sessions 
may be audio or video recorded so that if a participant misses the meeting, they 
are able to receive the information and learn the materials on their own time. They 
will be provided general information on healthy diet, physical activity and 
medication adherence. During the in lab appointments participants will be taught 
a number of behavioral treatment techniques. The treatment includes: 1) The 
Traffic Light Diet, which utilizes RED, YELLOW, and GREEN labels for food to 
guide participants toward the goal of consuming low energy dense, low glycemic, 
high nutrient dense foods; 2) the Traffic Light Activity Program, which also 
utilizes RED, YELLOW and GREEN labels for different levels of caloric 
expenditure, and 3) a variety of behavioral techniques, including stimulus control, 
self-monitoring, goal setting, problem solving, resetting rewarding mechanisms 
by reducing need for immediate gratification, finding behavioral substitutes for 
highly reinforcing food, and EFT (for the intervention group).  
During each treatment meeting, participants will be weighed and then have a   
group session that lasts up to 60 minutes either preceded or followed by a session 
with a case manager that may last up to 30 minutes. The group sessions review 
information about weight loss and maintenance and engage in group problem 
solving for participants who are struggling with behavior change. During the 
individual meeting with their case manager, participants are taught behavior 
change techniques and review and address diet and activity self-monitoring and 
any barriers to adherence with the weight-loss behaviors.  

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After participants are randomized, participants in the EFT group will be asked to 
generate episodic cues similar to the tasks used in our previous studies on EFT’s 
effect (Daniel et al., 2013). Each group will list and describe events for different 
time periods. The episodic component of the thinking task will occur while the 
participants are asked to describe what they are imagining about each event (e.g., 
vacations, weddings, parties, and so forth). EFT participants will list positive 
future events they are looking forward to and list events that could happen at 
different general future time points (e.g., 1 month, 2-6 months, 7-12 months). In 
contrast, the BT group will not generate any cues. All EFT participants may rate 
the salience, valence, arousal, feasibility and vividness of each event and events 
with the highest ratings for vividness will be used in the generation of episodic 
cues. An “imagery” score may be calculated by averaging the frequency/vividness 
scores for each event. Reductions in rate of discounting occur at higher levels of 
episodic imagery (Peters & Buchel, 2010). Additionally, participants may record 
their highest rated events into audio cues. 
Experimenters will train participants in the EFT group on how to retrieve cues 
from their cell phone or alternative internet accessible device (e.g. laptop, tablet, 
desktop computer), to pay attention to and think about the cues, and how to 
adhere to the study’s expectations for utilizing the cues. If participants do not 
have an internet accessible device one may be provided to them (e.g. smartphone) 
for the duration of the study at no cost to them. Participants may be prompted 
several times a day to use their cues and instructed to use their cues any time that 
need to, especially around eating episodes, using the thought training website – 
Mobile Audio Management and Response Tracker (MAMRT) (Sze, Daniel, 
Kilanowski, Collins, Epstein, 2015). 
Ecological momentary intervention (EMI) uses mobile technology to deliver 
interventions to individuals during their everyday lives (i.e. in real time) and in 
their natural settings (i.e. real world). EMIs enhance the ability to influence 
behavior in real-world contexts as participants often experience tempting food 
situations in their natural environments. In this study, the EMI will involve daily 
prompts to use EFT cues and answer questions about their cues using the thought 
training (MAMRT) (Sze, Daniel, Kilanowski, Collins, Epstein, 2015). MAMRT 
will deliver cues/prompts daily to participants. Participants will also be able to 
access MAMRT and their EFT cues as many times a day as they desire. 
During individual sessions case managers may review progress, habit changes, 
medication adherence, and use of EFT. In the control group participants will not 
use cues but will still be prompted to log into the MAMRT website and answer 
questions about their eating behaviors. Participants in the control group will 
otherwise engage in the same tasks. During weeks when participants do not visit 
the lab and do not meet with their case manager, they may be contacted by phone, 
email, or text by their case manager to check in and review progress, similar to an 
in-person case management meeting. 
In response to the coronavirus pandemic, we are enacting preventative measures 
to ensure both participants and employees limit exposure. For group sessions and 
case management sessions, this may entail conducting group sessions by sending 

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participants a recorded video or using a password-protected video conference 
(Such as via Webex or Zoom Meeting) on a secured network. In this event, a link 
with a password to access the secured meeting room would be sent to participants 
and necessary staff. Case management sessions intended to occur in-person may 
also be carried out via secured video conference or by phone. As is the case for 
in-person group sessions, video-conference group sessions may be audio or video 
recorded so that if a participant misses the meeting, they are able to receive the 
information and learn the materials on their own time.  
The impact of the coronavirus on participants will be monitored via a 
questionnaire to be administered about once a month. The questionnaire may ask 
about any major changes participants have experienced, a measure of delay 
discounting, questions about food demand, perceived stress, loneliness as well as 
perceived risk of testing positive for coronavirus. This may be administered via 
phone/video conference interview or via survey link sent to participants. The 
MAMRT website will be used to provide information about the intervention, 
downloadable manuals for the Traffic Light Diet and Activity Program, provide 
tools for cooking and getting more physical activity, and managing the EFT 
component of the intervention where participants may be able to read and listen to 
recordings of their self-generated EFT cues. Quizzes to assess mastery of 
educational materials will be implemented on the study website, with multiple 
versions of quizzes on each module available to account for those participants 
who will acquire the information more slowly than others. . Participants may have 
access to traditional paper and pencil self-monitoring. After self-monitoring skill 
is acquired, participants can choose to use traditional or technology-based 
recording. The website will also contain password protected sections that are for 
internal use by study personnel. The website will not contain protected health 
information. 
Participants will also be taught how to record food and drink, exercise, and at 
home weight measurements in MyFitnessPal. MyFitnessPal is a smartphone and 
web based app that tracks diet and exercise and can record the number of calories, 
macro and micronutrients consumed. These recordings may be shared with their 
case manager and other study team members to review progress and behavior 
change.  
Measurements for blood HbA1c, blood pressure, cholesterol, height and weight 
measured to calculate BMI, measures of delay discounting, food demand, other 
executive functions (e.g. working memory), energy intake, physical activity, and 
medication adherence will be collected at baseline, 3 months, and 6 months. In 
response to the coronavirus mandatory closures, these assessment measures may 
also be recorded remotely. In the event that a participant must have assessment 
measures performed remotely, a staff member may conduct a conference call or 
video conference with the participant to instruct them on how to complete 
questionnaires and complete executive function tasks online via online survey 
(For example, on Qualtrics). The staff member may also instruct the participant 
on how to weigh themselves and observe the participant taking their weight at 
home via video conference. In order to collect A1c measures for remote 

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assessment sessions, participants may be sent an A1CNow test kit (PTS 
Diagnostics, Sunnyvale, CA), a commonly used self-administered A1c test that is 
available over-the-counter and that provides a valid measure of A1c (Chang et al., 
2010), and may also be observed conducting the at-home A1c test by a staff 
member. In addition, participants may be sent an Actigraph with instructions on 
its use in order to assess physical activity for remote assessments. At the 3 and 6 
month assessment sessions, an adverse event questionnaire will also be 
administered. After completion of the final assessment session, study staff will 
request records of participants’ prescription refills from their current pharmacies 
and will be debriefed about the study. Participants may also be asked if they 
would be willing to anonymously complete a study evaluation on which 
participants can check a box to indicate whether or not they would allow their 
anonymous responses to be shared with others as testimonials. Research staff will 
be able to answer any questions the participant may have about the group they 
were assigned to at that time. For those consenting to be recontacted for a longer-
term follow up, there may be an additional assessment at the 12-month time point 
that will entail follow-up measures of A1c, delay discounting and weight and 
could be conducted via video conferencing in the same manner as assessments 
done during the coronavirus mandatory closures. In addition, participants electing 
to complete the 12-month assessment will also complete the coronavirus and AE 
questionnaires. 
 
 
 
Month 1 
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Month 3 
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4 
Mont
h 5 
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6 
Month 
12*** 
Week # 
Screening 
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(base
line) 
1 
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3 
4 
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6 
7 
8 
9-10 
11-12 
13-16 
17-20 
21-25 
~52 
weeks 
Group 
Meeting 
Topic* 
 
Orien
tation 
TLD 
TLD 
Meal 
Planni
ng 
Phys
ical 
Acti
vity 
Portion 
Contro
l 
EFT/C
ontrol 
High 
Risk 
Situatio
ns 
Stimulu
s 
Control 
Review, 
Portion 
Control 
Shoppin
g 
Healthy
** 
Self-
monitorin
g weight 
EFT/RT 
in high 
risk 
situation
s 
Maintaini
ng 
Healthy 
Habits** 
 
Review with 
Case Manager 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Primary 
Assessment 
Session 
 
X 
 
 
X 
 
 
X 
X 
DD 
Assessment 
with EFT 
Cues 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
X 
Wearing 
Actigraph 
 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Use Cues On 
MAMRT 
 
 
 
 
Starts around week 7 
 
 
 
 
 
Compensatio
n 
 
x 
 
 
x 
 
 
x 
X 
*Group meeting topics are subject to change and may be presented in a different order.  
**Group meeting content may be shared via video in lieu of in-lab group session. 
*TLD = Traffic Light Diet 
*** 12-month session only for those consenting for re-contact following 6-month assessment – to be conducted via video conferencing 
 
12.0 Measurements 
Recordings: Sessions where treatment is delivered may be audio or video 
recorded for Clinical Supervisor to review treatment fidelity and provide feedback 
to Interventionists/Case Managers. 

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Demographics and Health Behavior: Race/ethnicity, household income, and 
educational level will be assessed using a survey-based questionnaire. Participants 
will also be asked about their health behavior, including substance use, mental 
health, medical history, and food consumption. 
Food Consumption Questionnaire. Food consumption, including any food or 
beverages ingested in the last 24 hours will be measured using the ASA24 
(Automated Self-Administered Recall System). 
Major Life Events: Individuals will be asked to complete the major life events 
questionnaire which measures major life events that may have been experienced 
during their involvement in the study. Individuals who are undergoing major life 
events such as a move, new baby or a new job may influence their performance 
on study measures and tasks. 
Financial Planning and Longevity. Individual differences in time period of 
financial planning will be assessed with the question, “In planning your, or your 
family’s, saving and spending, which of the time periods is more important to you 
and your partner, if you have one?” (Picone, Sloan, & Taylor, 2004). Answer 
choices provided will range from not planning, to planning longer than ten years. 
Financial planning will be reported categorically, and will be converted to a 
continuous variable for analysis using midpoints of the categories. Subjective 
probability of living to age 75 will be measured by asking “What do you think are 
the chances you will live to be 75 or more (where 0 means there is no chance you 
will live to 75 or more, and 100 means you will definitely live to 75 or more)?” 
(Picone et al., 2004). Higher values on either question will indicate greater future 
orientation.  
Time Perspective: Individual differences in temporal perspective will be assessed 
using measures that assess temporal orientation. Consideration of Future 
Consequences Scale (CFCS). CFCS assesses the extent to which individuals 
consider the potential future outcomes of their current behavior and the extent to 
which they are influenced by the imagined outcomes (Strathman et al., 1994).   
Positive and Negative Affect Schedule (PANAS): The PANAS comprises two 
mood scales, one that measures positive affect and the other which measures 
negative affect (Watson et. al., 1988). 
Medication Adherence (pill counts): Participants will be asked to bring their 
prescription bottles to both baseline and follow-up visits. Remaining pills will be 
counted and medication adherence will be calculated as: (quantity dispensed – 
remaining)/(quantity prescribed per day * days since last refill))*100, yielding a 
measure of percent adherence. In addition, we will utilize participant refill history 
from their pharmacies to estimate prescription adherence from baseline to final 
assessment. 
Medication Adherence (self-report): Participants will complete a self-report 
medication adherence questionnaire validated for use with patients with type 2 
diabetes, yielding a measure of percent adherence. 

Version Date 1/15/2021 
 
Height, Weight, BMI: Participants’ height will be assessed using a digital 
stadiometer. Participants’ weight will be assessed using a digital scale. Based on 
the height and weight data, Body Mass Index (BMI) will be calculated according 
to the following formula: BMI = kg/m2. These are the current standards set forth 
by the Centers for Disease Control and Prevention (Kuczmarski et al., 2002). 
Blood pressure: Blood pressure will be measured 3 times using an OMRON 
automated blood pressure device by trained personnel. The latter two readings 
will be averaged. 
Hemoglobin A1c (HbA1c): HbA1c will be measured using the A1CNow+® or 
A1CNow® self-check systems (PTS Diagnostics, Sunnyvale, CA) or the Alere 
AfinionTM AS100 Analyzer System (Abbott, Abbott Park, IL). 
Blood Glucose: Blood glucose may be measured using the FreeStyle Lite Glucose 
Monitor or the FreeStyle Libre Pro (Abbott, Abbott Park, IL). 
Cholesterol: Blood for lipid profile (e.g., total cholesterol, HDL, LDL, 
triglycerides, HDL/LDL ratio, etc.) will be measured using the Alere Cholestech 
LDX® system (Alere Inc., Coral Springs, FL). 
Physical Activity. Physical activity may be measured using the Actigraph 
WGT3X-BT accelerometer. Participants will be shown how to properly 
wear the monitors and will be asked to wear their monitors for about a 
week. Data will be collected at a rate of 30 Hz and converted to one 
minute epochs for data analysis. Total activity counts and activity in the 
moderate to vigorous (MVPA) and vigorous (VPA) ranges will be 
estimated. Physical activity may be measured using a Fitbit (San 
Francisco, CA) or other activity monitor. 
Subjective Hunger: Participants will be asked to provide subjective ratings of 
their hunger. Hunger will be assessed using a 5-point Likert scale (anchored by 1- 
Extremely Full and 5-Extremely Hungry). 
Subjective Preferences: Participants may be asked to provide subjective ratings of 
their food/activity preferences by ranking, rating their liking using a 5-point 
Likert scale (anchored by 1-Do not like and 5-Like very much), and making 
choices between their food/activity. 
Cue Attention: A Likert-style scale assessing attentiveness to the episodic cues 
and vividness cues during tasks will be assessed on a scale from 1 to 5, where 1 
indicates “not at all” and 5 indicates “very much”.   
Delay Discounting: An operational definition of impulsivity is delay discounting, 
the degree to which a person will discount the value of a larger delayed reward in 
favor of a smaller immediate reward. Computerized/ experimenter administered 
assessments will provide participants with choices between a smaller amount of a 
hypothetical commodity available immediately or a larger amount available later. 
Participants will make choices between rewards such as money, food, physical 
activity, and health gains. Two methods may be used to measure discounting, 
Adjusting Amount and Adjusting Delay. 

Version Date 1/15/2021 
 
 
Adjusting Amount Discounting. The magnitude of the immediate 
commodity is adjusted until it is subjectively equivalent to the later larger amount. 
Subjective equivalence will be obtained at delays such as; 1 day, 1 week, 1 
month, 3 months, 6 months, and 1 year. To ensure comparison between money 
and non-monetary rewards, prior to running the discounting programs for food, 
physical activity and health, participants will indicate the amount of the 
commodity whose receipt “right now” would be equally valuable to the 
participants as receiving a set amount of money, for example $100. Participants 
may be presented with their EFT cues before making decisions at each delay 
period. 
Adjusting Delay Discounting. The adjusting delay discounting task is a 
five trial task in which participants are asked how much money they would prefer 
(e.g. $500) immediately or a larger reward after a delay (e.g. $1000). This task is 
presented on a computer screen and is designed to measure the amount of 
monetary discounting that occurs when rewards are presented at a delay. This task 
adjusts the delay to the larger reward and allows for the calculation of k-values. 
This task will be completed matching each of the traditional tasks parameters (i.e. 
type and magnitude of the reinforcer).  
Executive Function: Cognitive processes, such as planning, cognitive flexibility, 
working memory, prospective memory, retrospective memory and attention may 
be measured by using computerized tasks or paper and pencil that involves 
solving problems, remembering a set of letters or spatial locations while 
alternating with a distracter tasks (e.g., Backwards CORSI). 
Relative Reinforcing Efficacy Food Purchasing Task: The food purchasing task is 
modified off of the cigarette purchasing task (CPT) that has been used by Jacobs 
and Bickel (1999) and assesses a number of different metrics of relative 
reinforcing efficacy. The procedure we will use is a modified version of this 
procedure and will assess the relative reinforcing efficacy of a range of foods via 
an online survey or computerized task.  The chosen food will be displayed during 
the task so that participants have a frame of reference when completing the 
questionnaire. 
Coronavirus Questionnaire: A questionnaire developed to monitor the effects of 
the coronavirus pandemic on participants will include a modified Major Life 
Events questionnaire similar to that described above but asking about a longer 
time frame (about a month), the five-trial Adjusting Delay Discounting task 
described above, food purchasing questions asking the maximum amount a 
participant would spend on preferred snack foods, a question asking if participants 
know someone diagnosed with coronavirus, a question asking their perceived risk 
of being diagnosed with coronavirus (measured on a 0-100 scale), two self-report 
questionnaires the 10-item Perceived Stress Scale (PSS; Cohen, 1994), and the 5-
item Loneliness Scale from the NIH toolbox for assessment of neurological and 
behavioral function (Gerson et al., 2013). The PSS asks that participants rate on a 
5-point scale (0 = never; 1 = almost never; 2 = sometimes; 3 = fairly often; 4 = 
very often) how often over the last month they have thought or felt different 
situations were stressful. Example questions include, “In the last month, how 

Version Date 1/15/2021 
 
often have you been upset because of something that happened unexpectedly?” 
and, “In the last month, how often have you felt that things were going your 
way?” The 5-item longlines scale asks participants to select how often over the 
past month they feel lonely as described by 5 different statements. Answers are 
given on a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = 
Usually; 5 = Always). Example statements include, “I feel alone and apart from 
others” and “I feel that I am no longer close to anyone”. 
13.0 Setting 
This research will be conducted at the University at Buffalo (UB) and Virginia 
Tech University (VT). All facilities are locked and require key or badge access to 
enter in relevant research areas.  
The UB team will conduct research at the Division of Behavioral Medicine 
Research Labs, University at Buffalo South Campus. 
The VT research team will conduct research at the Addiction Recovery Research 
Center at the Virginia Tech Carilion Research Institute. Recruitment and 
screening will be in collaboration with Carilion Clinic Department of Family and 
Community Medicine in Roanoke and surrounding areas. 
Virginia Tech Carilion Research Institute will follow the same scientific and 
ethical review structure as the University at Buffalo. All research staff working on 
the project will need to complete Human Subjects Training as per the University 
requirements. Staff will be trained across sites to follow the same procedures and 
weekly/monthly meetings will be organized to ensure this. 
14.0 Statistical Analysis Plan 
Analytic plan is to use factorial ANCOVA to compare between group differences 
in different measures of DD, executive function, weight loss, changes in 
metabolic control, dietary composition, and physical activity for subjects 
randomly assigned BT-EFT/BT. Covariates will be used if significant differences 
between groups are observed in subject characteristics. We predict a main effect 
of EFT such that EFT will reduce the discounting, improve metabolic control, and 
increase weight loss compared to BTsubjects. 
The estimated sample size for this study is based on an ESd for reducing DD of 
0.72 in obese/overweight subjects. In our pilot study of EFT vs control in a weight 
control program we observed even larger ESd of 1.64 for weight and 1.04 for 
energy intake. Based on ESd = 0.72 for DD, using power of 0.80 and alpha of 
0.05, we can detect differences between groups in DD with 32 subjects per group, 
64 total. Since we are anticipating 20% attrition for the field study, we will recruit 
78 persons with prediabetes to start. 
15.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Data will be reviewed weekly and secured in Division of Behavioral Medicine 
Research Lab. The Principal Investigator, Leonard H. Epstein, PhD, will be 
responsible for ensuring data integrity and safety monitoring for human subjects 

Version Date 1/15/2021 
 
who are involved in the research and may work with a Data Safety Officer 
consistent with our NIH DSMP. 
Study questionnaires and measurements that are collected by study personnel will 
be reviewed and monitored. 
This study poses no greater than minimal risk; therefore, there are no safety 
endpoints. 
Participants will be encouraged to contact study personnel if they experience any 
problems or difficulties, and if any adverse events (AE) are reported, the study 
personnel contacted will record the AE. AE will be recorded as soon as they are 
reported, and the PI and study coordinator will be made aware. The study 
coordinator will summarize the AE in a memo; the participant will be called and 
the summary will be read to them to ensure that the information is accurate. The 
memo will then be submitted to the University at Buffalo IRB and the PI. If the 
PI, or the IRB decide that further action is warranted, the PI and study coordinator 
will then formulate and carry out a plan to respond to the AE. The study 
coordinator will write a memo summarizing such actions; this memo will then be 
forwarded to the IRB. Safety information will be collected and reported to both 
the UBIRB and the Safety Officer in the time frames outlined by the UBIRB. 
Serious Events and Problems (SEP) will be monitored by the Principal 
Investigator and project coordinator as well as reported to both the IRB and the 
Safety Officer in the timeframes outlined by the IRB. 
16.0 Withdrawal of Subjects 
Subjects who do not adhere to the protocol procedures and study instructions may 
be withdrawn from research analyses, as determined by the Principal Investigator 
and/or NIH Data Safety Committee. In addition to not adhering to study 
instructions, possible reasons for removal may include nonsystematic responding 
to questionnaires and HbA1c (blood sugar) levels that are not in the study 
prediabetes range. If a participant is withdrawn from the study without their 
consent, they will be debriefed about the nature of the study and be compensated 
for the amount of time spent in the study. We may also stop an ongoing session, 
or end participation in the study because we have collected all the information we 
need. 
Participants will be debriefed about the nature of the study and the reason for their 
removal. No additional follow-up is needed. 
Participants can withdraw from the research at any time. If participants withdraw, 
no further data will be collected, but any information that had been provided may 
be retained by the researcher and analyzed. 
17.0 Risks to Subjects 
There may be some sensitivity associated from certain questions asked when 
filling out questionnaires or having body measurements taken and subjects might 
feel uncomfortable disclosing some personal information such as medical history. 
Subjects can refuse to answer any questions that they are not comfortable 

Version Date 1/15/2021 
 
answering. Subjects will be free to withdraw from the study at any time, and their 
refusal to continue will not affect other medical care provided at any healthcare 
facility. 
Participants may experience hunger due to refraining from eating before the 
session. Feelings of hunger will subside when the participant is able to eat after 
the. In addition, only personnel certified in CPR, first aid, and AED will conduct 
study sessions and these individuals are trained to contact appropriate medical 
personnel in the event of an emergency. 
Breach of confidentiality is another potential risk. The studies will occur in our 
facilities at the University at Buffalo and the Virginia Tech Carilion Research 
Institute. To protect confidentiality, we will use only ID numbers and keep all 
data in locked cabinets or in locked offices and password protected electronic files 
in password protected computers. Any data shared between sites will involve de-
identified data only and files will be encrypted or password protected. These 
screening, monitoring, and confidentiality procedures have been in effect for more 
than 10 years and for more than 2,000 subjects across the various protocols 
employed by our group. 
Participants may have a small bruised area on the finger from the pinprick site. 
The bruise should fade over time without treatment. If during the course of the 
study, a subject’s blood glucose exceeds the range for prediabetes (Fasting Plasma 
Glucose (FPG) 100-125 mg/dl, or 2h glucose 140-199 mg/dl after Oral Glucose 
Tolerance Test (OGTT) or hemoglobin A1c (HbA1c) 5.4-6.7%), that subject may 
be directed to his or her physician or other medical care provider for further 
evaluation.  
Participants may have their blood pressure measured. If during the course of the 
study, a subject’s blood pressure reaches hypertensive crisis (180/110 mmHg), 
that subject may be directed to his or her physician or other medical care provider 
for further evaluation. 
There are no other risks anticipated. All personnel on the study will be CITI 
course certified and have completed the good research practices certification. All 
identifiable data will be password protected and only the research team will have 
access to that information. Subjects will be informed of the risks associated with 
the study. 
We have several provisions in place to ensure participants’ privacy and safety is 
protected while the data is being collected. The lab facilities of the Division of 
Behavioral Medicine research laboratory consist of private interview rooms that 
will be used. Only the interviewer and participant will be present in the room 
during interviews. Data is recorded such that not even the person putting it in the 
file would ever be able to associate the data with the identity of the person 
providing it. Data and files that have been de-identified and encrypted will be 
shared between sites. Therefore, there is no reasonable risk of a breach of 
confidentiality. Only personnel certified in CPR, first aid, and AED will conduct 
study sessions and these individuals are trained to contact appropriate medical 
personnel in the case of a serious event.  

Version Date 1/15/2021 
 
Subjects will be allowed to refuse to answer any questions they are not 
comfortable with. 
We may offer urine pregnancy test for females at the beginning and throughout 
the study. We will notify females of positive pregnancy test results and 
discontinue them from the study. 
18.0 Potential Benefits to Subjects 
Participants may benefit from improved health such as weight loss, improvements 
in blood sugar regulation, HbA1c, and blood cholesterol levels. Participants may 
also learn about the experimental research process and their health. 
19.0 Compensation for Participation 
Participants may earn up to $250 in the form of a personal check, cash, gift card 
(e.g., Target, Wegmans, Amazon), or reloadable debit card, based on preference. 
Participants will be compensated $10 for completing the screening session and if 
eligible to continue, will be compensated $10 for completing the baseline 
assessment session. Participants will also be compensated $20 for wearing the 
Actigraph for 7 days and completing the food recall for 3 days. Participants will 
be compensated $30 at the 3-month assessment session, $20 for wearing the 
Actigraph for 7 days and completing the food recall for 3 days. Finally, 
participants will be compensated $40 at the 6-month assessment session, $20 for 
wearing the Actigraph for 7 days and completing the food recall for 3 days. 
Incomplete sessions will be paid on a prorated basis. In response to the novel 
coronavirus outbreak participants may be asked to complete an additional 
questionnaire battery on a monthly basis. Each time they complete this battery 
they can earn an additional $10 ($60 for completion during each month of the 
study). Participants electing to complete the longer-term (12 month) follow-up 
will be compensated $30 for the 12-month assessment session, and an additional 
$10 for the completion of the coronavirus questionnaire. 
20.0 Consent Process 
Interested participants will be screened over the phone or have an opportunity to 
complete the survey online. Consent to screen for eligibility will be obtained 
verbally over the phone or through an action (e.g. clicking an “I agree” button) 
online. Screening consent will be obtained prior to asking any contact or 
eligibility questions. Documented informed consent will be obtained in a private 
room at the Division of Behavioral Medicine Research Lab during the scheduled 
laboratory appointment. 
There will not be a significant interval of time between obtaining and 
documenting consent and the actual participation in the initial research procedures 
(i.e. shortly after the person signs the document they will begin research 
procedures at their scheduled convenience).  However, if a subject requests more 
time to review the consent form, they are able to take the consent home to review 
and discuss with family members, then schedule a visit at a later date.  

Version Date 1/15/2021 
 
Subjects will be seen weekly or monthly; therefore, have the ability to 
discontinue the study at any time. Future revisions or modifications will be 
reviewed with the participants to insure continued consent if necessary. 
21.0 Multi-Site Research (Multisite/Multicenter Only) 
Principal Investigators. Leonard H. Epstein, PhD, at the University at Buffalo will 
be responsible for the oversight of subject issues and coordination of experimental 
behavioral medicine approaches. Warren K. Bickel, PhD, at Virginia Tech will be 
responsible for management related to behavioral task data collection and 
analyses. Each PI will be responsible for recruitment at their site, communication 
with each other and their team, and for his own fiscal and research administration. 
Communication Process. Project coordinator, study staff and/or the PIs will have 
a local weekly meeting to discuss any current issues with the study, including, but 
not limited to; IRB approvals, procedures, staff training, data safety, and interim 
analyses. PI and/or project coordinator will schedule monthly conference calls to 
discuss study information. Monthly reports/meetings will be used to track 
recruitment, data, data quality control, interim analyses and any IRB concerns. 
The agendas and reports will be saved and filed at both locations. The PIs will 
communicate as needed, either by phone, e-mail, or in person, to discuss 
experimental design, data analysis, and all administrative responsibilities. Each PI 
will share their respective research results with the other PI, key personnel, and 
collaborators. 
IRB approval records. UB’s IRB will be the IRB of record for both sites. UB will 
have records of IRB approval for both sites.  This will include copies of consents, 
protocols, questionnaires, and any other IRB-related document. Amendments and 
modifications will be discussed in weekly conference call meetings and 
implemented through UB’s IRB as required. 
Data Safety & Sharing/Transfer. Any and all potential safety concerns will be 
reported both to the IRB and additional site in a timely manner. We will follow 
the outlined procedures based on UB’s IRB New Information Reporting form. 
Any adverse event will be communicated to both sites within 24 hours to inform. 
UB will report new information to the IRB. 
Procedures. The two research groups will work collaboratively to implement 
research methods across the sites, and will develop common training procedures 
for the delay discounting, episodic future thinking, dietary protocol, exercise and 
activity protocol, and prediabetes components of the study. Members of each 
research team will be responsible for development of relevant manuals of 
operation for study methods. These will be communicated in regular email and 
phone meetings, as well as face-to-face meetings where investigators will travel to 
the other University for training and quality control issues. Team members are 
used to this approach since they have been involved in multi- center basic science 
and clinical projects. Each site will be responsible for data quality control, based 
on a common protocol, and quality control will be implemented after data sets are 
built prior to analysis. 

Version Date 1/15/2021 
 
Problems. Problems will be reported within 24 hours for adverse events and 
within 1 week for any methodological problems to both study coordinators. Study 
coordinators and PI’s will be responsible for reporting adverse events to the IRB 
within the UB IRB Reporting form time frame (i.e. 5 days for new information 
that impacts participant risk). Study coordinators and PI’s will be responsible for 
determining amendments required for changes to study protocol. 
Interim results. Data will be shared between sites and all data will be de-identified 
prior to sending a password-protected/encrypted file. Study coordinators and PI’s 
will be responsible for communicating any interim results that are analyzed. 
Closure. All continuing review and closure forms will be shared between sites in 
an IRB related file. 
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