Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study
Phase: NA
Conditions: Health Behavior, Quality of Life, Chronic Disease, Health Promotion, Stress, Mental Health Wellness 1
Sponsor: McMaster University

Alvarez, Study proposal, Feasibility and implementation of a healthy lifestyles program: A pilot study 
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Official title of the study:  Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study 
 
 
 
NCT Number:         03258138 
 
 
 
 
 
Date of document:             December 11, 2017 
 
 

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SIGNIFICANCE AND IMPACT OF THE RESEARCH 
 
Background and rationale of study 
Rates of obesity and chronic conditions, such as diabetes and depression, are rising in 
Ontario, Canada, as well as around the world. (1–6) These chronic conditions can, on their own 
or as co-morbidities, impact the quality and quantity of people’s lives. (3,7,8)  
There are some simple, yet effective, lifestyle (e.g., behavioural) interventions which 
have been shown to improve the signs and symptoms of many chronic conditions. These 
interventions include eating a healthy diet, having proper and sufficient sleep, managing stress, 
smoking cessation, improving socialization, and being active, among others. (9,10) Cognitive 
behavioural therapy (CBT), in particular, has been shown to help with weight loss, to improve 
insomnia, and to decrease symptoms of anxiety and depression. (11–14) Mental health can play a 
role in the ability to seek out and follow through on the changes necessary to achieve or maintain 
a healthy lifestyle, yet this aspect is rarely addressed in chronic disease self-management or 
weight-loss programs. Access to mental health services is limited in Ontario by a lack of 
providers and non-coverage of services by the Ontario Health Insurance Plan (OHIP). (15–17) 
Therefore, many individuals go undiagnosed or untreated. 
Furthermore, individuals are shaped by the society in which they live. Determinants of 
health, such as income security, the built environment, and air quality, among others, play a role 
in weight management and in the development and progression of chronic conditions. The 
determinants of health can also act as barriers to achieving healthy lifestyles (e.g., lack of 
socialization, unsafe neighborhoods). There is simply not enough time in a regular office visit to 
address a whole range of possible individual barriers. Even with the time, most physicians do not 
have the training to deal with these issues or have an in-depth knowledge of community services 
available to patients and their families. 
 
Person-centered care 
While many studies continue to look at the effects of lifestyle modification on chronic 
conditions, aging and longevity, it is just as important to develop programs that encourage 
individuals to adopt healthier lifestyles and for communities to support individuals in leading 
these healthy lifestyles. (10,11) Changing habits takes time and requires the use of multiple 
techniques based on patient needs. This type of person-centered care is a different approach than 
simply bringing more services to one location, or having services follow individuals. (18–20) 
This approach starts by attending to the needs of the individual (e.g., improving mood, finding 
motivation, learning strategies to combat social isolation) instead of the pre-set indicators 
typically used to determine success in the clinical care of chronic conditions (e.g., lipid levels, 
asthma control, smoking cessation). The hypothesis is that approaching problems from the 
individual’s perspective (i.e., working on what is important to the patient) and providing the 
tools, skills and supports to meet self-identified goals, will lead to more sustainable 
improvements in health-related quality of life and healthier habits, which in turn lead to 
improvements in the clinically-relevant indicators. These approaches are not new and have been 
used in the setting of addictions and health promotion. (21,22) However, using these techniques 
is not mainstream in the clinical setting and few individuals have access to behavioural 
therapists. A new, multidisciplinary, person-centred, holistic and evidence- and practice-based 
healthy lifestyles program has been created to address these needs. This proposal aims to 
evaluate the feasibility and implementation of the healthy lifestyles program through a pilot 

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study. It will also be important to evaluate this program to determine if, and what components of, 
the program are effective. These answers will be needed so that the program may be improved 
and scaled-up to other sites.  
 
Novel intervention 
Each individual will be enrolled in the healthy lifestyles program for one year. This 
amount of time allows for determination of participant goals, identification of barriers and 
facilitators, healthy lifestyle education, and trial and modification of individualized action plans. 
To achieve these goals, participants will meet weekly for group health and wellness learning 
sessions or brainstorming group sessions. The health and wellness learning sessions provide a 
platform for concepts from a variety of health behaviour theories and CBT to be combined with 
evidence- and practice-based recommendations for healthy lifestyles. (11,23–29) These provide 
the basis for the individualized action plan. Monthly individual sessions with a family physician 
trained in medical CBT, a dietician and a physical therapist help individuals tailor their action 
plans and recommendations to their particular circumstances and provide supports based on their 
needs. (30,31) The brainstorming group sessions allow for facilitated discussions where 
individuals explore barriers and facilitators to achieving their goals and provide an interpersonal 
component to the program through the building of social interactions. Participants will also 
receive help in finding community programs to support healthy lifestyles.  
An ecological approach to behavior change is used throughout the entire program. An 
ecological perspective allows for the inclusion and assessment of factors at the individual, 
interpersonal, institutional or organizational, community and policy levels. (24) In addition, 
Prochaska’s stages of change, or transtheoretical model, is used to identify in which stage each 
participant is in for each health goal. These stages include precontemplation, contemplation, 
preparation, action, maintenance and relapse. (32–34) 
 
Preliminary evidence to support this approach 
Modified versions of this program have been used in presentations to graduate students 
on stress management (35) and time management (36) and in a classroom setting through a 
Theories of Health Behaviour course taught by the principal investigator in three different 
sessions (Spring/Summer 2016, Fall 2016 and Spring/Summer 2017) at McMaster University. In 
addition, a pre-trial test run recently completed with 9 individuals enhanced the style of delivery, 
format and content of the 8 core initial health and wellness learning sessions and the initial 
assessment segments of the program. While these results are not published, feedback from 
students and from participants in the pre-trial test have been positive for the content and structure 
as well as for reinforcing the ability of the program to address gaps in current care. 
 
Intervention group = usual care + healthy lifestyles program = more intensive program (MIP) 
Table 1 provides a more detailed listing of components for the program and its related 
research activities. All tables in this document follow the format used by Samaan et al (37). The 
intervention group participants will receive the full healthy lifestyles program with the weekly 
group sessions and with individualized monthly meetings with team members. They will develop 
individualized health goals and an action plan as well as receive supports for identifying barriers 
and facilitators to changing behaviours and for community supports. They will continue to 
receive usual care from their current healthcare providers (see below). 
 

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Control group = usual care + health goals = less intensive program (LIP) 
 
Currently, family physicians do give advice on healthy lifestyles. In addition, many 
Family Health Teams (FHTs) in the Hamilton area have complementary professionals, such as 
dieticians and social workers. However, care has still traditionally focused on meeting 
healthcare-set or guideline-directed care and, at times, the multi-disciplinary approach has not 
translated into integrated care. It is difficult to address the “how-to” in clinical settings. Time 
limits do not allow for a holistic approach to barriers or for teaching problem-solving skills, and 
payment schemes have drawn attention to physically based and acute treatment of conditions. It 
is not standard to have patients develop health goals that receive as much merit as medically 
directed goals. Therefore, individuals in the control group will develop health goals with the 
support of a research assistant trained in theories of health behaviour, and progress on these goals 
will be measured. However, the “how to” put these goals into practice will not be provided as the 
means to test the healthy lifestyles program. The hypothesis is that developing health goals may 
help individuals attend to improving their lifestyles, but having the “how to” will provide more 
movement in the stages of change necessary to carry out the proposed actions and will lead to 
improved outcomes. Because there is still an intervention, but it is modified, the control arm 
participants will be receiving a less intensive program (LIP). The LIP arm will also be referred to 
as ‘the program’ for the purposes of documents used in the study. This is done so that 
participants in both arms can relate to the questions asked and the forms can be standardized as 
much as possible. It will be important to note if simply developing health goals and having a 
modified treatment is sufficient to change habits.  
 
Usual care 
Both arms will continue to receive usual care as provided by their healthcare practitioners. The 
programs are meant to be adjuncts to usual care and deal with the prevention and management of 
chronic conditions from cognitive and behavioural perspectives where lifestyle changes are more 
likely to influence outcomes. No drug treatments or changes will be made through the study. If 
there are any significant changes to an individual’s health status, these will be communicated to 
the family physician, provided consent has been given by the participant. Furthermore, the 
number of visits to health providers will be captured through a costs and medical utilization log 
in both groups. This will help provide a truer representation of the time and costs involved in 
taking part in the programs. Lastly, in order to get a sense of clinicians’ perspectives on both 
programs, the study will include interviews with participants’ healthcare providers to obtain their 
views on these programs and/or development of patient goals and their perspectives on the 
influence of these programs on their patients’ wellbeing. 
 

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Research questions and study hypothesis 
This proposal lays out the plans for a pragmatic mixed methods study. This study design 
allows for the flexibility and responsiveness needed to study multiple dimensions of a new 
program, especially one designed for creating healthy lifestyles through the development of 
participant-directed goals and individualized action plans. (38–41). The proposal lays out the 
plans for a pilot phase. 
 
Primary research question and main study hypothesis: 
Does a holistic program based on CBT and behavioural theories provided through group and 
individual sessions over a year compared to usual care along with development of health goals 
help meet participant-directed and clinical outcomes for adults in the Hamilton area? 
We hypothesize that the MIP will be feasible and acceptable and will be more effective for 
helping participants move across stages of change and for meeting goals than the LIP. 
 
Sub-questions for this pilot study: 
Quantitative research questions 
1) Are participants meeting their self-identified health goals? 
2) Are there impacts seen on other health indicators? 
3) Are there specific participant characteristics (e.g., gender, age) that correlate with these 
outcomes (i.e., meeting self-identified goals, other health indicators) 
4) What are the costs of running the programs, and how do these compare to costs of usual 
care? 
 
Qualitative research questions:  
1) How do the interventions affect the participants, and do the interventions meet participant 
expectations and needs? 
2) How does the MIP affect the staff providing this intervention, and what do staff suggest 
can be done to improve the program or its provision? 
3) How does the MIP affect the participants’ families, and what is the role of families in 
adopting healthy lifestyle changes? 
4) How do other providers involved in the participants’ care view the program(s) and their 
patient’s involvement in the program(s)? 
5) What is the context within which the programs are being implemented? 
 
Mixed methods questions:  
1) Are the programs meeting their objectives? 
a. Process indicators – both quantitative data (e.g., number of participants recruited, 
number of participants developing health goals, participant satisfaction with the 
program as data collected through surveys) and qualitative data (e.g., participant 
satisfaction with the program as data collected through interviews) 
b. Short-term indicators – both quantitative data (e.g., number of participants 
finishing the programs) and qualitative data (e.g., information gathered through 
in-depth semi-structured exit interviews) 
2) Are the programs feasible? 
 
 

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Overall goals and objectives 
The goal of this pilot project is to determine the feasibility and implementation of the full 
healthy lifestyles program (MIP) in a real-life setting in the Hamilton area. Multiple aspects of 
the MIP will be studied to test the concept of the program, improve the program, examine the 
context and implementation of the program, and determine its effectiveness, cost-effectiveness, 
and feasibility. This pilot study will also identify the conditions for a larger randomized 
controlled trial to further evaluate effectiveness and cost-effectiveness, especially when the 
program is run at full capacity. Evaluating the context of this pilot phase will also help determine 
if, and how, the program should be considered for scaling up in other parts of Canada and/or 
internationally, and whether this is a cost-effective and sustainable adjunct to address the needs 
of patients and service providers in dealing with chronic conditions. The control group will help 
determine if the LIP is just as useful, keeping in mind these are small numbers, so findings 
cannot be generalized from this study. 
 
Primary objective: 
To study the feasibility and implementation of the MIP 
 
1) To assess the feasibility of recruitment, retention, attendance in group and individual 
sessions, and completion of data 
2) To assess resources needed to run the MIP, including the type and mix of health 
professionals, numbers and sizes of rooms for group and individual sessions, materials, 
costs and medical utilization 
3) To obtain feedback from multiple stakeholders, including participants, staff, family 
members, and other health providers in order to improve the healthy lifestyles program 
and to determine its acceptability 
 
Secondary objectives: 
To determine changes in participant-directed and clinical outcomes 
 
1) To determine changes in participant-directed outcomes through goal development and 
associated measures 
2) To determine changes in clinically relevant outcomes, such as health-related quality of 
life, anxious and depressive symptoms, sleep, loneliness, stress, other health indicators 
(HgA1C, fasting lipids, and complete blood count (CBC) as dictated by current 
guidelines) and measurements (blood pressure, height, weight, BMI, waist circumference, 
waist:hip ratio, Edmonton Obesity Scale (if relevant)) 
 
Anticipated project contributions 
This pilot phase is to assess the feasibility and implementation of the full healthy 
lifestyles program. However, in the longer-term, findings of this and future research in this area 
are expected to address gaps in knowledge around individuals’ attainment of healthier lifestyles 
and around which services can be provided to support these changes. In addition, the findings 
will inform future research, practice and policies around healthy lifestyles. The impact on 
participant experiences and outcomes is one of the main objectives of this study. The healthy 
lifestyles program is person-centered in that it allows for participants to self-identify relevant 
health goals and to develop realistic and sustainable action plans to achieve their goals. The 

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purpose of evaluating the healthy lifestyles program is to understand if and how it works, to 
iteratively improve the program, and to understand the implementation process so that it can be 
scaled up successfully in other sites. In addition, this project will build a program of study for 
trainees in a variety of disciplines who are interested in healthy lifestyles, chronic disease self-
management, integrated approaches to care, and research methods, among others. Training 
students will help advance their careers as well as the research program itself. 
The proposed healthy lifestyles program follows an ecological approach to health behavior 
where influences are looked at from individual, interpersonal, institutional or organizational, 
community and policy levels. Participants will identify barriers and facilitators at each of these 
levels, and these findings will be used to inform community efforts and stakeholder dialogues 
where policy implications will be considered. 
 
APPROACHES AND METHODS 
 
Methods 
A pragmatic mixed methods design including a randomized controlled trial and 
qualitative components will be used for the study. This study will have elements of concurrent 
and embedded mixed methods designs. A mixed methods design allows for both quantitative and 
qualitative data to be collected, analysed and interpreted to understand various aspects of the 
program or intervention better, while also allowing for different research questions to be asked 
that require different types of data (i.e., quantitative or qualitative) that link up at multiple points 
of the study. (41) Specifically, concurrent data collection will answer the mixed methods 
research questions around program evaluation, such as “is the program meeting its objectives,” 
which include process, and short-term indicators. The embedded design will allow for qualitative 
data to be collected to add depth to the quantitative empirical findings, to answer questions 
around the process of implementing the programs, and to test and inform the programs. (42)  
The randomized controlled trial will include a 1:1 allocation comparing MIP (usual care 
+ healthy lifestyles program) vs. LIP (usual care + development of health goals). It is not blinded 
as the amount of exposure to the programs will be known to participants and providers. This 
study is pragmatic in that it is being conducted in a real-life setting with few criteria for 
exclusion, which allows for a wider range of participants to be studied. (38) This is important 
given the person-centered focus of these programs and multiplicity of participant-identified 
priorities and individualized possible outcomes. Having this ability to include a wider range of 
participants will allow for increased generalizability of the findings. (38) One challenge of 
pragmatic trials is that they need to be large enough to detect treatment effects given the large 
variation in the participants. This study proposes a first stage that examines the concept itself 
(i.e., the intervention), and the feasibility and implementation of the intervention. These findings 
will, in turn, inform other stages of the study and the evaluation of a larger, scaled-up, 
intervention. For example, sample sizes will be determined for a randomized controlled trial 
based on effect sizes found through this pilot phase.  
The qualitative components include semi-structured interviews of participants (exit 
interviews at 12 months), MIP staff and participants’ healthcare providers (at 6 months and 12 
months). In addition, focus groups will be conducted with family members of MIP participants at 
9 months. These elements will provide perspectives from multiple stakeholders for improving 
the healthy lifestyles program and on their roles in creating and maintaining healthy lifestyles. 
The pragmatic design was, in part, chosen to allow for the 6-month interviews of MIP staff and 

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other healthcare providers, along with participant satisfaction surveys every three months, to be 
used to make changes to the programs, or their delivery, while the study continues. Any key 
changes will be noted in the final report. If changes impact the conduct of the study, amendments 
will be made for ethics approvals and reported through ClinicalTrials.gov. 
 
Setting and participants 
This study will be conducted through McMaster University, and the site of the study will 
be at the David Braley Health Sciences Centre, Hamilton, Ontario. This site currently houses 
family physician offices and student classrooms, with accessibility considerations, including 
elevators and automatic doors. It is in a centrally located part of Hamilton with access through 
car and bus routes. The required office and meeting spaces are available.  
Participants in the randomized trial will include English-speaking individuals 18 years of 
age or older. Because this phase incorporates group sessions, it is important to test the program 
concept with individuals who are able to engage in these sessions. Participants will also need to 
understand and sign the informed consent form. 
 
Participants in qualitative components  
Exit interviews will be conducted with participants at 12 months. MIP staff (family 
physician, dietician, physical therapist, administrative assistant) who are involved in running the 
healthy lifestyles program will be recruited for staff interviews at 6 months and 12 months. 
Healthcare providers involved in the participant’s care outside of the study and identified by 
participants, with consent given to share information, will be approached to participate in semi-
structured interviews at 6 months and 12 months. Family focus groups will include family 
members, who are 16 years of age or older and English-speaking, of participants in the MIP 
group. 
 
Sampling and recruitment 
Up to 15 participants will be recruited for each arm of the randomized trial. This number 
accounts for ideal numbers of people involved in small group sessions (8-15) based on practice 
experience and for potential attrition throughout the year. Effect size determination and other 
variables found from this study will be used to guide the sampling approach and sample size for 
further studies.  
Initial recruitment for the randomized trial will occur at doctors’ offices in the Hamilton 
area. Outreach to physicians will include a description of the programs and of this study. Posters 
will be placed in their office with the consent of the staff. (Appendix 1. Recruitment poster) The 
doctors’ willingness to recommend the programs and number of participants recruited will 
determine the number of offices needed for recruitment. These outreach efforts are already in 
progress. (See letters of support) The posters contain contact information for the research 
assistant and a link to the healthy lifestyles program website (www.hlirc.com). PowerPoint slides 
will be provided to offices to show on their waiting room screens, if willing (Appendix 20). In 
addition, potential participants will be approached by a research assistant and/or student 
researcher during an office visit (as coordinated with the clinic staff), who will describe the 
purpose of the study and answer participant questions. The website will provide only information 
about the research study and how to contact the research assistant prior to the program starting. 
Following recruitment, the website may then be used to update participants of upcoming events 
or to add links to sources of information. No personal information or results from the study will 

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be published on the website. A Twitter account will be set up linked to the website to reach a 
broader audience, however, any information will only advertise the research study as already 
approved on the poster. Following recruitment, the Twitter account may then be used to update 
participants of upcoming events. No personal information or results from the study will be 
published through Twitter. If these recruitment efforts do not attain enough numbers of 
participants, posters will be placed in community settings, such as community centres, office 
buildings, etc. after obtaining consent from that facility. In addition, an advertisement will be 
placed in the Hamilton Spectator and in ‘Coffee News’ – both local media outlets. (See appendix 
20)  
The research assistant and/or student researcher will obtain consent and enroll 
participants into the study. (Appendix 2. Participant informed consent) Healthcare professionals 
involved with routine participant care or with the conduct of the programs will not be directly 
involved in enrolling participants into the study or obtaining informed consent. A participant 
maintains the right to drop out of the study at any time without consequences to her/his care. 
However, the numbers and reasons for dropping out of the study will be sought and noted as part 
of the program evaluation. Each participant will receive $30 each time data is collected through a 
meeting with the research assistant every three months (five times total).  
 
Sampling and recruitment for qualitative components 
All participants will partake in a semi-structured exit interview during their last data 
collection meeting at 12 months. (Appendix 3. Participant interview guide) All MIP staff and 
health professionals involved in the participant’s care outside of the study and identified by 
participants (for participants in both arms), with consent given to share information, will be 
approached face-to-face or by email or phone by a research assistant to participate in semi-
structured interviews at 6 months and 12 months. Through the participants, family members (16 
years of age or older, and English-speaking) will be asked to participate in up to two family 
focus groups with 6-10 people each at 9 months. Participants in the family focus groups will be 
provided with $20 each. Informed consent will be obtained prior to the interviews or focus 
groups. (Appendices 4-9. Informed consent forms and interview/focus group guides) In addition, 
all relevant documents pertaining to the setting up and running of the programs will be reviewed. 
 
Allocation and randomization 
 
As participants are recruited for the randomized trial, they will be provided with a six 
digit ID number. Once 30 participants have been obtained, an Excel sheet will be created with 
just the ID numbers, and each one will be assigned a random number using the RAND function 
on Excel. Based on this randomization, participants will be allocated to the MIP or to the LIP in 
a ratio of 1:1, starting with the lowest number. The only change will occur if there are two or 
more participants who happen to be in a relationship and this is known to the research assistant. 
In this case, these participants will be placed in the same group based on who is randomized by 
the lowest number.  
 
Neither the participants nor the health providers will be blinded to the intervention. A 
research assistant not involved in the recruitment or in the programs will allocate the 
participants, as described. Once allocation has occurred, names will be revealed to the same 
research assistant and s/he will notify participants of their allocation and provide further 
instructions and scheduling information. MIP staff and the research assistant/student researchers 
involved in collecting data will not be aware of the allocation of participants until the start of the 

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sessions. Participants will fill out a registration form at the first session. (Appendix 10. 
Registration form) This form includes the participant’s contact information, emergency contacts 
and consent for sharing of information with their primary care provider. 
 
Data collection procedures 
Paper-based and/or electronic measures will be used to collect data. Please see Table 2 
for a list and description of instruments used in the pilot study. A standardized data collection 
form (Appendix 11. Data collection form) will be used by a research assistant to gather 
information. For the MIP arm, charts will be reviewed when possible to gather data, such as the 
initial assessment, action plans, labs and measurements. The rest of the data for the MIP arm and 
all the data for the LIP arm will be collected through face-to-face individual meetings. The 
meetings for the MIP arm participants will be set up to be concurrent with follow-up visits to 
minimize burden. The action plan (MIP group) and the data collection form (LIP group) are used 
to help participants identify health goals. With the support of the MIP team or the research 
assistant for the LIP group (all trained in theories of health behaviour), participants will identify 
relevant health goals and define how to measure these goals on a 1-7 scale, with 1 being the 
“worst case,” 7 being the “best case,” and 4 being the “middle”. Therefore, the measurements 
will also be participant-relevant while allowing for a variety of goals to be measured, including 
mental health-related goals such as decreasing symptoms of depression and behavioural changes 
such as amounts of physical activity. In addition, scales for motivation, stages of change, and 
self-efficacy are included for each goal. (See Appendix 11. Data collection form) If labwork 
information is not available in either arm, participants will be asked to have labwork drawn if 
they meet current screening guidelines. For HgA1C and lipids, this includes being 40 years of 
age or older or having risk factors as outlined in the guidelines for diabetes and cardiovascular 
disease, respectively. (43,44) A complete blood count (CBC) will only be conducted if the 
participant has symptoms, such as fatigue, or a history of cancer, infections or blood disorders as 
determined by the clinicians involved in the study. Measurements include blood pressure, height, 
weight, BMI, waist circumference, waist:hip ratio, and Edmonton obesity scale (if relevant). (45)  
Participant satisfaction and feedback will be assessed through surveys at 3 months, 6 
months and 9 months and will be provided and collected by the research assistant. (Appendices 
12 & 13. Patient satisfaction surveys) Weekly nutrition journals and physical activity journals 
will be provided to participants in the MIP arm through the group sessions every three months. A 
research assistant will photocopy these from the chart, black out the names and provide the 
participant ID number on the paper. For the LIP arm, these journals will be provided directly by 
and returned to the research assistant (Appendices 14 & 15. Nutrition and physical activity 
journals). In addition, a costs and medical utilization log will be provided to each participant in 
both arms and these will be collected by the research assistant every three months. (Appendix 16. 
Costs and medical utilization log) Worksheets for each health and wellness learning session will 
be provided for participants in the MIP group only. These will not be collected for study 
purposes but they do provide a space for reflection during and after each session.  
For research purposes the pilot involves the use of two generic and a number of specific 
measures of health status and health-related quality of life. The routine application of the 
intervention would involve a more parsimonious set of measures. Validated health and wellbeing 
scales will be filled out by participants at baseline and every three months to assess change in 
these indicators (five times total). The MIP arm participants will fill these out during group 
sessions and the research assistant will obtain this information through chart review. The LIP 

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participants will fill out these scales during their meeting with a research assistant. The Physical 
Activity Readiness Questionnaire for Everyone (PAR-Q+) will only be filled out at baseline to 
ensure goals related to physical activity are appropriate given a participant’s health status. Any 
concerns found through these or other scales will be relayed to the principal investigator and 
dealt with according to current practice and per the Good Clinical Practice guidelines for clinical 
trials. See also data monitoring section. The rest of these scales were selected for addressing a 
holistic range of mental health indicators that are dealt with in the healthy lifestyles program. 
The RAND SF-36 (46,47) and HUI 2/3 (48–50) are validated instruments for health-related 
quality of life indicators. The decision to use both is to compare findings from these instruments. 
The SF-36 has been used extensively in multiple settings and is readily available and free. 
However, there are some limitations concerning floor effects, which is why the HUI 2/3 has been 
suggested by collaborators. On the other hand, the HUI 2/3 is proprietary and not as readily 
accessible to health providers for use in practice. The Patient Health Questionnaire (PHQ) is 
made up of five domains to evaluate for depression (PHQ-9), anxiety (GAD-7), bulimia, 
somatoform disorders and alcohol misuse. (51–53) This scale was selected for general mental 
health indicators as it combines multiple related domains, has been used extensively for research 
and practice, and the components are used among family physicians in the Hamilton area 
(personal correspondence). Importantly, the PHQ-9 has also been found to be sensitive to change 
for monitoring of treatment outcomes. (54) The Insomnia Severity Index was identified as the 
most fitting validated scale to identify insomnia symptoms. (55) The Life Change Index Scale, 
otherwise known as the Holmes and Rahe stress scale, has been found to correlate with medical 
utilization in a family practice setting. (56) In addition, the Perceived Stress Scale measures the 
degree to which situations in one’s life are perceived as stressful. (57,58) Lastly, the DeJong 
Gierveld 6-item Loneliness Scale captures both emotional loneliness (missing an intimate 
relationship) and social loneliness (missing a wider social network). (59,60) 
Administrative data will be used for adherence information (e.g., number of participants 
attending each education session) and for data on costs of running the programs. 
Data from all these forms will be entered into Research Electronic Data Capture 
(REDCap) (https://www.project-redcap.org/). All information will be kept confidential and 
participants IDs will be used whenever data is coded. A list of participant IDs and their 
associated names will be kept in separate locations. Paper documents will be kept in a locked 
cabinet on campus and any electronic information will be kept on password-protected computers. 
Only research team members will have access to the data. Data collection methods will be 
evaluated to determine if any changes need to be made for the following phase. 
 
Qualitative data 
 
The participants (at 12 months), MIP staff (at 6 months and at 12 months), and health 
providers (at 6 months and at 12 months) will be asked to participate in face-to-face semi-
structured interviews. Family members will be asked to participate in focus groups (at 9 months). 
Informed consent will be obtained prior to conducting these interviews and/or focus groups. The 
interviews and focus groups will be recorded with a digital recorder and transcribed. Field notes 
will also be taken during these interviews and focus groups to describe the setting and keep track 
of other events. Recordings and transcriptions will be kept in locked cabinets and/or password-
protected computers on campus. Documents related to the programs or their implementation will 
also be used as data.  
 

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Incentives 
Incentives will be provided for participants in both arms, including $30 for each time 
measurements are completed (baseline, 3 months, 6 months, 9 months, and 12 months). This 
amount is seen as a fair amount given the time spent on providing information or having 
bloodwork done (about an hour), but it is not an amount that would be considered coercive. The 
incentive will be given to the participant upon attendance at the meeting, not based on data 
completeness as this could be seen as coercive. Participants in the family focus groups will be 
provided $20 for their participation. 
 
 
 
 
Training of health professionals and research staff 
The health professional leading the intervention is a family physician with training in medical 
CBT. In addition, she has developed and teaches a Theories of Health Behaviour course at 
McMaster University and has certificates of completion for the Tri-Council Policy Statement:  
Ethical Conduct for Research Involving Humans Course on Research Ethics (TCPS 2: CORE), 
the Tutorial for Researchers Conducting Retrospective Review of Health Records (Certification 
#698149) and Good Clinical Practice for clinical trials (Record ID #22456269). The dietician 
and physical therapist are fully licensed. Research assistants and student researchers will have 
training on research ethics through the Tri-Council Policy Statement: Ethical Conduct for 
Research Involving Humans Course on Research Ethics (TCPS 2: CORE) and will also complete 
the Tutorial for Researchers Conducting Retrospective Review of Health Records. They will 
have training on how to interview participants to obtain data during individual meetings, on how 
to obtain proper measurements and how to answer questions relating to the scales, nutrition and 
physical activity journals, and the costs and medical utilization logs. Lastly, training will be 
provided on how to support participants in the LIP to identify goals. If they are involved in the 
qualitative components, more intensive training will be provided by the team on how to conduct 
participant interviews and focus groups, and how to maintain field notes. All team members will 
have training on confidentiality and handling of data as set out in this proposal. Facilitators for 
the brainstorming sessions will have training on how to lead facilitated sessions around healthy 
lifestyles and conflict management. 
 

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Data analysis 
Quantitative 
See Table 3 for a description of the objectives of the study, outcomes measured, and 
analytic techniques for each component. Quantitative data will be reviewed for completeness and 

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entered into Excel and/or SPSS by the research assistant/student researchers. Missing data will 
be noted in order to evaluate the study instruments themselves. Descriptive statistics will be 
presented for the participants in the study. Changes within individuals over time, and differences 
within and between groups will be assessed. Regression and multivariate analyses will be 
conducted to the extent possible, realizing this pilot phase constitutes a small sample. Since this 
is a pilot study, this information will be looked at to help inform a larger randomized trial and 
statistical significance will not be sought. Total costs and cost-effectiveness analyses will also be 
conducted to the extent possible. 
 
Qualitative 
 
Transcripts, field notes, and documents will be entered into NVivo and coded. Concepts 
and themes will be developed using a constant comparative method of analysis in which new 
information is compared to previous information. Themes related to the concept of the programs, 
implementation of the programs and feasibility will be developed, among others. Confirming and 
disconfirming evidence will be sought to ensure data saturation or completeness of the findings. 
(61) 
 
Integration of data 
Integration of data will occur at various points. First, qualitative data will be used to 
understand the quantitative data in more depth. For example, adherence with particular aspects of 
the programs will be compared with themes developed from the qualitative data to understand 
what particular barriers impacted on adherence. In a similar fashion, qualitative data will be 
compared with effectiveness of the intervention (e.g., achieving goals) to understand what 
components may have led to success or non-success. These aspects will help evaluate the 
programs holistically and will provide insights for improving and scaling up the healthy 
lifestyles program. 
 
Data and participant monitoring 
 
Team members will meet weekly to discuss study progress and review data quality and 
monitoring of attendance or any concerns raised by participants or clinicians.  
Participants will fill out mental health scales, which will be scored during their visits. If 
any concerns around these findings or other signs of deterioration are encountered by anyone on 
the research or program teams, the principal investigator or alternate clinician will be notified 
while the participant is still in contact with the team member. An assessment will be conducted 
and if any concerns arise for self harm or harm to others, proper guidelines will be followed, 
including creating a safety plan (62), contacting the participant’s family physician or providing 
more frequent follow-ups, or contacting emergency services, as deemed appropriate.  
 
Few risks are anticipated for this study. However, there could be anxiety or fatigue 
caused by participating in the study or in filling out the forms. If any concerns are noted, the 
principal investigator will attend to these concerns and may remove the participant from the 
study, following a discussion with the participant and the team, if this is deemed in the 
participant’s best interests. This study does not require a data and safety monitoring board since 
there are no drugs or devices being tested and is considered low risk. 
 

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Knowledge translation 
 
Knowledge translation activities will occur throughout the study. Whenever possible, a 
knowledge exchange process will be sought so that knowledge is pushed to the audience but also 

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different perspectives are invited to improve the evaluation of the Program and what is learned 
through the findings. Peer-reviewed publications and presentations at conferences will target 
researchers and health professionals. Policymakers and other stakeholders will be engaged 
throughout the process to identify needs and community/policy implications of these findings. 
 
Timeline and activities (Appendix 17) 
The pilot phase will take approximately 24 months. This includes time for registering the 
proposal as a clinical trial with ClinicalTrials.gov, obtaining ethics approval, setting up the 
logistics of the programs (e.g., recruiting a research assistant, booking rooms), recruiting 
participants, running the full programs and generating knowledge translation activities. 
Information from this study will be used to improve the healthy lifestyles program, to test the 
logistics of running the healthy lifestyles program at capacity and to assess the conditions for a 
larger randomized controlled trial with the healthy lifestyles program running at full capacity.  
Budget  
The expected research budget is $363,500 CAD. (Appendix 18. Research budget) This 
includes a full time research assistant, part time biostatistician, and thesis and practicum students. 
This also includes consumables such as paper and toner, analytic software, transcription services, 
incentives for participants, child minders and snacks for the interviews and focus groups. The 
budget also allocates money towards knowledge translation activities such as publishing in open-
access peer-reviewed journals and presenting at conferences. In-kind contributions from 
McMaster University include $26,000 for students and overhead. Remaining needs are $337,500. 
The cost of running the programs for the pilot phase is expected to be $109,700. Funding 
for the programs has been secured, mainly through in-kind contributions from McMaster 
University and from team members. 
Potential challenges 
Ethical considerations 
The study protocol will be submitted to the Hamilton Integrated Research Ethics Board 
(HIREB).  In addition, the study will be registered as a clinical trial with ClinicalTrials.gov. A 
research assistant will approach potential study participants to explain the nature of the study, 
their rights as study participants, confidentiality of their data, voluntary entry into the study, and 
their ability to withdraw from the study at any time. (63,64) There is minimal risk of entering 
this study, however, participants will be informed about the potential risks of unintended 
disclosure, where they may potentially give away information about themselves or about a third 
party which could lead to recognition of themselves or the third party (in which case 
confidentiality will be sought for the third party as well). In addition, there are some risks to 
starting or increasing any exercise activity, such as injury. However, the benefits of increasing 
mobility outweigh most of the risks of potential injury and having trained team members and 
setting realistic goals will allow for gradual adjustments in their mobility levels. Any questions 
will be answered, and informed consent will be obtained prior to enrolling any participant into 
the study. All data gathered for the study will be kept confidential by using identifiers (with 
identifiers and identifying data kept separately), and access will only be given to the research 
team members. Paper documents will be stored in a locked cabinet on campus. Electronic 
documents will be kept on computers at McMaster, all with password access. 
Incentives – Participants will receive $30 each time they meet with the research assistant 
for data collection every three months (5 times total). These amounts are seen as valid, but not 

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coercive, for the amount of work involved. Control-arm participants (less intensive program) will 
be allowed to participate in the healthy lifestyles program (MIP) at a later date on the condition 
that the program is still running.  
If any changes are made to the research design, HIREB will be notified and changes will 
be made based on their recommendations. 
 
Scientific, technical or organizational considerations 
The main challenge with the proposed healthy lifestyles program is that the components 
are not traditionally covered by the current funding model in Ontario. While the physician 
components could be billed under OHIP, this billing would be considered ‘counseling’ under 
OHIP guidelines, and these fees are not comparable with fees charged for acute care diagnoses. 
In addition, dietician counseling and physical therapy are not generally covered services, except 
for specific diagnoses. Over-the-phone dietician services are offered for free in Ontario, 
however, there is no guaranteed continuity of care. Combining these services to provide holistic 
and team-based care is the purpose of this study. These funding considerations are critical for the 
sustainability of the healthy lifestyle programs, both during these pilot phases and in scaling up. 
On-going funding considerations will be drawn from cost-effective analysis through the larger 
randomized trial that will be informed by this pilot study.  
 
RESEARCH TEAM 
 
Team’s expertise and experience 
The team is comprised of researchers, health professionals, knowledge users and 
patients/stakeholders. Methodologically, the team has experience in quantitative, qualitative and 
mixed methods research. Combined, the team has experience developing and carrying out 
clinical trials, from conception to write-up. The team’s content expertise spans many fields, 
including medicine, public health, health promotion, mental health, physical therapy, nutrition, 
eHealth, health systems and policy, knowledge translation, and health economics.  
 
Team’s level of engagement and commitment (Appendix 19) 
Principal investigator - Dr. Elizabeth Alvarez – 14 hrs/week - manage all aspects of the research 
including human resources, funding and project completion. Helps research coordinator in 
identifying priorities and opportunities, especially with regards to qualitative data collection and 
analysis and mixed methods interpretation. Supervise students in multiple health-related fields. 
In addition, Dr. Alvarez is a certified family physician, so any medical concerns that arise during 
the study can be addressed. Because of her dual role in the MIP and in monitoring the research, 
any enrollment of participants into the study or gathering of informed consent will be carried out 
by a research assistant. In addition, qualitative data will be gathered by a research assistant 
and/or student investigator, and participant IDs will be assigned to any data by the research 
assistant prior to data analysis.  
Co-investigators 
Dr. Lawrence Mbuagbaw – 4 hrs/week – assist with project management, especially as it relates 
to quantitative data collection and analysis and mixed methods interpretation. Supervise students 
in health research methods.  
Dr. Majdi Qutob – 4 hrs/week – assist with project management, especially as it relates to data 
management and administrative issues.  

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Dr. Cynthia Lokker – 4 hrs/week – assist with all aspects of the research as needed, especially as 
it relates to eHealth initiatives and data management. Supervise students in eHealth. 
Ms. Marjan Walli-Attaei – 4 hrs/week – assist with all aspects of the research as needed, 
especially with regards to economic analyses and health policy. She is a doctoral candidate in 
health policy with a concentration in health economics at McMaster University. 
Dr. Zena Samaan – 2hrs/week – assist with all aspects of the research as needed, especially as it 
relates to mental health and data management. She is a clinician-researcher in Psychiatry and 
Behavioural Neurosciences with experience in pragmatic clinical trials involving mental health 
programs.  
Dr. John Lavis – 2 hrs/month – assist with knowledge translation activities and provide ongoing 
feedback on activities. Supervise students in health policy and other health-related fields. Dr. 
Lavis is the Canada Research Chair in Evidence-Informed Health Systems. 
Multiple other collaborators are engaged in this study (Appendix 19). Collaborators have helped 
shape this proposal and are available for questions throughout the study and in the interpretation 
of the results but are not involved in data collection or the conduct of the analysis. 
 
Research environment 
 
McMaster University provides a rich and supportive environment to conduct health-
related research. The facilities (e.g., David Braley Health Sciences Centre, offices), infrastructure 
(e.g., access to the university library), support personnel (e.g., administrative support), 
equipment (e.g., computers), and supplies (e.g., printer, paper) will allow each researcher to 
carry out his/her role for this proposed project.  
 
Appropriateness of the research team in relation to achieving stated goals, meaningful 
inclusion of participants, healthcare professionals and policymakers  
The research team comprises researchers, healthcare professionals, knowledge users, and 
patients/stakeholders, who have all provided input into the healthy lifestyles program and/or the 
evaluation of the program. Two patients/stakeholders have been involved in the development of 
this proposal. In addition, participants’ perspectives will be sought throughout the study 
especially with regards to implementation considerations and with regards to program 
evaluation. Program staff and participants’ health providers will also be included in evaluating 
the program and its implementation through qualitative in-depth interviews. Family members of 
participants in the MIP arm will be invited to participate in focus groups to gain insight into the 
role of family members in creating and maintaining healthy lifestyles and their perspectives on 
the MIP. Dissemination of findings will also occur through presentations at conferences and for 
community and health professional groups, publishing of findings in peer-reviewed journals and 
in reports, and through direct communication with other researchers, community and special 
interest groups (e.g., community pharmacists, pharmaceutical companies), and policymakers.   
 
ENGAGEMENT AND PARTNERSHIP 
 
Partnership building activities and plans to attain sustainable relationships 
 
The intent of the healthy lifestyles program is to help participants develop realistic and 
sustainable healthy lifestyle plans. Following the ecological model for health behavior, these 
plans will not only include individual but also interpersonal, community or organizational, and 
policy aspects of healthy lifestyles. To address these perspectives, further partnerships will be 

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sought with relevant community groups/individuals to support the participants’ healthy lifestyle 
changes. In addition, outreach to relevant decision-makers will be conducted to disseminate 
findings from the study but also to engage them on determining policy implications of the 
program especially with regards to a larger randomized trial. To meet these ends, more formal 
partnerships will also be sought at the regional level with public health and local health 
integration networks (LHIN) and with other researchers at McMaster University. One of the co-
applicants on this proposal is the Director of the McMaster Health Forum at McMaster 
University. The Forum works with citizens, policymakers and other stakeholders to support the 
use of research evidence in health decision-making. At a national level, links with the Pan-
Canadian SPOR Network in Primary and Integrated Health Care Innovations will be invaluable 
and membership into this Network will be sought. 
 
Engagement plan 
Because families and communities are an integral part of an individual’s abilities to make 
healthy lifestyle changes, they will be included in both evaluation as well as treatment aspects of 
the MIP. For example, with the participant’s permission, their families will be asked to partake in 
evaluation activities to understand their perspectives around issues of healthy lifestyles and 
chronic disease prevention and management. Community supports will be identified from the 
perspective of participants’ needs. Principles of community engagement (39,65,66) will be 
followed but modifications may be made as these approaches may necessitate new methods since 
the starting point is not the community, but rather, the individual and his/her needs. Links with 
health units and LHINS in Southern Ontario already exist through the McMaster Master of 
Public Health Program’s educational and practicum activities. These relationships will be 
strengthened through meetings and collaborations arising through this project. Membership into 
the Pan-Canadian SPOR Network in Primary and Integrated Health Care Innovations will help 
engage the larger Network, and collaborations with those working on integrating care and 
healthy lifestyles can be developed. 
 
MENTORING AND TRAINING 
 
Proposed actions to mentor and train junior team members in the conduct of participant-
oriented research 
Research team members will receive training in conducting data collection in participant-
oriented research. In addition, a number of practice-based students (e.g., clinical, public health, 
nursing, physician assistants) will be able to train in person-centered care as well as participant-
oriented research. Thesis and research practicum students will be able to help with patient 
recruitment, data collection and analysis, project management and related research activities. The 
adaptive design of this study, will allow trainees will have the opportunity to partake in this 
study and develop sub-studies to be conducted in a larger randomized trial or for future research. 
For example, eHealth students may take on reviewing and testing various wearable technologies 
for managing stress or for increasing physical activity. Public health students will be able to test 
innovative approaches to health promotion. Physician assistant students may be able to test their 
roles within a multidisciplinary approach to healthy lifestyles. If these projects are not already 
reflected in this proposal, additional project proposals will be submitted to HIREB prior to 
commencement of the projects. 
 

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