Gaining Optimism After Weight Loss Surgery (GOALS) I: Proof-of-Concept Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
Phase: NA
Conditions: Bariatric Surgery
Sponsor: Massachusetts General Hospital

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
 
I. BACKGROUND & SIGNIFICANCE 
 
A. Historical Background 
 
Metabolic and bariatric surgery (MBS) is the most effective treatment for severe 
obesity, but 25% of surgical patients do not achieve long-term weight loss maintenance.1–3 
Obesity affects more than 30% of U.S. adults and has been deemed a major public health issue, 
costing more than $150 billion in healthcare and lost productivity in 2008.4,5 MBS is effective for 
severe obesity, often resulting in cost-effective, sustained weight loss.2,3,6,7 Remission of weight-
related comorbidities (e.g., type 2 diabetes, hypertension, high cholesterol) is associated with 
weight loss, so weight loss maintenance is vital for preserving these improvements in health.2 
However, 25% of MBS patients do not maintain the expected weight loss.1–3,8,9 Given the 
significant systemic and individual cost of MBS, poor outcomes for so many patients are of 
major public health concern.  
 
Physical activity is critical for weight loss maintenance and improved health after 
MBS. Physical activity is particularly important in post-MBS patients because of their increased 
risk of weight-related disease.10–13 Post-MBS patients are recommended to engage in 150 
minutes per week of moderate to vigorous physical activity, and even higher levels may be 
needed to control weight.14–17 Unfortunately, 89-97% of post-MBS patients do not meet this 
recommendation.18–20 MBS clinics typically provide more support for nutrition than for 
physical activity, and while dietary adherence is critical to the success of MBS patients, low 
physical activity is independently linked to medical sequelae. Increasing physical activity, even 
without weight change, can improve insulin sensitivity, cardiorespiratory fitness, blood pressure, 
and blood lipids, all of which confer a lower risk for cardiac and/or metabolic disease.21–24 
Behavioral interventions to improve physical activity after MBS show promise, but the evidence 
is still limited by a lack of trials that are well-powered with long-term follow-up.25–27 Further, in-
person post-operative interventions have struggled with attendance, with common barriers 
including living long distances from the clinic and lack of time off from work.28–31  
 
Emotional factors play a role in physical activity engagement and health outcomes. 
Psychological distress predicts lower physical activity levels and less weight loss in post-MBS 
patients.32 Although most MBS patients do not meet criteria for a depressive disorder, they 
experience more depressive symptoms than the general population.33,34 Conversely, positive 
psychological constructs such as optimism and positive affect are associated with improved 
health independent of depression but have not been examined thoroughly in MBS patients.35–38 
These constructs are associated with physical activity in older adults and cardiac patients, 
suggesting that physical activity is a pathway by which positive psychological states can improve 
health.39–43  
 
Positive affect during physical activity predicts future physical activity. A systematic 
review of 24 studies found that positive affect during, but not after, physical activity predicted 
increased future physical activity, supporting the “upward spiral” theory of lifestyle change.44,45 
This theory posits that by experiencing positive affect during the act of a health behavior, 
nonconscious motives increase one’s likelihood of repeating that behavior. Over time, health 
behaviors become reinforcing rather than burdensome. However, sedentary women with obesity 
have been found to experience lower pleasure during physical activity compared to sedentary 
lean and overweight women.46 MBS patients may be missing out on this “upward spiral” due 
to emotional barriers to physical activity, such as feeling too overweight, shame about 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
appearance, and weight stigma.47,48 This group would benefit from new skills to increase positive 
affect during physical activity. 
 
Positive psychology (PP) interventions target positive emotions and may be 
particularly effective for increasing physical activity in post-MBS patients. PP programs use 
structured tasks, such as imagining an ideal future, expressing gratitude, or using personal 
strengths, to increase the frequency and intensity of positive psychological states (e.g., optimism, 
positive affect, gratitude). A meta-analysis of 51 studies of more than 4000 participants found 
that PP interventions enhance well-being and improve depressive symptoms for up to 6 
months.49,50 PP interventions have also been shown to improve physical activity in patients with 
cardiometabolic disease.51–53 PP can improve physical activity directly by affecting well-being, 
particularly if it targets positive affect during physical activity engagement.44,54 However, PP 
may be particularly effective in combination with an adherence-based program such as 
motivational interviewing (MI).55  
 
Motivational interviewing (MI) may enhance the effects of PP in post-MBS patients. 
Dr. Huffman’s group developed a combined positive psychology-motivational interviewing (PP-
MI) intervention to improve health behaviors in patients with type 2 diabetes, heart disease, and 
heart failure with promising findings from pilot studies (3.1a).52,53,56 MI is a technique that 
focuses on clarifying motivation, addressing ambivalence, and setting achievable goals. MI is 
used widely to help patients increase physical activity,57 but its effect size has been small to 
moderate when used alone in medical populations.58 Because low optimism and depressive 
symptoms are associated with poor outcomes with MI,59–61 a focus on increasing self-efficacy, 
motivation, and optimism through PP may enhance the effects of MI.62  
 
Remote intervention delivery could fill a care gap post-MBS. MBS centers often serve 
large geographic areas, yet require frequent, time-consuming, and expensive visits. Attendance is 
particularly low post-operatively.29,63 Therefore, a remotely delivered intervention is likely to be 
more feasible and increase access to care.64 PP-MI has been delivered via phone with high 
feasibility and acceptability, with use of activity trackers to allow participants to use their own 
objective data and set effective goals to increase activity.65  
 
B. Preliminary Studies 
 
PP-MI interventions to promote physical activity in other populations. Our group has 
tested PP-MI for health behavior change in randomized pilot trials patients after an acute 
coronary syndrome, in those with type 2 diabetes, and in patients with heart failure, with 
medium-to-large effect size changes in objectively measured physical activity in the PP-MI 
condition compared to the control.51,53,66,67 
 
PP pilot studies in post-MBS patients. To examine the relevance of PP-MI for post-
MBS patients, we first conducted a survey study of members of online MBS support forums. In 
95 respondents, positive affect and optimism were positively associated with adherence to MBS 
health behaviors and physical activity, supporting the idea that promoting positive psychological 
states could improve behavioral adherence and physical activity.33  
 
We also completed a qualitative study of 23 MGH Weight Center post-MBS patients that 
involved semi-structured individual interviews asking about participants’ experiences with 
physical activity before and after surgery, their barriers and facilitators to activity, the types of 
emotions they experience in relation to physical activity, and their ideas and preferences about 
the planned intervention.68 Interviews were transcribed and coded using inductive and deductive 
methods, and themes that emerged have informed the adaptation of PP-MI for this population.  

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
 
C. Rationale/Potential Benefits/Overview of Proposed Research 
 
Given: (a) the relationship between psychological well-being and health behavior 
adherence, (b) the preliminary efficacy of PP-MI interventions in other populations, and (c) the 
identified emotional barriers to adherence specific to the post-MBS population, this intervention, 
customized to apply to the unique experiences of post-MBS patients, 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 nonadherence 
to health behaviors is a major public health problem among patients with obesity.  
 
II. SPECIFIC AIMS 
 
We will conduct a one-arm proof-of-concept trial to refine the newly adapted intervention 
and study procedures.  
 
Specific Aim 1: To pilot the adapted post-MBS PP-MI intervention with exit interviews for 
further refinement (N=10). 
 
Hypothesis: We will recruit 10 participants and collect feedback from them that will aid 
in study refinement.  
 
III. PARTICIPANT SELECTION 
 
A. Inclusion/Exclusion Criteria 
Inclusion criteria: Participants eligible for this study must meet the following criteria: 
1. Adult (age 18+) 
2. History of MBS (gastric bypass or sleeve gastrectomy) at MGH or BWH 6-12 months 
prior to study enrollment. *Note: because there have been fewer surgeries than usual in 
the past year due to the Covid-19 pandemic, we will expand eligibility to surgery 3-15 
months prior to enrollment if we have difficulty recruiting sufficient numbers. 
3. Low physical activity, defined as <200 minutes/week self-reported moderate-to-vigorous 
physical activity on the International Physical Activity Questionnaire Short Form,69 plus 
a desire to increase physical activity.  
4. Access to telephone for study sessions 
5. Able to read and speak English 
 
Exclusion criteria: 
Participants will be excluded if they have: 
1. Cognitive deficits precluding participation or informed consent, assessed using a six-item 
screen70 designed to assess suitability for research participation.   
2. Illness likely to lead to death in the next 6 months per chart review 
3. Inability to be physically active (e.g., severe arthritis) 
4. Participation in another program targeting physical activity besides the standard offerings 
at the surgery center. 
5. Severe psychiatric conditions expected to interfere with study participation, as 
determined by chart review (e.g., recent psychiatric hospitalization, active substance use 
disorder, psychosis). 
 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
B. Sources of participants and recruitment methods 
Lists of participants who had surgery in the appropriate time frame at MGH or BWH will 
be identified via searches in RPDR. After these lists are generated, study staff will conduct a 
manual electronic chart review to verify eligibility criteria and physician linkage.  
For patients who have not opted out of receiving research invitations, study staff will 
send a research invitation through Patient Gateway and/or paper mail. The research invitation 
will describe 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. 
Should study staff receive no reply within two weeks, 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. If the patient 
remains interested and appears eligible, study staff will schedule an initial study visit at the MGH 
TCRC to complete the consent procedures and conduct the initial study visit. We will then mail 
or e-mail participants a consent form to look over ahead of time, so that they may prepare 
questions for the first visit. We will follow the MGB IRB guidelines around email contact, 
specifically that we will send all emails via an encrypted, SEND SECURE system, or that we 
will send them in a non-encrypted manner but only with the person’s approval and understanding 
of the risks associated with non-encrypted email (i.e., that there could be loss of confidentiality).   
 
In addition, referral by providers at the patients’ surgery center will be encouraged. For 
directly referred patients, we will send opt-out letters as above. Finally, we may use hospital 
press releases or RSVP for Health to publicize the study. 
 
 
IV. PARTICIPANT ENROLLMENT  
 
A. Methods of Enrollment 
Study staff will assess eligibility via phone interview/record review. Patients who are 
eligible after the phone screen and still interested in participating will attend a baseline in-person 
visit at which time informed consent will be obtained by a trained study staff member (PI or 
research coordinator; see below for details) and their baseline assessment will occur.  
 
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 send an electronic copy of the IRB-approved consent 
form for patient review, and will schedule an in-person visit at MGH. We will follow the MGB 
IRB guidelines around email contact, specifically that we will send all emails via an encrypted, 
SEND SECURE system, or that we will send them in a non-encrypted manner but only with the 
person’s approval and understanding of the risks associated with non-encrypted email (i.e., that 
there could be loss of confidentiality).  This will be discussed as part of the phone screen. This 
will allow patients to have adequate time to read the consent form. Informed consent will be 
obtained in person at MGH during the initial baseline visit by a trained study staff member (PI or 
research coordinator. Before collecting any data, the study coordinator will review the consent 
form during the study visit and will allow the patient 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 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
understanding of the study’s purpose and their role. 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. 
 
C. Treatment assignment/randomization 
 
Proof-of-concept trial: For the initial trial, all participants will receive the PP-MI 
intervention and there will be no randomization. 
 
V. STUDY PROCEDURES 
A. Study visits and parameters to be measured 
 
Enrollment/Baseline Assessment (Visit #1): Patients who are interested in participating in 
the study and are eligible per the phone screen will come to the MGH TCRC for their initial 
study visit. At this time, informed consent will be obtained by a trained study staff member (PI 
or research coordinator). After providing informed consent, participants will provide 
demographic and medical information (e.g., medical comorbidities, weight history) and complete 
self-report measures to assist in characterization of the sample.  
Furthermore, height, weight, body mass index (BMI), waist circumference, body composition, 
and blood pressure will be obtained, and 5 mL of blood will be drawn for measurement of lipids, 
A1C, and CRP. We will also ask participants to report their weight at home the next day, for 
consistency. We also will perform a six-minute walk test76 (6MWT) to assess functional exercise 
capacity. Finally, we will provide participants with an Actigraph GT3X+ accelerometer,77  which 
they will be asked to wear for 7 days (minimum acceptable use is 4+ days with 10+ hours of 
recorded data). Participants will be given the option to complete Visit 2 remotely. If the 
participant chooses to complete the visit remotely, they will be given all the materials needed to 
mail the Actigraph back during their first visit. 
 
 
Intervention Introduction (Visit #2; In person): This visit will take place approximately 1 
week after Visit #1. Participants will return their accelerometer and study staff will check for 
sufficient wear time. If wear time is insufficient, the participant will be asked to wear it for 
another week and delay their Visit #2. If there is sufficient wear time participants will next be 
provided with a Fitbit Inspire 2 to track activity. They will set up the Fitbit with the research 
coordinator, using a study-provided login so that the study staff can access participants’ Fitbit 
data during the study. After the study ends, participants will keep the Fitbit and will be instructed 
to change the account to a private one for ongoing personal use. They will then meet with the 
study interventionist for an introduction to the PP-MI intervention. Participants will be 
remunerated $40 after this visit. 
 
 
10-Week Follow-Up (Visit #3): After completion of the intervention, participants will 
wear the accelerometer for 7 days (the device will be mailed to them so they can start wearing it 
the day after their final intervention call). They will then return to the TCRC for another in-
person assessment where they will return the accelerometer and repeat all measures done at Visit 
#1. At this time participants will also complete an exit interview with a staff member who has 
not been in contact with them previously to provide feedback about their experience in the study. 
Participants will be remunerated $60. 
 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
For participants who withdraw prior to completing the intervention: In the event that a 
participant withdraws from the study prior to completing all 10 weeks of the intervention, we 
will ask them to complete a different exit interview that is specifically for participants who 
decide not complete the study, in order to better understand their reasons for withdrawing. We 
will schedule these interviews as close as possible to the time that a participant withdraws. For 
those participants who have already withdrawn, we will send them an opt-out letter followed by 
a phone call after two weeks inviting them to complete the exit interview. All exit interviews will 
be scheduled with a staff member who has not been in contact with them previously. Participants 
will be remunerated $50 for this phone call.  
 
B. Drugs to be used 
No drugs will be administered. 
 
C. Devices to be used 
No medical devices will be used. 
 
D. Procedures/surgical interventions, etc. 
 
Intervention: Participants will receive a written treatment manual at Visit #2 that has detailed 
information about each session’s topics. The intervention consists of 10 weekly phone sessions 
(30-45 minutes each). Each session includes a combination of a new psychological skill designed 
to increase positive emotions experienced during physical activity, a motivational skill designed 
to boost physical activity, plus setting a physical activity goal for the next week using 
information from their Fitbit. The sessions will be structured such that they begin with a review 
of the past week’s activity (using Fitbit data plus any supplemental tracking) and determining 
whether the participant met their goal. The prior week’s physical activity and psychological 
topics will also be reviewed, with discussion of how they used these skills, the positive emotions 
they experienced, and how they can continue to integrate the skills. Next, the new topics will be 
introduced and the participant will set a new physical activity goal for the upcoming week. A 
motivational interviewing approach will be used for all topics.  
 
Proof-of-Concept Trial Intervention Weekly Topics: 
 
Week 
PP Topic 
Physical Activity Topic 
1 
Noticing the positive during activity 
Getting started with increasing physical 
activity 
2 
Gratitude for health-related positive 
events 
Pros and cons of change and SMART 
goals 
3 
Positive reappraisal part 1 
Barriers and problem-solving 
4 
Positive reappraisal part 2 
Strength Training and Equipment 
5 
Review PP skills, choose one to 
integrate into daily life 
Review and reflect on progress 
6 
Using perseverance 
Neighborhood and social resources 
7 
Focusing on meaning during 
physical activity 
Reducing sedentary time and moving in 
small ways 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
8 
Remembering past successes around 
physical activity 
Managing slips 
9 
Using a personal strength to achieve 
an activity goal 
Finding new routes 
10 
Wrap up and plan for the future 
Wrap up and plan for the future 
 
E. Data to be collected and when the data is to be collected 
Baseline characteristics: To allow us to better understand our study population, we will record 
subjects’ baseline characteristics (e.g. age, gender, race/ethnicity) during their initial visit.  
 
Feasibility and acceptability: We will ask participants receiving PP-MI to rate each topic on ease 
and usefulness on a scale from 0-10 (0=not at all easy/helpful, 10=very easy/helpful). We will 
also collect exit interview data from proof-of-concept trial participants to get more detail about 
what they liked or did not like about the study overall and any suggestions they have for 
improvement.  
 
Self-report measures: These will be collected at baseline and 10 weeks. 
• Optimism: Life Orientation Test – Revised (LOT-R)79 
• Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)80 
• Motivation (stage of change): University of Rhode Island Change Assessment (URICA)81 
• Self-Efficacy (general and exercise-specific): General Self-Efficacy Scale82 and Self-
Efficacy for Exercise Scale83 
• Internalized Weight Bias: Weight Bias Internalization Scale – Modified (WBIS-M)84 
• Exercise Identity: Exercise Identity Scale (EIS)85 
• MBS-specific Diet and Vitamin Adherence: Bariatric Surgery Self-Management 
Questionnaire86 
• Physical Activity and sedentary time (self-reported): International Physical Activity 
Questionnaire (IPAQ)69 
• Household Members Survey 
• Social Support and Eating Habits Survey87 
• Social Support and Exercise Survey87 
 
Objectively-measured physical activity: These measures will be collected at baseline and 10 
weeks using the Actigraph GT3X-BT. 
• Moderate-to-vigorous physical activity in met-minutes/week and mean minutes/week 
• Light physical activity in met-minutes/week and mean minutes/week 
• Steps in mean number/day 
• Sedentary time in mean minutes/day 
 
Health-related measures: These will be assessed at baseline and 10 weeks. 
• Weight, height, body composition, and waist circumference, assessed by trained MGH 
TCRC nurses during in person visits. Weight, height, and waist circumference will be 
measured and self-reported by the participant during remote visits.  

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
• Blood pressure (in mm Hg), assessed via MGH TCRC nurses using their protocol during 
in person visits. Blood pressure will not be collected during remote visits. 
• Lipids, A1C, and CRP via blood draw by MGH TCRC nurses during in person visits. 
Phlebotomists at Quest Diagnostics Service Center will complete the labwork for remote 
visits.   
• Six-minute walk test, assessed by MCH TCRC nurses using their established protocol 
during in person visits. Six-minute walk test will not be completed during remote visits.  
 
All participants will be asked to complete all measures at all time points, if possible. However, 
should a participant decline a certain measure or choose not to attend a follow-up visit, we 
collect as much data as possible from that person and proceed with all collected data. While we 
will try to avoid it, we expect there will be missing data in this study. 
 
VI. BIOSTATISTICAL ANALYSIS 
A. Specific data variables being collected for the study 
 
We will collect data from 12 participants in the proof-of-concept trial (assessments at 
baseline and 10 weeks plus weekly session ratings and exit interviews). Assessments will include 
the measures detailed above. 
 
B. Study endpoints 
Proof-of-concept trial: the primary goal of this phase is to refine the intervention to a place where 
it is feasible and acceptable. We will aim to obtain follow-up data from at least 10 participants. 
Feedback from this trial will inform any necessary further modification of the intervention or 
procedures prior to beginning the RCT. 
 
C. Statistical methods 
Proof-of-concept trial:  
 
This small proof-of-concept trial is designed to test initial feasibility and acceptability of 
the newly developed intervention and to refine the intervention as needed.  
 
Feasibility. Descriptive statistics will be used to calculate proportions to test feasibility, 
defined as % of sessions completed.  
 
Acceptability will be measured with means and standard deviations of participants’ 
ratings of session ease and utility on a 0-10 scale (0 = very difficult/not at all useful, 10 = very 
easy/very useful). Cutoffs will not be used to determine feasibility and acceptability for this 
study as the sample is so small, and the goal of Aim 2 is to refine the intervention content and 
procedures. Rather, completion rates and participant ease and utility ratings will be examined in 
combination with open-ended feedback to inform further refining.  
 
Exploratory outcomes. For physical activity and all other psychological, behavioral, and 
health-related outcomes, we will model within-subjects pre-post changes in each outcome using 
a mixed effects regression model with a random intercept for each participant, to account for 
missing data. Given the sample size, tests of statistical significance will be exploratory. 
However, the effect size (Cohen’s d) of the within-subjects change in each outcome measure 
from baseline to 10 weeks will be estimated to assess for a signal of intervention effect. 
 
 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
D. Power analysis (e.g., sample size, evaluable subjects, etc.) 
Proof-of-concept trial: We have not conducted a power analysis for this study because the 
primary aim is to establish and refine procedures, troubleshooting any unexpected problems. We 
anticipate a sample of N=10 to be sufficient to do this, although will consider expanding the 
sample if initial results do not show changes in outcome measures in the expected direction. 
 
VII. RISKS AND DISCOMFORTS 
A. Complications of surgical and non-surgical procedures, etc. 
 
Blood sampling. We will collect blood at Visits #1 and #3. 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 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. 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 specific mediations are being studied or administered solely for research purposes in 
this study. 
 
C. Device complications/malfunctions 
 
We will be utilizing two devices that measure physical activity in this study: the 
Actigraph GT3X-BT accelerometer and the Fitbit Inspire 2 activity tracker. These devices pose 
minimal risk. The accelerometer (ActiGraph GT3X-BT) used to measure activity is small, light, 
and without sharp edges. Immersing the device in water for a prolonged period may render it 
unusable but does not pose a shock risk. The Fitbit provided to participants for activity self-
monitoring similarly poses minimal risk, given that it has no sharp edges, no potential to cause 
shocks, and no other known risks. We will educate participants about the use of both devices 
when providing the devices to them, and study staff will be available to troubleshoot any 
problems that arise during their use. 
 
D. Psychosocial (non-medical) 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 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 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
obtain activity data. No personally identifiable information will be recorded physically or 
electronically onto the accelerometers or within the software program.  
Participants will be asked to create a Fitbit account using a username and password that 
the study team provides, so that the study staff can access their physical activity information for 
the duration of the study. We will create this account together with them at Visit #2, to ensure 
that they do not enter identifying information (e.g., their name) into the account. When the study 
is over, participants will be instructed to change their username and password so that the study 
no longer has access to their account.  
Digital recordings of PP-MI sessions will be collected using portable recorders. 
Randomly-selected sessions will be reviewed for competence and adherence to the protocol by  
our lab’s behavioral intervention expert, using fidelity scales created for this intervention. 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. 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 participants is confidential by using only the phone 
numbers and other contact information that are specifically allowed by the participants and not 
leaving study-related messages for them unless expressly allowed by participants. 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.  
 
 
Physical activity safety. To ensure that patients can safely participate in physical activity,  
we will confirm with the patient’s surgery center clinician (physician, nurse practitioner or 
psychologist) that the patient is able to participate in a physical activity promotion program prior 
to approaching the patient. 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. This information will be recorded in the REDCap system so interventionists can use 
this information when developing plans with the patient at phone sessions. We will provide 
education to all participants about symptoms that could be concerning during activity (e.g., chest 
pain, dyspnea), including when to report symptoms to their primary care provider and when to 
present to the emergency room.  
 
 
Depression/anxiety symptoms and suicidal ideation. Participants will complete the 
Hospital Anxiety and Depression Scale (HADS) as part of assessments; although this is a 
symptom measure and is not used to make a diagnosis of depression, for participants with HADS 
depression subscale scores of 10 or more, the study PI (Dr. Feig) will call the patient to assess for 
suicidality using the suicide item from the PHQ-9. For patients without active suicidal ideation, 
we will encourage them to discuss their symptoms with their primary care provider and/or 
surgery center psychologist. 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), the study PI (Dr. Feig) will perform a separate 
assessment and will arrange for urgent evaluation (e.g., in an emergency department) if clinically 
indicated, with consultation from a study psychiatrist (Dr. Huffman or Dr. Celano).  
 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
physical activity after bariatric surgery 
Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
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 
MGB HRC guidelines, and any events requiring immediate clinical follow-up will be addressed 
by the study PI by directly contacting participants. 
 
E. Radiation Risks 
 
There will be no radiation exposure in this study. 
 
VIII. POTENTIAL BENEFITS 
A. Potential benefits to participating individuals. All participants will receive serial 
assessments of medical, psychiatric, and functional status, allowing them access to emergent care 
if required. All participants will also receive our PP-MI intervention, which has shown to 
improve physical activity and psychological well-being in studies of other populations (type 2 
diabetes, heart disease, metabolic syndrome).  
 
B. Potential benefits to society. Participation in physical activity (and other health behaviors) is 
crucial in preventing weight regain and onset of comorbidities for patients who have had MBS. 
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. By completing this project, we will learn whether the 
PP-MI intervention is feasible and well-accepted by post-MBS patients who have low physical 
activity. We will also examine whether the intervention is associated with increased physical 
activity (objectively measured by accelerometer), psychological well-being, and other outcomes 
in this cohort. 
            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 post-
MBS patients who have low physical activity. This, in turn, could lead to better long-term weight 
loss outcomes after surgery, 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.  
 
IX. MONITORING AND QUALITY ASSURANCE 
A. Independent monitoring of source data 
All source data (e.g., chart review data and participant self-report) will be entered into the 
REDCap database. At intervals throughout the study, the PI (Dr. Feig) will review this data to 
ensure that it is being entered correctly and will perform ‘test downloads’ of the data to ensure 
that it can be captured in the statistical package to be used in this study.  
 
B. Safety monitoring (e.g., Data Safety Monitoring Board, etc.) 
Safety monitoring will be performed by Dr. Feig (PI), who will ensure that the study 
team is adequately identifying, reviewing, and reporting adverse events and unanticipated 
problems to the MGB Institutional Review Board (IRB). The PI will submit an annual progress 
report to the NHLBI 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 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
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Emily Feig, PhD – Detailed Protocol 11/01/2022 
 
period, as well as any changes made to the protocol and any new and continuing IRB approvals 
since the last filed report.  
Monitoring mechanism. The PI will take primary responsibility for data safety 
monitoring. Monitoring will occur on an ongoing basis by the PI and study staff, 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. Christina Psaros (psychology, co-mentor), 
and Dr. Anne Thorndike (internal medicine, co-mentor). 
Monitoring intervals. Monitoring of adverse events will occur on an ongoing basis by the 
PI and the study staff, based on information gathered from participants at assessment visits and 
weekly phone sessions. More systematic weekly meetings for review of feasibility/acceptability 
information and minor IRB deviations will be held between Dr. Feig and study staff, including 
the lead research coordinator. Dr. Feig will then discuss any potential issues regarding data 
safety or protocol deviations with mentor Dr. Huffman during weekly supervision meetings. This 
allows the team to review this information and make adjustments to procedures as required. 
Furthermore, journal clubs are held within the study team monthly. These include discussions of 
related projects and timely studies (e.g., studies of physical activity in related patient 
populations, studies of positive psychological interventions). These ongoing, weekly, and 
intermittent reviews ensure that the study procedures minimize research-related risk by 
reviewing specific outcomes linked to the project and by reviewing relevant literature to ensure 
that interventions are best practice. Dr. Feig (study PI) is responsible for directly reporting any 
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 NHLBI. 
Information to be monitored. Information to be monitored 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., 
ensuring study databases have no personal identifying information, using 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, such as 
through the journal club listed above. 
 
C. Outcomes monitoring 
The research team will meet on a weekly basis to review study progress. The study team 
will also discuss any procedural difficulties, recruitment issues, randomization issues, and 
adverse events at this meeting (and before if needed). If there are consistent issues with the 
logistics, feasibility, or acceptability of the assessment visits or intervention calls (e.g., 
participant complaints about length of visits, frequent missed calls), we will review our methods 
and alter the study protocol as needed. For this pilot study, we will not plan to perform interim 
analyses. However, we will review feasibility/acceptability ratings of phone sessions in an 
ongoing manner, and if they are consistently low for a certain topic during the proof-of-concept 

Gaining Optimism After weight Loss Surgery (GOALS): A positive psychology-based intervention to increase 
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trial, we will review and alter that topic accordingly. This is in line with the purpose of this 
proof-of-concept trial, to trial and refine the newly developed intervention and study protocol. 
 
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 unexpected 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 
May 2017 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. Feig) 
will amend the protocol if it is deemed necessary to protect the safety and welfare of the 
participants. 
 
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