Coordinating Pragmatic Primary Care Population Management for Obesity
Phase: NA
Conditions: Obesity, Cardiovascular Risk Factor
Sponsor: Northwestern University

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Title: Coordinating Pragmatic Primary Care Population Management for Obesity 
Clinical Trials Record Number: NCT03998046 
Date: 7/1/2020 
 

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PROTOCOL TITLE:  Coordinating Pragmatic Primary care Population management for Obesity (C3PO) Study  
 
 
PRINCIPAL INVESTIGATOR: 
Ronald T Ackermann 
General Internal Medicine 
Center for Community Health 
312.503.6417 
r.ackermann@northwestern.edu 
 
 
VERSION NUMBER: 6.0 
 
 
VERSION DATE: July 1, 2020 
 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
N/A 
IND / IDE / HDE #  N/A 
Indicate 
Special Population(s) 
 Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 205 
Funding Source National Institutes of Health 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site ( For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
 
 

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OBJECTIVES: 
The purpose of this study is to develop and pretest the feasibility and preliminary effectiveness of a pragmatic 
approach for population-level obesity management that has a high potential for replication and sustainability in 
busy primary care settings. This initial study protocol describes the approaches and procedures that will be 
used to develop and pretest usability of intervention components. 
 
BACKGROUND: 
Collectively, heart diseases, stroke, diabetes, and hypertension account for one-third of all deaths in the U.S. 
and cost more than $300 billion annually.27,28 Overweight and obesity are reversible health states that are 
linked with cardiovascular risks and more than 20 other chronic conditions.14,29 Half of Americans have at least 
one major cardiovascular risk factor, more than one in three is obese, and an additional third is overweight.30 
Among obese adults, the prevalence of diabetes, hypertension, and dyslipidemia is 14%, 30%, and 34%, 
respectively, whereas those same conditions affect only 3%, 12%, and 7% of adults with normal body mass.31 
Not surprisingly, recommendations for healthy behavioral changes and weight loss are considered a 
cornerstone of both public health and health system efforts to address both overweight/obesity and 
cardiovascular risk. 
 
POPULATION HEALTH MANAGEMENT – AN ORGANIZING FRAMEWORK FOR PRIMARY CARE: Population health 
management (PHM) is an approach used increasingly by health systems for the strategic deployment of 
healthcare resources and interventions to systematically address the preventive and chronic care needs of 
every patient, with the goal of promoting health and reducing the future need for more costly healthcare 
services.23,24 PHM involves the coordination of systems, personnel, health IT, policies, and partnerships to 
enable proactive patient engagement and an expanded focus on health behavior and lifestyle changes.24,25 
Most prior PHM research has focused on preventing excessive healthcare encounters by “super-utilizers,” as 
well as the role of patient-centered medical homes to prevent complications and co-morbidities for persons 
with complex chronic conditions.26 Because of the common and chronic nature of overweight and obesity, the 
PHM approach provides a natural scaffold for coordinating the primary care management of a full population of 
overweight and obese patients. The proposed study will address prevailing gaps between evidence and 
practice by engaging patients and other stakeholders in specific steps needed to design and pre-test a 
pragmatic and generalizable framework for population management of obesity that leverages existing primary 
care professionals and technologies to support: 1) proactive patient outreach and assessment; 2) weight loss 
goal setting & action planning; 3) targeted linkages to evidence-driven intensive lifestyle resources in both 
clinical and community settings; and 4) the integration of self-weighing data to refine both the form and 
intensity of follow up support services overseen primarily by a nurse coordinator via existing patient portal, 
telephone, and occasionally face-to-face channels.  
 
STUDY ENDPOINTS: 
The primary endpoint for this initial study is to develop a prototype intervention approach for offering evidence-
based obesity management services that uses a population health management framework and leverages 
widely available electronic health record system (EHRS) technologies, existing members of the primary care 
workforce, and linkages to extant community-based intensive lifestyle intervention resources. This initial study 
will involve two phases (Figure 1): Intervention Development and Intervention Evaluation. Intervention 
Development will use 2 research activities: interviews of healthcare professionals (n=15); patient usability 
testing (n=10). Intervention Evaluation also involves 2 research activities:  a randomized pilot trial of the weight 
loss intervention (n=80); post-intervention interviews with patients targeted for and exposed to different patient 
engagement and health promotion interventions (n=20). 
 
 
STUDY ACTIVITIES: 
Phase 1: Intervention Development 
Patient goal setting, brief behavioral counseling, and linkages to intensive lifestyle programs are already part of 
the practice guidelines for overweight or obese primary care patients with cardiovascular risk factors, our 
research has been designed to help the Northwestern Medical Group to deploy different available intervention 

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components in ways that prove most engaging to patients and most effective in achieving healthy weight 
management. The intervention personnel and technologies already exist and are being used to support patient 
care in many areas. However, we will use several forms of research that pose no more than minimal risk to 
patients in order to optimize the use of these interventions in busy practice settings.  
 
The goal of the Intervention Development Phase is to use multi-stakeholder input to assist primary care 
providers within Northwestern Medical Group Primary Care to design and offer a coordinated lifestyle 
intervention “package” that is engaging to patients and optimally effective in promoting healthy weight 
management across the entire patient population. Primary care leadership and IT support experts will 
ultimately make the final decisions about how available intervention components will be used. Our team of 
communications experts, behavioral scientists, and implementation researchers will use theory and strong 
research designs to help inform the intervention choices. 
 
Research activities used during the Intervention Development phase include semi-structured interviews with 15 
health professionals and usability tests of technology components with 10 eligible patients. The 15 semi-
structured interviews with relevant health care providers will assess intervention needs, priorities, and 
preferences of clinicians. Using this input, the team will combine new forms of support offered by existing 
health professionals (primarily a care coordination nurse) with technology components used for outreach to 
patients; supporting patient goal setting; and providing longitudinal support for healthy lifestyle behaviors and 
weight management that will be guided by use of a cellular-enabled electronic body weight scale that each 
patient may use in their home to connect information about their progress and weight loss success to the NMG 
electronic health record. Prior to studying these interventions using a pilot intervention trial in phase 2 of the 
research, we will conduct limited usability tests of new patient-facing intervention IT components with 10 
primary care patients. This phase will likely inform small intervention refinements prior to advancing to the pilot 
intervention trial. 
 
Phase 2: Intervention Evaluation 
The novel combination of existing lifestyle intervention components resulting from phase 1 of the research will 
subsequently be evaluated using a pragmatic randomized intervention design. The goal of this research is to 
evaluate the new cluster of interventions, which we call Coordinating Pragmatic Primary care Population 
management for Obesity (C3PO), among a sample of patients who are representative of all patients who might 
be offered the intervention in routine practice. Thus, instead of recruiting highly selected research volunteers 
for the pilot trial, we will use a pragmatic randomization design that will use a “behind the scenes” 
randomization approach to assign 80 eligible patients to receive Basic Resources and Services for healthy 
lifestyle support (n=40) or the C3PO pilot intervention (n=40). We will not collect data for research purposes 
only in this trial. Rather, we will use routinely collected clinical data (i.e. available from the electronic health 
record) for each patient. Following completion of the 4-month pilot trial phase, we will then recruit and consent 
20 patients who were eligible for the intervention to complete semi-structured interviews to assess patient 
experiences, perceptions, and barriers faced during the intervention period. This final step will help to inform 
any additional relevant intervention refinements prior to conducting a larger and more definitive future trial of 
the intervention’s effectiveness. 
Figure 1. Development & Pre-Testing of a Novel Intervention for Coordinating Pragmatic Primary care 
Population management for Obesity (C3PO) 

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THE INTERVENTION DEVELOPMENT PHASE HAS 4 GENERAL OBJECTIVES: 
1) ASSESS HEALTHCARE PROVIDER PERCEPTIONS REGARDING C3PO INTERVENTION NEEDS, PRIORITIES, AND 
PREFERENCES 
2) ASSESS EXISTING RESOURCES & WORKFLOWS 
3) INTEGRATE EXISTING WORKFORCE, WORKFLOW, AND IT COMPONENTS NEEDED FOR POPULATION HEALTH 
MANAGEMENT TO BE EFFICIENT AND EFFECTIVE 
4) PRETEST IT COMPONENTS USING LIMITED PATIENT USABILITY TESTING 
 
INTERVENTION DEVELOPMENT OBJECTIVES 1 & 2: ASSESS C3PO INTERVENTION NEEDS, PRIORITIES, AND 
PREFERENCES; ASSESS EXISTING RESOURCES & WORKFLOWS: The C3PO intervention requires both provider- 
and patient-facing communication and behavioral support tools. The needs, priorities, and preferences of 
providers for supporting health behaviors, weight loss, and cardiovascular risk factor management of their own 
overweight and obese patients is not well understood. We will conduct semi-structured healthcare provider 
interviews with 15 members of the primary care team to elicit these needs and preferences, as well as any 
recommendations for how best to use existing practice resources and IT to fulfill those needs.  
 
There is an extensive published literature regarding the essential patient-facing components of interventions 
that are most successful supporting the adoption of physical activity, healthier eating, and weight loss goals 

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among adult patients. These components have been abstracted from the published literature and will be 
incorporated into the existing NMG practice IT resources and workflows in ways that are pragmatic and 
sustainable. These evidence based intervention components, and the proposed process for incorporating them 
into C3PO is explained below under Intervention Development Objective 3. 
 
INTERVENTION DEVELOPMENT OBJECTIVE 3: INTEGRATE EXISTING PRACTICE ACTIVITIES WITH NEW IT 
COMPONENTS NEEDED FOR POPULATION HEALTH MANAGEMENT TO BE EFFICIENT AND EFFECTIVE: Integration of 
new intervention components into existing IT resources and workflows will be needed in both provider- and 
patient-facing directions. Because the population management of obesity and of cardiovascular risk have 
become priorities of NMG practice leadership, intervention development is not considered a research-only 
activity, but rather, it is a practice driven priority that will be supported by our research. Thus, all technology 
development and programming will be led by the Northwestern Medicine Epic IT team, with collaborative input 
from the local NMG practice leadership and our academic research team.  
 
Provider-facing IT Development: Informed by semi-structured interviews with members of the primary 
healthcare team, the deployment of C3PO will leverage existing clinical IT and workflows within EpicCare’s 
provider-facing Ambulatory EHRS application. Drawing upon existing population health management tools 
currently used by NMG providers to support the care of other population groups, such as patients with 
congestive heart failure, we anticipate that providers will express some need for an overweight/obesity 
population management dashboard, tools for individual- or batch-outreach communications with patients within 
this population; and some means to efficiently track and filter the entire overweight patient population based on 
whether or not patients have achieved specific goals or outcomes relating to weight management or 
cardiovascular risk. The classification of a group of patients with a particular condition or health risk such as 
overweight/obesity into a dedicated list that can be used for clinical communications and care coordination is 
commonly called a patient registry. As NM Epic IT builds such a clinical patient registry for NMG providers, we 
will work with the Epic IT team to ensure that the needs, priorities, and preferences expressed during semi-
structured interviews with providers (below) are considered in the design of these provider-facing intervention 
development components.  
 
Patient-facing IT Development: Building on extensive prior research, the C3PO intervention will apply 
evidence-based principles for providing the essential components of effective behavioral weight management 
interventions, including: 1) Individualized goal setting; 2) Self-monitoring of body weight; 3) Supportive 
accountability for achieving self-management goals and objectives; 4) Linkages to community or clinical 
intensive lifestyle support programs; and 5) Targeted, person-centered follow-up support. Technology 
platforms tethered to the EHRS will help coordinate communication and the delivery of different forms of 
support between clinical encounters. Existing members of the primary care team will provide support at a 
minimum level necessary. The intensity of human support will be guided by each patient’s decisions about goal 
setting, their self-weighing behavior, and weekly progress toward their individual weight goal. Supportive 
communication, the negotiation of individual goals, and targeted problem solving will be facilitated by existing 
bidirectional messaging and patient survey functions within the EpicCare MyChart patient portal. An existing 
primary care nurse coordinator will function as a population health management (PHM) nurse, who will 
manage the outreach messaging with all patients included in the clinical patient registry. C3PO will utilize 
secure patient-facing EHRS technologies to deliver recommendations of the patient’s own primary care 
provider via the practice team’s PHM nurse. For patients who request additional information or assistance in 
goal setting or decision making, the PHM nurse will offer a telephone or face-to-face encounter as an 
alternative. The planned approaches for supporting goal setting, self-monitoring, and intensive intervention 
linkages are described further below. 
 
1) Individualized Goal Setting: Even in the presence of strong external support, adherence to a 
particular behavior is unlikely unless one understands the reasons for the behavior and has explicit 
expectations about the intended goal(s).13 Providing support for goal setting involves helping a patient 
to articulate a clear expectation for which he/she will feel committed and accountable.78 The C3PO 
intervention will stimulate goal setting among eligible patients by using semi-automated outreach 
messages that are delivered via EpicCare’s MyChart patient portal. Outreach messages will adopt 

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components of the 5Rs of tobacco cessation to briefly frame the relevance, risks, and rewards of 
lifestyle changes leading to modest weight loss.79,80 Using MyChart’s branching logic survey function, 
patients will then be guided through the steps of a brief action planning procss,68 which are rooted in 
principles of brief motivational interviewing.66,70  
 
Patients will be asked routinely if there is anything they would like to begin doing now to try to reach a 
lower body weight. Patients who are not ready to begin doing something now will be asked if it is okay 
for the PHM nurse to check back in a few weeks to assess if their interests have changed. Patients who 
do indicate readiness will be guided through simple steps to set a SMART goal (Specific, Measurable, 
Achievable, Relevant, and Timed) for weight loss. Brief probing questions will guide development of this 
goal, and individual patient responses will be stored in the EHRS. The branching logic of each step will 
automate the bulk of this process for most patients, while preserving a patient’s perspective that he/she 
is communicating directly with the PHM nurse, who is working with his/her own PCP. Based on 
individual patient responses at each step, the branching logic will trigger a specific next step of 
validation, motivational messaging, and additional brief questioning, which are guided by the patient’s 
level of readiness and perceived self-efficacy. For example, individuals who indicate needing 
suggestions for a goal will be presented with two to three ideas that “other patients have told us are 
very helpful.” If this helps the individual choose a goal area, the questionnaire will then confirm a 
commitment statement, for example: “Just to make sure we understand your plan correctly, you want to 
X. Is that correct?” After confirming the commitment, the patient will be asked about their confidence 
with reaching the goal. Those expressing high confidence will be given encouragement and asked 
about their preference for when we should check in with them again. Patients with only modest or low 
confidence will be asked if they have ideas about what might raise their confidence. Patients with low 
confidence will receive reassurance and an offer for a telephone call from the PHM nurse to discuss 
steps to help build their confidence.  
 
2) Self-monitoring of Body Weight: Prior research suggests that process accountability (e.g. 
accountability over self-weighing) increases completion of a target behavior even more than outcome 
accountability alone (e.g. accountability over achieving a weight loss goal).13 Self-weighing is a form of 
behavioral self-monitoring that past research has found to be strongly predictive of weight loss 
success.12 C3PO will provide each patient with a BodyTrace electronic scale (eScale), which transmits 
weight data wirelessly to a secure, private repository using digital mobile telecommunications 
technology (i.e. the same cellular networks as a smartphone). The manufacturer reports accuracy 
within +/-0.1 kg to a weight limit of about 150 kg (330 lbs.).81 This approach, used in prior research by 
our group,82 also enables the seamless integration of self-weighing information back into the EpicCare 
EHRS (i.e. back to the registry as well as to the PHM nurse). This integration will allow dynamic 
individualized feedback from the nurse back to each patient in a way that further strengthens supportive 
accountability and progress toward weight goals. More details are provided below. 
 
3) Supportive Accountability for Achieving Self-management Goals and Objectives: Nurse-patient 
interactions, largely facilitated by the patient portal, will be designed to strengthen each patient’s 
commitment toward their goal, as well as a greater sense of “supportive accountability.” 
Accountability toward a behavior exists when an individual has an expectation that he/she may be 
called upon to justify his/her actions or inactions to another person.13 Accountability requires real or 
perceived social interactions with another human (i.e. a coach) who the patient views as trustworthy 
and possessing suitable expertise. This relationship may be established in person, by telephone, or via 
an electronic channel. C3PO will utilize secure patient-facing EHRS technologies to deliver 
recommendations of the patient’s own primary care provider via the practice team’s PHM nurse. For 
patients who request additional information or assistance in goal setting or decision making, the PHM 
nurse will offer a telephone or face-to-face encounter as an alternative. The planned approaches for 
supporting goal setting, self-monitoring, and intensive intervention linkages are described further below. 
 
4) Linkages to Evidence-based Lifestyle Interventions: Once patients have set a goal and begun using 
their eScale, the PHM intervention will utilize MyChart messaging to offer a selection of links to 

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available lifestyle programs and services, with brief summary information about benefits and attributes 
to help in making choices among them, or to facilitate a request for additional information or assistance 
from the PHM nurse. Based on the key characteristics of evidence-based intensive lifestyle 
programs,12,14 we have identified an array of extant lifestyle interventions to include in a menu of initial 
program choices for each patient. 
 
5) Targeted, Person-centered Follow-up Support: The PHM framework attempts to provide basic 
support to all patients and uses “lighter touches” with patients who are engaged and having success; 
more intensive support is reserved for patients who are less successful. C3PO will use the frequency 
and results of self-weighing to stratify patients to different forms of support. Immediately after a patient 
sets a weight goal, the PHM nurse will ship him/her an eScale and welcome package, including 
additional support materials and instructions for initializing the scale and registering a first body weight. 
If there is no weight received from the eScale within 1 week, the patient will receive a short message 
offering assistance or to talk to the nurse for help troubleshooting technical issues or revisiting action 
planning steps if engagement has diminished. Patients who do register their first weight will receive a 
MyChart message offering praise and relisting a short menu of linkages where the patient can find 
further information about evidence-based community programs. All messages will also offer an option 
of telephonic support from the PHM nurse. 
 
After the eScale is initialized and weight #1 is received, each patient will be classified weekly by their 
frequency of self-weighing (i.e. weekly vs. less than weekly) and whether they do/don’t meet or exceed 
their target weight for the week. Patients who continue to self-weigh but who are not at their progress 
goal will receive an automated MyChart message praising them for their self-weighing and summarizing 
their weight loss progress. They will be offered additional help and the opportunity to speak directly with 
the PHM nurse to identify barriers and reassess and refine their action plan if desired. Patients who 
request different lifestyle resources will be given information about other linkages, such as a nearby 
fitness facility that offers intensively support programs as well as access to registered dietitians who 
provide medical nutrition therapy with direct payment by most commercial payers in our region.  
 
Patients who are continuing to self-weigh and who are reaching or exceeding the progress target for 
their individual weight loss goal will receive a MyChart message summarizing weight loss progress, 
along with praise and positive feedback to reinforce actions and behaviors that are helping. Links to 
community and clinical resources to provide ongoing support will again be listed. The timing and exact 
content of these messages will be developed and refined during the first 6 months of intervention 
delivery, with input from clinicians, patients, and behavioral and communications experts who comprise 
the research team. 
 
INTERVENTION DEVELOPMENT OBJECTIVE 4: PRETESTS OF PATIENT-FACING IT COMPONENTS:  
RESEARCH ACTIVITIES TO INFORM INTERVENTION REFINEMENT AND PRE-TESTING 
 
Research Activity #1: Conduct 15 semi-structured interviews with relevant health care providers to assess 
intervention needs, priorities, and preferences of clinicians.  
 
Research Activity #2: Conduct limited usability tests of new patient-facing intervention IT components with 10 
primary care patients to inform any necessary refinements needed to enhance the human-IT interaction prior to 
advancing to a future pilot trial evaluation of the integrated intervention. 
 
PROCEDURES INVOLVED: 
Research Activity #1:  Stakeholder interviews with primary care professional staff will be framed as a 
discussion about experiences with primary care services and electronic communication tools to support weight 
mangagment by primary care patients. Interviews will be recorded with a digital voice recorder and transcribed 
verbatim by an experienced transcriptionist. Interviewees will also be asked to complete a basic 
sociodemographic form. The provider interview guide and sociodemographic form are as follows: 

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INTERVIEWER NOTE: TURN RECORDER ON 
 
Background & Objective: 
Why we are doing interviews: 
We are interested in whether new technologies and communication tools that are linked to the Epic EHR can 
help primary care teams support their patients’ goals around healthier eating, physical activity, and weight loss.  
Before studying whether these technologies will work, we want to ensure that they benefit the healthcare team 
and are easy and efficient to use.  They also should fit into existing practice workflows not interfere with other 
functions of different members of the care team.    
The purpose of this interview is to gather insights from healthcare professionals like you to both better 
understand your current work flow, as well as obtain your opinions as to how the addition of new technologies 
could help you manage your patients without generating additional work for the care team.  
 
Current Workflow 
The following questions relate to your roles and the current workflow in the primary care relevant to supporting 
weight loss and management among the patients you serve.  
1. What is your role in supporting healthy eating, exercise, and weight loss by your patients?  
PROBE: What are the roles of other team members? For example, Nurses? Medical Assistants? 
Care Coordination Nurses? Other members of the care team? 
 
2. In your opinion, what have you found to be most motivating for your patients to help them 
achieve…  
Healthy eating? 
Exercise?  
Weight loss? 
 
3. How does the care team communicate with each other, if at all, regarding healthy eating, exercise 
and weight loss relevant to patients in need of these services? 
PROBE: How do care team members communicate verbally, via documentation in Epic, or 
through other channels? 
PROBE: What are existing challenges related to these communication channels?  
PROBE: What suggestions or thoughts do you have based on your experiences that you think 
could overcome the challenges you identified? 
 
4. What is the role of other resources and services available to patients of Northwestern Medicine? 
(Such as referrals to services like, SEE BELOW) 
PROBE: The Northwestern Medicine Health Learning Center? 
PROBE: The Northwestern Medicine Lifestyle Medicine Clinic? 
PROBE: Other resources and services in the community? (i.e. DPP, Weight Watchers) 
 
Overview of the Intervention: 
The goal of this intervention is to use existing Epic platforms and remote intervention technologies to improve 
goal setting, self-weighing, and ongoing support for overweight and obese patients while MINIMIZING any 
additional work for members of the primary care team. We plan to do this by reaching out to eligible patients 

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via an automated MyChart message, sending them a wireless eScale that transmits weight data back into Epic, 
and providing tailored support through automated MyChart messaging with support from a nurse care 
coordinator (like “STAFF NAME”) over a 10-week period.  
We’d like to get your initial impressions on the implications for the practice and recommendations for a 
successful rollout of this intervention.  
5. What, if anything, do you foresee as being potential barriers to implementing this intervention?    
PROBE: What challenges, if any, do you think we might face in implementing this intervention?  
PROBE: For example, a patient may message physicians directly in response to outreach messaging, 
how might we prepare the practice so this is not a problem? 
 
6. How would you recommend we introduce this to the practice to make sure the broader care team 
is aware of this intervention when it goes live?  
 
 
7. Our intervention plans to collect weight loss goals and patient weights every time they step on the 
scale, and goal setting progress. Which of these data would you want to see? 
 
PROBE: What is your preferred method for viewing/receiving these data (i.e., weight graphs, total 
amount of weight lost, most recent weight prior to primary care visit) and how often? 
 
 
Wrap-up: 
8. Is there anything else you think we should know or consider regarding how to support primary 
care teams to assist patients in increasing their physical activity, eating better, or losing weight?  
 
9. Is there anything else I didn’t ask you today that you’d like to comment on? 
 
Thank you for your time. 
 
INTERVIEWER NOTE: TURN RECORDER OFF, COLLECT DEMOGRAPHIC 
INFORMATION, PROVIDE PARTICIPANT COMPENSATION AND COMPLETE *form 
 
 
SOCIO-DEMOGRAPHIC SURVEY 
 
1. Are you… 
 
Male 
Female 
Transgender 
 
 Prefer not to respond 
 
 
2. What is your specific title: _________________________________________________________ 
 
 
3. Year you completed training: ______________________________________________________ 
 
 
4. Year you began current employment at Northwestern:__________________________________ 

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Research Activity #2: Each patient participant (n=10) will take part in a 60 to 90-minute videotaped session 
during which they will go through all steps of the logging in, opening the MyChart message, entering responses 
to the goal setting / action planning survey prompts, and navigating community resource links and other 
associated patient decision support. Mr. Kaiser and Dr. Ackermann will facilitate and observe all usability 
testing, noting preferred navigation paths and the nature of any errors or sources of confusion. Noldus software 
will record user-system interaction (i.e., logging mouse click, keystrokes) and will organize the data and 
analyses. After the first three participants, Dr. Ackermann and Mr. Kaiser will meet with the Epic programmers 
to review key findings and refine the system interfaces to enhance usability. After the second wave, any 
remaining enhancements to optimize workflow integration will be made before launch of the future pilot trial. 
 
THE INTERVENTION EVALUATION PHASE HAS 2 GENERAL OBJECTIVES: 
1) CONDUCT A PILOT INTERVENTION TRIAL ASSESSING FEASIBILITY AND PRELIMINARY EFFECTS SIZES FOR THE 
IMPLEMENTATION STRATEGY/INTERVENTION. 
2) REFINE INTERVENTION IMPLEMENTATION APPROACHES PRIOR TO DESIGNING A FUTURE MORE DEFINITIVE 
EFFECTIVENESS TRIAL 
 
INTERVENTION EVALUATION OBJECTIVE 1: CONDUCTING THE PILOT TRIAL: The pilot trial will include 2 general 
research activities that are designed to assess feasibility and preliminary reach and effectiveness of 
the intervention implementation approaches. Findings of the evaluation will be used to inform 
intervention refinements prior to designing and conducting a future larger scale effectiveness trial. 
 
RESEARCH ACTIVITIES INCLUDED DURING THE PILOT TRIAL: 
 
Research Activity #3: For the pilot intervention trial, each patient participant will be randomized to receive 
either Basic Resources and Services or the C3PO intervention. Patients assigned to Basic Resources and 
Services (BRS) will receive approaches 1-4 described in detail above in Objective 3, “Patient-Facing IT 
Development” which include 1. Individualized goal setting, 2. Self-monitoring of body weight, 3. Supportive 
accountability for achieving self-management goals and objectives and 4. Linkages to evidence-based lifestyle 
interventions. Patients assigned to C3PO will also receive BRS approaches 1-4 described above as well as 
approach 5. Targeted, person-centered follow up support. From among all patients who are deemed eligible 
but who are not recruited, a no-intervention comparison group of 80 additional patients also will be selected for 
additional comparisons. Routinely collected clinical data for participants will be analyzed after trial completion. 
 
Research Activity #4: After the pilot phase, 20 semi-structured interviews will be completed by the study team 
with eligible patients to assess patient experiences, perceptions, and barriers faced during the intervention 
period.  
 
 
SHARING RESULTS WITH PARTICIPANTS 
Study results and individual participant results will not be shared with participants or anyone else. Only the PI 
can give permission for the release of aggregated study data. No confidential information will be released 
without the expressed written consent of the study participants. 
 
 
 

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STUDY TIMELINES 
 
Table 1. Timeline for Steps of Intervention Development 
Milestone 
Q1 
Q2 
Q3 
Q4 
Weekly meetings of core research team 
X 
X 
X 
X 
Kick off presentation at practice monthly business meeting 
X 
 
 
 
Biweekly meetings with practice director and population health nurse 
X 
X 
 
 
Clinical provider interviews (n=15) 
X 
X 
 
 
Focused pretesting of outreach message content with patients 
 
X 
X 
 
Finalize language of outreach messages & action planning algorithms 
 
 
X 
 
Programming of action planning items for collection in the EHRS patient portal 
 
 
X 
 
Usability tests of patient-facing survey navigation and goal setting functions (n=10) 
 
 
X 
X 
Assist NMG Epic IT to integrate health IT into their OW/OB patient registry 
X 
X 
 
 
Complete integration of electronic Scale data feeds into registry 
 
X 
X 
 
Develop patient registry tracking dashboard for PHM nurse view 
 
X 
X 
 
“Dry” runs of all health IT components with dummy patients 
 
 
 
X 
 
INCLUSION AND EXCLUSION CRITERIA FOR EACH RESEARCH ACTIVITY 
Research Activity #1: With approval of the NMG practice director, 15 primary care professionals will be 
recruited as participants, including the PHM nurse, practice administrators, physicians, and other primary care 
team members (e.g. nurses; health educators). Inclusion and exclusion criteria are as follows:   
 
Table 2. Inclusion and Exclusion Criteria for Professionals Completing Interviews 
 
 
Inclusions  
Exclusions 
Staff members employed at Northwestern Medical Group (e.g. MD, NP, PA, 
health educator, care manager, practice administrator) involved in the 
management of cardiovascular risk data collection and obesity management 
NMG staff involved in protocol development 
 
Research Activities #2, #3, and #4:  With approval of the NMG practice director, eligible patients will be 
identified by an NMG clinical data manager performing an electronic health record data query. The query will 
identify patients who meet the eligibility criteria for the clinical weight management services, as detailed in 
Table 3 below. In this development and preliminary evaluation phase, patients targeted for the clinical services 
will have had 1 or more routine (non-urgent) visits to the NMG primary care practice and will have an active 
MyChart account with one or more log-in attempts within 12 months. Body mass index (BMI) will be 
determined using the last available height and weight (must be within 12 months). BMI is calculated as (weight 
in kg) ÷ (height in meters)2. CVD risk conditions will be determined by evidence of one of the following: 1) a 
diagnosis of hypertension, hyperlipidemia, diabetes, or prediabetes (i.e. one or more ambulatory encounter 
with an ICD encounter diagnosis code or active problem specifying either type 2 diabetes, prediabetes, 
hypertension, or abnormal blood cholesterol); 2) an active prescription drug order for an antilipidemic class 
medication, long or intermediate acting insulin analog, or oral antiglycemic medication. Pregnant women will be 
excluded from the study, as participation involves setting a weight loss goal, which may not be medically 
appropriate for all pregnant women. 
 
Patient usability testing of technology components (Research Activity #2) will occur before the pilot trial. The 
clinical database manager will draw names randomly from the patient eligibility list for the clinical service 
(Table 3), and patients will be recruited until 10 patients have completed the usability tests.  
 
The pragmatic trial (Research Activity #3) will be completed following development and usability testing of the 
new intervention technology components. The pragmatic trial will target all patients eligible for the clinical 
service (Table 3). All patients meeting these eligibility criteria who open an outreach MyChart message that 
offers the intervention components and who indicate their interest in receiving weight management support 
from the clinical team will be included in the evaluation until 80 patients have been accrued. From among all 
patients who are deemed eligible but who are not recruited, a no-intervention comparison group of 80 
additional patients also will be selected for additional comparisons.  

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Semi-structured interviews (Research Activity #4) will be conducted at the conclusion of the trial.  To identify 
participants, the database manager will draw names randomly from the pragmatic trial recruitment list 
(regardless of their response to the MyChart message or their use of intervention resources/materials) until 20 
patients have completed the interview.  
 
Table 3. Inclusion and Exclusion Criteria for Patients Completing Usability Tests and Semi-
structured Interviews 
 
 
Inclusions  
Exclusions 
Age 18 or older 
Evidence of hospitalization in past 30 days 
%0,NJPplus  
Most recent blood pressure >180/105 
&9'ULVNFRQGLWLRQK\SHUWHQVLRQG\VOLSLGHPLD
prediabetes, or type 2 diabetes) 
Cancer (non-skin) treatment within the past 2 years 
Registered in EpicCare’s MyChart patient portal, 
with 1 or more log-on episodes in the past 12 months 
Encounter diagnosis for hypoglycemia in past 30 days  
 
Actively receiving care from the bariatric surgery service or a bariatric 
medication order in the past 100 days 
 
A medication order in the past 100 days that is known to cause weight 
change or prevent weight loss (e.g., >21 day supply of oral glucocorticoid, 
atypical antipsychotic, or bariatric medication) 
 
Unable to provide consent 
Unable to understand English sufficiently to complete the informed 
consent process or follow instructions needed to complete usability tests 
 
Individuals who are not yet adults (infants, children, teenagers) 
Pregnant women 
Prisoners 
 
PARTICIPANT POPULATION(S) 
 
A non-intervention group of 80 participants, described above in “Research Activity #3” under the STUDY 
ACTIVITIES section, has been added, increasing the total targeted accrual number to 205.  
 
Targeted 
Accrual 
Numbers 
Category/Group: 
(Adults/Children 
Special/Vulnerable 
Populations) 
Consented: 
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened 
Enrolled: 
Number to Complete the 
Study or Needed to Address 
the Research Question 
Local 
Adults: 205 
Children/Vulnerable: 0 
Adults: 45 
Children/Vulnerable: 0 
Adults: 205 
Children/Vulnerable: 0 
Other Sites 
Study-wide 
Adults: 0 
Children/Vulnerable: 0 
Adults: 0 
Children/Vulnerable: 0 
Adults: 0 
Children/Vulnerable: 0 
Total: 
Adults: 205 
Children/Vulnerable: 0 
Adults: 45 
Children/Vulnerable: 0 
Adults: 205 
Children/Vulnerable: 0 
 
RECRUITMENT METHODS 
Research Activity #1: After securing approval from the NMG practice operations director and quality committee 
to proceed with recruitment, the PI will obtain from the operations director a list of all practice employees who 
are involved in the care of overweight or obese patients. Working off this list, 15 professionals from 
Northwestern Medical Group will be recruited. Recruitment efforts will target a broad mix of professionals, 
including the population health management (PHM) nurse, practice administrators, physicians, and other 
primary care team members (e.g. nurses; health educators). Practice leadership will not be involved in 
recruitment efforts aside from providing the initial list of staff members.  
 
Study team members will visit the NMG primary care clinic and present details of the study to the practice 
leaders and medical staff during a weekly practice business meeting. Interested providers can sign up to be 

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contacted for participation. After this meeting, the providers and staff will also receive an email (example 
below) from the study project manager, describing the research once again, identifying Dr. Ackermann as the 
PI, and inviting their participation. Providers who do not reply to the email will be phoned (script below) as an 
alternative approach to confirm interest and proceed with scheduling. Volunteers will be offered $75 to 
complete the interview. Research staff will assist the volunteers to schedule the interview in a private location 
at or near the clinical practice site and at a time and date that is mutually convenient. A template and phone 
script for provider recruitment materials can be found appended to the protocol.  
 
Research Activity #2: Ten overweight or obese patients with at least one cardiovascular risk factor will be 
recruited for limited usability testing of new patient-facing technologies to support weight loss.  With approval of 
the NMG practice director, eligible patients will be identified by an NMG clinical data manager performing an 
electronic health record data query. The query will identify patients who meet the eligibility criteria in Table 3 
above, who have had 1 or more routine (non-urgent) visits to the NMG primary care practice, and who have an 
active MyChart account with one or more log-in attempts within 12 months. The clinical data manager will 
randomly select and generate a shorter list of 40 eligible patients from the complete eligibility list, attempting to 
target patients who are already scheduled for an upcoming non-urgent healthcare visit with their primary care 
provider. Identifying patients who have upcoming visits will be done because scheduling the usability test in 
conjunction with an upcoming clinical visit may be desirable to some patients to minimize the burden of 
traveling back to the clinic for the research procedure alone. After generating this shorter list, the clinical 
database manager will follow a standard process for patient recruitment approved by the NMG primary care 
practice site by sending a MyChart staff message to each primary care provider (PCP) of those 40 patients. 
PCPs will be notified via Epic email regarding which of their patients are eligible and will be given the option of 
excluding any specific patient(s) from being recruited. PCPs will be given 5 days to respond to Epic message 
to exclude a patient. No response will be considered assent to recruit patient. This is a standard protocol that 
the NMG practice has approved, as it provides sufficient advanced notification to providers, with the ability to 
exclude any patients as needed, while presenting minimal administrative burden to provider’s existing 
workload.  
 
Once eligible patients are identified, an opt-out recruitment letter will be mailed to eligible patients with a 
number to call to remove themselves from further recruitment contacts.  
 
Five days following mailing the letter, study staff will call patients who have not opted-out to explain the nature 
of the project and the procedures for the study. To be included in the study, participants must be willing to 
undergo screening.  
 
Research Activity #3: For the pilot intervention trial, 80 overweight or obese patients with at least one 
cardiovascular risk factor will be recruited. With approval of the NMG practice director, eligible patients will be 
identified by an NMG clinical data manager performing an electronic health record data query. The query will 
identify patients for the clinical weight management services, as detailed in Table 3 above. Based on these 
criteria defining whom to target with the new clinical services, patients included in the evaluation will reflect the 
entire target group, having had 1 or more routine (non-urgent) visits to the NMG primary care practice, and 
who have an active MyChart account with one or more log-in attempts within 12 months. The clinical data 
manager will randomly select and generate a shorter list of 100 eligible patients from the complete eligibility 
list, attempting to target patients who completed a recent clinic encounter (in the preceding 1 to 3 week period). 
After generating this shorter list, the clinical database manager will follow a standard process for patient 
recruitment approved by the NMG primary care practice site by sending a MyChart staff message to each 
primary care provider (PCP) of those 100 patients. PCPs will be notified via Epic email regarding which of their 
patients are eligible and will be given the option of excluding any specific patient(s) from being recruited. PCPs 
will be given 5 days to respond to Epic message to exclude a patient. No response will be considered assent to 
recruit patient. This process will be repeated every 2 weeks until target enrollment goal (n=80) is reached. This 
is a standard protocol that the NMG practice has approved, as it provides sufficient advanced notification to 
providers, with the ability to exclude any patients as needed, while presenting minimal administrative burden to 
provider’s existing workload.  

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Once eligible patients are identified, a recruitment message will be sent via Epic MyChart inviting patients to 
complete a MyChart survey assessing weight loss interest and goal setting as described above in Patient-
facing IT Development. All eligible patients who receive the MyChart message and affirm their weight loss 
interest and goals will be included in the pragmatic evaluation sample and randomized. 
 
For the no-intervention comparison arm, patients will be identified from the list of approximately 1,800 
remaining patients who were deemed eligible but not yet recruited before all 80 pilot intervention patients are 
accrued. From this list, we will select 80 patients with similar age and sex characteristics as trial participants. 
Patients in this no-intervention comparison group will not be contacted, will receive no intervention, and only 
their routinely collected clinical data will be used for the retrospective comparison evaluation (i.e. the same 
existing clinical data elements used to assess outcomes for the trial groups), so they will not receive contact or 
specific recruitment materials. Detailed information about consent and HIPAA waivers is described below in 
“CONSENT PROCESS” section 
 
 
Research Activity #4: For the semi-structured interviews, the database manager will draw names randomly 
from the pragmatic trial recruitment list until 20 patients have completed the interview. After obtaining approval 
from the primary care provider, a research assistant (RA) will send a lead letter by email to patients and then 
contact each patient by phone between 8 and 12 weeks after being sent their initial MyChart message. 
Purposeful sampling will be used to ensure that the sample is representative of between 5 and 10 patients who 
did not complete the goal setting step and 10 to 15 patients who did complete that step. Phone interviews will 
be conducted for both patients who did not complete the goal setting step and patients who did complete the 
goal setting step. The RA will explain the research and assist interested participants to provide informed 
consent prior to completion of a one-time interview.  
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Research Activity #1: Each volunteering health care professional (n=15) will be compensated $75 for their 
participation in a 60 minute interview. Health care professional participants will be paid in the form of a Visa gift 
card.  Research Activity #2: Patient participants (n=10 patients) will be reimbursed $75 for their participation in 
a 60-90 minute usability test. Patient participants will be paid in the form of a Visa gift card. Research Activity 
#4: For phone interviews, each patient participant will be compensated $25 for their participation in a 20 minute 
interview. For in-person interviews, each patient participant will be compensated $75 for their participation in a 
60 minute interview. Patient participants will be paid in the form of a Visa gift card. 
 
WITHDRAWAL OF PARTICIPANTS 
Participants may withdraw from the study at any time. There are no specific criteria for administratively 
removing a patient from the study. However, a patient will be removed if continued participation is determined 
by the PI to constitute a danger to the patient’s health or well-being. The PI and study staff will perform all 
necessary evaluations. If the PI determines the patient must be removed from the study immediately, the 
patient will be removed and all appropriate referrals will be made. The IRB will be informed. 
 
RISKS TO PARTICIPANTS 
Research Activity #1: It is possible that some interview topics relating to how different members of the NMG 
clinical staff support weight management and healthy lifestyle behaviors of their patients could be frustrating for 
an employee to discuss. Any participants who have an adverse reaction to discussing sensitive topics during 
in-person interviews will be comforted, allowed to stop the interview, and referred for further support, if 
requested, by medical providers in primary care or in employee health at NMG. All clinical provider participants 
who complete the consent process will be informed that participation may result in a loss of privacy, since 
persons other than the investigators may view their study data if deemed necessary for oversight purposes. 
However, they will be informed that their NMG employers, supervisors, and practice leadership will only 
receive information about the general conclusions of all interview findings, in aggregate; no individual interview 
audio recordings or the transcription of these activities will be shared beyond the research team, except if 

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required by regulatory oversight bodies. Even though our study will store all data on secure, password 
protected, Northwestern University network drive folders, all audio files will be destroyed once the research is 
completed. 
 
Research Activity #2: It is possible that discussing sensitive topics such as body mass can sometimes be 
distressing to some patients. Usability tests also may cause distress or stigma for some individuals who feel 
uncomfortable being directly observed in their work roles. All participants who complete the consent process 
will be informed that participation may result in a loss of privacy, since persons other than the investigators 
may view their study data if deemed necessary for oversight purposes. However, they will be informed that 
their health care providers and NMG practice leadership will only receive information about the general 
conclusions of the usability testing, in aggregate; no individual interview video recordings or the transcription of 
these activities will be shared with care providers at the clinic who are not part of the research team, except if 
required by regulatory oversight bodies. Even though our study will store all data on secure, password 
protected, Northwestern University network drive folders, all video files will be destroyed once the research is 
completed. 
 
Research Activity #3: It is possible that completing a survey on weight loss, engaging in weight loss goal 
setting, and/or weight loss activities can sometimes be distressing to some patients. All participants will be 
provided with the option of speaking with their primary care provider or another member of their health care 
team about their questions or concerns when completing the MyChart survey and when receiving all additional 
outreach and follow up messaging via My Chart.  
 
Research Activity #4: It is possible that discussing sensitive topics such as body mass can sometimes be 
distressing to some patients. Any participants who have an adverse reaction to discussing sensitive topics 
during in-person interviews will be comforted, allowed to stop the interview, and referred for further support, if 
requested, by medical providers in primary care. All participants who complete the consent process will be 
informed that participation may result in a loss of privacy, since persons other than the investigators may view 
their study data if deemed necessary for oversight purposes. However, they will be informed that their health 
care providers and NMG practice leadership will only receive information about the general conclusions of the 
interviews, in aggregate; no individual interview recordings or transcription will be shared with care providers at 
the clinic who are not part of the research team, except if required by regulatory oversight bodies. Even though 
our study will store all data on secure, password protected, Northwestern University network drive folders, all 
video files will be destroyed once the research is completed. 
 
 
All research staff who participate in patient usability tests and provider and patient interviews will have 
completed human subjects training, including sensitivity regarding the potential for survey procedures or direct 
observation to cause anxiety and other forms of emotional adverse effects. Staff members will be trained by 
the PI to recognize discomfort and to ask periodically “if it is okay to continue.” Patient participants who 
become visibly upset or who express the desire to stop will be asked whether the tests are causing them to 
feel uncomfortable. Any participant who expresses upset or anxiety will be asked if they prefer to stop the test. 
Participants who stop prematurely will still be compensated and thanked for their time. Those who terminate 
the test early or who state at the conclusion that the tests were upsetting will be asked if they wish to speak to 
Dr. Ackermann or to another healthcare provider from the clinic. Patients requesting additional emotional 
support will be offered immediate full clinical services of the Northwestern Medical Group.   
 
Measures to decrease risk will involve conducting all provider/staff/patient interviews and patient usability tests 
in a private and discreet fashion and giving persons an opportunity to ask questions or voice concerns. All 
participants who complete the consent process will be informed that participation may result in a loss of 
privacy, since persons other than the investigators may view their study data if deemed necessary for oversight 
purposes. However, they will be informed that only general conclusions about the aggregate results of our 
research will be shared with other health providers, NMG leadership, or supervisors; no individual audio or 
video recordings or the transcription of these activities will be shared with anyone who is not part of the 

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research team. Even though our study will store all data on secure, password protected, Northwestern 
University network drive folders, all audio and video files and other identifying information will be destroyed 
once the research is completed. In compliance with guidelines for comparative effectiveness trials, we will also 
establish an internal data and safety monitoring plan to ensure the safety of study subjects. Protections against 
these risks are described further below. (see Data and Safety Monitoring Plan below). 
 
POTENTIAL BENEFITS TO PARTICIPANTS 
The proposed study has the potential to improve community and healthcare clinical strategies for 
cardiovascular health promotion and disease prevention for a large number of overweight and obese adults.  
The interventions are designed to build capacity, improve practice, and enhance overall population health.   
 
The health IT and primary care delivery system interventions under evaluation will be designed to address a 
critical gap in health care delivery systems and has great promise for expanding the reach and effectiveness of 
health promotion efforts involving the coordination of clinical and community resources and services to address 
overweight and obesity. Our evaluation will provide critical information for stakeholders to help them make 
more informed decisions about whether it is feasible and effective to use existing new technologies in the 
management of overweight and obesity to improve the prevention and care for adults cardiovascular risk 
conditions.  
For patients, the study will help to answer whether it is worthwhile to conduct additional research regarding 
novel interventions that use health IT to provide new information, referrals, and feedback about health 
promotion resources across clinical and community settings to improve knowledge about community 
resources, increase goal setting, support behavior change, and result in greater weight loss success. 
 
DATA MANAGEMENT AND CONFIDENTIALITY 
Best practices will be employed by investigators and study staff to protect the integrity of the data. The 
participant tracking database will use Research Electronic Data Capture (REDCap) through a FSM computer 
with secure wireless VPN connection to Northwestern servers. Once the study is complete and data have been 
collected and passed the audit process, the research manager will make the data available to the PI and Co-
Investigators. Only copies of the finalized data will be released so that original data can remain untouched. 
 
Interviews with primary care professionals will be digitally audio recorded and then transcribed verbatim by an 
experienced, externally contracted transcriptionist. Content analysis of transcripts will be used to code small 
portions of the text representing unique concepts. Methods of open and axial coding will be employed to 
analyze the data. Digital audio files of interviews collected will be kept on a password-secured computer with 
the study ID as the identifier. After completion of the study, the digital audio tapes will be deleted. All 
participants will be identified by an identification number and not by a name in the research database and in 
the digital audio files, so that their identity and personal information will be kept as confidential as possible. 
 
For usability tests, Noldus software will record user-system interaction (i.e., logging mouse click, keystrokes) 
and will organize the data and analyses. Digital video files and transcripts of usability tests, and digital audio 
files and transcripts of provider interviews, will be stored under a filename identified by a coded studyID (not a 
participant’s name) on a password-secured Northwestern University network folder. Participant names, contact 
information, any other personal identifiers, and a key file linking those identifiers with coded studyID’s will be 
stored in a separate password-secured file folder. After completion of the study, all digital files will be deleted. 
 
Interviews with patients will be digitally audio recorded and then transcribed verbatim by an experienced, 
externally contracted transcriptionist. Participants will receive a lead letter with the option to opt out of phone 
recruitment. Interviewers will conduct all phone interviews in a private space. Content analysis of transcripts 
will be used to code small portions of the text representing unique concepts. Methods of open and axial coding 
will be employed to analyze the data. Digital audio files of interviews collected will be kept on a password-
secured computer with the study ID as the identifier. After completion of the study, the digital audio tapes will 
be deleted. All participants will be identified by an identification number and not by a name in the research 

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database and in the digital audio files, so that their identity and personal information will be kept as confidential 
as possible. 
 
In addition, to help us protect the confidentiality of participants we have a Certificate of Confidentiality from the 
National Institutes of Health, which will protect against attempts by law enforcement or other government 
agencies from accessing data. To help us protect patient’s privacy, a Certificate of Confidentiality from the 
National Institutes of Health is in place. The researchers can use this Certificate to legally refuse to disclose 
information that may identify patients in any federal, state, or local civil, criminal, administrative, legislative, or 
other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist 
any demands for information that would identify patients. The Certificate of Confidentiality does not prevent 
patients from voluntarily releasing information about themselves or involvement in this research. If an insurer, 
medical care provider, or other person obtains a participant’s written consent to receive research information, 
then the researchers will not use the Certificate to withhold that information. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS 
It is important to understand that the intervention is not an experimental drug or device but represents the 
introduction of new electronic tools and workflows into healthcare delivery (changes that could be adopted by 
the participating systems without the need for this research). Commensurate with the very low level of risk to 
participants, we will use a data safety and monitoring plan that is led by the study PI and involves the 
remainder of the study team. The plan includes prompt reporting of any unanticipated or serious adverse 
events that become known to the study team through process measurement and semi-structured patient 
interviews. In such cases, these findings will be communicated immediately to the sponsor (NIDDK) and to the 
NU Institutional Review Board. The study PI will have ultimate responsibility over insuring the fidelity of this 
plan. Study investigators will monitor the integrity of the research and the safety of participants.  The IRB and 
Dr. Ackermann (PI) will assess after any such events if revisions are required to the study procedures. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Healthcare providers who work in the primary care practice will be asked to participate after a general 
announcement is made at a routine business meeting about the purpose of the research. Secure emails will be 
sent by the PI and research team directly to those employees, enabling them to discreetly opt out of further 
contact. Recruitment procedures will not involve supervisors or other members of the practice leadership. All 
interviews will be conducted in a discreet setting at or near the practice setting, where voices cannot be 
overheard by others. Only minimal identifying information that is needed to conduct this research will be 
collected, stored, and analyzed. Audio recordings of interviews will be transcribed, analyzed, and then 
destroyed. When sharing results / findings beyond the research team, only general aggregate findings, 
illustrative quotes, or themes will be used. No data or results will be shared in a way that could identify an 
individual participant.  
 
Patients who are recruited for limited usability testing will be identified using a clinical electronic health record 
query conducted by a NM data manager. Primary care providers of those patients will be informed of the study 
and asked if they believe there is a reason why one or more of their own patients should not be contacted to 
participate. Only patients who are believed eligible and potentially interested after these filtering steps will be 
recruited. Emailed letters will be sent directly to those patients by the PI and research team, enabling them to 
learn about the study and to discreetly and easily opt out of further contact. Recruitment procedures will not 
directly involve the patient’s own primary care provider. The study team will conduct all telephone recruitment 
calls and subsequent usability testing in a discreet setting at or near the practice setting, where voices cannot 
be overheard by others. Only minimal patient identifiers and PHI needed to conduct this research will be 
collected, stored, and analyzed. Video recordings of usability tests will be transcribed, analyzed, and then 
destroyed. When sharing results / findings beyond the research team, only general aggregate findings, 
illustrative quotes, or themes will be used. No data or results will be shared in a way that could identify an 
individual participant.  
 

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All research personnel have received training in research related to Human Subjects. Access will remain 
consistent to those on the Authorized Personnel list of the IRB approved protocol. Study documentation will be 
retained for a period of five years following completion of data analysis, manuscript preparation, and report 
submission. All research databases will be password protected and accessible only to the research team and 
the Institutional Review Board (IRB). Any key files that link coded identifiers with NM patient identifiers will not 
be shared with the study team. Using these methods, which we have used in prior studies, we will be compliant 
with the “Standards for Privacy of Individual Identifiable Health Information” under the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. We will obtain approval from our IRB prior to 
the study start date. 
 
ECONOMIC BURDEN TO PARTICIPANTS 
Participants should have no additional costs because of participation in the research. 
 
CONSENT PROCESS 
This Human Subject Research falls under Biomedical Research with minimal risk to participants. The research 
will involve usability tests involving individual patients and interviews with primary care professionals, a pilot 
intervention trial, and follow up interviews with eligible participants. The consent process for each activity varies 
and is described in detail below: 
 
Research Activity #1: Primary care professional staff will be presented with a written explanation of the study 
and given an opportunity to have any potential questions answered. Prior to their participation in individual 
interviews, participants will provide written informed consent. The consent form outlines the potential risks, 
expected benefits, and the manner in which confidentiality will be maintained. The consent form also offers 
assurances that the participant can withdraw from the study at any time without penalty. 
 
At the agreed upon time of the staff member’s interview, the research assistant (RA) or PI will take him/her to a 
quiet, closed-door office and will read the consent document and explain the details of the study in such a way 
that the staff member understands what it would be like to take part in the research study. The RA or PI 
collecting the informed consent will stop after each section of the consent process and ask if the staff member 
has any questions. If the staff member has any questions, the RA or PI will answer them clearly, verifying that 
the patient has understood and has no further questions before proceeding. If at any point in the process the 
participant indicates that he or she does not want to take part in the research study, the process will stop, and 
the RA will thank the patient for their time. After signing the informed consent, the RA will off the participant a 
signed copy. A second signed copy of the consent form will be filed in a locked, limited access file cabinet at 
Northwestern research offices and each participant will also be given a copy of the consent form. 
 
Research Activity #2: Primary care providers will be informed of this research study during routine business 
meetings of the participating practice and subsequently in writing. PCPs will be notified via Epic email of which 
of their patients are eligible for participation and given the option of excluding any from being recruited. PCPs 
will be given 5 days to respond to Epic message to exclude a patient. No response will be considered assent to 
recruit patient. This process follows the standard approach for patient recruitment within the participating 
clinical practice location and is described in detail under “Recruitment Methods” above. Eligible patients will 
then be informed of the research by lead letter and then via an outreach phone call placed by the research 
team. Patients interested in proceeding to volunteer for usability testing will be scheduled and enrolled face-to-
face by completing written, informed consent, prior to completing those tests.  
 
Consent will be documented in writing. In accordance with Northwestern University’s Biomedical Template 
Consent Document, the consent form explains the study, potential risks, expected benefits, and the manner in 
which confidentiality will be maintained. The consent form includes information regarding protections afforded 
by the Certificate of Confidentiality. The consent form also offers assurances that the participant can withdraw 
from the study at any time without penalty.  
 
At the agreed upon time of a patient’s usability test, the research assistant (RA) will take him/her to a quiet, 
closed-door office and will read the consent document and explain the details of the study in such a way that 

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the patient understands what it would be like to take part in the research study. The RA will stop after each 
section of the consent process and ask if the patient has any questions. If there are questions, the RA will 
answer them clearly, verifying that the patient has understood and has no further questions before proceeding. 
If at any point in the process the patient has questions that he/she does not believe have been addressed 
adequately by the RA, the RA will page the PI, who will attempt to answer the patient’s question(s) more 
completely. If at any point in the process the participant indicates that he or she does not want to take part in 
the research study, the process will stop, and the RA will thank the patient for their time. After signing the 
informed consent, the RA will offer the participant a signed copy. A second signed copy of the consent form will 
be filed in a locked, limited access file cabinet at Northwestern research offices, and each participant will also 
be given a copy of the consent form. 
 
Research Activity #3: For the pilot intervention trial, primary care providers will be informed of this research 
study during routine business meetings of the participating practice and subsequently in writing. PCPs will be 
notified via Epic email of which of their patients are eligible for participation and given the option of excluding 
any from being recruited. PCPs will be given 5 days to respond to Epic message to exclude a patient. No 
response will be considered assent to recruit patient. This process follows the standard approach for patient 
recruitment within the participating clinical practice location and is described in detail under “Recruitment 
Methods” above. As described in detail below under “Protected Health Information (PHI and HIPAA), a HIPAA 
waiver of consent will apply to patients participating in the pragmatic pilot trial, as the use of participants’ PHI 
involves no more than minimal risk to the participant, is not collected for research purposes alone, and a 
detailed plan to protect participant identifiers from improper use and disclosure is in place. 
 
For the no-intervention comparison group, patients will not be contacted, will receive no intervention, and only 
their routinely collected clinical data will be used for the retrospective comparison evaluation (i.e. the same 
existing clinical data elements used to assess outcomes for the trial groups) so a waiver of consent will apply 
to participants in this group. As described in detail below under “Protected Health Information (PHI and 
HIPAA), a HIPAA waiver of consent will also apply to participants in this no-intervention comparison group, as 
the use of participants’ PHI involves no more than minimal risk to the participant, is not collected for research 
purposes alone, and a detailed plan to protect participant identifiers from improper use and disclosure is in 
place. 
 
Research Activity #4: For phone interviews: The research assistant will contact patient by phone and read the 
verbal consent document and explain the details of the study in such a way that the patient understands what it 
would be like to take part in the research study. The RA will stop after each section of the consent process and 
ask if the patient has any questions. If there are questions, the RA will answer them clearly, verifying that the 
patient has understood and has no further questions before proceeding. If at any point in the process the 
patient has questions that he/she does not believe have been addressed adequately by the RA, the RA will 
page the PI, who will attempt to answer the patient’s question(s) more completely. If at any point in the process 
the participant indicates that he or she does not want to take part in the research study, the process will stop, 
and the RA will thank the patient for their time. After the RA signs the informed consent, s/he will offer to email 
the participant a copy. A second copy of the consent form signed by the RA will be electronically stored in a 
password protected, limited access shared file on the Northwestern FSM server. 
 
During study consent and initial enrollment, all participants also will be given information about the protections 
afforded by the Certificate of Confidentiality from the National Institutes of Health. A copy of the consent form 
signed by the RA will be electronically stored in a password protected, limited access shared file on the 
Northwestern FSM server. 
 
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
The goal of the evaluation is to assess the reach/uptake and effectiveness of specific new implementation 
strategies used to offer common health behavioral preventive services to “usual” patients under “usual” 
circumstances. Research procedures that introduce additional participant risks or that selectively recruit only 
motivated volunteers into the evaluation activities would be disruptive of busy clinical workflows and would alter 

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the findings of the evaluation in ways that are unpredictable and potentially misleading. For this reason, the 
pilot trial has been designed as a pragmatic, “whole population” study using data collected routinely within the 
clinical IT systems. The pragmatic nature of the pilot trial component (Research Activity #3) of this evaluation 
dictates that it could not practicably be conducted without a HIPAA waiver. This HIPAA waiver applies to the 
intervention, control, and no intervention groups described above under Research Activity #3. The protected 
health information necessary for the purposes of this evaluation are those routinely collected through clinical 
care and not for the sole purposes of the research. As described above, the use of this PHI involves no more 
than a minimal risk to the privacy of participants and a detailed plan to protect participant identifiers from 
improper use and disclosure is in place, as well as written assurances that the protected health information will 
not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of 
the research study, or for other research for which the use or disclosure of protected health information for 
which an authorization or opportunity to agree or object is not required.   
 
For all other research activities (provider interviews; patient usability tests; patient semi-structured interviews), 
a HIPAA Authorization will be obtained from all participants. We are requesting the minimum necessary data 
available from the electronic health record that will be needed to identify potentially eligible patients who will be 
recruited for usability tests. Videotaped usability tests will then collect only the minimum necessary information 
needed to assess and improve the human-IT interaction. As we are only requesting data related to the 
preventive services being studied, we have made all reasonable efforts to limit the information to the minimum 
necessary to accomplish our intended purpose for the data set. 
 
For Research Activity #1, this study will utilize the following information about clinical staff member participants 
(not PHI): 
- Names (first and last) 
- Work telephone numbers, Email addresses 
- Professional role (e.g. staff physician, PA, NP, RN, LPN, MA, care coordinator, clerk, etc) 
- Sex/Gender 
- Year completing training 
- Year beginning current employment at NMG 
- Attitudes and beliefs about role in patient weight management support and use of health IT to achieve this 
 
For Research Activities #2 & 4, this study will utilize the following information about patient participant, 
collected directly from the participant or from administrative and clinical data systems during routine care 
delivery and queried at the individual level via the Northwestern Medicine Enterprise Data Warehouse 
(includes (includes PHI): 
- Names (first and last) 
- Elements of patient’s address including street address, city, county, ZIP code  
- Telephone numbers, Email addresses 
- Age 
- Sex/Gender 
- Race/Ethnicity 
- Primary or preferred language 
- MyChart Status (Active vs. Not Active) 
- Body Weight measured at the last clinical patient visit 
- Cardiovascular risk factors (High Blood Pressure; dyslipidemia; diabetes; prediabetes) indicated in the 
EPIC active patient problem list 
- Healthy lifestyle goals 
- Video and audio recordings of the patient during use of MyChart and a wireless home scale (Research 
Activity #2) 
- Perceptions of healthy behavioral clinical services and support tools, including perceived benefits, barriers, 
and suggestions for improvements (Research Activities #2 and #4) 
 
For Research Activity #3 (trial with waiver of HIPAA authorization), this study will utilize the following 
information about patient participants, all collected from administrative and clinical data systems during routine 

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care delivery and queried at the individual level via the Northwestern Medicine Enterprise Data Warehouse 
(includes (includes PHI): 
- Age 
- Sex/Gender 
- Race/Ethnicity 
- Primary or preferred language 
- Body Weight and Height measured at clinical patient visits during the follow up period 
- Cardiovascular risk factors (High Blood Pressure; dyslipidemia; diabetes; prediabetes) indicated in the 
EPIC active patient problem list 
- A1C and glucose values measured at clinical patient visits during the follow up period 
- Systolic blood pressure measured at clinical patient visits during the follow up period 
- Total and non-HDL cholesterol measured at clinical patient visits during the follow up period 
- Changes in antidiabetic, cholesterol, and blood pressure management medications during the follow up 
period 
- Number of visits during the follow up period 
- Healthy lifestyle goals as entered by a patient and/or care team members into the MyChart portal 
- Patient message reports for study-specific outbound messages* 
- Individual questionnaire responses for study-specific MyChart questionnaires* 
- Information about patterns of an individual’s use of a wireless home body weight scale, along with the 
date/time and value of each recorded weight that is transmitted to the Epic electronic health record system 
during the evaluation period* 
 
 
*Not applicable to no-intervention comparison arm patient participants. 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
Our research team is multi-disciplinary and experienced in areas of health promotion, disease prevention, 
health communication, health behavior, and sustainable implementation of evidence-based programs and 
services to prevent and manage chronic conditions across primary care and community settings. RONALD 
ACKERMANN has 15 years of experience in stakeholder-engaged health promotion and disease prevention 
research focusing on the sustainable implementation of evidence-based lifestyle interventions spanning 
primary care and the community. KENZIE CAMERON is a health communications expert with extensive expertise 
in qualitative research and survey design. BRIAN HITSMAN is a behavioral scientist with expertise in the 
implementation of theory-driven health promotion interventions that span the interface of healthcare practice 
and community settings. DAVID LISS is an expert in evaluating health care professional and delivery system 
interventions using experimental, quasi-experimental, and qualitative research designs. ANDREW COOPER has 
considerable experience in the management and analysis of large multi-source healthcare and public health 
data sources. Research assistants and other project coordination and management staff have completed CITI 
training and good practice, such as in areas of the proper collection of informed consent, data collection and 
entry, and how to manage adverse events (both anticipated and unanticipated) in the course of routine 
research.  
Because the proposed trial is a pilot and feasibility study, we have chosen a sample size needed to design the 
intervention to be implemented and sustained within routine practice workflows and to be usable to patients.  
Primary care practices in the Northwestern Medical Group (NMG) central region deliver care to more about 
183,000 unique adult patients annually. Our pilot study will take place at the Galter Primary Care (GPC) site, 
which is relatively close to the medical campus and sees a patient case mix that mirrors the larger NMG patient 
population. About 70% of GPC patients have used MyChart in the past year, and 32% of those (N=5,967) meet 
the study’s eligibility criteria. Thus, recruitment of the proposed sample will be feasible.