Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Phase: NA
Conditions: Metabolic Syndrome
Sponsor: Massachusetts General Hospital

Title:  
Developing a Positive Psychology Intervention to Promote Health Behaviors 
in Metabolic Syndrome: Proof-of Concept Trial 
 
NCT03473886 
 
Date: 8/16/2018 

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Rachel Millstein, Ph.D. 
 
PROTOCOL TITLE 
Developing a positive psychology intervention to promote health behaviors in metabolic syndrome: 
Proof-of concept trial 
 
FUNDING 
NIH/NHLBI 
 
VERSION DATE 
8.16.2018 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical 
activity intervention and outcome assessments in patients with MetS. 
 
Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of 
participants will complete 6/8 exercises/sessions.  Furthermore, we will be able to obtain objective 
physical activity measurement follow-up data from at least 80% of enrolled participants at 8 weeks. 
 
Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as 
measured by ratings provided after each PP and MI exercise. 
 
Hypothesis: The intervention will be acceptable: participants will rate each PP and MI exercise with a 
mean score of at least 7 out of 10 on ratings of ease of completion and helpfulness.   
 
Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in 
improvement of physical activity, related health behaviors (sedentary time, diet quality), and 
psychological well-being (optimism, positive affect, anxiety, depression). 
 
Hypothesis: The intervention will lead to improvements in physical activity, related health behaviors, 
optimism and positive affect, and reductions in depression and anxiety at 8 weeks compared to baseline. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Metabolic syndrome (MetS). MetS affects 34% of US adults. MetS is comprised of dyslipidemia, 
central obesity, impaired glucose metabolism, and elevated blood pressure, which together dramatically 
increase the risk of chronic diseases like type 2 diabetes (T2D) and cardiovascular disease (CVD). 
Intervening at this pre-disease state can have major implications for reducing morbidity, mortality, and 
health care costs. Health behaviors, including physical activity, are critical for reducing the risk of MetS 
and the development of T2D, CVD, and end-organ consequences. Though intensive lifestyle interventions 

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can prevent or slow MetS, they have been difficult to sustain or implement broadly. The prevalence of 
MetS is projected to increase, and effective and sustainable interventions are greatly needed.  
 
Physical activity and MetS. Engaging in regular physical activity has great benefits for patients with 
MetS. Adherence to physical activity recommendations has been associated with better health and 
reduced risk of progressing to a chronic disease like T2D and CVD.  Despite the clear importance of 
physical activity for MetS patients, most have difficulty achieving the recommended amounts of activity. 
Furthermore, interventions designed to increase physical activity adherence have been met with limited 
success.   
 
Positive psychology (PP). PP is an area of study that aims to boost positive psychological states (e.g., 
optimism, gratitude, positive affect) through systematic exercises, such as performing kind acts, writing a 
letter of gratitude, or using a personal strength in a new way. These exercises are easily delivered and 
completed, generally with high participant liking. In research studies, these interventions have 
consistently increased well-being and reduced depression. Positive psychological states, such as optimism 
and positive affect, may play an important role in adherence to physical activity and related health 
behaviors.  Despite this, there has been minimal study of interventions in MetS patients that specifically 
focus on cultivating positive emotional states and their relationship to physical activity. To address this 
gap in knowledge, we are proposing a study that will focus on the development of a novel positive 
psychology (PP) intervention, combined with motivational interviewing (MI), a widely-used health 
behavior change intervention, that is adapted for patients with MetS. 
 
Motivational interviewing (MI). MI is a patient-centered approach to behavior change that can improve 
physical activity. It has been used in many settings to help patients increase physical activity and other 
health behaviors. It focuses on clarifying motivation, addressing ambivalence, and setting achievable 
goals. MI can be used with patients at any stage of change, from those who are not motivated to become 
active, to those wishing to maintain activity levels. MI integrates well with other treatments and has been 
successfully combined with health behavior interventions in medical populations. 
 
Creation of an intervention to increase positive emotions and physical activity in MetS patients. The 
overall aim of this research project is to develop and test a combined PP-MI behavioral intervention to 
improve positive emotions and increase physical activity among suboptimally active patients with MetS. 
The first phase was a qualitative research study to gather interview data on 21 participants’ experiences of 
living with MetS (PHS IRB Protocol #: 2016P002824). From these interviews, we have compiled patient 
preferences and needs to create the present intervention. Finally, there is evidence that neighborhood 
walkability features (e.g., sidewalks, crosswalks, safety) leads to more walking. In order to help sustain 
participants’ walking behavior, we will bring the groups on various walking routes around the clinics to 
assess for walkable features.   
 
In this proof-of-concept study, we will run two 8-week PP-MI groups (n=8 each, n=16 total) for primary 
care patients with MetS. We will use ratings of feasibility and acceptability for each of the sessions and 
obtain objective physical activity measures pre- and post- group. We will also obtain questionnaire-based 
information related to health behavior adherence and psychological and physical health to ensure the 
feasibility of these methods prior to further testing. Finally, we will gather exit interview data to assess 
participant liking, utility, and additional needs, to allow us to further refine the intervention. If this proof-
of concept data demonstrate feasibility and acceptability, the next step study would include a larger, 
randomized trial to test the feasibility and impact of the intervention. 
  
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 

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restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
This non-randomized proof-of-concept study will test a novel PP-MI intervention adapted for patients 
with MetS. The MGH Charlestown HealthCare Center and MGH Revere HealthCare Center will serve as 
the sources of participants for the study. Each healthcare center will be the site of one group during this 
phase of research. We will recruit up to 30 patients with MetS (15 from each site) in order to have n=16 
(8 per group) complete the study and provide follow-up data; this is to account for drop outs and loss to 
follow up. 
 
Inclusion criteria: 
• 
Both of the two MetS components most strongly related to MetS outcomes and most sensitive to 
lifestyle change:  
o elevated abdominal obesity (waist circumference >102 cm in men or >88 cm in women)  
▪ 
If waist circumference is not available, body mass index (BMI) will be used as a 
surrogate measure based on prior research (BMI ≥29.1 kg/m2 for men and 27.2 
kg/m2 for women). 
AND 
o elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg or be on blood 
pressure medication).  
• 
Plus ≥1 additional MetS component:  
o Serum triglycerides ≥150 mg/dL 
o High-density lipoprotein (HDL) cholesterol <40 mg/dL in men or <50 mg/dL in women 
o Fasting plasma glucose >100mg/dL.  
OR 
• 
Fewer than 3 MetS criteria but with PCP approval 
• 
Suboptimal physical activity defined as ≤150 minutes/week moderate intensity activity, which 
represents less than national-level recommendations.  
 
Exclusion criteria: 
• 
Inability to speak/read English  
• 
Cognitive deficits impeding ability to participate or provide informed consent (measured by a 6-
item screen)  
• 
Illness likely to lead to death in the next 6 months per PCP  
• 
Current treatment for cancer, liver, or renal disease 
• 
Pregnancy  
• 
Documented severe mental illness (e.g., psychosis, suicidality) 
• 
No telephone access  
• 
Inability to be physically active 
• 
Diabetes or known or suggested cardiac disease, given that this is a primary prevention study. 
 
There are no exclusion criteria with respect to ethnicity or socioeconomic status.  
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
The goals are to assess the feasibility, acceptability, and preliminary impact of this newly developed 8-
week PP-MI group-based intervention in two pilot groups.  Materials will be further revised based on 
group feedback.  

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Measures: Following consent and before beginning the intervention, participants will complete the Life 
Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety 
and Depression Scale (HADS), four subscales of the Neighborhood Environment Walkability Survey – 
Abbreviated (NEWS-A), Barriers to Being Active Quiz, SOM (State Optimism Measure), Community 
Healthy Activities Model Program for Seniors (CHAMPS), Medical Outcomes Study Short Form-12 (SF-
12), Microscale Audit of Pedestrian Streetscapes-Mini (MAPS-Mini) and two dietary screening measures: 
fruits and vegetables, and fats.  Participants will be asked to complete each of these measures at the end of 
the 8-week intervention as well.   
 
At the first, middle, and final sessions, height, weight, and blood pressure will be collected. 
 
Objective physical activity measures: Participants will be asked to wear an Actigraph GT3x+ for 1 
week at baseline and 1 week at follow-up to assess the feasibility of doing so.  Accelerometers such as 
this one are often considered to be the standard for measuring habitual physical activity.  They are 
pedometer-size devices that attach to a belt and are worn at the waist.  Participants will also be given a 
Fitbit Zip to keep, which they will be asked to wear daily for the duration of the study in order to track 
their steps.   
 
Baseline chart review data: Medical information about enrolled participants will be obtained from the 
patients, care providers, and the electronic medical record as required for characterization of our 
population. This information will include data about medical data related to MetS (e.g., blood sugar, 
blood pressure, body mass index, triglycerides, cholesterol), current medications, and sociodemographic 
data (age, gender, race/ethnicity, education, and marital status). This information will help us to ensure 
that the population we recruit indeed does meet MetS criteria, and is a representative population of 
patients living with MetS so that the intervention data we are gathering is applicable to the broadest 
population of patients.  
 
Measurement of psychological outcomes. Before and after the intervention, we will measure optimism, 
positive affect and other psychological constructs that may potentially be impacted by the PP-MI 
intervention. Doing so in this study will allow us to evaluate the feasibility using of these scales in this 
specific patient population.  
 
(a) Dispositional optimism (primary psychological outcome measure) will be measured using the Life 
Orientation Test-Revised (LOT-R), a well-validated 6-item instrument. Dispositional optimism is the 
positive psychological state most linked to cardiac outcomes, and the LOT-R has been used to measure 
optimism in many studies of cardiac patients. Though dispositional optimism theoretically would be 
stable over time, research suggests that LOT-R scores can change in response to psychological 
interventions.  
 
(b) Positive affect will be measured using the 10 positive affect items on the Positive and Negative 
Affect Schedule (PANAS), a well-validated scale used in other intervention trials.  
 
(c) Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS). 
This well-validated scale has been used in many studies with medical patients (including our group’s 
studies of heart disease), and has the advantage of having few somatic symptom items that can confound 
mood/anxiety assessment in medical patients. 
 
(d) Environmental barriers and resources will be assessed using four subscales from the Neighborhood 
Environment Walkability Scale – Abbreviated (NEWS-A), which measures various aspects of the built 
environment related to walking. The NEWS-A assesses residents' perception of neighborhood design 
features related to physical activity, including street connectivity, infrastructure for walking/cycling, 
neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction.  For this study, we will 

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ask participants to rate their neighborhood on the following four subscales: places for walking and 
cycling, aesthetics, traffic hazards, and crime. 
 
(e) Barriers to physical activity will be measured using the Barriers to Being Active Quiz, published by 
the US Centers for Disease Control and Prevention (CDC).  This 21-item measure explores seven main 
categories of barriers, including lack of time, energy, and resources.     
 
Measurement of quality of life and behavioral outcomes. We will also assess selected behavioral and 
quality of life outcomes. 
 
(a) HRQoL will be assessed via the Medical Outcomes Study Short Form-12 (SF-12), an instrument 
which has been used in multiple cardiac studies in the past, including our work. The SF-12 also is a 
reliable marker of QoL in cardiac patients and has been associated with mortality in this high-risk cohort.  
 
(b) Physical activity will be initially assessed using the well-validated International Physical Activity 
Questionnaire-Short Form (IPAQ-SF).  This scale measures self-reported physical activity in the past 7 
days in the domains of vigorous activity, moderate activity, and walking.  It has been used widely in 
many populations, with good reliability and acceptable validity.  It will initially be used as a screening 
tool to ensure that participants are sub-optimally active (<150 minutes of moderate-vigorous physical 
activity in a typical or past week).  It will also be used as a follow-up measure at the end of the program.  
The secondary physical activity measure will be the Community Healthy Activities Model Program for 
Seniors (CHAMPS), which was designed for use in older adults and is a checklist of activities completed 
in the past week.  CHAMPS includes strength and flexibility items, which the IPAQ-SF does not, and is 
designed to detect changes in physical activity among older adults (which most MetS patients are, 
including most of our participants in the qualitative study).  The CHAMPS has 41 items, but we will not 
include the first 6 items which ask about social activities, rather than physical activities, for a total of 35 
questions answered by participants. 
 
(c) Diet will be assessed in two broad categories: fruits and vegetables and percent calories from fat.  For 
fruit and vegetable intake, we will administer the CDC’s Behavioral Risk Factor Surveillance System 
(BRFSS) Fruit and Vegetable Module. This questionnaire consists of six items asking about frequency of 
eating different types of fruits and vegetables.  The National Cancer Institute’s Percentage Energy from 
Fat Screener is a 15-item questionnaire that estimates people’s typical percentage of energy derived from 
eating common fat-containing foods (e.g., butter, cheese, bacon).   
 
Prior to week 1. Before the first session, interested and eligible participants who gave phone consent will 
be offered times to come to their healthcare center to complete the consent form and the questionnaires in 
person with the study staff.  Participants will be provided an option to complete the questionnaire packet 
at home if they have time constraints.  In either case, HADS will be completed in-person with the study 
staff present. After a participant completes the HADS, we will review their answers to screen for 
depression. Participants who wish to enroll at that time will be given a copy of the consent form for their 
records.  The questionnaire that will be excluded will be the IPAQ-SF, which will have already been 
asked on the phone.  Participants will also then be given an Actigraph and instructions to track their 
baseline physical activity for 1 week prior to starting the study. Participants will be asked to bring back 
their Actigraphs at the first group session.  Upon receiving the Actigraphs, the research assistant will 
upload the data to check for valid wear time.  If participants did not wear it for long enough (>4 days), 
they will be asked to wear it again for a week and return it at the next session.  If there is a scheduling 
constraint such that an interested and eligible participant is not able to attend the pre-study visit, we will 
offer the option of completing the consent form, questionnaires, and receiving the Actigraph in an 
abbreviated 30-minute session immediately prior to the first group visit.  
 
Group sessions: overall. All group sessions will be 90 minutes and held in a group room at the 
respective Healthcare Centers.  The overall structure of each session will be: 30 minutes for positive 

Partners Human Subjects Research Application Form 
  
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psychology exercise review/discussion, 30 minutes for physical activity goal setting, education, and 
discussion, and 30 minutes for a group walk or indoor exercises in inclement weather.  
 
Week 1 session. Participants will be provided with a treatment manual, with weekly PP exercises and 
information to teach participants about the importance of physical activity and related health behaviors, 
and set goals to improve these behaviors.  
 
The PI (who will lead all groups) will then introduce the participants to the PP and goal-setting 
portions of the intervention.  For the PP portion, participants will discuss and be assigned the first 
exercise, gratitude for positive events, and will be instructed to perform the PP exercise during the next 
week. Prior to completing the exercise, participants will be asked to rate their current levels of happiness 
and optimism, using a 10-point Likert scale. Immediately after completing the exercise, participants will 
rate the ease of exercise completion, overall utility of the exercise, and their current levels of happiness 
and optimism, all using 10-point Likert scales. We will then introduce the first goal-setting session.  The 
leader will discuss the importance of physical activity in MetS. Participants will be given a Fitbit Zip to 
keep, which they will use to track the number of steps they take each day, for the duration of the study. 
We will review instructions for use and set a goal for monitoring their baseline physical activity over the 
next week. Fitbits will not be used as an outcome measure but as a tool that participants can use to 
monitor their activity and set goals.  
 
Finally, the last 30 minutes will be spent doing a group walk around the local clinic 
neighborhood.  As this will be the first group walk, we will move at a pace comfortable for all 
participants.   
 
Remainder of weekly sessions (Weeks 2-8). All participants will be asked to complete 8 weekly PP 
exercises, set physical activity goals, and attend as many group sessions as they can.    
 
Program Content. All sessions will include (a) a review and discussion of the past week’s PP exercise, (b) 
a discussion of the rationale of the next week’s PP exercise using the PP manual, and (c) assignment of 
the next week’s PP exercise.  For the goal-setting/MI portion, participants will (a) review their goals and 
steps from the prior week, (b) discuss techniques for improving physical activity (e.g., monitoring 
physical activity, taking standing breaks), and (c) set goals for the next week. The exercises and content 
for both PP and MI will be assigned in the same order for all participants receiving them.  
 
Positive Psychology Exercises. The PP exercises used in this study were selected based on their 
performance in our pilot research and published literature.   
 
Week 1: Gratitude for health. Participants recall three events, small or large, from the 
preceding week that were associated with satisfaction, happiness, pride, or other positive states 
related to their health or exercise. 
 
Week 2: Capitalizing on goals and health. Participants identify three positive activities related 
to their physical activity goals and/or overall health and find ways to capitalize on these activities 
by sharing or celebrating them in some way. 
 
 Week 3: Perseverance. Participants will think of a time in the coming week when they want or 
need to use the skill of perseverance to achieve a health-related goal.  They will write about how 
they used perseverance and any associated positive thoughts or feelings. 
 
Week 4: Enjoyable and meaningful activities. Participants choose a personal strength that is 
important to them and then find a new way to use that strength over the following week. 
 
Week 5: Using personal strengths. Participants complete a series of self-selected activities that 
vary between those that bring immediate boosts in mood and those that are more deeply 
meaningful.  

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Week 6: Past successes related to health or exercise. Participants will recall a prior event in 
which they experienced success, around health or exercise. They write about the event, their 
contribution to the success, and the positive feelings evoked by recalling it. Finally, they consider 
how they might use the experience to be successful in the future. 
 
Week 7: The good life. Participants will focus on the skill of optimism as they envision and 
write about their “good life” or how they want their lives to be in one year, related to health, or 
other important values.   
 
Week 8: Planning for the future. Participants create a plan for using these whichever of these 
positive psychology skills they found helpful, in a more regular way as they move forward after 
this program ends.   
 
Goal-setting. The goal-setting portion of the program aims to provide patients with knowledge about the 
benefits of physical activity, with some basic information about healthy eating, sleep, and sedentary time.  
This section will assist them with setting goals to become more active and adherent to these health 
behaviors. Each session follows the same structure.  The leader will: (a) ask participants about their 
physical activity goals and self-monitoring (tracking), (b) provide education about a physical activity, and 
(c) set an activity goal for the next week. Physical activity goals will be individualized to the participant, 
and participants will be encouraged to speak with their treatment team if they have any questions about 
appropriate goals for physical activity. All sessions will involve tracking participants’ progress towards 
their health behavior goals. Participants who complete their tracking each week will be entered into a 
weekly raffle to win physical activity-related prizes, such as resistance bands and water bottles.  The 
physical activity educational components will vary from week to week: 
 
Week 1: Introduction to increasing physical activity (moving for better health) and self-
monitoring. The leader will review with participants the potential health benefits of physical 
activity, as well as participants’ current physical activity. Participants will receive a Fitbit, learn 
how to use it, and set a goal of monitoring their physical activity (through steps measured by the 
Fitbit or other device if they already have one) over the next week. 
 
Week 2: Setting a SMART physical activity goal. Participants will learn about setting goals 
that are SMART (specific, measurable, attainable, relevant, and time-based) and will be 
encouraged to set a SMART behavioral goal related to physical activity.  
 
Week 3: Barriers and problem-solving. We will review common barriers to being active and 
ask participants to think about ways to work around their barriers by problem-solving.   
 
Week 4: Finding new routes. At the mid-point of the group sessions, we will introduce the 
concept of neighborhood walkability and explore the local clinic neighborhood using the MAPS-
Mini walk audit.  This is a 15-item survey of environmental features that make places more or 
less walkable, e.g., sidewalks, cross walks, benches.   
 
Week 5: Using neighborhood and social resources. Participants will be asked to identify local 
resources that can promote activity, such as a local YMCA, a school track, and equipment that 
they may already have to be more active, such as household items like lifting cans of soup.  
Participants will also be asked to think about people and community groups that help them 
engage in physical activity and how they can use them to work toward their goals. Participants 
will be given resistance bands during this week, along with instructions for use at home.   
 

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Week 6: Reducing sitting time/standing breaks. We will bring awareness to the negative 
effects of prolonged sitting and introduce ways that participants can add in standing breaks to 
their day, such as standing during TV commercial breaks, and walking during lunch time. 
 
Week 7: Strength training. This session will emphasize the importance of strength training (at 
appropriate levels) for metabolic syndrome benefit.  Participants will be shown additional 
exercises and ways to do more simple strength exercises at home.  During this session, we will 
also give participants the follow-up Actigraph accelerometer to wear for one week and return at 
the next session. 
 
Week 8: Managing slips and planning for the future. This session will review ways to keep 
going with activity even if they have not been progressing as planned.  We will review their 
progress over the past 8 weeks, set short- and long-term physical activity goals, and help 
participants plan to stay active after the program ends.   
 
Follow-up surveys and Actigraph collection (Week 8). Immediately after the week 8 session, we will 
distribute the same self-report questionnaires that were administered at baseline (before week 1). These 
scales should take approximately 30-40 minutes to complete. If participants would rather complete the 
follow-up questionnaires at home, they may send them back in a pre-paid envelope.  We will collect the 
Actigraphs at this point and upload the data to assess for valid wear time.  If participants have not worn 
them for enough time (>4 days), we will send it home with them and ask them to re-wear it and mail it 
back.  Participants will be mailed a $25 check at baseline and follow-up (up to $50 in total) for 
completing both the questionnaire packet and returning the Actigraph. 
 
Table 1. Schedule of study events. 
 
Pre-enroll-
ment 
Week 0 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Chart review to 
confirm eligibility 
X 
 
 
 
 
 
 
 
 
 
Assessment of inclusion criteria 
(cognitive screen, low physical 
activity on IPAQ-SF) and self-
reported medical conditions 
X 
 
 
 
 
 
 
 
 
 
Chart review for 
baseline characteristics  
 
X 
 
 
 
 
 
 
 
 
Measure weight, height, BP 
 
 
X 
 
 
X 
 
 
 
X 
PP exercise 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
MI goal-setting exercise 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Neighborhood walk audit 
(MAPS-Mini) 
 
 
 
 
 
X 
 
 
 
 
Exercise ease and utility ratings 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Self-report measures 
(LOT-R, PANAS, HADS, 
BBAQ, NEWS-A, CHAMPS, 
diet screeners, SF-12, IPAQ-SF, 
SOM) 
 
X 
 
 
 
 
 
 
 
X 
Objective physical activity 
measurement data (ActiGraph) 
 
X 
 
 
 
 
 
 
 
X 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
This study is in addition to the standard of care at Partners.  Programs to help people increase their 
physical activity are not currently part of the Partners standard of care.  All participants will continue to 
see their PCPs and complete all standard/recommended treatments while they are enrolled in this study.  
Patients’ physicians can refer them to receive counseling to help with physical activity, mental health, or 

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other aspects of their treatment plan. Patients can discuss these options with their doctors at any time, and 
they can still be in this study if they choose to also take advantage of those other treatment options.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
Study staff will take all measures to ensure participants’ comfort, which includes postponing or ending 
the questionnaires or exercises at a participant’s request. The principal investigator (PI) or other physician 
study staff will be available to intervene if needed (due to patient discomfort or in case of physical 
emergency) during all study visits.  
 
As with any study, there is the risk of a breach of confidentiality. These risks will be minimized by using 
participant ID numbers rather than identifying personal data on study documents. We will also use locked 
cabinets and locked offices to store physical data. Electronic data (i.e., personal information; step counter 
data) will be stored in password-protected databases on a Partners computer in a locked office. 
 
In addition, participants may end their participation in the study at any time, for any reason. If they feel 
their participation is becoming too burdensome or is exacerbating symptoms, they always have the option 
to decline further participation. 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
Medical & psychiatric emergencies. If patients report or study staff witnesses acute medical symptoms, 
they will be directed to emergency medical care, and their primary medical physicians may be contacted 
as needed. If study staff have questions regarding medical symptoms and their urgency, Drs. Huffman or 
Thorndike (MD co-investigators) and the PI will be available to consult as needed.  
 
The main psychosocial safety concern related to patients in this study is regarding depression and suicidal 
ideation, since we will be asking about depressive symptoms via the HADS. Due to this possibility, the 
HADS will be administered in person, when the PI, a licensed clinical psychologist, is available to assess 
and intervene as needed. Though the HADS does not specifically ask about suicidality, if a participant 
reports suicidal ideation, the PI will complete a suicide risk assessment (see suicide protocol) to assess 
immediate risk of self-harm or if additional information is needed to clarify risk. If the patient is at 
imminent risk, the PI will take all needed steps to ensure emergent evaluation, which may include 
ensuring evaluation in the nearest emergency room. Participants will be informed of these measures to 
ensure confidentiality—and the limits of confidentiality, such as arranging for emergent medical or 
psychiatric care if safety is at imminent risk—as part of the informed consent process. 
 
For participants in this study who have elevated depression symptoms as demonstrated by the HADS, we 
will offer to inform their clinicians and help to facilitate a mental health evaluation as appropriate. For 
participants who decline enrollment in this study, if the subject is actively suicidal, the study team will 
intervene to get the patient emergent care via security/ED referral as needed. We have done this in the 
past in other studies and have established a viable safety plan. 
 
Given that this is a medical rather than a psychiatric population we anticipate the rate of suicidality in this 
population will be low. 
 

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We will ask participants to report adverse events 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, 
and any events requiring immediate clinical follow-up will be addressed by study physician staff by 
directly contacting participants. 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
Participants may experience discomfort from discussing psychological experiences and could experience 
the questionnaires as intrusive.  Participants who do not find the study to provide a benefit to them may 
find this upsetting as well. Activities to obtain data through the follow-up assessments may be 
inconvenient for subjects. We will take all measures to ensure patient comfort and will postpone or end 
interviews at subjects’ requests. We will also ensure that the PI is available to intervene if needed (due to 
patient discomfort or to answer specific questions about the study), during all study interactions. We have 
used the briefest methods necessary to assess emotional states and other outcomes to reduce patient 
discomfort. 
 
All participants will be contacted only after receiving physician approval.  Group walks and indoor 
activities will be conducted at a moderate intensity.  Nonetheless, if a participant experiences any physical 
symptoms during a group walk or exercise, study staff will immediately inform them to stop and sit 
down, and we will call for emergency assistance.  Activities will be performed at or near the primary care 
clinics, which will also be an available resource for accessing emergency care.   
 
All data will be encoded only with the study participant number that is linked to personal identifying 
information only in the study database.  
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
Participants may or may not receive benefit from participation. Participants will complete a series 
of exercises that are designed to increase optimism, improve well-being, and improve physical activity. 
Physical activity itself can have important physiological benefits for each of the MetS components.  They 
will be given the opportunity to identify positive emotions and strategies to enhance their own positive 
emotions. Analyses of PP studies have shown that these types of interventions are associated with 
improved psychological well-being and decreased depressive symptoms.  Optimism and other positive 
affective states are prospectively associated with increased participation in healthy behaviors and with 
superior health outcomes.  Furthermore, they will have the opportunity to increase and reduce possible 
barriers to adherence to health-related behaviors.  This study has the potential to identify key factors 
related to poor adherence to health behaviors in MetS patients. Therefore, participants may benefit by 
seeing improvements in these important and clinically relevant outcomes. Overall, contact with study 
staff and the follow-up assessments may also provide support and social connection for participants. This 
may be an improvement over no such contact or systematic evaluation, as is current standard practice.  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
11 
 
 
If the PP-MI intervention in these studies prove to be feasible, well-accepted, and associated with 
improvements in physical activity and other key outcomes, it may be possible to utilize these easily-
delivered and completed exercises as part of a clinical care package for MetS patients. Thus participation 
in this study may result in benefit to future patients. 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
We will recruit up to a total of 30 individuals over age 18 who have at least three MetS risk factors: both 
elevated abdominal obesity and hypertension, and at least one additional MetS risk factor (elevated blood 
sugar, triglycerides, or low HDL cholesterol), in keeping with current MetS definitions, or PCP approval 
or referral. We elected to base inclusion on these MetS risk factors due to i) their demonstrated 
associations with disease outcomes, ii) that they have shown the largest response to lifestyle treatments, 
and iii) the feasibility of using the electronic health record to screen for these well-documented factors in 
primary care notes. Participants must also have suboptimal physical activity adherence (average of less 
than 150 minutes of moderate-intensity activity per week, representing not meeting national 
recommendations).  This criterion will allow us to assess barriers to physical activity in an already low-
active population that has a potential and great need for improvement, while being applicable to a large 
possible number of MetS patients. This study will focus on increasing physical activity in patients with 
MetS risk factors because this is a potentially high yield population in a pre-disease state. Intervening 
with physical activity, one of the most effective health behavior changes patients can make, has the 
potential to reduce progression to type 2 diabetes, cardiovascular disease, and associated mortality.  
 
The main purpose of our exclusion criteria is to ensure that all potential participants are able to fully 
participate in the intervention and provide outcome data. Children under age 18 will be excluded because 
they have a much lower prevalence of MetS risk factors, are not usually directly responsible for their 
adherence to health behaviors, and they will not be able to provide informed consent. Patients with major 
medical impairments (e.g., cancer, renal, liver disease) or who have severe mental illness will likely 
struggle to complete the PP and MI activities, adhere to a plan to increase physical activity, and partake in 
other study procedures. Pregnant women will be excluded based on potential decreases in their ability to 
perform moderate to vigorous activity in the later stages of pregnancy, a time when increased physical 
activity might be contra-indicated. All potential participants will be evaluated for exclusion criteria by 
their PCP and the principal investigator prior to enrollment. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
For this proof of concept study, we will exclude non-English speaking patients. We do not have study 
staff who are fluent in Spanish or other non-English languages to conduct the intervention or give the 
assessments.  However, if our overall work in this area does appear to be promising in English, we will 
plan future studies of the program that do include subjects who speak other languages, since our goal is to 
develop a program that is applicable and helpful to the broadest set of cultures/languages/people with 
MetS. 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
12 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Non-
English_Speaking_Subjects.1.10.pdf
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Outpatient recruitment via outpatient clinics. All participants will be adults with at least 3 risk factors 
for MetS, who are currently under the care of a primary care provider at the two primary care practices 
that have agreed to be part of this study: MGH Revere or Charlestown HealthCare Centers, or who have 
fewer than 3 risk factors for MetS who have PCP approval to participate. 
 
Participants will be identified using medical records from these two primary care practices.  Once 
medically eligible patients have been identified, we will confirm eligibility with primary care providers, 
get provider approval for patient contact, and send potential participants two IRB- approved opt-out 
letters describing the study (one from the PCP/provider and one from the PI).  For patients who do not opt 
out, we will call them within 2 weeks of mailing the letter to further describe the study (see Recruitment 
Script) and screen for exclusion criteria. Interested patients will complete the six-item cognitive screener, 
discussion of medical history to review for exclusion criteria (asking participants to complete the self-
report checklist of medical conditions), and complete the IPAQ-SF to ensure suboptimal physical activity. 
 
Outpatient recruitment via Research Patient Database Registry (RPDR). All participants will be 
adults with at least 3 risk factors for MetS listed in their electronic medical record, or adults with fewer 
than 3 risk factors for MetS who have PCP approval to participate. Participants can be referred to the 
study by an outpatient treatment team member (physician, nurse, or nurse practitioner) or through 
systematic searches using the RPDR at MGH. The RPDR is a centralized clinical data registry that 
gathers data from various hospital legacy systems and stores it in one place. Researchers access this data 
using the RPDR online Query Tool. They may query the RPDR data for aggregate totals and, with proper 
IRB approval, obtain medical record data. The RPDR ensures the security of patient information by 
controlling and auditing the distribution of patient data within the guidelines of the IRB and with the use 
of several built-in, automated security measures.  
To identify potentially eligible patients: 
1.) An RPDR query will be performed to identify those patients with at least 3 risk factors for 
MetS. Study staff will review the medical record to confirm potential participant eligibility 
and to identify their linkage to a PCP. 
2.) Study staff then will obtain permission for initial contact from each potentially eligible 
patient’s PCP via e-mail or by having providers review letters and discard ones that they do 
not approve. 
3.) For physician-approved patients, study staff will send a study introduction letter signed by the 
patient’s PCP (using secretarial notation or a pdf signature [provider’s choice]) and a study 
opt-out letter signed by Rachel Millstein, PhD (PI). The letter from the PCP informs the 
patient that he or she is allowing the study to contact patients with at least 3 risk factors for 
MetS in case they are interested in learning about the trial. Dr. Millstein’s PI letter is an opt-
out letter describing the study, the procedure to opt out of further contact, and whom to call 
for further information. These letters will be sent from a central location at MGH. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
13 
4.) Should study staff receive no reply within 10 days, staff members will call the patient on the 
phone to assess interest in the study and to describe the study over the phone. If the patient 
remains interested, staff will confirm eligibility and assess for exclusion criteria.  
Outpatient recruitment via PCPs and flyers. Patients with qualifying risk factors may be referred to 
this study by their PCPs at either healthcare center.  If a potential participant has fewer than 3 of 5 MetS 
symptoms but has PCP approval or referral, they will also be eligible.  We will also post recruitment 
flyers at each healthcare center, and interested patients may call to inquire about the study and be 
screened over the phone.  If participants screen in and have not been previously approved by their PCP, 
the study staff will obtain physician approval prior to sending the consent form. If recruitment via PCP 
referrals and posted flyers is slow, we will (with clinic permission) set up a recruitment table at the clinics 
with our study recruitment flyer and speak to any interested people. We will not initiate contact nor 
approach patients. We will only collect the names and phone numbers of those who approached us after 
having randomly viewed our displayed flyers and are willing to learn more about our research study. 
Procedures to follow up from this type of recruitment will be identical to those who respond to flyers: 
e.g., calling them to complete screening questionnaires, obtaining PCP approval.    
 
For all recruitment methods, if a patient remains interested and screens in on the phone, we will mail them 
a letter with information to invite them to their clinic at a pre-determined time to review the IRB-
approved consent form.  A study staff member will review it with them, and if they still wish to 
participate, to sign and keep one copy for their records.   
 
Sociodemographic and medical data (age, gender, education, marital status, medical and psychiatric 
diagnoses, and smoking history) will be obtained through chart review. 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Participants will receive a $25 check after completing each assessment: the initial assessment, which 
includes the baseline (pre-week 1) questionnaires and returning the Actigraph with sufficient wear-
time data, as well as the follow up (post week 8) questionnaires and sufficient Actigraph data.  
Participants may therefore earn up to $50.  After completing the assessment(s), the check(s) will be 
mailed to participants. We will ask the participants to verify their correct mailing address before the 
initial session.  Participants will also be receiving a Fitbit Zip (retail price $60) and may win raffle 
prizes of small financial value (e.g., a water bottle, approximately $10).   
 
The study should not result in any additional expenses, and it will not involve extra hospital visits, 
travel, or other activities that would require out-of-pocket expenses.  
 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
14 
          Remuneration for Research Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
On the recruitment phone call, if the patient is interested in the study after the discussion and screening 
for exclusion criteria, the PI or research assistant will discuss the study in detail and mail the pre-study 
visit invitation letter, which reviews the study details and information on where to meet.  
 
If the person wishes to attend the pre-study visit, at that time, study staff will review with them IRB-
approved consent form and ask any questions.  Interested participants can sign the consent form at this 
visit.  If so, we will give them the questionnaires as described above, and the Actigraph. After this time, 
research staff will perform a focused review of the subject’s medical record (including current 
medications and laboratory data). 
  
Patients will be informed that they will receive a $25 check for completing each of the assessments.   
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
15 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
All source data (e.g., chart review data and participant self-report) will be entered into the 
REDCap database. The PI will review this data after each assessment timepoint to ensure that it is being 
entered correctly and completely. 
Safety monitoring will be performed by Dr. Millstein (PI), who will ensure that the study team is 
adequately identifying, reviewing, and reporting adverse events and unanticipated problems to the 
Partners Institutional Review Board (IRB). Upon IRB approval of this protocol, we will submit this 
document to the NHLBI Grants Management Officer prior to beginning any study procedures. Dr. 
Millstein will also submit an annual progress report confirming adherence to the data and safety 
monitoring plan, including a summary of any data and safety monitoring issues that occurred since the 
previous reporting period, as well as any changes made to the protocol and any new and continuing IRB 
approvals since the last filed report. A more detailed description of monitoring mechanisms, intervals, and 
the information monitored is outlined below. 
Monitoring mechanism: The PI will take primary responsibility for the data safety monitoring. 
Monitoring will occur on an ongoing basis by the PI, using an Adverse Event log.  A committee of 
mentors will assist the PI as an internal data and safety monitoring team in the event of questions around 
adverse events.  This committee will include Dr. Jeff Huffman (psychiatry, primary mentor), Dr. Elyse 
Park (psychology, co-mentor), and Dr. Anne Thorndike (internal medicine, co-mentor). 
Monitoring intervals: Monitoring of adverse events will occur on an ongoing basis by Dr. 
Millstein and the research assistant. More systematic weekly meetings for review of 
feasibility/acceptability information and minor IRB deviations will be held between Dr. Millstein and 
study staff, including the lead research coordinator. Dr. Millstein will then discuss any potential issues 
regarding data safety or protocol deviations with Dr. Huffman during weekly supervision meetings. This 
method will allow the team to review this information and make adjustments to procedures as required. 
These ongoing, weekly, and bi-monthly reviews ensure that the study procedures minimize research-
related risk by reviewing specific outcomes linked to the project. The PI is responsible for directly 
reporting any serious study-related adverse events to the NIH/NHLBI. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
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 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
16 
as per PHRC protocol. Finally, if there are unanticipated problems, especially if serious or recurrent, the 
PI will amend the protocol if it is deemed necessary to protect the safety and welfare of the participants. 
Dr. Millstein (study PI) is responsible for directly reporting serious study-related adverse events 
to the NIH/NHLBI.  If there are no such events, a yearly report summarizing adherence to the DSMP, 
review of study-related enrollment and issues during the study period, and any relevant changes to the 
protocol, will be sent to the sponsor, NHLBI. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
This study is a proof-of-concept trial to determine if all aspects of the protocol are feasible, 
acceptable, and effective. After one group (n=8) of participants have completed the trial, we will briefly 
review the study and our outcomes. If participants’ acceptability scores in the PP group are low, optimism 
scores decrease following the exercises, or we hear that some participants have been dissatisfied with the 
program, we will alter the protocol to address these issues. Similarly, if our rates of session completion 
are far below expected rates, we will reassess our protocol and make improvements.  We will then 
complete the more formal data analysis once the second group of (n=8) participants complete the trial.  
We will seek IRB approval prior to making any significant changes to study procedures if they seem 
warranted. 
On a weekly basis, the research team will meet to review study progress. At that time, the 
principal investigator will review informed consent documents, study forms, and procedures completed 
that week, as well as all chart review forms performed that week for completeness and accuracy. The 
study team will also discuss any procedural difficulties, recruitment issues, and adverse events at this 
meeting (and before if needed). Investigators will also review consent documents and address acute issues 
in real time throughout the week. We will take several measures to ensure the integrity of data 
collection/entry/analysis and the fidelity of our intervention.  
 
Information to be monitored: Information to be monitored by the PI and primary mentor will 
include: (a) an evaluation of the progress of the research study, including assessments of data quality and 
timeliness and participant recruitment, accrual and retention consistent with plans for diversity and 
generalizability, (b) a review of study safety data—adverse event (and minor deviation) information—to 
determine whether the study should continue as originally designed, be changed, or be stopped, (c) review 
of procedures to maintain participant confidentiality (e.g., storage of identifiable information in locked 
cabinets, ensuring study databases have no personal identifying information, use of study participant 
numbers on communications about the study), and (d) an assessment of external factors or relevant 
information (e.g., developments in the literature, results of related studies, etc.) that may have an impact 
on the safety of participants or on the ethics of the research study. 
 
Feasibility and acceptability. Descriptive statistics will be used to calculate: (i) proportions to 
test feasibility, defined as % of sessions completed, and (ii) means and standard deviations to test 
acceptability, defined as mean ratings of session ease and usefulness. These will be compared to the 
hypothesized targets of ≥50% of participants completing ≥6/8 sessions with acceptability ratings >7.0/10.  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
17 
Outcomes. For physical activity (minutes/day of moderate-to-vigorous activity) and all other 
psychological, behavioral, and physiological outcomes, I will model changes in the outcomes using a 
mixed effects regression model with a random intercept for each participant, to account for the repeated 
measures on each participant and missing data. This will allow me to estimate both the change over time 
in the intervention group as well as between group differences of MAPP versus EUC at 8 and 24 weeks, 
correcting for multiple comparisons. In addition to tests of statistical significance, which will be 
exploratory given the sample size, the effect size (Cohen’s d) of the intervention will be estimated for 
each outcome to aid in design of future trials. I will also perform sensitivity analyses to compare within 
and between-group effects by gender. For all analyses, an intent-to-treat approach will be used to explore 
between-group differences, and all tests will be considered significant based on a two-tailed alpha level of 
.05.  
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
            https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf  
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_Adverse_Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
As noted, risks will be minimized by using participant ID numbers rather than identifying 
personal data on study documents, and by using locked cabinets/offices and password-protected databases 
to store personal information. Only study staff (the PI, the research assistant entering data) will have any 
access to personally identifiable information about participants, and such access will be limited only to 
information necessary to complete study tasks. The data entered into HIPAA-compliant REDCap 
database will also be identified only with a number (with this number linked to identifying information 
that is kept in a separate password-protected database) will be accessed on Partners’ secure network.  
All data regarding the objective physical activity monitoring devices (Actigraphs) will be 
encoded only with the participant ID number. The devices will not be marked with any personally 
identifiable information, and the database that will be used to monitor accelerometer data will only 
contain participant ID numbers. The accelerometers do not record or link participants’ names with their 
data, and accelerometer data will only be accessed from a locked Partners laptop stored in our locked 
offices or used on-site in the clinics.  
We will ask for participants’ email addresses in order to send them weekly reminder emails about 
session content and dates/times.  We will begin by sending emails using the “send secure” encrypted 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
18 
method.  For participants who prefer to receive unencrypted emails, we will review with them the risks of 
this method, and if they continue to prefer this, we will document this on their contact information sheet 
and send emails with the PHS-approved disclaimer from that time forward. 
“The Partners standard is to send email securely. This requires you to initially set up and activate 
an account with a password. You can then use the password to access secure emails sent to you from 
Partners HealthCare. If you prefer, we can send you “unencrypted” email that is not secure and could 
result in the unauthorized use or disclosure of your information. If you want to receive communications 
by unencrypted email despite these risks, Partners HealthCare will not be held responsible. Your 
preference to receive unencrypted email will apply to emails sent to you from research staff in this study 
ONLY.  If you wish to communicate with other research staff at Partners regarding additional studies, 
your preference will have to be documented with each research group.”  
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
N/A 
 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
N/A 
 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
N/A