A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes
Phase: NA
Conditions: Type2 Diabetes
Sponsor: Massachusetts General Hospital

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
I.  Background 
 
 
A. Historical Background  
Physical inactivity among patients with type 2 diabetes (T2D) is a major clinical and 
public health problem. Roughly 18 million Americans with T2D do not follow recommended 
guidelines for physical activity,1 and inactivity is independently associated with major diabetes-
related complications and mortality.2-4  Intensive multicomponent programs for physical activity 
and other health behaviors in T2D have had positive results in research trials but may be less 
feasible and effective when applied in front-line clinical settings.5-8  
Motivational interviewing (MI) is a more widely applied technique that can improve 
physical activity in T2D. MI is a patient-centered approach used to address ambivalence and 
promote change,9 and it can be effectively delivered in person and by phone.10-12 MI can be used 
with patients at any stage of change, from those who currently are not ready to become active, to 
those who are highly motivated to make change.9 MI has been used in many settings for >30 
years and has resulted in increased physical activity in patients with T2D.13  However, MI alone 
may not be enough. Though MI is associated with increased physical activity in T2D, the effect 
size has been relatively small (~0.2 in 3 recent trials),14 and these somewhat limited effects on 
physical activity may not translate to fewer adverse clinical events. Also, specific subgroups may 
be less likely to benefit from MI, such as those who have low expectation of improvement, low 
overall optimism, or low perceived social support.15-17 Fortunately, MI has integrated well with 
other treatments in research and clinical settings.18,19 
Positive psychology (PP) interventions have the potential to promote physical 
activity in T2D. Baseline levels of optimism and positive affect are associated with greater 
subsequent improvements in physical activity (and medical outcomes) in patients with T2D and 
other chronic illnesses, controlling for baseline physical activity, medical illness severity, and 
depression.20-22 This suggests a prospective, independent role of positive constructs on physical 
activity.  PP interventions use structured exercises to boost the frequency and intensity of 
positive states, and have reduced distress and improved well-being in >3000 study 
participants.23,24 PP is well-accepted, requires little staff training, and can be delivered 
remotely.24,25 PP programs have increased physical activity and related behaviors in randomized 
trials of patients with medical illness,26,27 bolstering the scientific rationale for PP to improve 
physical activity in chronic medical conditions like T2D. PP also addresses psychological 
distress and low motivation, which are common in T2D and impair self-care.28 Despite these 
features, there has been minimal use of PP in T2D.29 
A novel physical activity intervention combining PP and MI in T2D may be very 
effective. MI represents an established health behavior intervention to increase motivation, boost 
confidence, and reduce ambivalence related to physical activity. A PP intervention could 
enhance the effects of MI by promoting factors (optimism, perceived support, and confidence) 
linked to superior outcomes in health behavior interventions,19,30 and PP could have direct effects 
on physical activity mediated by increased well-being and confidence.23,29,31 Such a combined 
PP-MI intervention could be delivered by phone, allowing inclusion of patients who are unable 
to attend regular in-person visits. Novel components that focus on social connection, built 
environment, and reducing sedentary time could further improve outcomes while maintaining a 
phone-based individual intervention.   
 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
B. Preliminary Data. This project continues our progress in developing a PP-MI 
intervention in T2D.  
Positive psychological states and physical activity. In 164 patients with an acute 
coronary syndrome (ACS), we found that optimism 2 weeks post-ACS predicted greater 6-month 
physical activity (measured by accelerometer), controlling for baseline physical activity, medical 
factors, sociodemographics, depression, and anxiety (β=102.5; p=.026).32 We also completed a 
mixed methods project with ACS patients (N=32), finding that optimism and positive affect led 
to initiation of physical activity and predicted overall future health behavior adherence.33,34  
PP intervention studies in cardiac patients. We tested PP in two controlled trials in 
patients with heart disease. In a small pilot (N=28), PP was associated with more improvement in 
mental health outcomes than either attentional control or mindfulness interventions.25 We then 
used the above qualitative interviews to refine the PP intervention and studied the revised 
intervention in 48 post-ACS patients. The intervention was well-accepted and led to 
improvements in psychological status (positive affect, depression, and anxiety), compared to 
usual care.35 We are now examining the effects of PP on activity after ACS.  
PP-MI intervention studies. In concert with Dr. Elyse Park, who has much experience 
testing MI in medical cohorts,10-12 we have developed a combined PP-MI intervention that is 
now being studied in a trial (N=128) comparing PP and PP-MI for ACS patients with low 
physical activity.36 In the first 50 participants, both conditions were associated with increases in 
physical activity. However, PP-MI participants had even greater physical activity improvement 
(12.6 metabolic equivalent [MET]-hours; effect size difference: d=.33) at 16 weeks, compared to 
PP. This data further supports the idea that PP, and especially PP-MI, can improve physical 
activity in medical populations.  
Expansion to T2D. We have spent the past 3 years developing PP and PP-MI in T2D 
patients using the NIH-supported Rounsaville37 and ORBIT38 models of iterative behavioral 
intervention development. We completed a review of positive psychological states and outcomes 
in diabetes22 and published a theoretical model for PP-MI in T2D.39 Empirically, we completed a 
single-arm pilot (N=15) of a 12-week PP-alone intervention to assess its feasibility in T2D.39,40 
PP exercise completion rates were high, and participants rated the exercises as useful (mean 
ratings: 7.8/10). PP was associated with improvements in optimism, depression, diabetes self-
care, and health behavior adherence, with a large pre-post effect (Cohen’s d=.81) on physical 
activity. We have completed qualitative interviews in 20 T2D patients with low physical activity 
that focused on relationships between psychological issues and health behaviors, and gathered 
feedback about a proposed PP-MI intervention to adapt it to the nuances of T2D. Compared to 
ACS patients, T2D patients reported more unsuccessful attempts to become active, and they 
showed the most interest in PP activities that focus on the use of personal strengths to meet new 
health goals.41 We are currently completing a single-arm pilot (N=12) of a 16-week PP-MI 
intervention to evaluate its feasibility and acceptability in T2D.  
Relevance to proposed project. In sum, we have identified relationships between 
positive states and physical activity, generated PP and PP-MI interventions in cardiac patients, 
and begun to develop a PP-MI intervention for T2D using feedback from a PP-alone pilot trial 
and qualitative interviews in T2D patients. The T2D projects also provided valuable experience 
recruiting from the Massachusetts General Hospital (MGH) Diabetes Center where the proposed 
project will occur, making us well-positioned to successfully complete the proposed trial.  
 
C. Rationale/potential benefits/overview of proposed research 
 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
Given: (a) the relationship between psychological well-being and physical activity, (b) 
the potential for combined PP and behavioral interventions to improve physical activity more 
than either alone, and (c) the great need for effective activity interventions in T2D patients, the 
use of a combined PP and MI intervention has the potential to increase physical activity and 
reduce adverse events in a high-risk, high-yield population of patients. This would have direct 
benefits to patients and would impact public health, given that >18 million Americans have T2D. 
This project could represent a key first step in determining the feasibility and efficacy of such a 
program.  
 
II. Specific aims. In a randomized trial of 60 T2D patients with low baseline physical activity, 
our goal is to complete the following specific aims:  
 
Specific Aim 1 (feasibility and acceptability): To determine whether the PP-MI intervention is 
feasible (assessed by % of total PP-MI phone sessions completed) and well-accepted (assessed 
by participant ratings of the ease and utility of each PP-MI session) among T2D patients with 
low baseline activity.  
 
Specific Aim 2 (physical activity): To assess whether PP-MI is associated with larger increases 
in moderate to vigorous physical activity (MVPA), and less sedentary time, on accelerometer at 
8 and 16 weeks, compared to standard MI. 
 
Specific Aim 3 (additional outcomes): To explore whether the PP-MI intervention is associated 
with greater improvements on other psychological, behavioral, and medical outcomes, compared 
to MI. 
 
Hypotheses: Our primary hypotheses are that a majority of the PP-MI participants (n=30) will 
fully complete at least 6 of 8 PP-MI sessions (feasibility) and provide mean ratings of over 7/10 
for the ease and utility of PP-MI sessions (acceptability). We also expect participants in PP-MI to 
have larger improvements in MVPA (minutes/day) and other key outcomes, warranting further 
testing in a well-powered efficacy trial.  
 
III. Subject selection 
 
A. Inclusion/exclusion criteria 
 
Inclusion criteria. We will enroll adults who are seen in an outpatient clinic at MGH (including 
the MGH Diabetes Center) and meet the following criteria:  
(1) T2D. Eligible patients will meet American Diabetes Association (ADA) criteria42 for T2D 
(e.g., HbA1c  [A1C] ≥6.5%, fasting glucose ≥126 mg/d), with diagnosis confirmed by their 
diabetes clinician and/or medical record review. We will include patients with well-controlled 
T2D if they have low physical activity because inactivity still puts them at risk for complications. 
(2) Low physical activity. We will define low physical activity as ≤150 minutes/week of MVPA 
(corresponding to ADA recommendations for moderate or greater intensity aerobic physical 
activity). Physical activity will be measured using a brief questionnaire adapted from the 
International Physical Activity Questionnaire (IPAQ) which has been used and validated in 
medical cohorts.44,45 Patients will complete the brief IPAQ regarding their activity in the past 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
week (or a typical week, if the past 7 days atypical) to assess # of minutes spent performing 
MVPA. Patients reporting ≤150 minutes/week of MVPA will be eligible for inclusion in the 
study.  We chose this cutoff in order to ensure adequate room for improvement over the course 
of the study.  
 
Exclusion criteria:  
(1) Cognitive impairment precluding consent or meaningful participation, assessed using a six-
item screen developed for this purpose.54  
(2) Lack of phone availability. 
(3) Inability to read/write in English.  We are excluding other languages for this initial pilot trial 
to maintain consistency but will expand to additional languages (e.g., Spanish) if the intervention 
proves to be effective.  
(4) Additional medical conditions (e.g., severe arthritis) that preclude physical activity. 
(5) Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac 
rehabilitation), or other clinical trials. 
 
 
B.  Source of subjects and recruitment methods 
The outpatient MGH Diabetes Center and MGH primary care clinics will serve as the 
source of study participants. Recruitment and informed consent procedures for this trial will be 
highly similar to those outlined in our IRB-approved protocol (Partners Healthcare System IRB 
#2016P-002523) for the pilot PP-MI study in T2D patients at the same outpatient location with 
similar inclusion and exclusion criteria. The procedures to protect enrolled and non-enrolled 
participants outlined below are being used in the pilot PP-MI study to good effect. 
Potential participants will be adult outpatients in these clinics with a diagnosis of T2D for 
>1 year who have ever had an A1C of at least 6.5%. Algorithms in TopCare (a population-based 
information management system that is used in clinical care) and RPDR, as well as customized 
Epic reports (including but not limited to PHS One View Report Diabetes PCP and 
2012p002605-222010), will be used to generate lists of potential patients for providers to review 
and individually approve eligible patients. In addition, we will use the D4Q data warehouse, a 
tool commonly used at MGH for clinical outcomes research and operations improvement, in our 
search for eligible participants. After these lists are generated, study staff will conduct a manual 
electronic chart review to verify eligibility criteria and physician linkage.  
For potentially eligible patients who are enrolled in the MGH Research Options Direct to 
You (RODY) Program, we will send them an opt-out letter and call 10 days later to inform them 
about the study. Otherwise, we will next obtain permission for initial contact from each 
potentially eligible patient’s physician or other health care provider (e.g., nurse practitioner). We 
will send provider-approved patients opt-out letters using the following two-letter approach: 
For these patients, a study coordinator will send an opt-out letter packet composed of two 
letters. The mailing will have a cover letter (see attached sample) with their clinician’s name at 
the bottom generally informing the recipient why they are being contacted about this study. The 
cover letter will also explain that their participation is completely voluntary and whether they 
enroll or not will have no bearing on their ability to receive care. The opt-out letter, signed by the 
study PI, will briefly explain this optional study and will describe that if they do not wish to 
receive a call explaining the study, they can call the study team opt-out line to inform the study 
team. If the team does not receive an opt-out call after 10 days, a study coordinator will call the 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
potential participant and describe the study. The study coordinator will further describe details 
regarding the study, including its goals (to improve physical activity), study procedures (e.g., a 
total of 3 in-person visits, a total of 8 weekly sessions), and a review of risks and benefits. If 
patients do not meet criteria, they will also be asked for their permission to be contacted about 
participation in future studies. 
In addition, we will reach out directly to physician groups, and patient referral will be 
encouraged. For directly referred patients, we will send opt-out letters as above. Finally, we may 
use hospital press releases, RSVP for Health, and/or the MGH Diabetes Research Center website 
to publicize the study.  
 
IV. Subject enrollment 
 
A. Methods of enrollment 
If the patient is interested in the study during the phone discussion outlined above, the 
study staff member will evaluate for inclusion criteria, first assessing for physical activity using 
the brief IPAQ. Staff will similarly assess for exclusion criteria (e.g., cognitive deficits on six-
item screen) via interview.  
 
 
B. Procedures for obtaining informed consent 
If patients, as identified above, meet study criteria and remain interested in the study, the 
coordinator or other study staff will mail, or email, the patient a written IRB-approved consent 
form for their review, and will schedule an in-person visit that will take place at MGH. This will 
allow patients to have adequate time to read the consent form. Upon arrival at the hospital, the 
study coordinator will review the consent form and allow the patent to ask any questions he or 
she may have; the study PI will also be available to answer any questions. To ensure that 
participants have the capacity to provide informed consent, we will ask potential participants to 
describe their understanding of the study’s purpose and their role (i.e., that they understand the 
purpose of the study, timing of study visits/ accelerometers/phone calls and their purpose, 
confidentiality and its limits, our focused review of medical records, recording of phone sessions, 
and their ability to end participation in the study at any time for any reason). Participants will 
also complete a release of information to allow the study team to speak with their primary 
medical providers about safe physical activity goals. They will also be asked for their permission 
to be contacted about participation in future studies. We will not exclude patients on the basis of 
race, ethnicity, or gender. 
If a potential subject is a patient in an investigator’s clinical practice (e.g., a patient of 
Co-I Dr. Wexler), we will ensure that this investigator will not be involved in recruitment, 
obtaining informed consent, or other aspects of the enrollment process. Patients will be given as 
much time as they desire to consider study participation and review the consent form, and 
enrollment will be deferred to a future appointment if desired.  
Upon signing informed consent, participants will complete baseline self-report 
assessments and a blood draw (for A1C) by a trained phlebotomist in the MGH Corrigan 
Minehan Heart Center. A total of 5 ml/cc of blood will be drawn (this is equivalent to 1 
tablespoon of blood). We will collect basic de-identified information (e.g., age, race, gender, 
living alone, medical diagnoses) on eligible patients who decline participation to assess the 
representativeness of patients who enroll; such data will only be recorded, analyzed, and reported 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
in aggregate in comparison to enrollees, with no personal identifiable information collected. We 
will also measure the participant’s weight at this initial visit. 
 
C. Treatment assignment/randomization 
Regarding randomization, we will utilize treatment allocation by minimization55 under 
the direction of biostatistician Dr. Brian Healy to reduce accidental bias/chance imbalance of key 
participant variables between the two groups. Minimization is a dynamic randomization 
technique for achieving a balance of prognostic factors across treatment groups that allows 
balancing over a larger number of covariates than in stratification.56,57 Initially, slips of paper 
detailing study condition (with assignments generated using a random number generator; 30 per 
condition) will be generated by a research coordinator who is not otherwise involved in the 
project. The slips will be placed into sealed, opaque, and identical envelopes, and these will be 
allocated to numbered study binders by a study coordinator. Participants will be assigned to a 
study condition via this simple randomization method initially. Once at least 8 participants have 
been enrolled in each group (to allow initial population of both groups prior to balancing via 
minimization), we will activate the minimization procedure. For all subsequent enrollees, 
allocation of participants to study condition using a dynamic automated minimization 
algorithm55 will occur to ensure balance on dichotomized age, gender, baseline physical activity, 
and medical comorbidity (Charlson index58) variables, using established methods.55,57,59 These 
covariables will also be included in the statistical models used to analyze study outcomes as per 
published methods using this technique.60 No study staff or investigators will be aware of a 
participant’s condition until consent and all baseline assessments have been completed; 
participants and study staff will learn of the participant’s study condition contemporaneously (via 
envelope [initial 16 enrollees] or computer assignment [subsequent enrollees]).     
 
V. Study procedures 
A. Study visits/assessments (See Figure, below)   
 
 
 
 
 
 
 
 
 
 
 
Overview.  At baseline, we will obtain self-report measures (see below), height and 
weight, a blood sample for A1C, and accelerometer data for physical activity. At each 
intervention phone session, interventionists will collect feasibility and acceptability data (see 
below). At the follow-up visit (8 weeks), a blinded assessor will obtain repeat self-report data, 
vitals, A1C, and accelerometer data. At 16 weeks, a blinded assessor will obtain self-report data 
by telephone, and an accelerometer will be mailed to the participant to measure physical activity. 
All participants will receive pedometers, free parking or public transportation at all visits, $20 
Figure. Assessment procedures. 
Assessment for 
study criteria 
(T2D, low 
physical 
activity, oral 
T2D meds, 
exclusions) 
Baseline data 
baseline 
characteristics
, self-report 
data, weight, 
A1C, 
accelerometer 
PP-MI  
(n=30; 8 weeks) 
Assessment by 
blinded assessor, 
week 8:  
self-report data, 
vitals, A1C, 
accelerometer 
MI alone 
(n=30; 8 weeks) 
Assessment by 
blinded assessor, 
week 16:  
self-report data, 
accelerometer 
Visit #1  
(in-person) 
Follow-up 
Assessment (phone) 
Follow-up Visit 
(in-person) 
Phone Sessions 
Visit #2 
(in-person) 
Screening 
(phone) 
Randomization 
participants 
receive 
manual, 
introduction to 
treatment arm 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
after the second visit, $40 after the 8-week follow-up visit, and $40 after the 16-week phone 
assessment, after all devices have been returned.  
 
Initial/Enrollment Visit (in-person visit #1).  We will collect data on basic 
sociodemographic variables (age, gender, race/ethnicity, living alone, duration of T2D, 
medical/psychiatric comorbidities, medications) needed to characterize our population (and to be 
used as part of randomization by minimization).  Next, participants will complete self-report 
measures, and we will draw blood for A1C if participants did not have these procedures 
completed as part of a clinical visit (if they had A1C in the last 3 weeks, including this visit, we 
will use that value to prevent subjecting participants to the blood draw).  This visit will occur on 
site, partially in offices in the Warren building and partially in the MGH Corrigan Minehan Heart 
Center. Finally, participants will be given an accelerometer, which will be worn over the 
subsequent week (prior to visit #2) to measure baseline physical activity.  
Objective physical activity assessment and in-person visit #2. In order to gather 
baseline physical activity data, participants will take home and wear accelerometers for 1 week 
prior to visit #2. During in-person visit #2, participants will return their accelerometers and will 
begin the study intervention, as outlined below.   
 
Intervention (PP-MI vs. MI alone: 8 weekly phone sessions).  
PP-MI intervention. Participants randomized to PP-MI will receive a treatment manual. 
For each session, a PP exercise will be described in the manual, with instructions and space to 
write about the exercise and its effects. Next, an MI section will outline specific MI-based topics 
(e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following 
randomization (in-person visit #2), interventionists will introduce PP exercise #1 and MI session 
#1 to participants to aid engagement. Following visit #2, participants will engage in weekly, 30-
minute phone calls for the next 8 weeks. Participants will independently complete PP exercises 
and MI-based goals between phone sessions and review them during phone sessions over 8 
weeks. PP and MI components will be delivered stepwise within sessions (rather than 
intertwined) based on our experience, participant feedback, and pilot work.  
PP component details. The PP portion of phone sessions (15 mins) will be structured to 
include: (i) review of the prior PP exercise, (ii) discussion about how to translate the PP exercise 
skills to daily life (e.g., related to physical activity goals or other activities), including a specific 
focus on how such skills can be used to foster social support and interactions, and (iii) 
assignment of the next exercise via guided review of the treatment manual.  
 
Table 1. PP exercises  
Session 1: Counting blessings61  
Participants recall three events, small or large, in the preceding week that were 
associated with satisfaction, happiness, pride, or other positive states 
Session 2: Gratitude letter24 
Participants write a letter of gratitude thanking a person for their support or 
kindness.  
Session 3:  Enjoyable and 
meaningful activities64 
Participants complete three activities: an enjoyable activity alone, an enjoyable 
activity with another person, and a meaningful activity completed alone or with 
others.   
Session 4: Implementation 
Participants focus on implementing positive psychology skills into daily life.  
Session 5: Recalling past success63 
Participants recall an event in which they experienced success. They next write 
about the event, their contribution to the success, and positive feelings elicited 
by recalling it.  
Session 6: Using personal 
strengths, part 124 
Participants identify a signature strength, then find a specific new way to use that 
strength in the next 7 days.  

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
 
 
MI component of PP-MI. This will be adapted from our PP-MI program in ACS 
patients, Dr. Park’s MI interventions,10-12 and data from T2D patients. The MI portion of calls 
(15 mins) will assess participant motivation to increase physical activity (safe, specific activity 
goals will be obtained from their medical providers), and plan action steps or cognitive work to 
boost motivation. We will use established models of goal-setting and feedback based in social 
cognitive theory67,68 and the transtheoretical model of behavior change69 that utilize setting of 
proximal, attainable, explicit goals and specific feedback to reinforce progress and enhance self-
efficacy.  We will typically focus on walking, as brisk walking is feasible as a first step in 
becoming active for T2D patients70 and can improve health.71 The ultimate physical activity goal 
in nearly all cases will be moderate physical activity for ≥150 min/week, per ADA guidelines.43 
Gradual, safe physical activity progression will be ensured via a stepwise approach, symptom 
monitoring, and coordination with participants’ physicians. Participants will also be given a 
digital pedometer (Omron) that clips on a belt or other article of clothing, to promote and track 
physical activity. Finally, this enhanced MI program will also focus on reduction of sedentary 
time by helping participants to track sitting time and develop strategies to reduce such 
episodes,72-74 using the framework for increasing physical activity and our team’s experience 
with sedentary time interventions.75 Participants will be mailed a graph of their weekly step 
counts two times over the course of the study. The graph updates will be sent at the middle and 
end of the study (i.e. following sessions 4 and 8).     
 
 
Walkability audit. Built environment audits (see attachment) can promote physical 
activity by helping participants find new opportunities for physical activity, manage 
environmental barriers, and change perceptions about their environment.76,77 PP-MI participants 
will complete the 15-item Microscale Audit of Pedestrian Streetscapes-Mini (MAPS-Mini),78 a 
walkability audit that has participants identify walkways, parks, traffic, and other features in their 
neighborhood and usual walking routes by completing checklists as they explore these areas. 
Participants will be oriented to MAPS-Mini administration in session 5 and complete it in the 
Session 7: Using personal 
strengths, part 224 
Participants identify a second signature strength, then find a specific new way to 
use that strength in the next 7 days.  
Session 8:  Acts of kindness62 
Participants complete three acts of kindness, planned or spontaneous, in a single 
day. 
Session 9: Planning for the future 
Participants review the positive psychology skills they learned in the program, 
then make a plan to use their skills in the future.  
Table 2. MI sessions.  
5A’s model (all 
sessions)  
Interventionists: (a) Ask about progress on the prior cognitive (e.g., pros/cons of becoming 
active) or physical activity goal, (b) Advise about the benefits of physical activity on health 
and function, (c) Assess current stage of change and barriers/facilitators to change, (d) Assist 
with setting a goal, and (e) Arrange the next phone session. 
Session-specific 
topics 
Session 1: Introduction to MI tools and tracking of physical activity  
Session 2: Setting a SMART (Specific, Measurable, Attainable, Relevant, Time-based) 
activity goal  
Session 3: Identifying barriers and problem-solving around them  
Session 4: Using social and equipment resources  
Session 5: Finding new walking routes (neighborhood walkability audit) 
Session 6: Using neighborhood resources  
Session 7: Managing slips  
Session 8: Reducing sedentary time/taking breaks 
Session 9: Planning for the future  

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
next week. Information from this audit will be used during MI sessions to facilitate the setting of 
practical physical activity goals based in participants’ local areas.   
Training and fidelity. All team interventionists have delivered PP-MI. Once the 
intervention is refined for T2D, they will receive additional training via didactics, role play, and 
supervised interviews. During the study, weekly interventionist supervision will be led by PI Dr. 
Celano (PP content) and Dr. Millstein (MI). All sessions will be recorded; supervising study staff 
(Drs. Huffman, Celano, Millstein, or Park) will rate a random selection (20% at minimum) for 
fidelity using scales for the PP and MI components, respectively, and provide feedback. 
MI-based health behavior education condition (time matched).The MI-based health 
behavior education intervention was selected as the control condition for several reasons.  The 
inclusion of MI and education regarding key diabetes health behaviors aims to increase the 
retention of participants included in this condition.  However, the focus of this intervention on 
multiple health behaviors and the lack of specific physical activity goal-setting make it less likely 
that this control intervention will significantly impact physical activity (our primary health 
behavior outcome).  Finally, as an attentional control, it has a parallel structure to the 
experimental arm with a treatment manual, weekly exercises, and weekly calls to review 
exercises. 
 
Each week, participants will learn about a different health behavior topic related to diabetes 
health. They will also be introduced to motivational interviewing topics in concert with the 
health behavior education topics.  The intervention is divided into four sections, focusing on 
different important diabetes health-related topics: 
 
Part One: Diabetes Self-care 
How to Take Care of Your Diabetes (Session 1) 
Participants will review information about the importance of self-care (e.g., glucose 
monitoring, foot checks, eye exams) to reduce the risk of T2D complications.  
 
Part Two: Medication Adherence 
 
Taking Medications Regularly (Session 2) 
Participants will review the importance of medication adherence and learn about 
medications typically prescribed for T2D.  Participants will be encouraged to create a list 
of their current medications, as well as any questions they have for their physicians about 
their medications. 
 
 
Barriers to and Resources for Taking Medications Regularly (Session 3) 
Participants will identify barriers to taking medications, problem-solve those barriers, and 
identify resources to help them maintain adherence to medications. 
 
Part Three: Staying Active 
 
The Importance of Staying Active (Session 4) 
Participants will review the cardiovascular benefits of physical activity, questions to ask 
their physician prior to starting physical activity, and ways to set goals related to physical 
activity. 
 
 
How You Can Stay Active (Session 5) 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
Participants will identify one way in which they wish to change their physical activity.  
They will discuss the importance of making the change and their confidence about being 
able to do so.  Finally, they will create a list of pros and cons for behavior change. 
 
 
Barriers to and Resources for Activity (Session 6) 
Participants will identify barriers to physical activity in their life and brainstorm ways to 
problem-solve around those barriers.  Furthermore, they will identify social, community-
based, and equipment resources available to help them with physical activity. 
 
Part Four: Having a Healthy Diet 
 
Making Dietary Changes (Session 7) 
Participants will learn about the importance of reducing sugar, fat, and cholesterol in their 
diet.   Next, they will identify one way in which they wish to change their diet.  They will 
discuss the importance of making the change and their confidence about being able to do 
so.  Finally, they will create a list of pros and cons for behavior change. 
 
 
Barriers to and Resources for a Healthy Diet (Session 8) 
Participants will review how to properly read a food label and learn techniques to make 
healthy decisions while food shopping.  They also will identify barriers to a healthy diet, 
problem-solve those barriers, and identify resources that can help to improve their diet. 
 
 
Planning for the Future (Session 9) 
Participants will review the information learned over the course of the program and think 
of ways to remain healthy after the end of the program. 
 
Follow-up assessments (weeks 8 [in-person] and 16 [by phone]).  After completion of 
the intervention, participants will wear the Actigraph accelerometers for 1 week (they will have 
had the devices [which have no identifying information outside of a serial #] mailed to them 
prior to the visit and will return them at the in-person session), then return to the TCRC for an in-
person session (8 weeks). At this session, height and weight, hemoglobin A1c, and self-report 
data will be obtained. These visits will occur on the MGH main campus (TCRC). At 16 weeks, a 
follow-up phone session will be performed to obtain self-reported outcome data, and participants 
will be asked to wear an accelerometer for one week. We will allow a window of 3 weeks, to 
allow flexibility of scheduling such in-person appointments in Boston (and to allow coordination 
with other medical visits at MGH) while maintaining integrity of study findings. Follow-up 
assessments will be completed by a study staff member who is blinded to the participant’s study 
condition. 
 
B.  Drugs to be used 
There are no drugs used in this study. 
 
C.  Devices to be used  
To measure physical activity, we will use the ActiGraph GT3X+ accelerometer,82 a 
small, silent device without readout that is worn at the hip and stores data for several weeks; it 
has been validated and used in many populations, including T2D, to measure habitual physical 
activity.83  The GT3X+ is a half-dollar-sized device that is very lightweight, clips to a belt or 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
shoe, and has no sharp edges, shock risk, or visible readout (or any identifying data).  
Participants will wear the devices for 7 days. We will consider 5 valid days of wear (8+ hours 
per day) to be sufficient; participants will re-wear devices if needed. In a recently completed PP-
MI study in ACS patients (n=128; PHS IRB# 2014P001756), we used these devices/methods 
with good results. Sedentary time will also be measured with Actigraphs, using protocols to 
differentiate between sedentary time and device non-wear.84,85  Data will be downloaded onto 
our study team’s local computers without need to transmit data to external servers.  
 
D. Procedures  
A single venous blood sample will be collected at baseline and 8 weeks by study staff 
trained in phlebotomy, for A1C. No other procedures will be performed.   
 
E.  Data collected and when the data is to be collected (see Table 1, below) 
Baseline characteristics. To allow us to better understand our study population (and to 
allow for limited/qualitative accounting for covariates, we will record subjects’ baseline 
characteristics (age, gender, race/ethnicity, duration of diabetes diagnosis, medical and 
psychiatric comorbidities, medications, and baseline lipids, and hemoglobin A1c). Data will be 
obtained at the initial interview and supplemented with information from medical records.   
Feasibility and acceptability (Aim 1; # of PP-MI sessions completed, participant ratings 
of PP-MI ease and utility). Interventionists will record completion of PP-MI sessions at each 
session (weeks 1-8).  A completed PP-MI session requires both: (i) PP exercise completion and 
phone discussion, and (ii) the MI portion of the call must end with a specific physical activity-
based goal for the next week. In addition, at intervention calls, participants will separately report 
ease and utility (0-10 scales) of the prior week’s PP exercise and MI-based goal-setting, for 4 
total ratings per session.  
Physical activity (Aim 2; moderate to vigorous physical activity (MVPA) and sedentary 
time, in mean minutes/day). As noted, we will follow established protocols86 for ActiGraphs. 
Participants will wear the devices for 7 days and we will consider 5 valid days of wear (8+ hours 
per day) to be sufficient; participants will re-wear devices if needed. We will use standard cutoffs 
(in counts/minute) for MVPA and non-wear time per the literature87,88 and Dr. Kerr. Sedentary 
time will also be measured with Actigraphs.84,85  This data will be collected at baseline and 8 
weeks.  
Self-report measures (Aim 3; psychological, behavioral, and functional measures).  
These measures, except for the AUDIT-C and Cigarette Use Questionnaire (baseline only), will 
be collected by blinded study staff at baseline, 8 weeks, and 16 weeks: 
 
• Positive affect (our main psychological outcome given its links to health outcomes and 
sensitivity to change53,65) will be assessed using the relevant items from the PANAS.50  
• Additional psychological measures will include the well-validated Life Orientation Test-
Revised (LOT-R)89 for optimism, the Self-Efficacy for Exercise scale90-92 (SEE) for 
physical activity self-efficacy, and the Hospital Anxiety and Depression Scale (HADS) 
for depression and anxiety;93 the HADS was designed for medically ill cohorts. We will 
also include validated measures that may mediate connections between PP-MI and PA; 
these include the Brief Resilience Scale (BRS), the Self-Efficacy for Exercise (SEE) 
scale, and the Multidimensional Scale of Perceived Social Support (MSPSS).  
• Overall diabetes self-care (e.g., diet, medication, foot care), will be measured using we 
will use the 11-item Summary of Diabetes Self-Care Activities (SDSCA),94 a well-

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
validated self-report measure associated with clinical outcomes.95,96  
• For T2D medication adherence, we will use a %-based self-report measure97 found to 
correlate highly with pillcap measurement in T2D patients, allowing us to include 
patients with varied medications/dosing schedules.  
• For dietary adherence, we will analyze the dietary items in the SDSCA as a separate 
outcome.95  
• For physical function, the PROMIS 20-item short form (PF-20) will be used. The PF-20 
has strong item clarity,98 and it has been highly responsive to change in patients with a 
wide range of physical function.98-100  
• For pain-related disability, we will use the Pain Disability Index (PDI), validated in 
medical settings.  
• For self-reported physical activity, we will use the IPAQ, well-validated in diverse 
settings.  
• For self-reported smoking history, we will use the Cigarette Use Questionnaire.  
• For self-reported alcohol use, we will use the Alcohol Use Disorder Identification Test – 
Consumption (AUDIT-C).  
  
Medical outcomes (Aim #3; exploratory). At baseline and follow-up, we will also 
measure weight and A1C.  
 
Table 1. Schedule of study events/assessments. 
 
*Will use values from clinical visit (or within 3 weeks in the case of A1C) if available.  
 
VI. Biostatistical analyses: 
 
A and B. Specific data variables and study endpoints 
 
Specific Aim 1 (feasibility and acceptability): To determine whether the PP-MI intervention is 
feasible (assessed by % of total PP-MI phone sessions completed) and well-accepted (assessed 
by participant ratings of the ease and utility of each PP-MI session) among T2D patients with 
low baseline activity.  
 
Measures: 
 
Pre-
enrollment 
Enrollment 
Weeks 
1-8 
Week 8 
Week 
16 
Assessment for inclusion criteria (T2D, 
IPAQ)   
X 
 
 
 
 
Assessment for exclusion criteria (e.g., 
cognitive screen, other medical conditions 
limiting activity)   
X 
 
 
 
 
Interview and chart review for baseline 
characteristics  
 
X 
 
 
 
Self-report measures 
 
X 
 
X 
X 
Vital signs (weight) and A1C* 
 
X 
 
X 
 
Accelerometer (MVPA and sedentary time) 
 
X 
 
X 
X 
PP-MI exercise sessions 
 
 
X 
 
 
Session ratings by participants (ease/utility) 
 
 
X 
 
 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
• Rates of completion of exercises (recorded by study trainer) 
 
Specific Aim 2 (physical activity): To assess whether PP-MI is associated with larger increases 
in MVPA, and less sedentary time, on accelerometer at 8 and 16 weeks, compared to MI. 
 
Measures: 
• MVPA in mean minutes per day 
• Sedentary time in mean minutes per day 
 
Specific Aim 3 (additional outcomes): To explore whether the PP-MI intervention is associated 
with greater improvements on other psychological, behavioral, and medical outcomes, compared 
to MI. 
 
Measures: 
• Psychological measures: PANAS, LOT-R, SEE, HADS, BRS, MSPSS 
• Behavioral measures: SDSCA, % medication adherence, IPAQ, PF-20, PDI 
• Medical outcomes: Weight, BMI, and A1C 
 
C. Statistical methods  
All analyses will be performed under the direction of biostatistician Dr. Brian Healy. All 
analyses will be performed using Stata 14.0.  Alpha for between-group comparisons will be set at 
p=.05.  We will use descriptive statistics (means, standard deviations, proportions for the Aim 1 
feasibility/acceptability outcomes. For Aim 2, we will compare between-group improvement 
from baseline in mean minutes/day of MVPA (and sedentary time) at 8 weeks using a random 
effects regression model, with a random intercept for each patient, allowing us to include 
participants with some missing data.101 For Aim 3, we will likewise compare change from 
baseline on all measures (e.g., self-care, A1C) at 8 weeks, using random effects models. We will 
secondarily compare outcomes at 16 weeks, and will complete sensitivity analyses by sex. All 
variables used in minimization (age, gender, baseline MVPA, Charlson index) will be included 
as covariates in these models as per protocol using this method.60 We will also measure pre-post 
effect size (Cohen’s d, defined as change in the outcome measure divided by the standard 
deviation of the measure across all time points) of PP-MI for each Aim 2/3 outcome. If there are 
significant between-group differences in physical activity outcomes, we will use mediation 
analyses102 to evaluate a pathway from PP-MI to proximal targets (positive affect/optimism/self-
efficacy) to physical activity.  
 
 
D. Power analysis 
For our primary aim (feasibility/acceptability), in our prior work, 75% of subjects 
completed three-quarters of sessions.25,35 Using the same rate, with 30 PP-MI participants we 
will have 80% power (two-sided α=0.05, binomial proportion test) to demonstrate that the 
proportion who complete >8 of 11 PP-MI sessions is larger than 50% (i.e., a majority). Likewise, 
mean PP ease/utility scores were 7.8+/- 1.8 in prior work;35 with n=30 (and 4 weekly ratings per 
participant), we will have 93% power (using a within-person correlation of 0.5 for ratings across 
exercises) to detect a true mean score of >7.0 on composite ratings. This initial trial is not 
powered to definitively test group differences on physical activity and other Aim 2/3 outcomes, 
but it will allow us to gather data on PP-MI’s impact on these outcomes at this key early stage.  

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
 
 
VII. Risks and discomforts 
 
A. Complications of surgical/non-surgical procedures 
Blood sampling. We will obtain A1C data at baseline and 8 weeks. Risks of venous 
blood sampling include pain, bruising at the phlebotomy site, and emotional discomfort from the 
process. More rarely, participants may become lightheaded or experience syncope, or have an 
infection at the site. We will minimize these risks by: (1) ensuring that blood samples are drawn 
by study staff who have received specific training in phlebotomy (TCRC research protocol 
nurse) and have specific experience with this procedure, and (2) if A1C is drawn at the clinical 
visit or was obtained within the prior 3 weeks, that value will be used rather than subjecting the 
participant to an additional blood draw. Procedurally, we will make sure participants are seated 
comfortably during and after the sampling, and we will temporarily (or permanently) halt blood 
draws if patients voice pain or discomfort. If participants experience problems after blood draws 
(e.g., concerns about infection), they will be able to reach a study physician at any time, who can 
help to assess the situation over the phone or arrange to have the participant seen by their own 
physician or by study physician staff to assess any problems.  
 
B. Drug side effects and toxicities 
No medications are being used in this study. 
 
C. Device complications 
Accelerometer. The devices used to measure physical activity should pose minimal risk 
to subjects. The accelerometer (ActiGraph G3TX+) used to measure activity as a formal study 
outcome is small, lightweight, and without sharp edges. Immersing the device in water for a 
prolonged period may render it unusable, but does not pose a shock risk. We will provide explicit 
instructions regarding the use of this device to ensure safety and proper use, and to reduce 
inconvenience/distress associated with uncertainty about their use. Participants will also have 
study staff contact information if they have questions about the devices; project staff will be 
well-versed in the use of these devices given their experience from our prior projects that have 
used the G3TX+.   
 
D. Psychosocial risks 
Confidentiality. To minimize confidentiality-related risks, we will use participant ID 
numbers—as opposed to identifiable personal data or medical record numbers—on all study 
documents. We will discuss only information that is related directly to the study with subjects’ 
clinicians, and we will use locked cabinets and offices as well as password-protected databases 
to store personal information. Information from self-report assessments will be collected and 
stored using the secure, HIPPA-compliant, firewalled, and password-protected REDCap system. 
REDCap is a free web-based application developed for management of research and clinical 
data; it has separate password-protected data collection repositories for each trial. We have used 
this system for numerous prior studies without difficulty. Accelerometers will be labeled only 
with participant numbers; they will be connected to staff computers via USB and staff will utilize 
the password-protected Actigraph software downloaded onto our local computers to obtain 
activity data. No personally identifiable information will be recorded physically or electronically 
onto the accelerometers or within the software program.  

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
Finally, digital recordings of PP-MI and MI sessions will be completed using portable 
recorders. Randomly-selected sessions will be reviewed for competence and adherence to the 
protocol by supervising study staff members (e.g., Project Director, PI) using PP and MI fidelity 
rating scales. For sessions in the MI alone condition, supervising study staff will complete 
fidelity ratings with additional rating items to ensure that interventionists are not delivering PP 
content or other content (e.g., related to sedentary time) specific to PP-MI. All recordings will be 
downloaded immediately from the recorders and the electronic files will be kept within the 
firewalled, password-protected shared file area for fidelity review. Recordings will contain no 
personally identifiable information (and study interventionists will be specifically trained not to 
use names or other identifying information on the recordings) and will be erased following 
review. We have used all of these methods to maintain confidentiality in prior projects using the 
same measures, data repository, accelerometers, and recorders.  
We will ensure that contact with subjects is confidential by using only the phone numbers 
and other contact information that are specifically allowed by the subjects and not leaving study-
related messages for subjects unless expressly allowed by subjects. Upon enrollment, we ask all 
participants if it is acceptable to leave voice messages on their phones, as well as the appropriate 
times to call them. We adhere to any and all patient requests regarding contact.  
Medical/psychiatric issues. If there is an urgent medical or psychiatric condition that 
becomes apparent during in-person or phone-based sessions or at follow-up assessments, a study 
physician will assess the patient’s situation and ensure that the patient is seen immediately for an 
assessment in an emergency department or other urgent care setting if this is necessary; the PI 
(Dr. Huffman) and study internist/endocrinologist (Dr. Wexler) are available 24/7 by page for 
emergencies and have arranged emergent evaluation for patients as part of studies on several 
occasions in the past.  
Hypoglycemia. Some medications for T2D (i.e., insulin, sulfonylureas, repaglinide, 
nateglinide) can lead to hypoglycemia, and patients increasing their activity may become 
hypoglycemic. To address this for all participants who are on medications that can lower 
glucose, we will provide specific verbal and written guidance about symptoms of hypoglycemia, 
self-monitoring of blood glucose, and management of hypoglycemia, using handouts and 
protocols adapted from the NIDDK-funded Look AHEAD and REAL HEALTH-Diabetes (Look 
AHEAD implementation) studies focused on increasing activity in patients with T2D.103,104 
Participants in both groups will also be given contact information for the study team and will be 
asked to contact the study team if hypoglycemia occurs during exercise. At all calls and follow-
up assessments, interventionists and study staff will also query participants who are currently 
taking medications known to predispose patients to hypoglycemia during exercise (i.e., insulin, 
meglitinides, or sulfonylureas) about signs and symptoms of hypoglycemia. If such symptoms 
arise, the study endocrinologist (Dr. Wexler) will coordinate with participants’ medical care 
providers (and evaluate participants by phone or in-person as needed) to assist in making 
medication and other care adjustments to address these episodes, utilizing the approach used by 
Dr. Wexler when managing T2D participants on glucose-lowering medications in REAL 
HEALTH-Diabetes. Patients who are not currently taking medications known to increase risk of 
hypoglycemia during physical activity will not be asked about hypoglycemia symptoms at every 
call, in order to minimize participant burden. However, these participants will still be encouraged 
to notify their interventionist should they experience any symptoms of hypoglycemia. 
Physical activity safety. To ensure that patients can safely participate in physical activity, 
we will confirm with the patient’s clinician (physician or nurse practitioner) that the patient is 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
able to participate in a physical activity promotion program prior to approaching the patient. For 
those who enroll in the program, we will discuss the patient again with the clinician. Specifically, 
for participants in either condition, we will describe to the clinician the plan for setting goals to 
increase physical activity, and will ask if there are any specific instructions or cautions to be 
conveyed to participants, including specific warning signs such as atypical presentations of 
angina that may be common in T2D patients, such as dyspnea or nausea. This information will 
be recorded in the REDCap system so interventionists can use this information when developing 
plans with the patient at phone sessions. If participants have concerning symptoms, 
interventionists will contact the study physicians (e.g., Dr. Wexler), who will reach out to the 
participant’s clinician to inform them, obtain direction, and alter the physical activity plan as 
needed; she will also reach out to participants as needed. As noted above, participants will sign a 
release of information to allow such contact with clinicians (diabetologist, primary care 
physician) during the informed consent process.  
Depression/anxiety symptoms and suicidal ideation. Participants will complete the 
Hospital Anxiety and Depression Scale (HADS)93 as part of assessments; although this is a 
symptom measure and is not used to make a diagnosis of depression or an anxiety disorder, for 
participants with HADS depression or anxiety subscale scores of 10 or more, we will complete 
an assessment for suicidal ideation using our standardized, published protocol105 and inform 
patients’ primary providers of the elevated depression/anxiety score. For participants who have 
active suicidal ideation or are otherwise considered to be at high risk (e.g., due to combinations 
of depression symptom severity, history of prior attempt, and passive suicidal ideation), a study 
psychiatrist will perform a separate assessment and will arrange for urgent evaluation (e.g., in an 
emergency department) if clinically indicated.  
 
We will ask subjects to report adverse events related to study participation they may have 
experienced at any time throughout the study.  Any adverse events will be reported to the PI and 
to the IRB according to Partners HRC guidelines. 
 
VIII. Potential benefits 
 
A. Potential benefits to participants 
Participants in the project may not benefit from their participation. All participants (in 
either study condition) will receive serial assessments of medical, psychiatric, and functional 
status, allowing them access to emergent care if required. Participants in the control condition 
will receive MI, an established health behavior intervention associated with improvements in 
physical activity in patients with T2D, as well as T2D-specific education.14 Participants in this 
study arm therefore have the potential to increase their physical activity and to experience 
associated benefits in mood, energy, and health.   
Participants randomized to the PP-MI arm may obtain additional benefit. Along with 
receiving MI as above, participants will also receive PP content. Our preliminary studies have 
suggested that PP exercises are associated with lower depression and anxiety, greater positive 
affect, and improved mental health-related quality of life in other medically ill patients. Along 
with these possible psychological benefits, a prior  randomized trial of a PP-based intervention in 
medically ill persons led to increased physical activity,27 and our pilot PP project in T2D showed 
a moderate-large effect on physical activity over 12 weeks. Furthermore, the PP intervention 
component may lead to improved engagement in MI, potentially leading to greater efficacy of 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
MI techniques on physical activity. For these reasons, the PP-MI intervention may lead to 
increased physical activity (and reduced distress) in participants randomized to PP-MI. PP-MI 
participants will also have additional novel content, including systematic encouragement to 
utilize social supports, use of a neighborhood walkability audit to identify local physical activity 
opportunities, and a focus on reducing sitting time. These may further promote physical activity 
and reduce sedentary time, which has been associated with adverse medical outcomes in T2D 
independent of MVPA.106,107  
 
B. Potential benefits to society 
Participation in physical activity (and other health behaviors) is crucial in preventing 
adverse events in T2D.1-3,108 However, the majority of T2D patients do not complete 
recommended amounts of physical activity.5,109,110 Existing complex health behavior 
interventions can be difficult to implement in real-world settings, and more straightforward 
interventions, like MI, may require additional components to increase engagement and boost 
efficacy. We postulate that a combined PP-MI intervention has the potential to increase physical 
activity in inactive T2D patients through the combined effects of its two components. However, 
a PP-MI intervention has never been studied in patients with T2D prior to our team’s exploratory 
work. At this stage, there is still much knowledge to be gained about the feasibility, efficacy, and 
optimal implementation of this innovative intervention for T2D patients who are at elevated risk 
of adverse outcomes and mortality due to their inactivity.  
By completing this project, we will learn whether this intervention is feasible and well-
accepted by T2D patients who have low physical activity at baseline. We will also examine 
whether the intervention is associated with increased physical activity (objectively measured by 
accelerometer) in this cohort compared to those receiving standard MI. Finally, we will be able 
to explore whether this PP-MI intervention may have  
effects on additional psychological, adherence-related, and medical outcomes.  
            This knowledge could be of substantial importance. If the PP-MI intervention proves to 
be feasible, well-accepted, and effective in this study and larger follow-up studies, it may be 
possible to implement this easily-delivered program as part of a clinical care package for T2D 
patients who have low physical activity. This, in turn, could lead to better glycemic control, 
greater self-care, and fewer complications in a vulnerable population at high risk of 
complications and mortality. Therefore the knowledge gained from this initial study may 
ultimately translate to substantial benefit for future patients and public health.  
 
VIII. MONITORING AND QUALITY ASSURANCE 
 
A. Independent monitoring of source data 
 
Entry of data into REDCap will be reviewed by the PI and study biostatistician at 
intervals to ensure that data is being correctly captured/entered into this system.  They will also 
review downloading of data from REDCap into Stata to ensure that the data is being accurately 
transmitted to the study database for study analyses.  
.  
B. Safety monitoring  
We will utilize an Data Safety Monitoring Board (DSMB) for this study. The following 
procedures will be followed to ensure participant safety and the validity and integrity of data: 
Functions of the DSMB. The DSMB will review proposed amendments to the study 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
protocol, complete expedited monitoring of all serious adverse events, monitor drop-outs and 
non-serious adverse events, determine whether study procedures should be changed or the study 
should be halted for reasons related to the safety of study subjects, and perform periodic review 
of the completeness and validity of data to be used for analysis of safety and efficacy. The 
DSMB will also ensure subject privacy and research data confidentiality. 
Membership of the DSMB. The DSMB will consist of members with extensive research 
experience in diabetes, mental health, and biostatistics of clinical trials. Three members will be 
Dr. Andrew Nierenberg (Psychiatry), Dr. Enrico Cagliero (Diabetes/Endocrinology), and Dr. Lee 
Baer (Biostatistics); all have agreed to serve in this role throughout the study. The DSMB 
Chairperson (Dr. Nierenberg) will communicate by email and phone with the other members, 
and will coordinate formal, scheduled meetings of all members of the study and the PI.  
Monitoring of Safety Data by the DSMB. Safety information for this study will be 
reported to the DSMB in an unblinded manner. A statistical penalty will not be assessed for the 
unblinded review of safety by the DSMB. Unblinded data will not be released to investigators 
unless necessary for safety reasons. 
Range of Safety Reporting to the DSMB. It is considered necessary that the DSMB 
review not only adverse events (AEs) and serious adverse events (SAEs), but other data that may 
reflect differences in safety between treatment groups. This includes treatment retention rates 
and reasons for dropout.  
Serious Adverse Events. Expedited review will occur for all events meeting the definition 
of Serious Adverse Events (SAEs); i.e., any fatal event, immediately life-threatening event, 
permanently or substantially disabling event, or event requiring or prolonging inpatient 
hospitalization. This also includes any event that a study investigator or the DSMB judges to 
impose a significant hazard, contraindication, side effect, or precaution. All relevant information 
will be reported to the DSMB for each SAE including information about the event and its 
outcome, study group assignment, medications, the subject’s medical history and current 
conditions, and any relevant laboratory data. Notification by e-mail and FAX transmittal of all 
related study forms shall be made to the DSMB. Information will be reviewed and a 
determination made of possible relevance to the study.  
Non-Serious Adverse Events. At periodic intervals determined by the DSMB (e.g., 
quarterly during the study and then again at its completion), the DSMB will be provided with 
unblinded summaries of the numbers and rates of adverse events by treatment group. These 
reports will include types of events, severity, and treatment phase. Data on individual non-
serious adverse events is not expected to be needed for this review. 
Other Safety-Related Reports. At quarterly intervals, the DSMB will also receive 
unblinded summary reports of treatment retention and reasons for drop-out, by treatment arm and 
study phase.  
Study Stopping Rules. If at any time during the course of the study, the DSMB judges 
that risk to participants outweighs the potential benefits, the DSMB shall have the discretion and 
responsibility to recommend that the study be terminated. 
Monitoring of Data Quality by the DSMB. At least on a quarterly basis during the course 
of the study, the DSMB will receive a report on data quality and completeness. Dr. Brian Healy 
(study biostatistician) will prepare these reports in collaboration with Dr. Huffman. At a 
minimum, this will include an overview of the progress of patient intake and retention; summary 
reports describing patient compliance with evaluations as described in the protocol; and a 
summary of the completeness and quality of key data elements needed to characterize patients, 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
study interventions, and primary and secondary outcomes. These reports will be used by the 
DSMB to evaluate the capacity of the data capture and processing to support scientifically valid 
analyses.  
Annual DSMB Report to NIH/NIDDK. During the course of the study, the DSMB will 
prepare annual summary reports (two reports in total) of its findings regarding safety and quality 
based on data received to that point in the study. If there are more specific concerns about data 
quality, study safety, or other issues, the DSMB can elect to generate reports more frequently. 
This report will include a summary of all safety findings, as well as an assessment of protocol 
compliance and data quality. Any recommendations to improve patient safety, protocol 
adherence, or data quality will be made in this DSMB report. A copy of this DSMB report will 
also be sent to the PHS IRB along with the annual renewal report. 
In addition to the work of the DSMB, the research team will meet on a weekly basis to 
review study progress. During these weekly meetings, the principal investigator will review 
informed consent documents, study forms, and procedures completed that week. The study team 
will also discuss any procedural difficulties, recruitment issues, and adverse events at this 
meeting (and before if needed). If there are consistent issues with the logistics, feasibility, or 
acceptability of recruitment, enrollment, follow-ups, or the intervention (e.g., participant 
complaints about length of follow-ups), we will review our methods and alter the study protocol 
as needed.  
Patient Alert System. MGH has an electronic system that lets the study team know if a 
participant is admitted to a Partners Hospital, or if they visit a Partners Hospital Emergency 
Department for any reason. This alert will let the study doctors know why a participant is there, 
to make sure the study doctors know about any possible problems or side effects participants 
experience while taking part in the study. 
 
C. Outcomes monitoring 
For this initial randomized pilot trial, we will not plan to perform interim analyses 
beyond the analyses performed by the DSMB. However, given the feasibility and acceptability 
focus of this study, we will review ratings of intervention ease/utility after 10 and/or 20 
participants if our weekly team meeting reviews suggest that there are substantial barriers to 
acceptability (e.g., reports from participants at follow-ups/interviews, high rates of dropout) and 
consider changes to the protocol as indicated.  
 
 D. Adverse event reporting guidelines 
We will follow all PHRC guidelines with respect to reporting unanticipated problems, 
including adverse events. Specifically, when a serious or nonserious adverse event occurs, the PI 
will review the event to determine if it was possibly or definitely related to participation in the 
research. For all unanticipated problems and adverse events deemed related or possibly related to 
the research, we will complete and submit an Other Event report through Insight/eIRB as soon as 
possible and within 5 working days / 7 calendar days (as defined in the March 2014 Reporting 
Unanticipated Problems Including Adverse Events report). At Continuing Review, we will 
provide a summary of all unanticipated problems as per PHRC protocol. Finally, if there are 
unanticipated problems, especially if serious or recurrent, the PI (Dr. Huffman) will amend the 
protocol if it is deemed necessary to protect the safety and welfare of the participants.  
 
X. References 
 

A psychological-behavioral intervention for physical activity in type 2 diabetes—April 18, 2018 
 
 
1. 
Morrato EH, Hill JO, Wyatt HR, Sullivan PW. Physical activity in U.S. adults with 
diabetes and at risk for developing diabetes, 2003. Diabetes Care. Feb 2007;30(2):203-
209. 
2. 
Blomster JI, Chow CK, Zoungas S, et al. The influence of physical activity on vascular 
complications and mortality in patients with type 2 diabetes. Diabetes, Obesity and 
Metabolism. Nov 2013;15(11):1008-1012. 
3. 
Brown RE, Riddell MC, Macpherson AK, Canning KL, Kuk JL. All-cause and 
cardiovascular mortality risk in U.S. adults with and without type 2 diabetes: influence of 
physical activity, pharmacological treatment and glycemic control. Journal of Diabetes 
and Its Complications. May-Jun 2014;28(3):311-315. 
4. 
Reddigan JI, Riddell MC, Kuk JL. The joint association of physical activity and 
glycaemic control in predicting cardiovascular death and all-cause mortality in the US 
population. Diabetologia. Mar 2012;55(3):632-635. 
5. 
Carroll J, Winters P, Fiscella K, et al. Process evaluation of practice-based diabetes 
prevention programs: what are the implementation challenges? Diabetes Educator. Jun 
2015;41(3):271-279. 
6. 
Matthews L, Kirk A, Macmillan F, Mutrie N. Can physical activity interventions for 
adults with type 2 diabetes be translated into practice settings? A systematic review. 
Translational Behavioral Medicine. Mar 2014;4(1):60-78. 
7. 
Bastiaens H, Sunaert P, Wens J, et al. Supporting diabetes self-management in primary 
care: pilot-study of a group-based programme focusing on diet and exercise. Primary 
Care Diabetes. May 2009;3(2):103-109. 
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