Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
Phase: NA
Conditions: Body Weight, Weight Loss, Motor Activity
Sponsor: University of Pittsburgh

 Maintaining Activity and Nutrition through Technology-
Assisted Innovation in Primary Care  
(MAINTAIN-pc )   
 
Protocol Number: PRO13020257 
Principal Investigator: Margaret Conroy 
Funded by:  
Agency for Health Research and Quality (R18HS021162-02) and  
National Institutes of Health through Grant Number UL1TR000005 (University of 
Pittsburgh CTSI, providing research registry support) 
Trial Registration: ClinicalTrials.gov (NCT01946191) 
https://clinicaltrials.gov/ct2/show/NCT01946191?term=01946191&rank=1 
 
Version Number:  MAINTAIN-pc05232017,  
Update: 5/23/2017 
 

  
MAIANTAIN-pc Protocol 
ii 
Table of Contents 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 2 
1.3 
Schedule of Activities (SoA) : Month +/- 6 weeks ........................................................................... 3 
1.4 
Investigators ......................................................................................................................................... 4 
1.4.1 
Key Roles .......................................................................................................................... 4 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Obejectives ................................................................................................................................ 5 
2.1.1 
Primary objective and hypothesis .................................................................................. 5 
2.1.2 
Secondary objective and hypothesis ............................................................................. 5 
2.1.3 
Additional objective and hypothesis .............................................................................. 5 
2.2 
Study Rationale .................................................................................................................................... 5 
2.3 
Background........................................................................................................................................... 6 
2.4 
Risk/Benefit Assessment .................................................................................................................... 6 
2.4.1 
Known Potential Risks ..................................................................................................... 6 
2.4.2 
Known Potential Benefits ................................................................................................ 7 
2.4.3 
Assessment of Potential Risks and Benefits ................................................................ 7 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 7 
4 
STUDY DESIGN ............................................................................................................................................. 8 
4.1 
Overall Design ...................................................................................................................................... 8 
4.2 
End of Study Definition ....................................................................................................................... 8 
5 
STUDY POPULATION: SELECTION AND ENROLLMENT OF PARTICIPANTS ............................... 8 
5.1 
Inclusion Criteria .................................................................................................................................. 8 
5.2 
Exclusion Criteria ................................................................................................................................. 9 
5.3 
Enrollment procedures ........................................................................................................................ 9 
5.4 
Screen Failures .................................................................................................................................. 10 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 10 
5.5.1 
Recruitment ..................................................................................................................... 10 
5.5.2 
Retention ......................................................................................................................... 11 
6 
Pre-intervention activities ............................................................................................................................ 12 
7 
STUDY INTERVENTION ............................................................................................................................ 12 
7.1 
Study procedures ............................................................................................................................... 12 
7.1.1 
Screening ........................................................................................................................ 12 
7.1.2 
Consenting procedure ................................................................................................... 13 
7.1.3 
Baseline assessment ..................................................................................................... 14 
7.1.4 
Randomization ................................................................................................................ 14 
7.1.5 
Blinding  .......................................................................................................................... 15 
7.1.6 
Follow up visits ............................................................................................................... 15 
7.1.7 
Final evaluation .............................................................................................................. 18 
7.2 
Study Intervention fidelity ................................................................................................................. 18 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 18 
8.1 
Discontinuation of Study Intervention ............................................................................................. 19 
8.1.1 
Participant Discontinuation/Withdrawal from the Study ........................................... 19 
8.2 
Lost to Follow-Up ............................................................................................................................... 19 
9 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 20 
9.1 
Efficacy Assessments ....................................................................................................................... 20 

  
MAIANTAIN-pc Protocol 
iii 
9.2 
Adverse medical Events ................................................................................................................... 22 
9.2.1 
Severity of Event ............................................................................................................ 22 
9.2.2 
Relationship to Study INTERVENTION ...................................................................... 22 
9.2.3 
Expectedness ................................................................................................................. 22 
9.2.4 
Adverse Event Reporting .............................................................................................. 23 
10 
STATISTICAL CONSIDERATIONS .......................................................................................................... 23 
10.1 
Sample Size Determination .............................................................................................................. 23 
10.1.1 
General Approach .......................................................................................................... 23 
11 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 24 
11.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 24 
11.1.1 
Informed Consent Process ........................................................................................... 24 
11.1.2 
Study Discontinuation and Closure ............................................................................. 25 
11.1.3 
Confidentiality and Privacy ........................................................................................... 25 
11.1.4 
datA Safety and monitoring plan .................................................................................. 26 
11.1.5 
Protocol Deviations ........................................................................................................ 27 
11.1.6 
Publication and Data Sharing Policy ........................................................................... 28 
11.2 
Abbreviations ...................................................................................................................................... 29 
11.3 
Summary of irb approved changes ................................................................................................. 30 
12 
REFERENCES ............................................................................................................................................. 34 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
1 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
 
Title: 
Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary 
Care (MAINTAIN-PC)   
Study Description: 
(MAINTAIN-PC is a randomized controlled trial  to test whether online tracking tools 
and weight maintenance “coaching” visits for patients and “real time” electronic 
progress reports for primary care providers (PCPs) [Coaching] will support more 
successful weight maintenance than online tracking tools alone [Tracking] in a group 
of primary care patients who have lost ≥ 5% of their body weight. The online coaching 
visits for participants will be delivered through the primary care site’s electronic 
patient portal (HealthTrak) and the electronic progress reports for PCPs delivered 
through the electronic health record (EHR). Participants will be randomized into one 
of two study groups, comparing the effects of continued online coaching and PCP 
support with online tracking only. In order to ensure optimal integration of the 
MAINTAIN-PC PCP decision support tools into routine clinical practice, we will also 
get feedback from the PCPs prior to the start of the intervention.  In order to ensure 
optimal integration of the MAINTAIN-PC PCP decision support tools into routine 
clinical practice, we will also get feedback from the PCPs prior to the start of the 
intervention. 
Objectives: 
This study aims to translate an evidence-based lifestyle intervention into the primary 
care setting, using health information technology to promote weight maintenance 
and relapse prevention in patients who have successfully lost weight.  
Specific Aim: 
To determine the efficacy of online coaching and electronic progress reports 
delivered through the primary care site’s electronic health portal to support weight 
maintenance after initial weight loss of ≥ 5%. 
Study Design:  
This is a randomized controlled trial comparing two online weight maintenance 
strategies in the primary care setting.   
Endpoints: 
Primary Endpoint: 24-months for participants 
Study Population: 
Outpatient adults (BMI ≥ 25 kg/m2) with intentional 5% weight loss in past 2 years 
and with no bariatric procedures in past 2 years. 
Description of 
Sites/Facilities 
Enrolling Participants: 
10 UPMC Health primary-care practices in Pittsburgh, PA. 
 
Description of Study 
Intervention: 
EHR tools for both groups include weight, diet, and physical activity (PA) tracking 
flowsheets; standardized surveys; and reminders. Coaching participants will receive 
24-months personalized coaching through EHR patient portal. 
Study Duration: 
60-Months 
Participant Duration: 
30-months 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
2 
 
 
1.2 
SCHEMA 
 
 
 
Recruitment Screening Consent
n= 194
Randomize
Coaching group
98 participants
Tracking group
98 participants
• 24-month personalized 
health coaching through 
EHR
• Tracking weight, diet, 
physical activity
• Support for PCPs and 
clinic staff
• 24-month quarterly 
prevention updates 
through EHR 
• Tracking weight, diet, 
physical activity
Baseline Assessment 
Follow up 6,12,24-month
Primary outcome 
24-months 
Controlled randomized trial overview
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
3 
1.3 SCHEDULE OF ACTIVITIES (SOA): MONTH +/- 6 WEEKS 
PROCEDURES 
 
 
 
PRE-
INTERVENTIO
SCREENING 
ENROLLMENT 
BASELINE 
ORIENTATIO
N 
MONTH 6  
MONTH 12  
MONTH 24  
MONTH 30 
EXPLORATOR
Participant verbal consent for phone screening 
 
X 
 
 
 
 
 
 
Phone screening 
 
X 
 
 
 
 
 
 
In person screen visit 
 
X 
 
 
 
 
 
 
Addendum of Informed consent 
 
X 
 
 
 
 
 
 
Completion of Baseline assessment 
 
 
X 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
Study Orientation (Group or Individual) 
 
 
 
X 
 
 
 
 
Research data collection 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
Work & travel 
 
X 
 
 
 
 
 
 
Medical history & medications that influence 
weight 
 
X 
 
 
 
 
 
 
Computer use and skills assessments 
 
 
X 
 
 
 
 
 
Health literacy1 (NVS) 
 
 
X 
 
 
 
 
 
Weight, diet & physical activity history 
 
 
X 
 
 
 
 
 
Prior physician weight loss advice 
 
 
X 
 
 
 
 
 
Substance use & marital status 
 
 
X 
 
 
 
 
 
Physical activity estimate 
 
 
X 
 
X 
X 
X 
X 
Dietary measures2 (Diet Habit Survey) 
 
 
X 
 
X 
X 
X 
X 
Health survey3 (SF-36) 
 
 
X 
 
X 
X 
X 
X 
Functionc (WOMAC) 
 
 
X 
 
X 
X 
X 
X 
Quality of life4 (EuroQOL) 
 
 
X 
 
X 
X 
X 
X 
Social support5 (ISEL) 
 
 
X 
 
X 
X 
X 
X 
Stress level6(Cohen) 
 
 
X 
 
X 
X 
X 
X 
Depression scale7 (PHQ) 
 
 
X 
 
X 
X 
X 
X 
Sedentary behavior  
 
 
X 
 
X 
X 
X 
X 
Weight maintenance strategies 
 
 
X 
 
X 
X 
X 
X 
Self-efficacy & sleep 
 
 
X 
 
X 
X 
X 
X 
Health & medication update 
 
 
X 
 
X 
X 
X 
X 
Important medical events 
 
 
 
 
X 
X 
X 
X 
Measurement of Tracking and Online Visit Usage 
 
 
 
X 
X 
X 
X 
X 
Participant tools use feedback (survey)  
 
 
 
 
X 
X 
X 
X 
Patient satisfaction (TSUQ) 
 
 
 
 
X 
X 
X 
X 
Research measures 
 
 
 
 
 
 
 
 
Height 
 
X 
 
 
X 
X 
X 
X 
Weight 
 
X 
 
X 
X 
X 
X 
X 
Waist Circumference 
 
X 
 
 
X 
X 
X 
X 
Blood Pressure 
 
X 
 
 
X 
X 
X 
X 
Physical activity measured by research 
pedometers 
 
 
 
X 
X 
X 
X 
X 
PCP Feedback  
 
 
 
 
 
 
 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
4 
 
1.4 
INVESTIGATORS 
 
Molly B. Conroy, MD, MPH 
Kathleen M. McTigue, MD, MS, MPH 
Cindy L. Bryce, PhD 
Dana Tudorascu, PhD 
Bethany Barone Gibbs, PhD 
Jonathan Arnold, MD, MSE 
Diane Comer, BA 
Kimberly Huber, MPH 
Laurey R. Simkin-Silverman, PhD 
Gary S. Fischer, MD 
 
1.4.1 KEY ROLES  
 
Principal Investigator: Conroy, McTigue 
Study concept and design: Conroy, McTigue, Bryce, Hess, Simkin-Silverman, Fischer 
Statistical analysis: Tudorascu, Arnold, Comer 
Administrative, technical, or material support: Conroy, Arnold, Huber. 
Study supervision: Conroy, McTigue 
 
 
 
 
 
PCP recruitment 
X 
X 
 
 
 
 
 
 
Patient progress report template 
X 
 
 
 
 
 
 
 
Post-recruitment & intervention surveys 
(Qualtrics) 
 
 
 
 
 
X 
X 
 
Progress reports: 10 lb. loss or gain reports 
(coaching group only) 
 
 
 
 
X 
X 
X 
 
Between follow-up visit reports (coaching group 
only) 
 
 
 
 
X 
X 
X 
 
Annual/Final progress reports (coaching and 
tracking groups) 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
1: The Newest Vital Sign (NVS) Health Literacy Western  
2: Dietary Habit Survey 
3: 36-Item Short-Form Health Survey (SF-36)  
4. Health Related Quality of Life (EuroQOL)d: Test of Functional 
Health Literacy in Adults (The Newest Vital Sign) 
5: Interpersonal Self Evaluation List (ISEL) 
6: Perceived Level of Stress (Cohen) 
7: Patient Health Questionnaire (PHQ) Depression 
Scale 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
5 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY OBEJECTIVES 
 
2.1.1 PRIMARY OBJECTIVE AND HYPOTHESIS 
 
To determine the efficacy of online coaching and electronic progress reports delivered through the 
primary care site’s electronic health portal to support weight maintenance after initial weight loss of ≥ 
5%.   
 
Hypothesis. Patients randomized to have online coaching and PCP receipt of electronic progress reports 
(Coaching  group) will be more likely than those randomized to use only online tracking tools (Tracking 
group) to maintain weight loss, higher levels of physical activity and healthy eating behaviors. 
 
2.1.2 SECONDARY OBJECTIVE AND HYPOTHESIS 
 
To evaluate whether online weight maintenance tools will be acceptable to patients and primary care 
providers (PCPs) when integrated into routine clinical workflow, and assess barriers to patient and PCP 
up-take. 
 
Hypothesis 1. Patients will find the online tools dedicated to weight maintenance acceptable and an 
enhancement to their ongoing care, with higher satisfaction levels observed in coaching group 
compared to tracking group. 
Hypothesis 2. PCPs will find the online tools dedicated to weight maintenance acceptable, useful, and 
easily integrated into their routine clinical workflow. 
 
2.1.3 ADDITIONAL OBJECTIVE AND HYPOTHESIS 
 
To determine the cost effectiveness of online coaching and electronic progress reports delivered 
through the primary care site’s electronic health portal.  
 
Hypothesis. Online coaching and electronic progress reports delivered through the primary care site’s 
electronic health portal will be a more cost-effective strategy than use of tracking tools alone to 
promote weight loss maintenance. 
 
2.2 
STUDY RATIONALE  
 
Weight gain after a lifestyle intervention is common and it is important to investigate mechanisms for 
promoting longer-term maintenance of a healthy body weight. Physicians are a trusted source of health 
advice for many adults, so may play an important role in helping to establish and sustain healthy body 
size, in the interest of long-term health. Yet, implementing effective chronic care for obesity in a clinical 
setting has been challenging. Health IT may be an important tool for overcoming these barriers. Here we 
test online approaches for delivering a weight maintenance intervention to individuals with high weight-
related health risk.  
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
6 
 
2.3 
BACKGROUND  
Obesity is a major and increasing health problem in the United States.(1) While many interventions have 
resulted in short-term weight loss, few programs support successful maintenance of a healthy body 
weight,(12-14) and fewer still are applicable to a primary care population.(15, 16) Obesity tends to be a 
chronic, lifelong condition and relapse after weight loss is common.(17, 18) Despite the fact that obesity 
is associated with a host of medical diseases,(2-5) weight loss interventions are usually conducted in a 
vacuum, divorced from the participants’ usual medical care and without the input from the primary care 
team.(15, 16) Therefore, there is a great need for interventions that can assist with long-term 
maintenance of healthy body weight in the general population and in persons with existing medical 
conditions. Furthermore, such efforts should be linked to ongoing medical care. Our research team has 
developed an intervention (19) that successfully uses health information technology (HIT) and 
standardized online coaching protocols to promote weight loss among primary care patients. We now 
propose extending our work to evaluation of HIT tools designed to promote weight maintenance and 
prevent relapse (i.e., weight regain) in primary care patients who have successfully lost weight. Our 
proposal leverages recent developments in HIT, such as online visits(20) and electronic health 
records,(21) to track progress and support primary care patients and their providers in patients’ ongoing 
weight maintenance efforts.  
 
2.4 
RISK/BENEFIT ASSESSMENT   
 
2.4.1 KNOWN POTENTIAL RISKS  
 
We categorize the frequency of known potential risk using the following categories:  
 
Category 
Frequency 
• 
Likely  
Occurs in >25% of people 
• 
Common  
Occurs in 10-25% of people 
• 
Infrequent  
Occurs in 1-10% of people 
• 
Rare  
Occurs in <1% of people 
 
Participants 
 
INCREASING PHYSICAL ACTIVITY 
 
The recommended physical activity may cause muscle soreness or fatigue (likely). There is also the 
possibility that the following could occur during exercise: injury of a joint or muscle (common), broken 
bones (rare), falls from an exercise bicycle or treadmill (infrequent). aggravation of pre-existing podiatry 
problems (common), shortness of breath (common), abnormal blood pressure (common), fainting 
(rare), disorders of heart rhythm (rare), and heart attack, stroke or even death (rare). If participants are 
on anti-hypertensive medication, the risk of hypotension (infrequent) exists. 
 
WEIGHT LOSS 
 
The risks of weight loss are constipation (common), and some dizziness upon standing (common). Rapid 
weight loss increases the chances of developing or enlarging gallstones (rare). Other risks of weight loss 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
7 
include hypoglycemia (infrequent) and light-headedness or weakness (common), and hunger (likely). 
Since participants may require dose adjustment of medications with weight loss, hypotension 
(infrequent) or hypoglycemia (infrequent) may occur among those treated for hypertension or elevated 
blood sugars, respectively. 
 
LOSS OF PRIVACY 
 
Study participation and outcomes collection may entail risk for loss of privacy regarding the collected 
information. For participants in the coaching group, there is a possibility of loss of privacy from posting 
information on the Internet, although the HealthTrak portal is a password-protected site meeting 
stringent security requirements for transmission of medical information. UPMC HealthTrak provides a 
web-based patient portal that permits enrolled patients to view portions of their medical record and 
communicate with their physician offices through secure messaging. Access to information is controlled 
through secure access codes, usernames, and passwords. HealthTrak uses 128-bit SSL encryptions 
technology with no caching to automatically encrypt the session with UPMC HealthTrak. To reduce the 
risk of unintended access, HealthTrak utilizes a 10 minute idle time out. In addition, HealthTrak 
undergoes an annual review of our System Security Plan, an in-depth security assessment used to 
evaluate the security posture and risks. To validate the security plan and to test the system, host-based 
network vulnerability assessments and web application vulnerability assessments are performed by the 
Information Security Group (ISG). Any discovered policy gaps and vulnerabilities are addressed or 
remediated within 30-days.  
 
Providers 
The only potential risk to the PCP participants is loss of privacy, although the surveys will be anonymous, 
making this risk unlikely. 
 
2.4.2 KNOWN POTENTIAL BENEFITS  
 
• 
Free of charge services: 
Participants will be to tracking sheets to self-monitor weight, diet and physical activity and participate in 
online visits related to prevention.  
Each participant will be given a pedometer and a calorie book.  
They may also receive personalized lifestyle coaching, and feedback on their self-monitoring.  
 
• 
Improved health and quality of life: 
Weight loss and physical activity have been linked with improved health and quality of life, so we 
anticipate that participants may feel better and possibly have improved long-term health. It is possible 
that some may be able to reduce their medication needs (e.g. blood pressure or anti-glycemic agents).  
 
2.4.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Since the risks of participating are minimal, and the benefits may be considerable, participating in this 
intervention should be a reasonable option for primary care patients.  
 
3 
OBJECTIVES AND ENDPOINTS 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
8 
OBJECTIVES 
ENDPOINTS 
Primary 
 
Assess change in body weight from baseline/enrollment 
24-months 
Secondary 
 
Assess maintenance of a 5% weight loss 
24-months 
Assess change in BMI from baseline/enrollment 
24-months 
Assess change in physical activity (steps per day) from 
baseline/enrollment 
24-months 
Assess change in quality of life from enrollment/baseline 
(EuroQOL) 
24-months 
Function (WOMAC) 
24-months 
Assess changes in blood pressure from enrollment/baseline 
24-months 
Assess patient satisfaction and perceived usefulness of a 
technologic intervention to improve self-management 
24-months 
Assess PCP satisfaction  
24-months 
Exploratory 
 
Assess change in dietary habits from enrollment/baseline 
24-months 
Assess change in body weight from baseline/enrollment 
30-months 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
• 
Trial design: Randomized Control Trial 
• 
Randomization: 1:1 to tracking tools with or without coaching 
• 
Randomization sequence generation: Computer-generated permuted block randomization with 
block sizes of four and six individuals and stratified by sex and site of primary care 
• 
Allocation sequence: by study statistician 
• 
Allocation concealment mechanism:  
o Study staff to obtain assignment from data center website 
o Assignments to be given to participants after baseline assessment and before 
orientation by study staff 
• 
Blinding: Not blinded 
 
4.2 
END OF STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed at least one follow 
up visit of the study including the last visit or the last scheduled procedure shown in the Schedule of 
Activities (SoA), Section 1.3. 
 
5 
STUDY POPULATION: SELECTION AND ENROLLMENT OF PARTICIPANTS 
5.1 
INCLUSION CRITERIA 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
9 
Participants 
1. Adults aged 18-75  
2. BMI of ≥ 25 prior to this intended weight loss 
3. Have experienced and maintained intentional weight loss of at least 5% of body weight in the past 
24 months 
4. Plan to maintain a PCP relationship in one of the participating primary care practices 
5. Have or be willing to get an account with the electronic health portal (HealthTrak) embedded in the 
EHR 
 
Providers 
• 
For progress report feedback:  
1. Primary care physician practicing at one of the designated UPMC sites with Epicare access 
2. Willing to review and comment on electronic progress reports 
• 
For intervention feedback: PCP who has sent at least one patient to the MAINTAIN-PC study 
 
5.2 
EXCLUSION CRITERIA 
 
Participants 
 
1. Medical conditions that might cause unintended weight loss such as cancer or thyroid disease  
2. Provider’s assessment that patient is unable to safely undertake moderately intense unsupervised 
physical activity (the equivalent of 30 minutes of brisk walking) 
3. Edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, 
end-stage renal disease, or ascites) 
4. Bariatric surgery in the last 2 years, or planned during the next 3 years  
5. Current or planned pregnancy in the next 3 years 
6. Currently breastfeeding 
7. Perceived lack of basic computer or Internet skills. 
8. Unable to attend the orientation session or comply with the protocol procedures 
9. Any other underlying reason or concomitant condition, which in the opinion of the principal 
investigator, could confound the results of the study or put the participant at undue risk.  
 
Provider 
1. Not a primary care physician practicing at one of the designated UPMC sites 
2. Does not have Epicare access 
3. Unwilling/unable to review and comment on electronic progress reports 
 
5.3 
ENROLLMENT PROCEDURES 
 
Participants 
• 
Phone screening 
• 
In-person screening visit 
• 
In-person written consent at screening visit 
• 
In-person written consent addendum form 
 
Providers 
• 
For progress report template feedback: Anonymous  

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
10 
• 
For post-recruitment and post-intervention feedback: IRB-approved mechanism for obtaining 
consent over the Internet at the time of completing the survey 
 
5.4 
SCREEN FAILURES 
 
Individuals who do not meet the criteria for participation in this trial (screen failure) will be told the 
reason why they cannot participate by the research staff. Should the participant be willing, there is the 
possibility of them coming back for a re-screening visit if they meet the entry criteria at a later date 
during the study’s recruitment phase. Rescreened participants should be assigned the same participant 
number as for the initial screening. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
5.5.1 RECRUITMENT 
 
Participants  
• 
Provider Referral - Health care providers from the participating clinics will be educated about 
the study and may refer patients to it during routine medical care. If a patient verbally indicates 
interest in participating in the study, the health care provider may fill out the Referral Form or 
may enter an electronic referral order into the patient’s chart. The referral will verify that 
moderate physical activity and a relatively low-fat diet is medically appropriate for the referred 
patient. When the referral is electronically signed, it will be forwarded automatically to a 
research staff member. A study staff member will call referred patients to conduct the study’s 
standard brief phone screen to determine preliminary eligibility criteria. Dr. MollyConroy, the 
study’s Principal Investigator, is a UPMC employee, and will be available to provide as-needed 
clinical and research expertise to the staff member receiving the referrals. We will create a best-
practice alert (BPA) to alert PCPs to patients with a weight loss of ≥ 5% of body weight who may 
qualify for a weight maintenance study, and will also target patients directly through posters 
and flyers in clinic and mailings to our primary care research registry. The BPA has been a 
successful strategy to recruit for numerous studies in our practice setting, including the VLM 
pilot, OCELOT-PC and Healthy Bodies, Healthy Hearts. The BPA recruitment has been 
demonstrated to increase participation from minority patients when compared to traditional 
staff-based methods. We will also recruit directly to patients via the patient portal of the EHR 
(HealthTrak) by sending them a brief electronic message if they have lost weight in the past 
year. We will also visit the regularly scheduled practice meetings of the designated practices to 
orient PCPs to the study and answer any questions they may have 
 
• 
Self-Referral - Recruitment flyers/brochures will be located in the exam rooms and waiting 
areas of the participating clinics. Interested individuals can call a phone number to complete the 
brief phone screen to assess preliminary eligibility criteria. In the UPMC Montefiore practice, the 
standard computerized intake survey will ask patients if they would be interested in learning 
more about an online weight management study. If they answer “yes”, an email will be sent to a 
study staff member, who will then call these patients to conduct the study’s standard brief 
phone screen to determine preliminary eligibility. If the individual meets the phone screen’s 
eligibility standards, research staff will contact the appropriate health care provider to request a 
referral. Patients who are not eligible based on the phone screening will be informed of their 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
11 
ineligibility at the conclusion of the phone screen and asked for permission to retain their 
contact information for possible future participation. Once a physician referral is received by the 
program staff and preliminary eligibility of the potential participant has been determined via the 
phone screening process, then the potential participant will be scheduled for an in-person 
SCREENING VISIT at one of the Center for Research on Healthcare's offices in Oakland or at 
another approved site. 
 
• 
OCELOT-PC (IRB#PRO09080118) sample. Consented participants who previously participated in 
the OCELOT-PC study will also be targeted for recruitment and screening for this study. The 
participants will be contacted by a member of the OCELOT-PC study team (either by phone, 
email or mail) informing them of the study. If they are interested and would like to find out if 
they are eligible to participate, the MAINTAIN-pc study contact number and email will be 
provided. A MAINTAIN-pc study staff member will then conduct a brief phone screen to 
determine their eligibility. 
 
• 
Potential participants may also learn of the study through mailings of potential studies due to 
their participation in the CTSI Research Participant Registry or UPMC/University mailings. 
 
• 
A study summary for advertisement will be submitted in the UPMC Extra! newsletter and in 
system-wide communications targeted to UPMC MyHealth Weight Race participants. 
 
• 
Printed materials will also be distributed and displayed at UPMC primary care outpatient offices, 
in buildings in and around the Oakland area, to UPMC MyHealth Weight Race staff, and to 
organizers of other weight-loss related programs. 
 
Recruitment for Providers 
• 
For progress report feedback: All PCPs present at site orientation meetings will be invited to 
provide anonymous feedback on what they would like to see included in the patient progress 
report template 
• 
For post-recruitment and post-intervention feedback: Invitations and reminders for 
confidential PCP surveys (Qualtrics) sent through campus e-mail 
5.5.2 RETENTION 
 
Participants 
 
Enrolled patients will be tracked in the EHR research module, allowing to both monitor their progress in 
the trial and run reports on their adherence.  
The study multifaceted retention plan consist of the following:  
1) Minimizing burdens during protocol design 
2) Setting expectations up-front during recruitment and orientation session including weight loss 
the demands of joining a randomized controlled trial, and making eating and activity changes,  
3) Promptly respond to inquiries and messages  
4) Weekly reminders to track their weight, diet, and exercise through the personal health record 
5) Reminders for upcoming visits and tasks 
6) Show appreciation and recognition and accommodate to participant’s schedule as much as 
possible 

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12 
7) In addition, we believe that PCP engagement will improve retention. 
8) Finally, understanding why a participant chooses to discontinue the intervention will be valuable 
information to obtain. This feedback may provide insight into what changes can be 
implemented to improve retention in future. 
9) Use retention enhancement techniques proven to work by us and other clinical trials: 
a.  Create ‘project identity’ that participants can recognize by using similar colors and fonts 
on trial materials 
b. Track eligibility status of potential participants on a computer database 
c. Write protocols to systematically address common participant questions 
d. Adhere to trial protocols and procedures 
e. Provide support to all participants 
f. Offer flexible scheduling 
g. Attempt to be on time for clinic appointments 
h. Make multiple attempts to contact participants for complete data email, and phone 
i. 
Encourage participants who move from the area to continue completing questionnaires, 
and have clinic data (e.g. weight, blood pressure) collected and verified by another 
health professional 
j. 
Send birthday cards to all participants 
k. Determine two secondary contacts by asking participants to sign letters notifying 
contacts of trial participation and giving permission to provide forwarding information 
(letters also served as an implicit behavioral commitment to complete the trial) 
 
Providers 
Retention plan consist of minimizing burdens during protocol design for provider’s participation 
including:  
1. IRB-approved mechanism for obtaining consent and administering confidential PCP 
surveys over the Internet  
2. Invitations and reminders for PCP surveys sent through their campus e-mail 
 
6 
PRE-INTERVENTION ACTIVITIES 
 
PROGRESS REPORT FEEDBACK 
Providers 
All PCPs present at site orientation meetings will be invited to complete a brief anonymous 
survey to get their general opinion on the patient progress report template. A script will be read 
to them describing the reason for collecting the information. If they are interested, they are 
welcome to review the report template and complete the survey. No identifiable information 
from this sample will be collected or retained.  
 
 
7 
STUDY INTERVENTION 
 
7.1 
STUDY PROCEDURES 
 
7.1.1 SCREENING 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
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Participants 
 
• 
PHONE SCREEN:  
o Ensure potential participants are preliminarily eligible to participate 
o Research staff will: 
 
Use PHONE SCRIPT  
 
Confirm 5% weight loss and a BMI greater than or equal to 25 within the past 
two years 
 
Confirm Additional Inclusion criteria 
 
Complete PHONE SCREEN ELIGIBILITY CHECKLIST 
 
Notify eligible participants of weight and BMI verification retrieving medical 
records 
 
• 
IN-PERSON SCREEING VISIT:  
o Determine preliminary eligibility 
o Duration: approximately 1 hour 
o Scheduled post-phone screen 
o Research staff will: 
 
Explain study in lay language to each potential research participant 
 
 Address participants questions and concerns 
 
Ask for informed consent signature before undergoing any additional screening 
or research procedures. 
 
Obtain additional BASELINE PROCEDURES if participant is eligible 
• 
Please refer to Schedule of Activities (SoA), Section 1.3 for complete list 
of baseline questionnaires and activities. 
o It is possible that after the screening measures are collected, the participant will not 
be eligible to participate in the study. 
o Dr. Conroy available to speak to the potential participant to further explain the details of 
the study, if necessary. 
o Location:   
 
At one of the designated sites in Oakland affiliated with the University of 
Pittsburgh’s Center for Research on Health Care 
 
 Another approved location by trained research staff.  
 
7.1.2 CONSENTING PROCEDURE 
 
Participants 
 
• 
For Phone screening 
o Verbal informed consent for the phone screening will be obtained using the phone 
screening script. If the patient does not provide verbal consent, the phone screening will 
not be conducted.  
 
• 
For Screen Visit 
o After the phone screen, the participant will be sent a copy of the consent form to review 
prior to their screening visit appointment 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
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14 
o At the screening visit, the Informed Consent document will be reviewed carefully with each 
participant. 
o Participants will have the opportunity to ask any additional questions. 
o  If uncomfortable with the study requirements, the participant may choose not to enroll in 
the study at that time. 
o The participant will also have the option to reschedule for a future screening visit if more 
time is needed for a decision about participation 
o All documents specifically state that participation in the study is voluntary and the decision 
NOT to participate in the study will have no negative consequences for the participant 
o Any listed investigator or designated research team member, will be able to obtain informed 
consent from each participant before the start of any research procedures 
o Potential study participants will read the consent form and be asked for a verbal indication 
of their understanding of the material contained in the consent form 
o The consenter will be available to answer any questions that arise 
o Participants will then be asked to sign the informed consent document if they agree with 
the material contained in the form 
o The consenter will sign the consent document and provide a copy to the participant  
o Research team members obtaining consent will have completed the approved University of 
Pittsburgh training to consent individuals for research 
• 
For enrollment 
o For enrolled participants who have completed either their screening/baseline or both 
screening/baseline and orientation visits, new information will initially be presented to them 
by phone or in-person using the currently IRB approved addendum consent form.  
o Written informed consent will either be obtained by mail or at their next scheduled visit 
o Participants who do not give their addendum consent will not be able to continue their 
participation in the study or will be considered lost to follow-up  
 
Providers 
For progress report feedback: survey is anonymous 
For intervention feedback: confidential web-based PCP surveys has detailed script provided before the 
survey questions. A box is included at the end of the script and will be required to check to indicate their 
approval to participate. 
 
7.1.3 BASELINE ASSESSMENT 
 
• 
Participants who are eligible after the collection of screening measures will be asked by a 
trained research staff member to complete additional baseline questionnaires at the in-person 
screening visit.  
• 
Baseline questionnaires will be approximately 1 hour 
• 
Please refer to Schedule of Activities (SoA), Section 1.3 for complete list of baseline 
questionnaires and activities. 
 
7.1.4 
RANDOMIZATION 
 
After the completion of the baseline assessment participants will be randomized to participate in either 
the coaching or tracking group intervention (approximately 98 individuals will be randomized to each 
group). 

Title: MAINTAIN-PC  
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(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
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15 
 
7.1.5 
BLINDING 
 
Not blinded 
 
7.1.6 FOLLOW UP VISITS 
 
IN-PERSON ORIENTATION SESSION 
 
• 
Successfully screened and randomized participants attend an in-person GROUP OR INDIVIDUAL 
ORIENTATION session for the group to which he/she was assigned 
• 
Sessions take place in one of the computer training labs or in the research office in Oakland 
• 
GROUP ORIENTATION VISIT:  
o Approximately 5-10 participants per session  
o Duration: approximately 90 minutes (evenings only) 
o Conducted by appropriately trained study investigator(s) and study staff 
 
• 
INDIVIDUAL ORIENTATION VISIT:  
o One participant per session with appropriately trained research staff 
o Duration: approximately 1 hour 
o Post-baseline visit, at another scheduled time in Oakland, or on the phone (during 
daytime hours).  
• 
At the end of the in-person orientation visit participants will: 
• 
Complete practice orientation survey  
• 
Receive health goals based on their most recent weight obtained at this visit 
• 
Receive recommendation to maintain at least a moderate level of physical activity (e.g., 
brisk walking) for up to 150-200 minutes per week  
o The type of physical activity will be chosen by the participant and will be 
unsupervised by the research staff  
• 
Receive pedometer to keep and calorie tracking book to keep along with instructions on 
how to use them 
• 
Receive a brief (45 minute) review of the most important concepts from the Diabetes 
Prevention Program (DPP)  
• 
Receive a brief review and link to access the most important concepts from the Diabetes 
Prevention Program (DPP), on line and free of cost 
• 
 Receive lessons on how to set realistic goals and tips for physical activity, healthy food 
choices, and portion control 
• 
Receive research pedometers for the purpose of collecting objective physical activity 
data for up to two weeks 
o Data will be collected for comparison with the pedometer data planned for 
collection at each follow-up visit 
• 
Receive additional instruction and education  
o Coaching Group 
 
Receive additional information about the online visits for weight 
maintenance 
 
Learn how to access weight maintenance behavior based surveys to 
complete at designated times 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
16 
 
Learn how to communicate with their assigned health coach and PCP 
through the HealthTrak portal   
 
Complete an online questionnaire for practice 
 
Receive encouragment to start tracking their weight, physical activity 
(e.g., average daily steps), calories, and fat grams via HealthTrak on a 
weekly basis 
 
Be assigned a Health Coach to provide them with consistent feedback, 
information, and education 
 
Learn that their PCP will receive regular summary reports on their 
progress  
 
Receive encouragement to follow-up with their PCP on a routine basis 
 
o Tracking Group 
 
Receive an overview of online visits on a lifestyle topics unrelated to 
weight maintenance  
 
Learn how to access health promotion-based surveys to complete every 
3 months 
 
Learn how to communicate with their PCP through the HealthTrak 
portal 
 
Receive encouragement to start tracking their weight, physical activity 
(e.g., average daily steps), calories, and fat grams via HealthTrak on a 
weekly basis. 
 
Learn that their PCP may choose to discuss the data they receive 
through HealthTrak as a part of their routine medical care. 
 
Receive encouragement to follow-up with their PCP on a routine basis 
 
 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
17 
 
FOLLOW UP VISIT:  
 
Participants  
• 
Schedule, activities, and contact for both groups 
 
FOLLOW UP ACTIVITIES 
 
RESPONSIBLE 
CG1 
 
TG2 
MONTH 
1 
MONTH 
2-6 
MONTH 
7-12 
MONTH 
13-24 
MONTH 
25-30 
Complete online visits: Virtual 
Lifestyle Management (VLM) 
surveys 
Participant 
X 
 
Weekly 
Biweekly 
Monthly 
Every 3 
months 
 
Complete online weight 
maintenance questionnaires 
Participant 
X 
 
Weekly 
Biweekly 
Monthly 
Every 3 
months 
 
Receive feedback from coach 
Participant 
X 
 
X 
X 
X 
X 
 
Complete additional 
questionnaires, if necessary 
Participant 
X 
 
X 
X 
X 
X 
 
Track physical activity and 
calories/fat in HealthTrak  
Participant 
X 
X 
X 
X 
X 
X 
X 
Make regular PCP 
appointments 
Participant 
X 
X 
X 
X 
X 
X 
X 
Wear pedometer for 2-weeks 
at end of: 
Participant 
X 
X 
 
Month-6 
Month-12 
Month-24 
 
Month-30 
Research measurements: 
• 
Waist 
• 
Blood pressure 
• 
Return pedometer 
Participant 
X 
X 
 
Month-6 
Month-12 
Month-24 
 
Month-30 
Complete online outcome 
questionnaires, feedback and 
satisfaction. At end of: 
Participant 
X 
X 
 
Month-6 
Month-12 
Month-24 
 
Month-30 
Complete health promotion 
topics. At end of: 
Participant 
 
X 
 
Month-3 
Month-6 
Month-9 
Month-12 
Every 3 
months  
 
Review VLM survey 
Coach 
X 
 
X 
X 
X 
X 
 
Provide additional educational 
lessons if need 
Coach 
X 
 
 
X 
X 
X 
X 
 
Review notification of 10 lb. 
weight gain or loss from EHR 
PCP  
X 
 
X 
X 
X 
Month-24 
 
Receive real-time progress 
report prior to patients’ 
appointment. 
PCP  
X 
X 
(annual 
only) 
X 
Month-6 
Month-12 
Month-24 
 
 
Feedback and satisfaction 
survey 
PCP  
X 
X 
 
 
  
Month-18 
Month-24 
 
1 Coaching Group 
2 Tracking Group 
 
• 
Additional contacts throughout the study: From research staff via letters, phone calls, emails, 
newsletters, post card reminders, etc. 
 
Providers: 
• 
Sustained support through study 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
18 
• 
PRE-INTERVENTION PHASE: Progress report feedback 
• 
RECRUITMENT PHASE: Referring appropriate study candidates  
• 
INTERVENTION PHASE:  
o Respond to alert reports for weight change >= 10 lbs to, which could prompt an office 
visit 
o Reviewing EHR intervention reports.  Estimated time for review of reports is 2 minutes 
 
Progress reports prior to scheduled office visits: summary of self-monitoring 
data on weight, fat, calorie intake, physical activity  
 
Interim progress reports: counseling tips suggested for incorporating into office 
visit 
 
End-of-study summary reports 
• 
POST-RECRUITMENT AND POST-INTERVENTION PHASE: intervention feedback 
o All PCPs at targeted clinical practices (i.e., PCPs who have and have not referred 
patients) and PCPs at other UPMC sites who approved participation for patients to 
participate in this study will also be asked to complete a confidential feedback survey 
after the first year following the start of recruitment and the end of the study.  
o The surveys will be created and distributed via the Qualtrics web-based system using a 
confidential link.  
o Even though the Qualtrics anonymous link does not record name or email address, it 
does collect the user's IP address. We have no plans to use the IP address to identify 
survey respondents. For data analysis, a study-specific number will be assigned to each 
survey by the research staff. Whether or not the PCPs choose to enter the prize 
drawing, survey responses will remain de-identified. For those PCPs wanting to enter 
the prize drawing, they will be re-directed to a separate survey where they will be asked 
to provide their contact information. Any potentially identifiable information collected 
will be kept separate from the survey data. 
 
7.1.7 FINAL EVALUATION 
• 
Please refer to Schedule of Activities (SoA), Section 1.3 for complete list of endpoint 
questionnaires and activities. 
 
7.2 
STUDY INTERVENTION FIDELITY 
 
A clear process evaluation protocols for monitoring the intervention groups to ensure that the integrity 
of the intervention is maintained will be used. An Intervention Team, made up of Drs. Conroy, McTigue, 
and Simkin-Silverman, the project coordinator and lifestyle coaches will meet weekly throughout the 
study. At these meetings, we will review progress (e.g., participant recruitment, online program use), 
check record-keeping to make sure it is up to date, and address problems as they arise. We have 
developed online tools that not only monitor patient progress, but also track whether the lifestyle 
coaches are delivering the virtual intervention per the designated schedule, and facilitate the auditing of 
online coaching notes (e.g., to check length and content). The co-investigators will provide the staff with 
feedback based on these intervention audits, and initiate additional training as needed. 
 
8 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
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8.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the 
study.  Participants who sign the informed consent form and are randomized but do not receive the 
study intervention may be replaced.  Participants who sign the informed consent form, and are 
randomized and receive the study intervention, and subsequently withdraw, or are withdrawn or 
discontinued from the study, will not be replaced. 
 
8.1.1 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
• 
Participants are free to withdraw from participation in the study at any time upon request 
o Will be documented as: Withdraw by participant 
 
• 
An investigator may discontinue a participant from the study for the following reasons: 
o Primary care provider feels that it is not in the participants best interest to stay in the 
study 
o Change in health condition which requires discontinuation of the study intervention 
o Pregnancy 
o Significant study intervention non-compliance  
o Underlying or concomitant condition, which in the opinion of the principal investigator, 
could confound the results of the study or put the participant at undue risk 
o If study is stopped 
o Participants who do not give their addendum consent 
o Will documented as: Protocol Violation or other appropriate documentation 
 
• The reason for participant discontinuation or withdrawal from the study will be recorded on the 
NOTE TO FILE form. 
 
8.2 
LOST TO FOLLOW-UP 
 
• 
Participants are considered lost to follow-up when they stop reporting to scheduled study visits 
and cannot be reached to complete all protocol-required study procedures.  
• 
A participant will be considered lost to follow-up if he or she fails to return for scheduled visits 
and is unable to be contacted by the study site staff.  
• 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
o The site will attempt to contact the participant and reschedule the missed visit within 24-
hours of a missed visit and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain if the participant wishes to and/or should continue in 
the study. 
o Before a participant is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
study file.  

Title: MAINTAIN-PC  
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20 
o For participants unable to contact/schedule but had not formally withdrawn, EHR weights 
were used.  
9 
STUDY ASSESSMENTS AND PROCEDURES 
 
9.1 
EFFICACY ASSESSMENTS  
 
Weight change: weight, 
height, BMI  
 
Change in body weight from baseline/enrollment is the primary 
outcome. Secondarily, maintenance of a 5% weight loss and change in 
body mass index (BMI). Weight and height will be measured using a 
calibrated scale and stadiometer, respectively. 
 
Fat distribution change: 
waist circumference  
 
Waist circumference measured at end-expiration at the level of the 
iliac crest, as a measure of body fat distribution, since central adiposity 
has been linked with increased cardiovascular risk.  
Lifestyle behavior 
change: physical 
activity, dietary habits 
 
Physical activity measured as change in physical activity (steps per 
day) from enrollment. Assessed in all groups at baseline, 6 months, 1-
year, 2-year and 3-years using pedometers. This objective approach 
has been widely used in research and community physical activity 
programs,(22-27) as well as in OCELOT-PC. Participants will be asked to 
wear a piezo-electric pedometer for 2 weeks and then return it in 
person or by mail. These pedometers are validated for use by obese 
individuals(22) and postage-paid protective packaging will be 
provided. 
 
Dietary habits: assessed using a self-reported tracking information 
provided by participants (fat and calories) as well as a validated diet 
habit survey.(28)  
 
Quality of Life and 
Function change : 
RAND-12, IWQOL-Lite, 
and short-form WOMAC 
function scale  
 RAND-12,(29) a commonly used, and often preferred(30) generic 
quality of life measure will be used. It includes measures of physical, 
mental, and social functioning. Its 12 questions are summarized into 
mental and physical health composite scores. It has been used in 
obesity studies,(31) is responsive to increasing levels of weight (e.g., 
those with increasing BMI have more HRQOL impairment),(31, 32) and 
improves with weight loss.(33)  In addition to the RAND-12, we will 
administer the EuroQOL (EQ-5), a brief (5-item) measure of 
HRQOL.(34, 35) Like the RAND-12, the EQ-5D is generic and therefore 
applicable to many health states; it is also a preference-based measure 
of HRQOL and can be used to compute quality-adjusted life years 
(QALYs), which will be important for the cost-effectiveness analysis 
phase of the study.    
 
Obesity-specific HRQOL assessed with the Impact of Weight on Quality 
of Life (IWQOL-Lite), a brief, psychometrically valid, self-administered, 
disease-specific HRQOL instrument.(36, 37) Its questions cover 
multiple domains (physical functioning, self-esteem, sexual life, public 
distress, and work), but, unlike generic instruments, questions are 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
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21 
phrased with the stem “because of my weight”.  
 
The short-form of the Western Ontario and McMaster Universities 
(WOMAC) function scale to measure functional status. The scale was 
shortened based on input from patients with knee or hip osteoarthritis 
and their rheumatologists(39) and is externally validated.(40) It 
includes 8 items, each describing an activity which may be limited. The 
degree of limitation is scored on a Likert-scale from 0 (none) to 4 
(extreme).(39)  
Cardiovascular risk 
factors change: blood 
pressure and 
medications for weight-
related cardiovascular 
risk factors 
blood pressure measured at baseline, 6, 12, 24-Months.. 
 
 changes in prescribed doses for anti-glycemic, anti-hypertensive, and 
lipid-lowering medications at these time points to be recorded 
Patient satisfaction and 
perceived usefulness 
 
We will adapt the “Use and Impact” questions from the Telemedicine 
Satisfaction and Usefulness Questionnaire (TSUQ; Appendix F)(41) to 
assess patient satisfaction. The TSUQ has been found to be valid, 
reliable, and readable at an eighth-grade level.(41) The 10 questions 
making up its Use and Impact factor are scored on a Likert scale from 1 
(strongly disagree) to 5 (strongly agree), and assesses different aspects 
of the participants’ satisfaction and perceived usefulness of a 
technologic intervention to improve self-management. They can be 
summed for a total factor score.  
 
Provider satisfaction 
 
 PCP satisfaction survey (Appendix E) to any PCP who had a patient 
enroll as a participant in MAINTAIN-PC. PCP satisfaction surveys will be 
administered twice – at the end of year 1 of the intervention (i.e. Year 
2 of study), and at the end of the intervention (year 4). PCPs will 
receive an incentive of $25 for completing each survey. The survey will 
assess PCP’s opinions on the various components of the study, 
including electronic summary reports received 24-48 hours before 
routine visits, paper reports generated every 12 months, and 
notifications for participants who have lost or gained 10 lbs. We will 
take into account in our skip pattern on the PCP satisfaction survey the 
fact that not all PCPs will receive all of these reports or messages if 
they have not had a patient randomized to the coaching. For PCPs who 
do endorse familiarity with any component of the MAINTAIN-PC 
intervention, we will ask them to complete a validated IT “Perceived 
Usefulness and Perceived Ease of Use” instrument, adapted from 
Davis.(42) The 12 questions making up the Perceived Usefulness and 
Perceived Ease of Use scales are scored on a Likert scale from 1 
(extremely likely) to 7 (extremely unlikely). The scales have excellent 
Cronbach alpha reliability (0.98 and 0.94, respectively) and have been 
found to be predictive of current and future IT use, which is an 
important dimension to consider when thinking about longer term 
uptake and dissemination of the MAINTAIN-PC intervention in clinical 
practice. In addition to these scales, we will also ask the PCPs specific 

Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
22 
questions about how well the MAINTAIN-PC tools were integrated into 
their clinical workflow, including any barriers to integration. We will 
also collect basic information about PCP (sex, years practicing, 
sessions/week, self-efficacy with weight loss counseling). We will use 
the results of the PCP survey to make modifications to the MAINTAIN-
PC tools prior to further dissemination efforts.  
 
   
9.2 
ADVERSE MEDICAL EVENTS 
9.2.1 SEVERITY OF EVENT 
 
Participants will be asked about any adverse medical events that might have affected their participation 
in usual daily activities at each follow-up assessment and self-rate the severity of the event  
 
For adverse medical events the following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities 
• 
Moderate – Events result in a low level of inconvenience or concern with the intervention measures. 
Moderate events may cause some interference with functioning 
• 
Severe – Events interrupt a participant’s usual daily activity. Severe events are usually potentially 
life-threatening or incapacitating.  Of note, the term “severe” does not necessarily equate to 
“serious” 
• 
Serious Adverse Event:  fatal or life-threatening, requires or prolongs hospitalization, produces a 
persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or based 
on appropriate medical judgment, may jeopardize the subject’s health and may require medical or 
surgical intervention  
 
9.2.2 RELATIONSHIP TO STUDY INTERVENTION 
 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment. 
The degree of certainty about causality will be graded using the categories below. 
  
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
9.2.3 
EXPECTEDNESS  

Title: MAINTAIN-PC  
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23 
 
Although the investigators do not anticipate any adverse events related to this study, all participants will 
be given contact information for the study’s lifestyle coaches at the orientation sessions, and instructed 
to contact them right away regarding any problems that they experience. This recommendation will be 
reiterated at each outcome assessment visit.  
 
9.2.4 ADVERSE EVENT REPORTING  
Any unexpected adverse events associated with the research that are fatal or life threatening will be 
reported to the IRB within 24 hours. Any unexpected adverse event associated with the study that are 
moderate to severe in nature, but not life threatening, will be reported to the IRB in 10 days.  
 
10 STATISTICAL CONSIDERATIONS  
 
10.1 SAMPLE SIZE DETERMINATION 
 
Participants 
• 
Sample size calculation is based on the primary outcome: change in weight (kg) at 36 months/3 
years or final visit. For aim 1 we hypothesize that the mean weight loss for the coaching group 
will be greater than that for the tracking group. Using group samples size of 136 (each group 
with 68), we can achieve 80% power to detect a difference of 2.3 kg assuming estimated three 
year change score standard deviation (SD) of 5.4 kg for each group (estimated from the weight 
change data from the DPP-OS where SD is estimated as IQR/1.35) and with a significance level 
(alpha) of 0.05.122 A minimum of 98 participants in each group will allow us to detect planned 
difference while accounting for a dropout rate of 30% (for outcome assessment). Since change 
in weight will also be measured at 6 mos, 1, 2 and 3 years/Final Visit we can also achieve 80% 
power to detect an overall difference (across all time points) of 1.7 kg under the same 
assumptions. If we are falling short of our recruitment goals, our strategy would be to expand 
the number of clinics from which we are recruiting, rather than lower the minimum weight loss 
requirement required for study entry. Because our pilot data indicate that most interested 
participants are about 50 years old and female, with fairly low immediate cardiovascular risk, we 
anticipate that any benefit in terms of cardiovascular events will be quite delayed. However, we 
will be able to detect a change in physical activity, physical functioning and HRQOL over the 
time-frame of this study. Significant change in blood pressure has been achieved by chronic care 
management models using a similar sample size.123  
 
PCPs 
For the pre-study sample, feedback from approximately 12 PCPs recruited from previously 
identified sites should be suitable to determine the optimal integration into the clinical 
workflow. 
 
10.1.1 GENERAL APPROACH 
Descriptive statistics will be reported for participants in both groups. Statistical significance of group 
differences in distributions will be tested using two sample t-test for continuous variables with a normal 
distribution, Wilcoxon test for continuous variables that did not follow a normal distribution, and χ2 test 
or Fisher’s exact tests for categorical variables, as appropriate. 

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24 
A linear mixed model will be estimated with treatment group and time represented as 4 dummy coded 
variables (baseline as the reference time point) as well as their interactions (where significant) as 
primary predictors. The models will adjust for sex, hypertension, maximum percent weight loss, and 
clinic type (main General Internal Medicine clinic [practice of authors MBC, GSF] vs. other). We will 
include clinic type as we thought most patients would be recruited from our large academic practice and 
they might differ from patients recruited elsewhere. We omitted an initial plan to use a last observation 
carried forward analysis, as this approach has fallen out of favor for studies.(20-23) The mixed model 
allows us to include participants with missing data (i.e., lost to follow-up at one or more time points) in 
analyses.(9) A repeated factor of time and a compound symmetry covariance structure will be used for 
mixed model analysis. We considered a multiple imputation approach for missing data, but statistical 
literature does not support its use in context of longitudinal data analysis technique with mixed models 
(23). We will use 2-sided testing and a significance threshold of 0.05. All our analyses will be performed 
in SAS 9.3 (SAS Institute, Cary NC) using proc mixed and proc glimmix procedures.  
Missing Data 
We will perform a multiple imputation analysis on the wide data set and then we will combine our 
estimates and compared those with the estimates from our model where multiple imputation will be 
performed with the MNAR option in proc MI. If our data has an arbitrary missing pattern, we will use 
proc MI for this approach (with the fcs option). 
(ref.https://www.sas.com/content/dam/SAS/support/en/sas-global-forum-proceedings/2018/1738-
2018.pdf) 
11 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
11.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
 
11.1.1 INFORMED CONSENT PROCESS 
 
 
IRB approved consent forms describing in detail the study intervention, study procedures, and risks are 
given to the participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  
 
 
11.1.1.1 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the participant will be asked to read and review the document. The 
investigator or study staff will explain the research study to the participant and answer any questions 
that may arise. A verbal explanation will be provided in terms suited to the participant’s comprehension 
of the purposes, procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the informed 
consent document prior to any procedures being done specifically for the study. Participants must be 

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MAINTAIN-PC 
 
25 
informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records. 
The informed consent process will be conducted and documented in the source document (including the 
date), and the form signed, before the participant undergoes any study-specific procedures. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
All research personnel obtaining consent will have completed the appropriate research compliance 
education (IRB modules) and will be trained by the project coordinator on the appropriate consenting 
procedures, as set forth by the University of Pittsburgh IRB. An investigator will be available by phone if 
the participants have additional questions or concerns that they would like to discuss before they 
provide their informed consent, as specified in the informed consent documents.  
 
11.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, funding agency, and 
regulatory authorities.  If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and funding agency 
and will provide the reason(s) for the termination or suspension.  Study participants will be contacted, 
as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants   
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency and IRB. 
 
11.1.3 CONFIDENTIALITY AND PRIVACY  
 
• 
After consent is obtained, participants will be assigned a study ID number. All subsequent 
information will be identified only by this ID number. 
• 
Strict confidentiality of information collected will be maintained.  
• 
All research staff will complete required research information and training modules. 
• 
HealthTrak is accessed by participants via a password-protected website which is hosted on a 
secure UPMC server.  
o Each authorized participant logs in with an assigned user name and secure password 
and then can access online lessons and input and information about his or her weight, 
daily intake of calories or fat, and physical activity.  
o An individual is only able to access his or her own information about lifestyle 
modification.  

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26 
o Secure passwords will include at least seven characters, including at least three of the 
following: lowercase letters, uppercase letters, numbers, and symbols. 
o The participant will be able to send messages to his or her lifestyle coach via the 
HealthTrak messaging system.  
o The program generates reminder emails, which are sent to the email account that each 
participant designates. However, no web-page within the HealthTrak program displays a 
list of these email addresses.  
o All participant information from the HealthTrak website, including participant research 
codes and email addresses, is encrypted using triple-DES encryption.  
o The encryption key is stored within the application in a compiled format and not in a 
database or flat file. Only an authenticated supervisor-level user can create new users 
on the system, and no deletions or updates are supported through any user interface.  
• 
All paper-based data will be kept in a secure, locked location, accessible only to research staff.  
• 
Electronic data will be kept in a password-protected database that is only accessible to research 
staff. Data confidentiality will be closely supervised. 
 
Future use of data  
• 
Data collected for this study will be analyzed and stored at the Division of General Internal 
Medicine Data Center. Data analyses will be conducted on de-identified data.  
• 
Research records including identifiable data will be securely stored according to the current IRB 
guidelines. Data will be anonymized, and the link destroyed (shredded) after this time. 
 
11.1.4 DATA SAFETY AND MONITORING PLAN 
An Internal Advisory Board will be convened to review the inclusion/exclusion criteria, the design of the 
intervention for safety, and plans for monitoring participants for adverse events. They will also review 
protocols for protection of privacy and confidentiality of data. The investigators anticipate that the 
Board will meet prior to implementation of recruitment and every year thereafter. Meetings will be 
closed to non-members of the group, to ensure participant confidentiality. The Internal Advisory Board 
will include a representative from a clinical practice, to ensure that the participants’ health interests are 
being adequately represented, a member of the Division of General Internal Medicine Data Center, to 
ensure integrity of data handling practices, and a clinical obesity researcher not affiliated with this study. 
At least one member will be a physician; study investigators will be excluded from membership. The 
roles of the DSMC will include review of the research protocol and plans for data and safety monitoring; 
and evaluation of the intervention (e.g., periodic assessments of data quality and timeliness, participant 
recruitment and retention, issues of risk versus benefit.). The monitoring will also consider how changes 
in the fields of behavioral medicine or preventive health may have influenced the safety of the 
participants. The DSMC will be charged with making recommendations to the IRB and investigators 
concerning study continuation or modification.  
 
11.1.4.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 

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27 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  
Routine Center for Research on Health Care Data Center procedures will be used to ensure that privacy 
is protected around the collection and storage of outcomes data. Physical measurement data will be 
manually entered into the study data base. All manual data entry will be key-entered, using a double 
entry system to ensure data integrity. The study forms will be paperless in that the data will be directly 
entered over the Internet at the time of data collection via a Secure Socket Layer (SSL) web server with 
128 bit encryption. A relational database management system will be stored on a dedicated web server 
where only select research team members will have access to the database through a secure login. Data 
will be protected by a network firewall, preventing unauthorized access. The database will include 
routine data edit checks for consistency both within and between forms. Once edited, temporary files 
will be merged to generate files for data analysis. All files will be backed-up daily and archived weekly. 
Database development and maintenance will occur with SQL Server and .Net programming available 
through the CRHC network.  
All study participants will be assigned unique study identifiers that will appear on all data collection 
instruments, tapes, documents, and files used in the statistical analysis and manuscript preparation. In 
order to be HIPAA compliant, no personal information concerning study participants will retained in the 
analysis database. A list linking ID numbers and patient names will be maintained in a locked file in the 
PI’s office. 
The intervention software we will use includes extensive measures to ensure the privacy of participants’ 
information-related information. The UPMC online visit program and HealthTrak portal have been 
developed to be HIPAA compliant, according to standard University of Pittsburgh Medical Center 
protocols. It is accessed by participants via a password-protected website. Each authorized participant 
logs in with an assigned user name and password and then track weight, daily intake of calories or fat, 
and physical activity or complete an online visit. The participant can also send messages to his or 
lifestyle coach via the HealthTrak messaging system. An individual is only able to access his or her own 
information about lifestyle modification. The program generates reminder emails, which are sent to the 
email account that each participant designates.  However, no web-page within HealthTrak displays a list 
of these email addresses. This pilot utilizes lifestyle coaches, who will have coach-level access to 
HealthTrak.  An authorized coach-level user can access only the names, self-reported lifestyle 
modification information, online questionnaires and messaging for the participants.  
 
11.1.4.2 STUDY RECORDS RETENTION  
 
Study documents should be retained for a period of five years from the date of NIH Federal Financial 
Report (FFR) submission.   
 
11.1.5 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Hgrouponisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 

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Protocol: OV_PRO13020257 
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28 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within <specify number> working days of identification of the protocol deviation, or within 
<specify number> working days of the scheduled protocol-required activity.  All deviations must be 
addressed in study source documents, reported to <specify NIH Institute or Center (IC)> Program Official 
and <specify Data Coordinating Center or sponsor>.  Protocol deviations must be sent to the reviewing 
Institutional Review Board (IRB) per their policies. The site investigator is responsible for knowing and 
adhering to the reviewing IRB requirements. Further details about the handling of protocol deviations 
will be included in the MOP.]  
 
 
11.1.6 PUBLICATION AND DATA SHARING POLICY 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested by researchers after the completion of the 
primary endpoint publication by contacting Dr. Conroy. 
 

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29 
11.2 ABBREVIATIONS 
 
AE 
Adverse Event 
GMP 
Good Manufacturing Practices 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Hgrouponisation  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
MAINTAIN-
pc 
Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary 
Care  
NIH  
National Institutes of Health 
PCP 
Primary Care Physician 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
 
 
 

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11.3 SUMMARY OF IRB APPROVED CHANGES 
 
Affected 
Section(s) 
IRB 
Modification 
Number 
Date 
Summary of Revisions Made 
to Protocol 
Rationale 
N/A 
MOD13020257-
01 
5/16/2013 
Change in protocol: Added 
invitation for all primary care 
physicians at participating 
sites to complete a very brief 
anonymous survey regarding 
their opinion on the template 
for the real-time progress 
reports  
Get a broad range of 
opinions in order to 
ensure the best 
possible incorporation 
of the reports into 
routine clinical 
practice 
N/A 
MOD13020257-
02 
6/5/2013 
Submit documents for IRB 
review: 
1. New advertisement 
2. Updated exempt script for 
anonymous PCP report 
template surveys 
3. PCP template report 
example 
Compliance to IRB 
guidelines and 
regulations 
1.3 
MOD13020257-
03 
2/12/2013 
Change in protocol: 
clarification study procedures 
prior to the initial recruitment 
of subjects 
Clarification 
11.1.4 
 
 
 
 
5.2 
MOD13020257-
04 
9/17/2013 
Change in protocol: Edits to 
the data and safety 
monitoring plan  
 
Addition of exclusion criteria: 
Bariatric surgery in the last 
two years or planned during 
the next three years 
 
Clarification 
 
 
 
 In an attempt to 
include bariatric 
patients, we needed 
to add limitations to 
who could safely 
benefit from the 
MAINTAIN-pc 
intervention 
5.1 
MOD13020257-
05 
10/16/2013 
Change in protocol: 
Deletion of  inclusion criteria: 
no bariatric procedures in past 
5 years 
Inclusion criteria 
would eliminate a 
larger portion of 
participants in need of 
weight maintenance 
strategies 
7.1.6 
MOD13020257-
06 
11/23/2013 
Change in protocol: 
Clarification of electronic 
pedometer collection 
procedures 
There was some initial 
confusion with the 
interpretation of the 
protocol regarding the 
distribution of these 
pedometers. (two 
pedometers given to 
each participant – one 

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31 
for them to keep for 
use throughout their 
study participation 
and one to wear for 14 
days for collecting an 
objective research 
measure of average 
steps at baseline and 
each follow-up time 
point).  
6.1.1 
MOD13020257-
07 
12/21/2013 
Change in protocol: 
 Addition of in-person 
individual time frame options 
for orientation sections during 
daylight hours 
Provide more 
opportunity  for 
participants to attend 
the orientation session 
In-person group 
sessions required that 
all participants attend 
during evening hours 
from 6:00 PM – 8:00 
PM. Allowing 
participants to choose 
the orientation time 
that was most 
convenient for them 
increased session 
attendance and 
continuation in the 
study.  
5.5.1 
MOD13020257-
08 
2/11/2014 
Change in protocol: Addition 
of recruitment method 
Increase reach for 
recruitment 
 
MOD13020257-
09 
3/6/2014 
Change in protocol :Update 
on recruitment methods and 
materials 
Increase reach for 
recruitment 
1.3 
MOD13020257-
10 
5/10/2014 
Change in protocol: follow up 
activity to include participants’ 
feedback at each follow up 
visit 
Capture feedback 
changes about the 
program at 6M, 12M, 
24M and 30M 
6 
7.1.6 
MOD13020257-
11 
1/17/2015 
Change in protocol: addition 
of  anonymous PCP feedback 
on newly created patient 
progress report template form  
Obtain unbiased input 
from PCPs on data 
points to included in 
the patient progress 
reports to be received 
during their patient’s 
study participation 
1.3, 6, 
7.1.6 
MOD13020257-
11 
1/17/2015 
Change in protocol: Change in 
the procedures and time 
frame for PCP feedback data 
collection 
Streamlined content of 
patient progress 
reports (based on PCP 
comments) and 
clarified time points 
when PCPs receive 
them.  

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7.1.6 
MOD13020257-
12 
2/27/2015 
Change in protocol: Replaced 
the term 'anonymous' with 
'confidential' in the PCP 
General Agreement Script for 
the PCP feedback survey  
Since the IP address is 
collected through 
Qualtrics, the survey is 
not considered 
anonymous.  
N/A 
MOD13020257-
13 
4/21/2015 
Submit advertisement: 
Uploaded email text for 
approval prior to sending 
Qualtrics survey link to PCPs 
Compliance to IRB 
guidelines and 
regulations 
1.1, 1.2, 
1.3, 3 
MOD13020257-
14 
9/11/2015 
Change in protocol: 
Modification of intervention 
endpoint to 24-months.  
Shorten the 
intervention from 36 
months to 24 months 
due to significant 
delays in EHR build 
and recruitment. If not 
modified, study would 
surpass grant-funding 
period. 
7.1.6 
MOD13020257-
14 
9/11/2015 
Change in protocol: Change in   
weekly online communication 
procedures 
In addition to sending 
participants’ weekly 
reminder messages to 
their online health 
portal mail, we 
included an option to 
also send the 
messages to an 
alternative e-mail 
address where they 
will read them on a 
more routine basis. 
1.3 
MOD13020257-
14 
9/11/2015 
Change in protocol: Addition 
of an exploratory 30 month 
weight outcome to assess 
duration of effect after the 
intervention concluded 
Secondary to changes 
for end point of trial 
 
MOD13020257-
16 
2/10/2016 
Change in study team: 
Addition of a Co-
Investigator 
 
1.3.1 
MOD13020257-
18 
10/7/2016 
Change in study team: Co-I 
Rachel Hess, MD, MSc will be 
replaced by Co-I Dr. Gary 
Fischer, Associate Medical 
Director of the Ambulatory 
eRecord.  
 
Dr. Hess accepted new 
position at University 
of Utah   
1.31 
MOD13020257-
19 
5/23/2017 
Change in study team:  PI, Dr. 
Margaret Conroy will be 
replaced by Co-I, Kathleen 
McTigue from after Dr. 
Conroy's departure until the 
end of the trial. 
PI, Dr. Margaret 
Conroy, accepted a 
new position as the 
Chief of General 
Internal Medicine at 
the University of Utah. 
The grant to remain at 
the University of 

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33 
Pittsburgh and the 
study will continue to 
be conducted under 
the general direction 
of Dr. Conroy. Current 
Co-I's, Kathleen 
McTigue, agreed to 
serve as the PI after 
Dr. Conroy's departure 
until the end of the 
trial. 
 
Dr. Conroy will 
continue to be actively 
involved in the project 
and will remain in 
touch with the study 
staff and investigators 
during bi-weekly and 
monthly conference 
calls, and as needed 
via email and phone 
contacts. 
 
 
 
 
 
 

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34 
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Title: MAINTAIN-PC  
Protocol: OV_PRO13020257 
(Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care)                   
 
 
  
MAINTAIN-PC 
 
36 
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