Promoting Successful Weight Loss in Primary Care in Louisiana
Phase: NA
Conditions: Obesity
Sponsor: Pennington Biomedical Research Center

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PROmoting Successful Weight Loss in Primary CarE in Louisiana 
(PROPEL) Trial 
 
 
 
PROTOCOL 
 
Version 13.1 
 
 
 
April 6, 2020 
 
 
 

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PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) Trial Protocol 
 
TABLE OF CONTENTS 
 
1. Abbreviations .............................................................................................................. 3 
 
2. Technical Abstract ...................................................................................................... 6 
 
3. Public Abstract ............................................................................................................ 9 
 
4. Specific Aims ............................................................................................................ 10 
 
5. Background and Significance ................................................................................. 11 
 
6. Overview of Research Design ................................................................................. 12 
 
7. Inclusion/Exclusion Criteria ..................................................................................... 14 
 
8. Recruitment and Retention of Patients ................................................................... 15 
 
9. Randomization and Blinding ................................................................................... 16 
 
10. Intervention Methods .............................................................................................. 17 
 
Overview of the Intervention Arms ...................................................................... 17 
 
Description of the Lifestyle Intervention Arm  ...................................................... 17 
 
Description of the Usual Care Arm ...................................................................... 22 
 
11. Data Collection ........................................................................................................ 23 
 
12. Quality Assurance and Control ............................................................................. 28 
 
13. Data Management ................................................................................................... 29 
 
14. Safety and Data Monitoring ................................................................................... 30 
 
Potential Risks .................................................................................................... 31 
 
Data and Safety Monitoring Plan ........................................................................ 33 
 
Inclusion of Women and Minorities ..................................................................... 38 
 
Inclusion of Children ...........................................................................................  38 
 
15. Power and Sample Size .......................................................................................... 39 
 
16. Data Analysis Plan .................................................................................................. 40 
 
17. Trial Organization ................................................................................................... 42 
 
18. Timeline ................................................................................................................... 43 
 
19. Literature Cited ....................................................................................................... 44 
 
20. Appendices .............................................................................................................. 49 

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1. Abbreviations 
AAHRPP 
Association for the Accreditation of Human Research Protection Programs 
ACC 
 
American College of Cardiology 
ACP 
 
American College of Physicians 
AE 
 
Adverse Event 
AHA 
 
American Heart Association 
AHEAD 
Action for Health in Diabetes 
BEV-Q  
Beverage Intake Questionnaire 
BMI 
 
Body Mass Index 
BV 
 
Baseline Visit 
CAHPS 
Consumer Assessment of Healthcare Providers and Systems 
CALERIE 
Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy 
CC 
 
Coordinating Center 
CMS  
Centers for Medicare and Medicaid Services 
CTS 
 
Computer Tracking System 
DPP 
 
Diabetes Prevention Program 
DSMB  
Data and Safety Monitoring Board 
DSMP  
Data and Safety Monitoring Plan 
HDL-C  
High-Density Lipoprotein Cholesterol 
HIPAA  
Health Insurance Portability and Accountability Act 
HTE 
 
Heterogeneity of Effects 
ID 
 
Identification 
IRB 
 
Institutional Review Board 
IPAQ-SF 
International Physical Activity Questionnaire - Short Form 
IWQOL 
Impact of Weight on Quality of Life 

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LA 
 
Louisiana 
LA CaTS 
Louisiana Clinical & Translational Science Center 
LDL-C  
Low-Density Lipoprotein Cholesterol 
LEAP  
Lifestyle Eating and Activity Program 
LOSS  
Louisiana Obese Subjects Study 
MET 
 
Metabolic Equivalent 
MM 
 
Medical Monitor 
MMT 
Medical Monitoring Team (MM, NP and CC) 
MOP  
Manual of Procedures 
NCI 
 
National Cancer Institute 
NHANES 
National Health and Nutrition Examination Survey 
NIH 
 
National Institutes of Health 
NP 
 
Nurse Practitioner 
PCORI  
Patient Centered Outcomes Research Institute 
PCP 
 
Primary Care Provider 
PI 
 
Principal Investigator 
POWER 
Practice-based Opportunities for Weight Reduction 
PROACTIVE Prevention and Reduction of Obesity through Active Living 
PROMIS®  
Patient Reported Outcomes Measurement Information System 
PROPEL 
PROmoting Successful Weight Loss in Primary CarE in Louisiana  
RD 
 
Registered Dietician 
REALM 
Rapid Estimate of Adult Literacy in Medicine 
RE-POWER Rural Engagement in Primary Care for Optimizing Weight Reduction 
REDCap 
Research Electronic Data Capture 
SAE 
 
Serious Adverse Event 
SF 
 
Short Form 

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SOP 
 
Standard Operating Procedures 
SV 
 
Screening Visit 
TOS 
 
The Obesity Society 
US 
 
United States 
VA 
 
Veterans Affairs 
YMCA  
Young Men’s Christian Association 
 

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2. Technical Abstract 
Background 
 
Obesity is a highly prevalent and serious medical and social condition in the United States, with 
Louisiana (LA) currently among the states with the highest rates of obesity. Obesity accounts for 
$2.4 billion in yearly health care expenditures in this state, 42.5% of which are financed by 
Medicaid/Medicare.1 Obesity and its health outcomes disproportionately affect underserved 
populations, and LA is characterized by high levels of poverty, low health literacy, and food 
insecurity, all of which may contribute to the high obesity levels in the state.  
Primary care physicians are the cornerstone of medical care in the United States. The US 
Preventive Services Task Force has recommended that physicians should offer intensive multi-
component behavioral interventions to obese individuals2, and the Centers for Medicare and 
Medicaid Services (CMS) covers intensive behavioral therapy for obesity by a qualified primary 
care practitioner (PCP). However, the sole reliance on physicians, nurse practitioners, or 
physician assistants to deliver intensive behavioral therapy for obesity has limitations, in part 
due to the limited time available during a typical primary care visit, and lack of training among 
PCPs in the delivery of behavior therapy protocols. Further research is required to develop 
evidence-based models of delivery of obesity treatment within primary care. There is a critical 
need to test models that incorporate the recently released 2013 AHA/ACC/TOS Guidelines for 
the Management of Overweight and Obesity in Adults3, which are adaptable to real-life settings 
and which provide effective and cost conscious delivery methods for obesity treatment in the 
primary care setting.  
 
Objectives 
 
The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-
centered, pragmatic and scalable obesity treatment program delivered within primary care in an 
underserved population. We hypothesize that: 
1) Relative to patients who receive usual care, patients who receive a high-intensity, health 
literacy-appropriate and culturally adapted lifestyle intervention targeting increased physical 
activity and reduced dietary intake delivered by trained health coaches embedded in a 
primary care setting and supervised by providers trained in obesity science will have greater 
percent reductions in body weight; and 
2) Relative to patients in usual care, patients who receive the intervention will have significant 
improvements in quality of life, functional capacity, satisfaction with medical care, and 
improve obesity co-morbidities (hypertension, dyslipidemia, insulin resistance, urinary 
incontinence and respiratory problems such as sleep apnea).  
There are three secondary aims. Secondary Aim 1 is to evaluate relationships between 
adherence to intervention components (physical activity, diet, sessions, etc.) and corresponding 
changes in body weight and secondary outcomes (post-hoc analyses). Secondary Aim 2 is to 
examine the effects of the intervention on system-level practices and patient satisfaction with 
care. Secondary Aim 3 is to test the heterogeneity of effects across clinics and across 
subgroups of patients (men versus women, white versus African American, older versus 
younger adults). 
 
Methods 
 
Study Design. This study is a cluster-randomized, two-arm controlled trial in a primary care 
setting. Study Population. A total of 18 primary care clinics inclusive of low income populations 

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with a high percentage of African Americans from urban and rural areas of Louisiana will be 
randomized to either 1) intervention or 2) usual care. The sample will include up to 850patients 
(18 clinics, 47 patients/clinic). Justification of Sample Size. The sample size calculations were 
based on the Louisiana Obese Subjects Study (LOSS), a pragmatic clinical trial conducted by 
Pennington Biomedical comparing intensive medical intervention for obesity versus usual care.4 
According to the 2013 Obesity Guidelines, as little as 3-5% weight loss is likely to result in 
clinically meaningful health outcomes.3 Thus, the sample size calculations assume that the 
study is powered to detect a mean weight loss in the intervention arm of 3.5% at 2 y, relative to 
usual care, in race- and sex-specific subgroups. We are targeting a mean weight loss of >5% 
which we anticipate to be 3.5% more than usual care. Both the total and relative weight loss 
meet accepted levels of clinical significance. Power calculations used a nominal 0.05 
significance level with a two-tailed test with minimal power of 80%. Based on LOSS, the 
standard deviation for weight change for patients nested within clinics was 8.4%. For the 
subgroup analysis, a net sample size of 92 patients/arm is sufficient for detecting a 3.5% weight 
loss with 80% power with patient-level randomization. After accounting for the design effect, at 
least 134 patients per arm are required to realize 80% power in a trial randomized at the clinic 
level.  Allowing for 30% attrition, at least 192 patients per arm are needed with a total enrollment 
of 384 patients per subgroup. Inclusion/Exclusion Criteria. Given that this is a pragmatic trial, 
the inclusion criteria are broad and include having a BMI 30 to 50 kg/m2, and an age 20 to 75 
years. Women will be required to be non-pregnant and agree to avoid pregnancy during the 
study. Exclusion criteria include a history of major depression, suicidal behavior or eating 
disorder, hospitalization for mental disorder or substance abuse in the previous year, active 
cancer, cardiovascular or cerebrovascular disease event in the past year, heart failure, and 
current use of weight loss medications or recent weight loss. Outcomes. The primary outcome is 
percent change in body weight from baseline. Secondary outcomes include change in quality of 
life, functional capacity, satisfaction with medical care, and obesity co-morbidities (hypertension, 
dyslipidemia, insulin resistance, urinary incontinence and respiratory problems such as sleep 
apnea). The secondary outcomes were selected based on the prior experience of the 
investigators working with obese patients, and they should be considered preliminary, as they 
could change based on our planned patient focus groups. Analytic Methods. Analyses will be 
performed on an intent-to-treat basis. For continuous outcomes, a linear mixed model for 
repeated measures over time will be used, including the fixed effects of intervention, time, and 
their 2-factor interactions, with age, sex and clinic as covariates. For dichotomous outcomes, a 
generalized linear mixed model with a logit link will be applied using the same modeling 
approach. Estimated within-group changes between baseline and 6 to 24 months will be 
estimated and compared using contrasts within the mixed models. Baseline outcomes will 
further be included in the models as covariates to determine the change in outcome from 
baseline. The study design will also allow for analysis of clinic-level characteristics that are 
associated with better outcomes. Anticipated Effect Size. Weight loss in the lifestyle intervention 
arm of Look Ahead was 6.4% at 2 y, compared to 1.1% in the education arm.5 The original 
Diabetes Prevention Program (DPP) intensive lifestyle intervention produced a weight loss of 
5.8% at 2 y6, and this effect has been replicated in a DPP adaptation for deployment through 
the YMCA, with an initial weight loss of 6% in the intervention versus 2% in control group at 6 
months7; a reduction which was maintained in the intervention arm at 2 y.8 Further, the 2 y 
results from LOSS showed between 4.9% (baseline carried forward analysis) to 9.6% 
(completers only) weight loss in the intensive medical intervention arm, compared to 0.4% for 
usual care.4 Thus, based on these prior studies, and the delivery of the proposed intervention in 
a primary care setting, we anticipate achieving at least a 3.5% weight loss differential between 
intervention and usual care. Treatment Arms. Trained coaches under provider supervision will 
deliver the active intervention - a comprehensive, “high-intensity" program, as recommended 

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first-line therapy by the 2013 Obesity Guidelines, and based on the Look Ahead intensive 
lifestyle intervention.9 This intervention will include 15 in-person sessions in the first six months, 
followed by at least monthly sessions for the remaining 18 months. The intervention will include 
evidence-based components and several behavioral strategies. Innovative aspects of the 
intervention include the addition of a trained “health coach” to the primary care team, a provider 
education program about energy balance and medical aspects of obesity, and a tailored 
treatment approach using a computer tracking system and novel toolbox strategies and 
algorithms.10 In addition, the intervention materials will be adapted to be health-literacy and 
culturally appropriate, which is both novel and important for the target population. The usual 
care arm will receive the obesity treatment currently approved by CMS. A baseline webinar will 
be conducted with the primary care providers randomized to usual care, describing the current 
CMS approach to reimbursing for obesity treatment, and background on obesity interventions; a 
reminder informational brochure will be sent to the providers at 1 y. 
 
Patient Outcomes 
 
The patient outcomes include reductions in body weight, improvements in quality of life, 
functional capacity, satisfaction with medical care, and resolution of obesity co-morbidities 
(hypertension, dyslipidemia, insulin resistance, urinary incontinence and respiratory problems 
such as sleep apnea). From our experience, “weight loss” per se is an important patient 
outcome and is the primary outcome of this trial. Further, in one of the few studies that have 
addressed patient-centered outcomes related to obesity surgery, the most important outcomes 
were weight loss and “a desire for changing medical co-morbidities".11  
 
Anticipated Outcomes 
 
This study will have a direct impact on “improving healthcare delivery and outcomes”, which are 
key components of the PCORI mission. Given the low uptake of the current CMS 
reimbursement for obesity in primary care, it is anticipated that the results will impact the way 
that CMS funds obesity treatment in the future. This is a five-year carefully designed and 
implemented research project; however, the intervention is designed to be economical and 
scalable to large patient populations, with all of the economies of scale that that entails.  
 
 

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3. Public Abstract 
Obesity is a very common and serious medical and social condition, with Louisiana currently 
ranked among the states with the highest levels of obesity. Obesity is a condition that increases 
the risk of type 2 diabetes, heart disease, stroke, gallbladder disease, respiratory problems, 
quality of life, and several cancers. Obesity and its health problems greatly affect underserved 
populations, and Louisiana is characterized by high levels of poverty, low health literacy, and 
food insecurity, all of which may contribute to the high obesity levels in the State. While the high 
rates of obesity are of great concern, a greater concern is that our health care system has failed 
to deliver medical interventions capable of producing even modest weight loss. 
Recently, the American Heart Association, American College of Cardiology, and the Obesity 
Society released a set of treatment guidelines for obese patients which are adaptable to real-life 
settings and which could add effective methods for obesity treatment in the primary care setting. 
Based on this, we know that modest weight loss is achievable in some settings; however, there 
has been no successful translation of this achievement to primary care practices. 
Primary care physicians remain the cornerstone of medical care in the United States. Thus, 
the primary aim of this study is to test the effectiveness of a 24 month, patient-centered, 
pragmatic and scalable obesity treatment program delivered within primary care in an 
underserved population. We will randomly assign 18 primary care clinics serving low income 
populations with a high percentage of African Americans throughout Louisiana to either a 
comprehensive obesity treatment program or to a usual care group that receives the current 
obesity treatment under Medicaid/Medicare.  
Patients and stakeholders will be engaged at all phases of the project. We will initiate and 
maintain the process of building trust among the community, investigators and the primary care 
clinics by expanding existing and fostering new trusted relationships. The partnerships will seek 
the well-being of its people through research, education and service. The four key aspects of 
community engagement and outreach rooted in the Community-Based Participatory Research 
principles will be: 1) create community and patient awareness; 2) inform the community of the 
study’s benefits; 3) involve patients and stakeholders as collaborators through active 
participation in the study, and 4) provide mechanisms to convey healthy weight information back 
to the community. 
This intervention is designed to be economical and scalable to large patient populations. 
Given the low uptake of the current Medicaid/Medicare reimbursement for obesity, it is 
anticipated that the results will impact the way that obesity treatment options are funded in the 
future. This study will have a direct impact on improving healthcare delivery and outcomes, 
which are key components of the PCORI mission. 
 
 
 

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4. Specific Aims 
The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-
centered, pragmatic and scalable obesity treatment program delivered within primary care in an 
underserved population. We hypothesize that: 
 
1) Relative to patients who receive usual care, patients who receive a high-intensity, health 
literacy-appropriate and culturally adapted lifestyle intervention targeting increased physical 
activity and reduced dietary intake delivered by trained health coaches embedded in a 
primary care setting and supervised by providers trained in obesity science will have greater 
percent reductions in body weight; and 
 
2) Relative to patients in usual care, patients who receive the intervention will have significant 
improvements in quality of life, functional capacity, satisfaction with medical care, and 
improve obesity co-morbidities (hypertension, dyslipidemia, insulin resistance, urinary 
incontinence and respiratory problems such as sleep apnea).  
 
There are three secondary aims: 
 
Secondary Aim 1 is to evaluate relationships between adherence to intervention components 
(physical activity, diet, sessions, etc.) and corresponding changes in body weight and 
secondary outcomes (post-hoc analyses).  
 
Secondary Aim 2 is to examine the effects of the intervention on system-level practices and 
patient satisfaction with care.  
 
Secondary Aim 3 is to test the heterogeneity of effects across clinics and across subgroups of 
patients (men versus women, white versus African American, older versus younger adults). 
 
 
 

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5. Background and Significance 
Background 
  
Obesity is a highly prevalent and serious medical condition in the United States, with Louisiana 
(LA) currently ranked among the states with the highest levels of adult obesity.12 Obesity is a 
condition that increases the risk of type 2 diabetes, heart disease, stroke, gallbladder disease, 
respiratory problems, poor quality of life, and several cancers.13 Further, obese adults have an 
elevated risk of dying prematurely14, resulting in lower estimates of life expectancy at the 
population level.15  
We are intimately familiar with the health burden that obesity imposes, since our region sits 
firmly in the “Chronic Disease Belt”, characterized by high prevalence of cancer16, 
cardiovascular disease17,18, diabetes19, and obesity.20 Furthermore, we are familiar with and 
have engaged in programs to address health management in minority populations (32% of LA 
population is African American)21, for those living in poverty (19% of residents live in poverty)21, 
and for those with low health literacy (LA is ranked 49th among the states for low levels of health 
literacy).22 Obesity accounts for $2.4 billion in yearly health care expenditures in LA, 42.5% of 
which are financed by Medicaid/Medicare.1  
While the high rates of overweight and obesity are of great concern, a greater concern is 
that our health care system has failed to deliver medical interventions capable of producing 
even modest weight loss.23 Modest weight loss can dramatically reduce the rates of conversion 
to type 2 diabetes among patients with pre-diabetes.24-26 With 15-30% of the 79 million 
Americans with pre-diabetes projected to progress to type 2 diabetes in the next 5 years without 
lifestyle intervention and weight loss27,28, the failure of current medical practice to address this 
issue effectively mandates action. Modest weight loss can improve levels of blood pressure, 
HDL cholesterol, triglycerides, C reactive protein, symptoms of sleep apnea, urinary 
incontinence, and sexual dysfunction and prevent loss of mobility.29 While we know that modest 
weight loss is achievable in some settings, such as in >2500 participants from 16 academic 
sites of the Look AHEAD trial30, there has been no successful translation of this achievement to 
primary care practices.  
Primary care physicians are the cornerstone of medical care in the United States. The U.S. 
Preventive Services Task Force recommends that physicians offer intensive multi-component 
behavioral interventions to obese individuals2, and the Centers for Medicare and Medicaid 
Services (CMS) covers intensive behavioral therapy for obesity by a qualified PCP.31 However, 
the sole reliance on physicians, nurse practitioners, or physician assistants to deliver intensive 
behavioral therapy for obesity has limitations, in part due to the limited time available during a 
typical primary care visit, and lack of training among PCPs in delivery of behavior therapy.23,32  
A recent review of obesity management in primary care indicated that obesity treatment 
options delivered in primary care have resulted in limited success, demonstrating only 1-3 kg 
(about 1-3% of baseline weight on average) weight loss over 6-24 months of intervention.23 The 
authors concluded that this low weight loss is likely due to the low intensity of the interventions, 
as most studies typically only employed monthly or quarterly visits of 10-15 min duration.23 
Thus, further research is required to develop sustainable, evidence-based models of obesity 
treatment in primary care.  
The recently released 2013 American Heart Association (AHA)/American College of 
Cardiology (ACC)/The Obesity Society (TOS) Guidelines for the Management of Overweight 
and Obesity in Adults3,29 are emphatic that comprehensive lifestyle intervention delivered 
intensively is the centerpiece of weight loss for health benefit. These guidelines, based on an 
exhaustive systematic review33, emphasizes that the gold standard is on-site, high intensity (>14 
sessions in 6 months) comprehensive intervention delivered in group or individual sessions by a 

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trained interventionist and persisting for a year or more. However, to date there is no evidence 
of effectiveness of using these guidelines in primary care. Treatment models based on the 
AHA/ACC/TOS Guidelines which are adaptable to real-life settings and which add effective and 
cost conscious delivery methods for obesity treatment in the primary care setting are needed. 
 
Significance 
  
This study is a comparative effectiveness trial of a sustainable, pragmatic obesity intervention 
set within primary care. This primary aim is directly related to the significance of the proposed 
research. As described above, obesity is a prevalent, serious medical condition, and effective 
weight management is not being adequately addressed in primary care practices. Thus, there is 
an urgent need to develop and test pragmatic treatment strategies in the primary care setting, 
especially those recommended in the 2013 AHA/ACC/TOS Guidelines for the Management of 
Overweight and Obesity in Adults.3,29 There is a gap between current guidelines and what is 
currently implemented in clinical practice; the goal of modest weight loss is not being achieved; 
thus, comparative effectiveness studies are required to change the way that primary care 
practitioners approach the problem of obesity, and engage and assist patients with obesity. This 
study directly addresses this gap by testing the effectiveness of intensive behavioral treatment 
for obesity relative to usual care.          
This study will have a direct impact on “improving healthcare delivery and outcomes”, which 
are key components of the PCORI mission. Given the low uptake of the current CMS 
reimbursement for obesity in primary care, it is anticipated that the results will impact the way 
that CMS funds obesity treatment in the future. As described above, effective obesity treatment 
programs currently exist; however a “translation-gap” also exists where the current science has 
not been implemented in primary care in any scalable format. The adaptation of an intensive 
lifestyle intervention34 for deployment in primary care settings has the potential to significantly 
address this gap. PROPEL is a five-year, carefully designed and implemented research project; 
however, the intervention is designed to be economical and scalable to large patient populations 
that can impact obese patients throughout the United States.  
By design, this is a patient-centered intervention with a strong focus on tailoring weight loss 
efforts to the individual patient. First, we are involving patients at every stage of the study, from 
the identification of patient-centered outcomes, to providing input on feasible intervention 
approaches, to the final dissemination of results and the potential for sustainability of the 
intervention in primary care. Second, the patient-centered intervention itself is personalized and 
individually adaptable. The focus of the intervention is on developing personalized, patient-
centered obesity treatment plans, through the close interaction between the patient, a health 
coach, and the primary care team. As described below, a range of “toolbox” options are 
available to aid in maintaining weight loss, all of which are tailored to patient preferences.    

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6. Overview of Research Design 
This study is a cluster-randomized, two-arm controlled trial in primary care settings. A total of 18 
primary care clinics inclusive of low income populations with a high percentage of African 
Americans from urban and rural areas across Louisiana will be randomized to either 1) 
intervention or 2) usual care. The sample will include up to 850obese (BMI 30-50 kg/m2) 
patients (18 clinics, 47 patients / clinic).  
The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-
centered, pragmatic and scalable obesity treatment program delivered within primary care, 
inclusive of an underserved population. Patients in the intervention arm will attend weekly (15 
in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 
months. The behavioral intervention will be delivered by a trained health coach embedded in the 
primary care clinic. PCPs in the intervention arm will receive a series of webinars on obesity 
science to help them manage and treat obese patients. Patients assigned to the usual care arm 
will continue to interact with their PCP according to their usual schedule, and will be provided 
newsletters and/or invited to attend group sessions where a listing of health promotion events 
offered in the community is combined with information on topics of interest, including importance 
of sleep for health, household money management, family coping skills, smoking cessation, etc. 
PCPs in the usual care arm will receive a webinar describing the current CMS approach to 
reimbursing for obesity treatment, and a reminder informational brochure will be sent to the 
PCPs each year. Patients in both arms will be assessed on primary and secondary outcome 
measures at baseline, and at 6, 12, 18 and 24 months of intervention. Figure 1 presents a 
schematic representation of patient flow through the trial. 
 

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7. Inclusion/Exclusion Criteria 
PROPEL is a pragmatic trial to be conducted in primary care clinics. Thus, the inclusion criteria 
are broad and designed to capture a large cross-section of the target population, including 
patients with controlled diabetes, hypertension and dyslipidemia. The specific inclusion and 
exclusion criteria are provided in Table 1. 
 
Table 1. Eligibility Criteria for the PROPEL trial. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion Criteria 
 
Age 20.0 – 75.0 years 
 
BMI 30.0 – 50.0 kg/m2 
 
Able to provide written informed consent 
 
Willing to change diet, physical activity and weight 
 
Patient of a participating clinic 
 
Able to participate in scheduled sessions 
 
Exclusion Criteria 
 
Currently participating in a weight loss program  
 
Current use of weight loss medication or recent weight loss (>10 lbs in last six months)  
 
Plans to move from the area within 2 years 
 
Given birth within the past year, is currently pregnant or plans to become pregnant within 
2 years 
 
Past bariatric surgery or plans for bariatric surgery within 2 years 
 
Current major depression 
 
History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia) 
 
Hospitalization for mental disorder or substance abuse in the previous year  
 
Active cancer (except prostate, skin and thyroid if approved by physician)  
 
Serious arrhythmias or cardiomyopathy 
 
Severe congestive heart failure 
 
Stroke or heart attack in previous six months 
 
Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or 
inflammatory bowel disease(i.e. Crohn’s disease or ulcerative colitis) 
 
Disease that is life threatening or that can interfere with or be aggravated by exercise or 
weight loss 
 
Discretion of primary care physician or principal investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8. Recruitment and Retention of Patients 
Patients will be recruited in the clinics through the primary care practitioners, who will identify 
patients who meet the inclusion criteria and provide them with a brochure about the study. A 
trained recruiter will follow up with the patient to assess their interest in participating and screen 
them for eligibility during a screening visit (SV) in which they will have their height, weight and 
blood pressure measured, and they will answer several questionnaires (see Section 11) to 
determine their eligibility. Importantly, the recruiter will administer a Study Feasibility Interview 
(see Appendix A) to identify and exclude from enrollment patients who will not be capable of 
completing the trial. For example, patients who intend to move out of the area or women who 
plan to become pregnant will be excluded. The interview does not evaluate the likelihood of the 
patient being able to adhere to the intervention (usual care or active intervention). The potential 
participant will provide written informed consent prior to participating in measurements during 
the SV. Following the SV, if the patient is deemed eligible, he/she will be formally enrolled in the 
study at the baseline visit. Patients who participate in the SV activities will not be considered 
enrolled in the study until they have received permission from their primary care physician to 
participate in the trial, and they return for their baseline visit.  
A variety of approaches will be used to retain patients. Based on our experience, we 
understand the importance of creating a pleasant clinic environment and friendly and welcoming 
staff presence. We are also very clear from the initial screening session onward about what we 
expect from patients and what they can expect from us, as keeping patients well informed 
enhances adherence to the intervention and test schedules. Further, we will provide small gifts 
to patients including hats, umbrellas, coffee cups, etc., with the study logo, which has improved 
retention in our previous studies. Finally, a total of $375/patient is budgeted for incentives 
related to the provision of outcome measures. All patients will be paid at the completion of each 
assessment visit ($75 at each of baseline, 6, 12, 18 and 24 months).  
 
 

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9. Randomization and Blinding 
Randomization 
 
This is a cluster-randomized trial, and enrolled patients at a given clinic will receive the 
intervention assigned to their clinic. A pool of 18 clinics will be randomized to either 1) usual 
care or 2) intervention, after stratification by health system. Stratification by health system is 
necessary to ensure adequate local staffing of clinics assigned to the intervention arm, 
representation from all regions of the state and types of health systems in both arms of the trial.     
 
Blinding 
 
Given that this trial is randomized at the clinic level and the interventions are very distinct, 
PROPEL patients will know their group assignment, as will clinic staff and health educators that 
are involved in delivering the intervention. However, every effort will be made to blind staff 
involved in data collection to the clinic randomization, and all intervention staff will be blinded to 
the patients’ official study measurements.  
 
 
 

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10. Intervention Methods 
Overview of Intervention Arms 
 
The overall study design of the PROPEL trial is a two-arm, cluster-randomized trial with clinics 
randomized to 1) intervention or 2) usual care. Trained health coaches will deliver the active 
intervention - a comprehensive, “high-intensity" program, as recommended first-line therapy by 
the 2013 AHA/ACC/TOS Obesity Guidelines29, and based on the Look AHEAD intensive 
lifestyle intervention.34 The Look AHEAD intervention was an adaptation of the Diabetes 
Prevention Program (DPP) which demonstrated that a lifestyle intervention decreased the risk of 
developing type 2 diabetes among overweight and obese individuals with impaired glucose 
tolerance.25 Following closely upon DPP, the Look AHEAD multi-center trial was designed to 
determine whether weight loss reduces cardiovascular morbidity and mortality in overweight 
individuals with type 2 diabetes.35 The Look AHEAD trial was stopped early on the basis of 
futility analysis on the primary cardiovascular outcome after 9.6 years; however, weight loss was 
significantly greater in the intervention group compared to control throughout the study.30  
Patients in the usual care condition will receive the obesity treatment guided by what is currently 
approved by CMS.31 
 
Intervention Arm 
 
The active intervention arm of the PROPEL trial is an adaptation of the Look AHEAD intensive 
lifestyle intervention, and will include 15 in-person sessions in the first six months, followed by 
monthly sessions for the remaining 18 months. The intervention will include evidence-based 
components such as the use of portion control and behavioral strategies. The intervention 
components have been adapted through input of patient focus groups and patient advisory 
boards. Innovative aspects of the intervention include the addition of a trained “health coach” to 
the primary care team, a PCP education program about energy balance and medical aspects of 
obesity, a tailored, patient-centered treatment approach using a computer tracking system 
(CTS) with novel toolbox strategies10, and a special emphasis on health literacy. The health 
coaches will have an educational background in nutrition and/or physical activity/kinesiology and 
will be formally trained at baseline by experienced interventionists from Pennington Biomedical 
and health literacy experts at LSUHSC-Shreveport and will attend refresher courses each year. 
Ideally, the health coaches will have a Bachelors or Masters degree, and/or a professional 
degree such as an R.D. Health coaches will be recruited from communities in close proximity to 
where the intervention will be delivered. In addition, the intervention materials will be adapted to 
be health-literacy and culturally appropriate, which is both novel and important for the target 
population. The key components of the intervention are described below, as well as novel 
adaptations for integrating the original Look AHEAD intervention into the primary care setting. 
 
Behavioral Therapy 
 
Patients in the intervention arm will attend weekly (15 in-person) sessions in the first six months, 
followed by monthly sessions for the remaining 18 months (see Figure 2). The behavioral 
intervention will be delivered by a trained health coach embedded in the primary care clinic. The 
health coaches will be trained by experienced interventionists from Pennington Biomedical with 
experience from DPP and Look AHEAD, similar to the training deployed in the LOSS trial.4 
Training will include: 1) study protocol review, 2) peer-tutored review of earlier lessons, 3) small 
group exercises to practice therapeutic skills, and 4) trainees’ observation of senior 
interventionists conducting individual and small-group sessions. Topics will include the use of 

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meal replacements, physical activity, calorie balance, self-monitoring, structured diets, health 
literacy and toolbox approaches (see description below under “Toolbox Strategies” heading). 
Health literacy training will include use of plain language, summarization and “teach back” to 
confirm understanding as well as strategies to help patients set personal health goals and action 
plans for how they will meet these. Certification will ensure that the health coaches have a clear 
understanding of the study protocol, manual of procedures, lifestyle manuals and health literacy 
approaches. To ensure ongoing fidelity of the intervention, Pennington Biomedical staff will 
conduct monthly monitoring of each site via conference call or site visits and monthly CTS 
reports. 
Results from Look AHEAD demonstrated that the greater the initial weight loss (at year 1), 
the greater the weight loss at year 4.36 Further, individuals who accumulated greater 
incremental weight losses and/or whose weight loss was more sustained during the first year 
had better maintenance of weight loss at year 4,37 and our group has found that fostering weight 
loss in the first weeks greatly improves patient engagement and motivation. Thus, a strong 
focus of the intervention will be on maximizing the initial (three month) weight loss in this group. 
Look AHEAD relied heavily on large group sessions to deliver the intervention, whereas DPP 
used mainly individual sessions. Large group sessions are not very feasible in the primary care 
setting due to a lack of adequate space, and lack of access during non-clinic hours when 
sessions are typically scheduled (evenings, weekends, etc.). Therefore, our intervention will rely 
more on individual and small group 
sessions in the clinic (3-5 patients, 
based on scheduling availability) during 
the initial 6-month phase, similar to DPP, 
followed by individual and small group 
in-person and telephone contact 
(alternating months) in the final 18 
months (see Figure 2). A comparative 
effectiveness trial38 provided evidence 
that remote contact (telephone, web, 
email) was as effective as in-person 
contact in obesity interventions in clinical 
practice, suggesting that a shift from in-
person to telephone contact in the final 18 months of the intervention will be effective at 
sustaining initial weight loss. 
An important component of the behavioral intervention is shared short-term goal setting 
between the health coach and the patient in order to reach the broader study goals, as 
described below. Two important goals in this trial are related to weight loss and physical activity. 
The weight loss goal for each of the study centers in Look AHEAD was 7% of initial weight by 
year 1.34 However, the participants in that trial were given a higher personal weight loss goal of 
10% in order increase the likelihood that the study would achieve a mean weight loss of 7%.34 
Indeed, participants in the Look AHEAD intervention arm had a mean weight loss of 8.6% at 
year 1 versus 0.7% in the education arm.30 This difference was reduced, but remained 
significant at year 2, with a maintained loss of 6.4% in the intervention arm versus 1.1% in the 
education arm.36 Given the successful weight loss achieved in Look AHEAD, we will retain the 
personal goal of 10% weight loss for patients in the intervention arm of this trial. Patients will 
then be coached to set their own goals and develop eating and physical activity action plans to 
meet that goal.  
The results from both DPP and Look AHEAD indicate that an important goal is related to 
physical activity, as increases in physical activity were significantly related to weight loss 
success.36,39 The 2008 Physical Activity Guidelines for Americans call for ≥150 minutes of 

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moderate-to-vigorous physical activity per week.40 This was also the goal for DPP; however, 
Look AHEAD selected a more ambitious goal of ≥175 minutes/week, given evidence that 
prescribing higher levels of physical activity may improve outcomes.41 Further, the American 
College of Sports Medicine also recommends higher levels of physical activity for weight loss 
maintenance.42 Given the importance of physical activity for successful weight loss and weight 
loss maintenance, the goal for this trial is for patients to achieve at least 175 minutes per week 
of moderate-to-vigorous physical activity.  
 
Computer Tracking System (CTS) 
 
A novel adaptation of the Look AHEAD intervention for the purpose of this study is the 
addition of a CTS into the intervention, which will allow for tailoring of the intervention to the 
individual patient. Patients will be encouraged to weigh themselves daily using an electronic 
scale (provided) that directly uploads data via a cellular signal to a website. We developed 
computer code that automatically retrieves the data from this website and plots it onto their 
personal weight graph (Figure 3). This weight graph will be available to the patient, his/her 
health coach, and primary care provider via the CTS over the internet. We have used this 
approach in other trials, including CALERIE, an intensive 2 y intervention.10 The CTS will be 
used by the health coaches to identify 
patients who are struggling to meet their 
weight loss goals, triggering the algorithm 
to deploy strategies from the “toolbox” 
(described below). Information from the 
CTS is also used by the intervention team 
to observe adherence on a study-wide 
basis, for each of the clinics, and for each 
patient. Reports generated from the CTS 
on session attendance, self-monitoring, 
dietary adherence, and weight loss serve 
as indices of adherence to the intervention 
and are used by the team to evaluate 
compliance.  
We will use a weight loss calculator to: 
1) calculate personalized daily energy targets for each patient that, if met, will result in 10% 
weight loss, and 2) create a weight graph that displays each patient’s weight loss over time (see 
Figure 3). This weight graph determines if they are meeting their energy intake target and 
losing weight at the rate expected. The weight loss calculator was developed by members of 
this research team and colleagues. The calculator accurately predicts weight loss and 
accurately estimates the amount of energy intake needed to achieve specific weight loss goals 
(a version of the calculator can be found at www.pbrc.edu/research-and-
faculty/calculators/weight-loss-predictor/).43-46  
We have experience using the weight graph to track dietary adherence in the delivery of the 
personalized meal plan that, if followed, will result in the rate of weight loss depicted in the 
graph. We stress that this approach is very patient-centered as each patient’s graph is unique 
and the rate of weight loss is personalized to their age, weight, height, and sex. Further, the 
meal plans consider dietary preferences and dislikes, eating patterns, work schedules, etc. 
Indeed, the intervention is a collaborative. Patients are active in intervention delivery and 
receive on-going training to learn how to interpret weight graphs and modify their meal plans.   
 
 

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Dietary Component 
 
The restriction of calories from dietary sources is the cornerstone of weight loss efforts.29 The 
diet in this trial is based on Look AHEAD and DPP34,47, though we made modifications to 
improve scalability, sustainability, and the ability to disseminate the approach through primary 
care clinics. The diet plans will be further refined from feedback obtained in the patient focus 
groups. Once the energy intake target is identified, the patient will develop a structured calorie 
restricted meal plan in collaboration with the health coach that considers their food preferences, 
dislikes, etc. The meal plan for weeks 1-4 will include portion-controlled foods, which include 
items that are easily available and affordable, such as fruits (bananas, apples) and granola 
bars. Additionally, pre-packaged portion-controlled foods will be available as part of our tool-box 
approach for patients who are interested in using them (see below). After week 5, portion-
controlled foods will be utilized as needed, though the meal plan will become less structured 
over time as the patient learns to purchase, prepare, and package foods to manage portion size 
and energy intake. The meal plans will be consistent with dietary guidelines, i.e., ~55% 
carbohydrate, ~15% protein, and ~30% fat,48 will include nutrient-dense foods (e.g., whole 
grains, fruits, lean protein), and will be formatted for easy creation and dissemination through 
physician offices.  
 
Physical Activity Component 
 
The first month, the health coach will work with the patient to derive personal goals and specific 
action plans to meet the goals the patient sets. The patient will be challenged to aim for a goal 
of 50 minutes/week, in bouts of at least 10 minutes. The study physical activity goal will be to 
increase to 125 minutes/week by week 16 and to 175 minutes/week by week 24.34 The health 
coach will review the health benefits of physical activity and help patients to develop achievable, 
patient-preferred strategies to increase physical activity. In addition, the health coach will give 
patients easy to use pedometers (step counters) and show them how to use them. Patients will 
also be told of the benefits of using pedometers as an effective way to increase physical 
activity.49,50 A major focus of the physical activity intervention is on increasing lifestyle activities, 
such as taking the stairs instead of the elevator, parking further away, actively commuting 
(walking or riding bicycle), and replacing sedentary activities with more active options. The 
health coach will be trained to teach patients how to walk at a “moderate-to-vigorous” pace and 
use the “teach-back/show back” technique to ensure proper understanding. They will also 
provide tips and feedback to patients on how to increase their daily steps to levels 
approximating their goals. For example, recent data from NHANES and our work in Louisiana 
suggest that 8000-9000 steps/day are good targets for achieving at least 30 min/day of 
moderate-to-vigorous physical activity.51,52   
   
Toolbox Strategies for Behavioral Therapy 
 
A novel aspect of the proposed intervention is the expansion of the “toolbox” weight loss 
approach to the primary care setting. The toolbox has been successfully deployed in previous 
clinical trials and shown to lead to improvements in intervention efficacy.10,34,47 By systematically 
following pre-specified decision rules, it is possible to intervene quickly in order to overcome 
obstacles to success and improve adherence to the intervention. This approach also fosters 
treatment fidelity among health coaches and across sites. Additionally, the toolbox enables 
health coaches to tailor treatment to address patient preferences and lifestyles, as well as 
regional, cultural and ethnic differences among patients. The intervention will be tailored to the 
needs of the patient, with specific nutritional, physical activity and behavioral strategies selected 

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from the toolbox. Examples include increasing dietary fiber, modifying recipes to decrease 
energy density, adding novel foods to relieve boredom, strategies to avoid impulse eating, 
limiting calories in restaurants, parties or at work, adding variety to physical activity routines, 
and so on. Additional toolbox options include recipe modifications and low calorie substitutions, 
mindful eating, portion size training, increased meal planning and preparation, meal repetition, 
increase frequency of contact with health coach, Remote Food Photography Method (RFPM) or 
other method of daily recording of food intake (paper food record or online app), and cabinet 
clean-outs. The tool box will also include the provision of portion controlled foods, such as 
nutrition shakes, bars, and pre-packaged entrees.  We intend to rely on two types of portion-
controlled foods during PROPEL, Health One shakes and pre-packaged entrees and snacks 
from Nutrisystem. Additionally, participants will be encouraged to purchase other portion-
controlled foods as part of their meal plan, and these foods consist of, among other foods, 
bananas, granola bars, small boxes of raisins, 100 calorie snack packs, small bags of baby 
carrots, frozen entrees such as Lean Cuisines, etc.  Finally, as participants’ nutrition knowledge 
improves, they will be encouraged to prepare healthy food items and weigh and package 
individual portions that meet the requirements of their meal plan. Selections from the toolbox will 
depend on the patient’s success in achieving adherence, and on overcoming problems that 
arise. This approach is highly individualized and the health coach will work with the patient to 
develop acceptable strategies, including how long they will deployed, and how to evaluate their 
effectiveness. Thus, this approach is very patient-centered and provides for continuous 
communication between patients and health coaches. A centrally maintained tracking system, 
containing data needed for decisions about selecting and modifying toolbox selections for each 
patient (e.g., data on adherence, attendance at group meetings) will be used in implementing 
the algorithm. The toolbox will be open continuously until a patient completes the intervention.  
 
Health Literacy Adaptation of Intervention Materials 
 
Health literacy refers to the ability to obtain, understand and act on health information and 
services needed to make appropriate health care decisions.53 As described above, Louisiana is 
ranked 49th nationally with respect to health literacy.22 Further, given that the target population 
for this trial includes an underserved population, the problem of health literacy is compounded. 
Thus, it is important to adapt intervention approaches and materials to be health-literacy 
appropriate. Drs. Davis and Arnold (Co-investigators) have a lengthy record of seminal health 
literacy research among vulnerable populations. As the Co-directors of the Health Literacy Core 
of LA CaTS, they have considerable experience in adapting intervention materials and informed 
consent documents to be health-literacy appropriate for the target population. Look AHEAD 
intervention materials will be adapted, and health coaches will be trained in principles of health 
literacy and motivational interviewing techniques to enhance patient communication and 
education and encourage patient activation.54,55 Patients will be engaged in the development of 
study materials through consultation with the Patient Advisory Boards, and by focus group input 
on feasible and understandable intervention components.  
In addition to adapting all intervention materials to be appropriate for the level of health 
literacy, the patient toolbox will also contain options that are specially developed for patients 
with low health literacy. For example, with funding from the American College of Physicians 
(ACP), Drs. Davis and Arnold along with a team of national health literacy experts, developed 
and evaluated literacy-appropriate diabetes and weight loss self-management guides and brief 
counseling procedures for coaching patients to set personal health goals and create easily 
achievable action plans aimed at improving health behaviors such as eating and physical 
activity.56-59 These guides and accompanying counseling framework, which have been 

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distributed by ACP to over 5 million people nationally, will be important options in the patient 
toolbox. 
 
Training of Primary Care Practitioners 
 
An important, novel component of our adaption of Look AHEAD to the primary care setting is 
the incorporation of obesity science education for the primary care practitioners. There is a 
knowledge gap between the current state of weight loss science and primary care practice. 
Thus, we will develop and deliver continuing education on the science of obesity and weight 
loss to the primary care practitioners in the intervention arm. This education (designed for later 
dissemination and translation) will also include information on the management of complex 
obesity and co-management of morbidities such as type 2 diabetes and hypertension. 
Education will be delivered to accommodate the schedules of the practitioners, and will involve 
a series of webinars and face-to-face brown-bag seminars conducted in the clinics by 
experienced obesity, patient engagement and health literacy experts.  
 
Usual Care Arm 
 
Patients in the usual care condition will receive the obesity treatment guided by what is currently 
approved by CMS.31 A baseline webinar will be conducted with the PCPs randomized to usual 
care, describing the current CMS approach to reimbursing for obesity treatment; a reminder 
informational brochure will be sent to the primary care providers each year. If updates to CMS 
policies occur, we will schedule another webinar to inform the physicians. Patients in the usual 
care arm will receive their normal, usual care from their primary care team, and they will 
participate in the measurement of the outcomes at 6, 12, 18 and 24 months.  
Because the study’s success depends on comparable retention of patients in both arms, we 
are providing a special program for patients in usual care. The aims of the program are to 
maintain contact and build loyalty to the study. Patients participate in the design of this program 
which consists of 3 yearly newsletters and/or group sessions where a listing of health promotion 
events offered in the community is combined with an informational program. Topics that may be 
covered in this program include the importance of sleep for health, household money 
management, family coping skills, smoking cessation, etc.  
 
 
 

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11. Data Collection 
 
Data will be collected at a screening visit (SV), a baseline visit (BV), and at 6, 12, 18 and 24 
month visits. The physical measurements that that will be made as well as the questionnaires to 
be used are described below. All physical measurements will be recorded on the Physical 
Measurements Form (see Appendix A). 
 
Physical Measurements 
 
Weight  
 
Weight is the primary outcome for this study and will be measured with the patient in light indoor 
clothes without shoes to the nearest 0.1 kg using a digital scale at each assessment visit. 
Patients will be instructed to stand still in the middle of the scale with head erect and eyes 
looking straight ahead. After the weight is recorded, the patient will step off of the scale and the 
research assistant will set the scale to zero, then repeat and record the second weight 
measurement. If the two readings differ by more than 0.5 kg, a third measurement will be 
obtained. The closest two measurements will be averaged for analysis. The accuracy of the 
scales will be checked at scheduled monitoring visits using standard weights. Weight will be 
measured at the screening visit, the baseline visit, and at the 6, 12, 18 and 24 month 
assessment visits.  
 
Height  
 
Height will be measured at the screening visit and the baseline visit using a portable 
stadiometer. The patient will be asked to remove their shoes and have their heels, buttocks and 
upper part of the back remain in contact with the stadiometer with their arms hanging naturally 
at their side. The patient is asked to inhale and hold their breath, while the technician lightly 
applies traction to the patient’s head in order to maintain alignment with the Frankfort Plane. 
The slide is lowered until it reaches the vertex of the skull and the reading from the indicator is 
recorded to the nearest 0.1 centimeter. This process will be repeated, and if the two readings 
differ by more than 0.5 cm, a third measurement will be obtained. The closest two 
measurements will be averaged for analysis. Calibration of the portable stadiometer is not 
required, however the accuracy of the stadiometer will be checked at scheduled monitoring 
visits against a standard meter stick. It is not necessary for the stadiometer to be calibrated 
once all Baseline Visits are completed as height is not measured at follow-up measurement 
visits.   
 
Waist Circumference  
 
Waist circumference will be measured at all assessment visits using a non-elastic 
anthropometric tape. The measurement is made midway between the lower rib margin and the 
iliac crest, at the end of gentle expiration. The patient will be asked to expose the areas to be 
measured by pulling undergarments down and to stand in an upright position with their feet 
together and arms slightly forward (at a 45° angle). The midpoint will be marked on the right 
side of the patient using a washable marker or pen. The tape will be aligned with the markings 
and positioned in the horizontal plane at the correct height. Measures are made at the end of 
normal expiration with special attention paid to ensure the tape lays perpendicular to the long 
axis of the body and parallel to the floor. This process will be repeated, and if the two readings 

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differ by more than 0.5 cm, a third measurement will be obtained. The closest two 
measurements will be averaged for analysis. 
 
 
Blood Pressure and Pulse 
 
Resting systolic and diastolic blood pressures and resting pulse will be measured using a 
validated automated Omron device, after the patient has been sitting comfortable for at least 5 
minutes prior to the first blood pressure and pulse measurement.60,61 Two sitting measurements 
will be made. A third measurement will be obtained if the first two systolic measurements are 
greater than 20 mmHg apart, or the first two diastolic measurements are greater than 10 mmHg 
apart.  A cuff of appropriate size will be identified at the baseline visit and used thereafter at all 
subsequent visits. 
 
Fasting Finger-stick Blood Sample 
 
Finger-stick blood samples will be used to measure fasting levels of lipids (total cholesterol, 
HDL cholesterol, LDL cholesterol, triglycerides) and glucose using a validated Cholestech LDX 
point-of-care device62,63 at baseline, month 12 and month 24 visits. The patients will be asked to 
arrive at the clinic after fasting from 10 pm on the prior evening. The LDX is a small, portable 
analyzer that requires only a single drop of blood from a finger stick and eliminates the anxiety 
of a venipuncture. The research assistant will clean the patient’s fingertip with an alcohol wipe 
and obtain a drop of blood using a lancet. The blood is collected via capillary tube and 
transferred to the LDX cassette. The results will available in less than five minutes, and LDX 
printout will be transferred to the PROPEL Physical Measurement Form (see Appendix A) and 
data-entered by the research staff. The LDX will print a second results label which will be 
attached to the Cholestech Patient Results Label Log.   
 
Questionnaires 
 
All questionnaires will be completed in paper form by patients,  and subsequently data-entered 
by research staff. Patients with low health literacy, as established by the REALM SF (described 
below) will complete the questionnaires using a semi-structured interview format with the help of 
research staff.    
 
Baseline Demographic and Health History Questionnaire 
 
A self-report demographic and health history questionnaire (see Appendix A) asks the patients 
about their age, sex, race/ethnicity, use of tobacco and alcohol, health insurance status, post-
menopausal status, income and employment, education level, and history of chronic diseases. 
Further, the questionnaire collects information on their physical home address and nearest 
cross-street for the purpose of built-environment analyses. This questionnaire will be 
administered at SV. 
 
Change in Health History Questionnaire 
 
A self-report questionnaire captures changes in health outcomes that have occurred across the 
2 years of the intervention (see Appendix A). This questionnaire is administered at the 6, 12, 18 
and 24 month assessment visits. 
 

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REALM-SF 
 
The REALM short form (SF) is a nine-item health literacy assessment (see Appendix A) that will 
be administered at SV.64 The patient will first read two unscored test words (“flu” and “pill”) 
followed by a standardized series of seven words provided on a laminated sheet, and the 
research assistant will record the number of words pronounced correctly on an un-laminated 
copy that is attached to a clipboard. The score (0-7) provides an assessment of how well the 
patient will be able to understand health information. Patients who are unable to correctly read 
one or both of the practice words will be deemed ineligible for PROPEL. Patients scoring 0-3 on 
the REALM SF at the screening visit will be provided assistance in completing the other 
questionnaires using a semi-structured interview. Patients scoring 4-7 on the REALM SF will be 
allowed to complete the other questionnaires on their own, but we will offer assistance as 
required. 
 
Food Security 
 
Household food security is measured at baseline and at the 12 and 24 month assessment visits 
using a 6-item subscale of the 12-month Food Security Scale Questionnaire (see Appendix A).65 
 
PROMIS-29 
 
PROMIS® stands for the Patient Reported Outcomes Measurement Information System 
(www.nihpromis.org), which is a system of highly reliable, precise measures of patient–reported 
health status for physical, mental, and social well–being (see Appendix A).66 The PROMIS-29 is 
a 29-item health-related quality of life questionnaire that includes questions covering health-
related domains of physical function, anxiety, depression, fatigue, sleep disturbance, ability to 
participate in social roles and activities, pain interference and pain intensity. The PROMIS items 
were developed using a rigorous methodology funded by the National Institutes of Health (NIH) 
with a goal to develop valid, reliable, and standardized questionnaires or tools to measure 
patient–reported outcomes.67 A previous study has shown that among people with disabilities, 
health-related quality of life was significantly lower among the obese as measured by the 
PROMIS scales as compared to the non-obese.68  The PROMIS 29 will be administered at the 
baseline visit, and at the 6, 12, and 24 month visits. 
 
Impact of Weight on Quality of Life – Lite (IWQOL-Lite) 
 
The IWQOL-Lite is a 31-item measure (see Appendix A) designed to measure obesity-specific 
aspects of quality of life, which produces a total score and separate scores for physical function, 
self-esteem, sexual life, public distress, and work or daily activities.69,70 The IWQOL-Lite is 
administered at baseline and at the 6, 12 and 24 month assessment visits. 
 
International Physical Activity Questionnaire – Short Form (IPAQ-SF) 
 
Physical activity levels are measured at baseline and at the 6, 12 and 24 month assessment 
visits using the IPAQ-SF (see Appendix A)71 which asks questions related to physical activity 
performed over the previous 7 days. The IPAQ-SF has acceptable reliability71 and has been 
shown to be sensitive to change within the context of a weight loss intervention.72  The results 
are reported as a continuous measure in median metabolic equivalent of task (MET)-minutes 
per week of physical activity. 
 

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Dietary Intake Questionnaire 
 
A questionnaire that assesses dietary fat, fruit, vegetable and alcohol intake is administered at 
baseline and at the 6, 12 and 24 month assessment visits (see Appendix A). The questionnaire 
contains scales derived from several sources. The National Cancer Institute (NCI) fat screener 
estimates the percentage of energy from fat by asking patients to report the frequency of 
consuming specific foods over the past 12 months.73 A standard 7-item fruit and vegetable 
screener developed by the NCI and National 5 a Day Program grantees asks how often fruit and 
vegetables were consumed in the past month.74,75 Three questions related to the frequency of 
alcohol intake (beer, wine, hard liquor) were adapted from the Brief Questionnaire to Assess 
Habitual Beverage Intake (BEVQ-15).76   
 
Eating Inventory 
 
The Three-Factor Eating Inventory is designed to measure different dimensions of eating 
behavior. Three factor-analyzed subscales (Cognitive Restraint, Disinhibition, and Hunger) are 
derived from the questionnaire.77 For the purpose of the PROPEL trial, only the Cognitive 
Restraint and Disinhibition sub-scales will be administered to patients. This questionnaire will be 
administered at baseline and at the 6, 12 and 24 month assessment visits.   
 
Patient-Provider Survey 
 
A patient-provider survey is completed by each patient at the baseline visit and at the 24 month 
assessment visit (see Appendix A). This is an 11-item instrument that was adapted from the 
POWER trial.78 The POWER investigators compiled the patient-provider survey from several 
sources, including six questions adapted from the validated Consumer Assessment of 
Healthcare Providers and Systems (CAHPS) 2.0 Adult Core Survey, which asks patients how 
often their providers explained things clearly, listened carefully, showed respect, provided easy 
to understand instructions, knew their medical history and spent enough time with them.79 A 
CAHPS global rating of the provider (rating from 0–10) is also included. Finally, a question 
addresses patient-centeredness or the perception of “being known as a person” has been 
identified as an important domain in the patient–provider relationship.80 The framing of all 
questions in the survey was adapted by asking patients about their care over the past 2 years 
given that the both the POWER and PROPEL trials were 2 years in duration. A summary 
patient–provider relationship score is computed by adding up the total responses from the 8 
questions (and reversing the 2 opposite scales). This summary score has a minimum of 14 and 
a maximum of 32. 
 
Intervention Satisfaction Survey 
 
A self-report questionnaire that asks about the patients experience with the intervention and 
satisfaction with care is administered to patients enrolled in the active intervention arm of the 
trial at the 6 month and 24 month assessment visits (see Appendix A). This questionnaire was 
developed by the RE-POWER study and includes questions obtained from the VA DPP, Rural 
LEAP and Hopkins POWER trial.    
 
Provider Survey 
 
The Provider Survey is completed by each patient’s primary care provider (not the patient) prior 
to the trial beginning and at the trial’s end (see Appendix A). The Provider Survey was 

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developed for the POWER trial78 and has been adapted for PROPEL. The questionnaire 
assesses the primary care provider’s demographic information (age, race, training, specialty, 
years in practice, weight, and height), and knowledge about weight management practices 
(calculation of BMI, weight loss counseling and referral, etc.). The survey will be programmed 
into the REDCap system, which will also send each participating provider an email requesting 
that they complete the web-based survey. If a provider has not completed the survey within 2 
days, the REDCap system will send 2 additional reminder emails 2 days apart. All contact 
information and survey responses will be kept private. 
 
Concomitant Medications Form 
 
Patients will be asked to bring their medications to the screening visit and all subsequent 
assessment visits. A concomitant medications form (see Appendix A), adapted from prior trials, 
will be completed by a member of the research team at each visit to track changes in the 
patient’s medications throughout the trial.  
 
Adverse Events 
 
A surveillance form, adapted from prior trials, will be used to screen for adverse events and 
serious adverse events (SAEs) at each assessment visit (see Appendix A).  The following 
events will not be recorded as they are viewed as expected or unrelated to the study (unless the 
event meets the definition of an SAE): constipation, joint/muscle pain, and fall-related injuries 
(other than those related to a secondary condition such as vertigo). All SAEs will be recorded 
and reported.  Serious, unexpected AEs that are related or are possibly related to the study will 
be reported to the IRB in accordance with requirements. 
 
Table 2. Data measurement and collection schedule for patient data. 
 
Measurement 
SV 
BV 
V6 
V12 
V18 
V24 
Anthropometry 
 
 
 
 
 
 
Weight 
X 
X 
X 
X 
X 
X 
Height 
 
X 
X 
 
 
 
 
Waist Circumference 
 
X 
X 
X 
X 
X 
Risk Factors 
 
 
 
 
 
 
Blood Pressure and Pulse 
 
X 
X 
X 
X 
X 
Fasting Finger-stick Blood Sample 
 
X 
 
X 
 
X 
Questionnaires 
 
 
 
 
 
 
Baseline Demographics and Health History 
X 
 
 
 
 
 
Change in Health History  
 
 
X 
X 
X 
X 
REALM-SF 
X 
 
 
 
 
 
Food Security 
 
X 
 
X 
 
X 
Eating Inventory 
 
X 
X 
X 
 
X 
PROMIS-29 
 
X 
X 
X 
 
X 
Impact of Weight on Quality of Life – Lite 
 
X 
X 
X 
 
X 
IPAQ-SF 
 
X 
X 
X 
 
X 
Dietary Intake Questionnaire 
 
X 
X 
X 
 
X 
Concomitant Medications 
 
X 
X 
X 
X 
X 
Adverse Event Form 
 
 
X 
X 
X 
X 
Patient-Provider Survey 
 
X 
 
 
 
X 

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Intervention Satisfaction Survey* 
 
 
X 
 
 
X 
*completed by patients in the active intervention arm only 
Parallel Medical Record Data Collection 
In addition to the “gold standard” data collection of outcome measurements by the research 
staff, a parallel data collection effort will be done in PROPEL by utilizing the medical records at 
the participating clinics. For each of the participating patients in both arms, a retrospective chart 
review covering the period of the intervention will be done to abstract data on changes in weight 
and other clinical variables of interest over the course of the intervention. The electronic medical 
records of the patients will be obtained, or in cases where electronic records are not available, 
paper medical records will be abstracted by hand and data-entered by research staff.     

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12. Quality Assurance and Control 
Quality assurance and quality control is of utmost importance in a randomized clinical trial. 
Standardized protocols for all measurements have been developed, and adherence to the 
written protocols is of paramount importance. All data collection personnel will be certified as 
competent to make the required measurements by trained experts. The following provides an 
outline of the quality assurance and control program developed for PROPEL:  
 
 
Training and certification of all data collection personnel by experts 
 
Development of detailed manual of operations 
 
Retraining and recertification of all data collection personnel twice-yearly 
 
Maintenance of logs of certified personnel  
 
Routine calibration of all equipment following manufacturers guidelines  
 
Maintenance of logs of calibrated equipment 
 
Performance of routine clinic site-visits and source document verification 
 
Setting realistic limits on data entry fields in REDCap  
 
Remote monitoring of data entry, missing data and lag times through REDCap 
 
Creating both real-time and subsequent executable data quality checks in REDCap 
 
Querying appropriate personnel regarding missing data 
 
Preparing quality control reports for personnel, investigators and Data and Safety 
Monitoring Board   
 
There are logistical issues that limit the research staff’s ability to perform site visits and monitor 
data collection readily at 18 remote clinics (budgetary restrictions, time constraints, limited staff, 
etc.). Therefore, consent will obtained from participants who are willing to have their intervention 
sessions audio and video recorded; consent status will be data entered and tracked in REDCap. 
These recordings will be used as a means of monitoring to ensure treatment fidelity. All 
components of the intervention sessions will be recorded and reviewed, including but not limited 
to, weight status, diet and exercise logs, barriers to weight loss, goal-setting, etc. Participants 
who sign the consent will be informed before each visit begins when the visit is bring recorded. 
Due to the intimate nature of the intervention sessions, this consent will also include consent to 
have sessions monitored in-person by research staff.  
 
 
 
 
 

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13. Data Management 
Assessment (REDCap) 
All data collected by the assessment team at SV, BV, and at month 6, 12, 18 and 24 
assessment visits will be transferred from paper form to the Research Electronic Data Capture 
(REDCap) system81 through data entry by study personnel. REDCap is a secure, HIPAA-
compliant, web-based application that can be utilized for electronic collection and management 
of research and clinical trial data. Study data and electronic data capture tools are housed in a 
secure data center at Pennington Biomedical, and all web-based information transmission is 
encrypted. The server is backed up nightly and is protected by an enterprise network security 
firewall. REDCap will be accessed through the Pennington Biomedical secure website, 
https://redcap.pbrc.edu, where research personnel are required to enter user ids and passwords 
previously approved and set up by the Pennington Biomedical REDCap Administrator. 
The level of user access and privilege will be determined on an individual basis and will rely 
upon each user’s role in the study and clinics they are associated with. Only select project 
management personnel will be able to edit participant record IDs or export data; the data 
collection staff will only be able to view and edit (not export) the participant data and run quality 
checks for the clinics with which they are associated, and investigators will only be able to view 
data collected at their site. All data entered will be run through multiple checks for internal 
consistency and biologic plausibility; these will be conducted in REDCap with either real-time 
error messages and data stoppage rules or user-initiated query reports, as well as with study-
specific SAS programs designed by the data manager. Missing or questionable data will be 
assessed and corrected by research staff at the clinics or project management staff at 
Pennington Biomedical. All users will be thoroughly trained in the use of the PROPEL REDCap 
data entry and validation system. Once it is determined that data collection, entry and 
verification is complete, the REDCap project will be locked so that users will no longer be able 
to edit the data, but investigators may still export and preserve it. 
 
Intervention – Computer Tracking System (CTS) 
 
The internet-based Computer Tracking System (CTS) will facilitate intervention delivery, 
treatment fidelity, scheduling of intervention visits with patients, and tracking of process 
measures for intervention delivery, such as attendance. The CTS will allow for tailoring the 
intervention to individual patients, and it will be used by the intervention team to quantify 
process measures related to intervention delivery. Specifically, it will be used to review 
participant attendance, adherence to the diet based on the weight graph, weight loss, exercise 
levels, and the frequency with which weight and exercise data are collected from participants. 
These process data will be provided in reports generated by the CTS and these data can be 
viewed at the study, clinic, counselor, and patient level. The CTS will be housed on a HIPAA 
compliant server.   
  
 
 
 

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14. Safety and Data Monitoring 
This Human Subjects Research meets the definition of a clinical trial. 
Potential Risks to Subjects 
 
Human Subjects Involvement, Characteristics, and Design  
This study is a two-year, cluster-randomized, two-arm controlled trial in a primary care setting. A 
total of 18 primary care clinics inclusive of low income populations with a high percentage of 
African Americans from urban and rural areas of Louisiana will be randomized to either 1) 
intervention or 2) usual care. The sample will include up to 850 patients (18 clinics, 47 patients 
per clinic). Given that this is a pragmatic trial, the inclusion criteria are broad.  
Inclusion criteria include: 
 
Age 20.0 – 75.0 years 
 
BMI 30.0 – 50.0 kg/m2 
 
Able to provide written informed consent 
 
Willing to change diet, physical activity and weight 
 
Patient of a participating clinic 
 
Able to participate in scheduled sessions 
 
Exclusion criteria include: 
 
Currently participating in a weight loss program  
 
Current use of weight loss medication or recent weight loss (>10 lbs in last six months)  
 
Plans to move from the area within 2 years 
 
Given birth within the past year, are currently pregnant or plans to become pregnant 
within 2 years 
 
Has had or plans to have bariatric surgery within 2 years 
 
Current major depression 
 
History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia) 
 
Hospitalization for mental disorder or substance abuse in the previous year  
 
Active cancer (except prostate, skin and thyroid if approved by physician)  
 
Serious arrhythmias or cardiomyopathy 
 
Severe congestive heart failure 
 
Stroke or heart attack in previous six months 
 
Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or 
inflammatory bowel disease(i.e. Crohn’s disease or ulcerative colitis) 
 
Disease that is life threatening or that can interfere with or be aggravated by exercise or 
weight loss 
 
Discretion of primary care physician or principal investigator 
 
The intervention arm will receive a comprehensive, “high-intensity" program, as recommended 
first-line therapy by the 2013 AHA/ACC/TOS Obesity Guidelines, and based on the Look 
AHEAD intensive lifestyle intervention, delivered by trained health coaches. The intervention will 
include 15 in-person sessions in the first six months, followed by monthly sessions for the 
remaining 18 months, and will include evidence-based components such as the use of portion 
control and several behavioral strategies.  

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The usual care arm will receive the obesity treatment currently approved by CMS. A baseline 
webinar will be conducted with the primary care providers randomized to usual care, describing 
the current CMS approach to reimbursing for obesity treatment and background on obesity 
interventions; a reminder informational brochure will be sent to the primary care providers at 1 y. 
Patients in the usual care arm will receive their normal, usual care from their primary care team, 
and they will participate in the measurement of the outcomes at 6, 12, 18 and 24 months. 
Sources of Materials  
Materials will be collected from human subjects in the form of outcome data at a screening visit, 
at baseline, and at 6, 12, 18 and 24 month assessment visits and will include questionnaire 
data, anthropometric measurements, blood pressure measurements (not performed at SV), and 
finger-stick blood samples (baseline, month 12 and month 24 only). We will conduct parallel 
data collection using the electronic medical records from the participating clinics in addition to 
data collection by our trained assessment team. We will rely on the primary care staff to track 
changes in body weight over the course of the intervention. Our study informatics staff will 
extract data on clinical variables (blood pressure, glucose, cholesterol, etc.) from the electronic 
medical records in the clinics.  
All outcomes will be assessed using validated scales and tests where they exist. For example, 
height, weight, and waist circumference will be measured using standard procedures. Blood 
pressure will be measured in all clinics using a validated Omron automated device, and finger-
stick blood samples will be used to measure fasting levels of cholesterol, triglycerides and 
glucose using a validated Cholestech LDX point-of-care device. In addition to direct health 
measures, several patient-reported outcomes will be measured by questionnaire, including 
quality of life, functional capacity, and satisfaction with care. 
The assessment team, health coach, and data management staff will have access to personally 
identifiable private information about human subjects. All volunteers are assured of their 
confidentiality both verbally and in the informed consent form. The facilities are strictly limited to 
the staff of the research institution, clinics and to research volunteers. All medical records are 
locked in a secure area. Access to these areas is limited to the clinical support staff and the 
study investigators. Medical records are filed according to identification (ID) numbers. All forms 
in the chart, with the exception of the consent form and participant contact form, display only the 
ID number. Electronic data storage is similarly restricted with only the data management staff 
having access to the databases containing confidential records, i.e. those containing names or 
identifying information.   
Potential Risks 
This study does not involve major risks to participants. Efforts to minimize the potential risks of 
the assessment methods and outcome variables include frequent monitoring by the 
investigators to assure that no volunteer suffers any adverse effects from participating in the 
research. Our staff have performed similar testing procedures in many studies. Participants with 
known serious disease will be excluded from the study. 
    Potential risks associated with the study procedures include: 
a) Body height, weight and waist circumference. There is minimal risk to participants from 
these measurements.  

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b) Blood pressure testing. Participants may experience temporary discomfort during blood 
pressure recordings due to the pressure of the cuff inflating on their arm. 
c) Finger stick blood sample. There is the possibility of pain and bruising on the finger 
where the finger prick is made. Aseptic (sterile) technique and trained personnel minimize 
these risks.  
d) Diet. Patients in the intervention arm will undergo a calorie-reduced diet that is safe for 
humans and has been tested repeatedly in numerous clinical trials.   
e) Increased physical activity. Patients in the intervention arm will be counseled to increase 
physical activity to levels that are consistent with the recommendations for US adults (30 
minutes of moderate intensity activity per day). There is the possibility of adverse events 
such as minor musculoskeletal problems, but risk is minimized by excluding potential 
participants with contraindications to exercise.  Considering these types of events are 
expected in this trial they will not be recorded or reported unless they meet the definition of 
a Serious Adverse Event. Patients with diabetes or prior CVD must have physician 
approval to begin exercise.   
f) Hypoglycemia during weight loss for patients on insulin and insulin secretagogues. To 
minimize hypoglycemia with weight loss in persons with type 2 diabetes, we will ask 
patients to monitor their blood sugar at least twice a day, once in the morning before 
breakfast and once in the evening before dinner.  
 
g) Gall bladder disease with weight loss.  All physicians will be educated on the health risks 
associated with weight loss. With the slow weight loss we anticipate, we do not expect gall 
bladder disease exacerbation and will not give patient prophylaxis with ursodiol or fat bolus; 
for patients with symptoms of gall bladder disease, we will advise appropriate evaluation 
and treatment. 
Adequacy of Protection against Risks 
Recruitment and Informed Consent  
The patients are volunteers that will be recruited through the primary care clinics. Potential 
subjects will then be screened in person to determine that they meet the initial recruitment 
criteria (such as age and BMI) and have no obvious contraindications to participating in the 
study. Screening of study participants will be conducted by a trained recruiter following a written 
manual of procedures. In a one-on-one or group consenting session, the potential participant(s) 
will be informed of the nature and requirements of the study, either via face-to-face interview or 
informed consent presentation. All patients will be given time to read the consent form and ask 
questions one-on-one with PROPEL staff. To continue, the participant must read and sign an 
informed consent to participate in further assessment and treatment. 
Protection against Risks 
This study will be required to have approval from the PBRC Institutional Review Board as well 
as IRBs at partner institutions. PBRC has full accreditation by the Association for the 
Accreditation of Human Research Protection Programs (AAHRPP). Efforts to minimize the 
potential risk of the assessment methods include frequent monitoring by the investigators to 
assure that no participant suffers any adverse effects. 

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All volunteers are assured of their confidentiality both verbally and in the informed consent form. 
The clinical facilities are strictly limited to the staff of the research institution, clinics and to 
research volunteers. This is accomplished by a variety of stringent security measures. All 
medical records are locked in a secure area. Access to these areas is limited to the clinical 
support staff, director of clinical facilities, and the investigators. Volunteers’ medical records are 
filed according to ID numbers. All forms in the chart, with the exception of the consent form, 
display only the ID number. Electronic data storage is similarly restricted with only data 
management staff having access to the databases containing confidential clinical records, i.e. 
those containing names or other identifying information.   
Potential Benefits of the Proposed Research to the Subjects and Others 
We cannot ensure direct benefits for patients in this study. However, it is likely that patients in 
the intervention arm will experience health benefits associated with a healthier diet, increased 
physical activity and weight loss. The results of the study will provide important information 
about the effectiveness of an innovative intervention delivered through primary care that can be 
replicated in other regions of the United States. 
Importance of the Knowledge to be Gained 
This study proposes a comparative effectiveness trial of a pragmatic obesity intervention set 
within primary care. Obesity is a prevalent, serious medical condition that disproportionately 
affects underserved populations. Thus, there is an urgent need to develop and test pragmatic 
treatment strategies in the primary care setting, especially those recommended in the 2013 
AHA/ACC/TOS Guidelines for the Management of Overweight and Obesity in Adults. There is a 
gap between current guidelines and what is currently implemented in clinical practice; thus, 
comparative effectiveness studies are required to change the way that primary care 
practitioners approach the problem of obesity. This study directly addresses this gap by testing 
the effectiveness of intensive behavioral intervention for obesity relative to usual care.       
Pregnancy and Other Exclusions 
If a participant experiences a pregnancy lasting beyond the first trimester, her data will be 
censured from the time of estimated conception and she will be excluded from further 
participation. In the case of a miscarriage or pregnancy termination within the first trimester, or if 
a participant develops another exclusionary condition, such as cancer, unstable angina, or 
another condition for which weight loss or exercise might be contraindicated, further 
participation will be determined by the medical monitoring team. 
Data and Safety Monitoring Plan 
 
 
I. Study Identification Information 
A. 
PCORI Study Number – OB-1402-10977 
B. 
Study Title - PROmoting Successful Weight Loss in Primary CarE in Louisiana 
(PROPEL) Trial (Funded under the PCORI proposal “The Louisiana Trial 
for Obesity Reduction in Primary Care”) 
 
C. 
Name of Principal Investigator(s) - Peter T. Katzmarzyk, PhD 
 
Medical Monitor -  Tina Thethi, MD, MPH 

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II. Study Overview 
A. Brief Description of the Purpose of the Study – The primary aim is to test the effectiveness of 
a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered 
within primary care in an underserved population. We will randomize 18 primary care clinics 
serving low income populations with a high percentage of African Americans to a 
comprehensive obesity treatment program or usual care. The study procedures pose little to no 
risk for human subjects. However, a Data and Safety Monitoring Board (DSMB) will review the 
protocol and monitor conduct of this study.  
B. Adherence Statement - The Data Safety Monitoring Plan (DSMP) outlined below will adhere 
to the protocol approved by the PBRC IRB. 
III. Confidentiality 
A.  Protection of Subject Privacy – All volunteers are assured of their confidentiality both 
verbally and in the informed consent forms. The facilities are strictly limited to the staff of the 
research institution, clinics and to research volunteers. This is accomplished by a variety of 
stringent security measures. All medical records are stored in locked areas. Access to these 
areas is limited to the clinical support staff and the PI of the study. Volunteers’ medical records 
are filed according to ID numbers. All forms on the chart, with the exception of consent form, 
display only the ID number.   
B. Database Protection – Electronic data storage is similarly restricted with only the data 
management staff having access to databases containing confidential clinical records, i.e. those 
containing name or other identifying information. 
C. Confidentiality during AE Reporting – Adverse events will be reported to the study PI, Project 
Manager, Medical Monitor, DSMB and Chair of the IRB throughout the trial. Adverse event data 
will be analyzed quarterly, but serious or life-threatening adverse events require immediate 
reporting and follow-up. AE reports and quarterly summaries will not include subject-identifiable 
material. Each will include the identification code only. 
IV. Adverse Event Information 
A. Definition - An adverse event (AE) is any untoward medical occurrence in a subject 
temporally associated with participation in the clinical study. An adverse finding can include a 
sign, symptom, abnormal assessment (laboratory test value, vital signs, electrocardiogram 
finding, etc.) or any combination of these. A Serious Adverse Event (SAE) is any adverse event 
that results in one or more of the following outcomes: death; a life-threatening event; inpatient 
hospitalization or prolongation of existing hospitalization; a persistent or significant 
disability/incapacity; a congenital anomaly or birth defect; important medical event based upon 
appropriate medical judgment. 
B. Classification of AE Severity – AEs will be labeled according to severity which is based on 
their impact on the patient. An AE will be termed ‘mild’ if it does not have a major impact on the 
patient, ‘moderate’ if it causes the patient some minor inconvenience and ‘severe’ if it causes a 
substantial disruption to the patient’s wellbeing. The Site Staff for this trial will be responsible for 
determining the ‘severity’ of AEs. Site Staff will also make an initial evaluation of the 
‘seriousness’ of the AE in order to determine if the AE needs to be elevated to the MMT 

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immediately upon discovery.  The MM and/or NP make the final and official determination of the 
‘seriousness’ of an AE.  We anticipate most adverse events will be “mild” and the participant will 
be able to resume daily activities within a day or two of reporting the event. 
C. AE Attribution Scale – AEs will be categorized according to the likelihood that they are 
related to the study intervention.  Specifically, they will be labeled as either related or unrelated 
to the study intervention, and this relationship will be confirmed by the Medical Monitoring Team 
(MMT) for this trial. 
D.  Expected Risks – This study does not involve major risk to screeners and trial participants. 
Efforts to minimize the potential risks of the assessment methods and outcome variables 
include frequent monitoring by the investigators to assure that no volunteer suffers any adverse 
effects from participating in the research. The expectedness of an AE will be determined by the 
Medical Monitoring Team (MMT). 
    The study procedures include: 
a) Body height, weight and waist circumference. There is minimal risk to participants from 
these measurements.  
b) Blood pressure testing. Participants may experience temporary discomfort during blood 
pressure recordings due to the pressure of the cuff inflating on their arm. 
c) Finger stick blood sample. There is the possibility of pain and bruising on the finger 
where the finger prick is made. Aseptic (sterile) technique and trained personnel minimize 
these risks.  
d) Diet. Patients in the intervention arm will undergo a calorie-reduced diet that is safe for 
humans and has been tested repeatedly in numerous clinical trials.   
e) Increased physical activity. Patients in the intervention arm will be counseled to 
increases physical activity levels which are consistent with the recommendations for US 
adults (30 minutes of moderate intensity activity per day). There is the possibility of 
adverse events such as minor musculoskeletal problems, but risk is minimized by 
excluding potential participants with contraindications to exercise. Considering these types 
of events are expected in this trial they will not be recorded or reported unless they meet 
the definition of a Serious Adverse Event.  Patients with diabetes or prior CVD must have 
physician approval to begin exercise.   
f) Hypoglycemia during weight loss for patients on insulin and insulin secretagogues. To 
minimize hypoglycemia with weight loss in persons with type 2 diabetes, we will ask 
patients to monitor their blood sugar at least twice a day, once in the morning before 
breakfast and once in the evening before dinner.  
g) Gall bladder disease with weight loss.  All physicians will be educated on the health 
risks associated with weight loss. With the slow weight loss we anticipate, we do not 
expect gall bladder disease exacerbation and will not give patients prophylaxis with 
ursodiol or fat bolus; for patients with symptoms of gall bladder disease, we will advise 
appropriate evaluation and treatment. 
E. SAE Reporting - SAEs that are unanticipated, serious, and possibly related to the study 
intervention will be reported to the PBRC Medical Committee, Medical Monitoring Team, the 
DSMB, and the PBRC IRB in accordance with requirements. Anticipated SAEs or those 

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unrelated to the study intervention will be reported to the same individuals/entities in accordance 
with requirements. Clinics will be required to report to the Medical Monitoring Team adverse 
events that are serious or in doubt about being serious within 24 hours of discovery. Other 
adverse events that are not serious but are unexpected and are associated with the study 
procedures will be reported within 10 days. 
V. Data Quality and Safety Review Plan and Monitoring 
A. Data Quality and Management – A Data and Safety Monitoring Board (DSMB) will be 
convened and will meet regularly throughout the study period. The DSMB will meet twice per 
year throughout the trial, and will be convened for a first meeting prior to recruitment of patients. 
A minimum of 1 meeting each year will be conducted in person, and the second meeting may 
be conducted via conference call. Prior to the start of recruitment the DSMB will give formal 
approval of the study protocol and informed consent.  
Size and Composition of DSMB: The DSMB will consist of 4 members both internal and 
external to the Pennington Biomedical Research Center.  The planned composition is as 
follows: biostatistician (1), exercise physiologist or dietician (1), clinician (1) and layperson 
(1). 
 
Major Responsibilities of DSMB Members: 
1. Sign and abide by a statement of confidentiality 
2. Disclose any actual or potential conflicts of interest 
3. Create a charter to define its function, signed by all members 
4. Be familiar with the research protocol and plans for safety monitoring 
5. Oversee safety of participants, which will include review of interim/cumulative data for 
evidence of study-related adverse events (including serious adverse events) 
6. Review data quality, completeness, and timeliness (including recruitment) 
7. Review adherence to the protocol 
8. Review factors that might affect the study outcome or compromise the confidentiality of 
the trial data (such as protocol violations, unmasking, etc.) 
9. Review reports of related studies, as appropriate 
10. Review major proposed protocol modifications 
 
Reports: Following each meeting, the DSMB will provide written documentation regarding 
findings for the study as a whole and any relevant recommendations related to continuing, 
changing, or terminating the study.  All DSMB recommendations will be submitted to the 
Principal Investigator and/or his designee, with a copy provided to the Pennington 
Biomedical Research Center IRB and PCORI Project Officer or designee. 
 
The DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and 
overall awardee performance. The PI and Project Manager will regularly review all data 
collection forms and source documents on an ongoing basis for data completeness, accuracy, 
and compliance with the protocol and Standard Operating Procedures (SOPs) of PBRC. A 
statement reflecting the results of the review and describing any protocol deviations will be sent 
to the PBRC IRB in an annual report (non-competing continuation). 
 
B. Subject Accrual and Compliance - Review of subject accrual, adherence to inclusion / 
exclusion criteria, and rates of study completion will occur quarterly. These data will be reviewed 
by the study PI and Medical Monitoring Team and presented to the DSMB.   

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C. Out of Range Data – Laboratory and physical measurement reports will be reviewed weekly 
by the Medical Monitoring Team for the study. Out-of-range values for clinical chemistry and 
blood pressure will be reported to the patient as soon as possible so that they can follow up with 
their PCP. See Table 3 for Alert and Emergency values and actions. 
 
 
 
Table 3. Alert and Emergency Values and Actions 
Measure 
Alert Value 
Notify Participant 
Notify PCP 
Blood Pressure 
Systolic ≥150 mmHg or 
Diastolic ≥100 mmHg 
Within 1 week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor 
Instruct the participant to 
notify their PCP within 1 
week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor 
Blood Glucose 
 ≥ 200 mg/dl or ≤400 mg/dl 
Within 1 week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor  
Instruct the participant to 
notify their PCP within 1 
week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor 
Triglycerides 
>650 mg/dl 
Within 1 week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor 
Instruct the participant to 
notify their PCP within 1 
week or sooner as 
indicated by exact value 
and judgment of Medical 
Monitor 
 
Measure 
Emergency Value 
Notify Participant 
Blood Pressure 
Systolic ≥170 mmHg or 
Diastolic ≥110 mmHg 
Instruct the participant to take their medications if they 
have not already and immediately walk with them to 
find clinic personnel who can evaluate them for 
possible additional treatment. 
Blood Glucose 
<50 mg/dl or >400 mg/dl 
Immediately walk with the participant to find clinic 
personnel who can evaluate them for possible 
additional treatment.  
 
D. Stopping Rules - This study will be stopped prior to its completion if: (1) adverse effects that 
significantly impact the risk-benefit ratio have been observed; (2) study recruitment or retention 
becomes futile; (3) any new information becomes available during the trial that necessitates 
stopping the trial; and (5) other situations occur that might warrant stopping the trial. Because 
one of the most likely reasons for stopping the trial is the inability to recruit the study sample, the 
PI will include an assessment of recruitment futility in the annual progress report to PCORI and 
will consult with a biostatistician if necessary to assess the impact of significant data loss due to 
problems in recruitment, retention or data collection.  
 
E. Justification of Sample Size - The sample size calculations for PROPEL were based on 
LOSS, a pragmatic clinical trial conducted by Pennington Biomedical in eight primary care 
clinics across the state of Louisiana comparing intensive medical intervention for obesity versus 
usual care.4 According to the 2013 AHA/ACC/TOS Obesity Guidelines, as little as 3-5% weight 
loss is likely to result in clinically meaningful health outcomes.29 The calculations assume that 

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PROPEL Trial Protocol 
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the study will be powered to detect a mean weight loss in the intervention arm of 3.5% at 2 y, 
relative to usual care, in race- and sex-specific subgroups. We are targeting a mean weight loss 
of >5% which we anticipate to be 3.5% more than usual care. Both the total and relative weight 
loss meet currently accepted levels of clinical significance. 
Power calculations used a nominal 0.05 significance level with a two-tailed test with minimal 
power of 80%. Based on the LOSS study, the standard deviation for weight change for patients 
nested within clinics was 8.4%. For the subgroup analysis, a net sample size of 252 patients 
(126/arm) is sufficient for detecting a 3.5% weight loss with 90% power when randomization is 
performed at the patient level. After accounting for the design effect, at least 134 patients per 
arm are required to realize 80% power in a trial randomized at the clinic level. A previous study 
in primary care (PROACTIVE) had 20% attrition over 24 months. However, given the challenges 
of working with a clinic population across an entire state, we have allowed for a conservative 
estimate of 30% attrition for this trial. Thus, allowing for 30% attrition, at least 192 patients per 
arm are needed with a total (2 arms) enrollment of at least 384 patients per subgroup analyses.  
Based on data from the patient population served by Louisiana safety net hospitals82 and 
Federally Qualified Health Centers in Louisiana which is approximately 50% African American 
and 50% female, this translates into a total sample size of at least 768patients, which will 
provide at least 97% power to detect a mean weight loss in the intervention arm of 3.5% at 2 y, 
relative to usual care in the total sample. To account for the increased rate of attrition in 
Federally Qualified Health Centers, up to 850 (425 patients per arm / 47 patients per clinic / 18 
clinics) participants will be enrolled. Although Hispanics will be included in the trial, the low 
Hispanic population in LA (4%)21 precludes sub-group analysis. 
F. Designation of Medical Monitoring Team - The Medical Monitor will be the leader of the 
Medical Monitoring Team and will be a medical doctor appointed by the PI. He/she will have an 
understanding of the types and severity of adverse events commonly experienced as a result of 
the testing protocols for this study. The Medical Monitoring Team will consist of the Coordinating 
Center Staff, a Nurse Practitioner and the Medical Monitor.  The Medical Monitoring Team 
reviews all safety reports and determines whether there is any corrective action, trigger an ad 
hoc review, or a stopping rule violation that should be communicated to the PI, the PBRC IRB, 
and PCORI. In addition, the Medical Monitoring Team may comment on whether the PI needs to 
report any specific out of range laboratory data to the patient and/or his/her physician. 
G. Safety Review Plan - The PI will monitor the progress of the study weekly, including reasons 
for attrition and whether all participants met entry criteria. Further, progress and safety will be 
reviewed quarterly. These progress reports will include information on recruitment, 
retention/attrition, and AEs and will be provided to the Medical Monitor quarterly. The Medical 
Monitor will also receive a yearly report that details data relevant to the possible early 
termination of the study. We will establish a DSMB and we will provide reports to the DSMB 
prior to each meeting on adverse events and recruitment.  
VI. Informed Consent 
Patients are volunteers that will be recruited through primary care clinics. The PBRC’s 
Institutional Review Board (IRB) as well as the IRBs of the partner institutions will approve the 
study protocol and all consent forms. Trained recruiters will obtain informed consent from all 
participants as well as HIPAA authorization. All questions and concerns are clarified before any 
forms are signed. 
 
 

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Inclusion of Women and Minorities 
I. Inclusion of Women - Women will be included in this intervention with equal probability as men 
as the inclusion criteria include both men and women. 
II. Inclusion of Minorities - We have selected clinics with a high proportion of patients with low 
socio-economic status and African Americans; however, our inclusion criteria do not specify any 
specific ethnicity. Thus, we anticipate that the socio-demographic distribution of patients will 
follow closely the patient population in selected clinics. 
Inclusion of Children 
The focus of the PCORI Funding Announcement under which this study was funded is on 
obesity reduction in adults therefore the patients in this study are mainly adults (20 - 75 y of 
age). The treatment of childhood obesity is beyond the scope of this intervention. 
 

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15. Power and Sample Size 
The sample size calculations for PROPEL were based on LOSS, a pragmatic clinical trial 
conducted by Pennington Biomedical in eight primary care clinics across the state of Louisiana 
comparing intensive medical intervention for obesity versus usual care.4 According to the 2013 
AHA/ACC/TOS Obesity Guidelines, as little as 3-5% weight loss is likely to result in clinically 
meaningful health outcomes.29 The calculations assume that the study will be powered to detect 
a mean weight loss in the intervention arm of 3.5% at 2 y, relative to usual care, in race- and 
sex-specific subgroups. We are targeting a mean weight loss of >5% which we anticipate to be 
3.5% more than usual care. Both the total and relative weight loss meet currently accepted 
levels of clinical significance. 
Power calculations used a nominal 0.05 significance level with a two-tailed test with minimal 
power of 80%. Based on the LOSS study, the standard deviation for weight change for patients 
nested within clinics was 8.4%. For the subgroup analysis, a net sample size of 184 patients 
(92/arm) is sufficient for detecting a 3.5% weight loss with 80% power when randomization is 
performed at the patient level. After accounting for the design effect, at least 134 patients per 
arm are required to realize 80% power in a trial randomized at the clinic level. A previous study 
in primary care (PROACTIVE) had 20% attrition over 24 months. However, given the challenges 
of working with a clinic population across an entire state, we have allowed for a conservative 
estimate of 30% attrition for this trial. Thus, allowing for 30% attrition, at least 192 patients per 
arm are needed with a total (2 arms) enrollment of at least 384 patients per subgroup analyses.  
Based on data from the patient population served by Louisiana safety net hospitals82 and 
Federally Qualified Health Centers in Louisiana which is approximately 50% African American 
and 50% female, this translates into a total sample size of at least 768patients, which will 
provide at least 97% power to detect a mean weight loss in the intervention arm of 3.5% at 2 y, 
relative to usual care in the total sample. To account for the increased rate of attrition in 
Federally Qualified Health Centers, up to 850 participants (425 patients per arm / 47 patients 
per clinic / 18 clinics) will be enrolled. Although Hispanics will be included in the trial, the low 
Hispanic population in LA (4%)21 precludes sub-group analysis. 
 
 
 

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16. Data Analysis Plan 
To address the primary aim, weight loss will be analyzed as mean percent of baseline weight 
loss at months 6, 12, 18 and 24 in the context of linear mixed (fixed and random) effects multi-
level models. In addition to intervention group, clinics and assessment time, and their interaction 
terms, the model may include and patient-level (weight, age, sex, race) and clinic-level (clinic 
size, %African American, % Medicaid/Medicare, etc.) variables as explanatory covariates. 
Preliminary analytical findings will be used to choose the most plausible and efficient 
repeated measures covariance structure (e.g., compound symmetric, autoregressive, 
unstructured) to use. Although substantial effort will be employed to minimize missing data, it is 
inevitable that some missing data will occur. An intention-to-treat analysis that includes all 
randomized patients, regardless of the number of assessments obtained, will be conducted. The 
primary analysis will use the mixed effects model mentioned above and employ restricted 
maximum likelihood using all available data. The analytical plans are flexible and will be 
adapted as scientific perspectives are advanced.    
 
Additional analyses to test the secondary aims are described below: 
 
Secondary Aim 1. Evaluate relationships between adherence to intervention components 
(physical activity, diet, sessions, etc.) and corresponding changes in body weight and secondary 
outcomes (post-hoc analyses). 
  
The first secondary aim will be accomplished by conducting analyses of adherence data and 
changes in the outcomes, and by conducting sub-analyses in different compliant groups 
(attended at ≥80% of sessions, etc.).  
 
Secondary Aim 2. Examine the effects of the intervention on system-level practices and patient 
satisfaction with care.  
 
The second secondary aim will be accomplished using a similar strategy as the primary aim. 
 
Secondary Aim 3. Test the heterogeneity of effects (HTE) across clinics and across subgroups 
of patients (men versus women, white versus African American, older versus younger adults). 
 
Analyses of HTE is an important aspect of this study, as the identification of systematic 
differences in response to the intervention will be important for broad dissemination of our 
model, and for further tailoring the intervention to specific sub-groups. We currently have three 
confirmatory HTE analyses planned: 1) white versus African American, 2) men versus women, 
and 3) younger (20-44 y) versus middle-aged (45-64 y) versus older (65+ y) adults. Further, we 
have one planned exploratory HTE analysis, which is to explore clinic-level differences in 
response within the intervention and usual care groups and identify factors that explain the 
clinic-level heterogeneity.  
Confirmatory HTE Analyses. Based on one-year results in patients in the Look AHEAD 
intervention, men lost more weight than women, older adults (65+ y) lost significantly  more 
weight than younger adults, and white participants lost more weight than African Americans.83 
Thus, we hypothesize that men, white patients, and older patients will lose significantly more 
weight in the primary care setting than women, African Americans and younger patients, 
respectively.      
Exploratory HTE Analysis. There is potential for heterogeneity in response across the clinics  
in this study. We plan to explore clinic-level variability in response and identify factors 

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associated with clinic-level variability. Potential factors that will be considered include clinic size, 
number of physicians, number of residents, percentage Medicaid/Medicare, percentage 
minority, and geo-spatial characteristics of the clinic location (population density, crime, etc.).     
Heterogeneity of treatment effect will be investigated in several subgroup analyses: men vs 
women, whites vs African Americans, ages 20-44 y vs 45-64 y vs ≥65 y. The intervention effect 
on weight loss will be investigated using a subgroup variable in mixed effects multilevel models 
analogous to the primary analysis with a focus on intervention-by-subgroup interactions coupled 
with illustrative graphics. Subsequent analyses will focus on elucidating underlying reasons for 
the subgroup differences and how these differences influence guidelines that may translate to 
the general population. Exploratory analyses using fixed and random effects models will 
determine treatment differences among clinics and estimate the variability associated with these 
differences.  
Significant subgroup heterogeneity in outcome response (e.g., significant sex differences in 
effectiveness), supported by significance of the test for intervention-by-sex interaction, would 
lead to further investigation in search of the underlying reasons for the differential response. 
Previous studies provide evidence that responses to weight loss interventions vary by age, race 
and sex.83 It is anticipated that these will be confirmed in this trial. Less is known about the 
influence of clinic-level variables on treatment response; thus, these analyses are considered 
exploratory.   
 
Handling of Missing Data 
 
Missing data are expected due to drop outs and missed visits. Weight loss is a subject-level 
variable and missing assessments would influence tests relative to treatment-by-time 
interactions. The primary analysis described above will employ restricted maximum likelihood 
using all data. No patients will be deleted from the analysis because of partial data. To assess 
the sensitivity of results, weight loss will be analyzed using: 1) all patients irrespective of missing 
data to perform analysis of variance using mixed effects multi-level models with repeated 
measures; 2) only patients who have competed all assessment visits and have no missing data, 
to perform analysis of variance employing mixed effects multi-level models with repeated 
measures; 3) all patients, irrespective of missing data, to conduct analyses using mixed effects 
multi-level time trend models with random coefficients to capture individual time trends (does 
not require complete data across time); and 4) multiple imputation.     
Multiple imputation will be employed to perform statistical inferences that properly account 
for statistical uncertainty due to missingness. Rubin’s multiple imputation procedure replaces 
each missing value with a set of plausible values that represent the uncertainty about the 
appropriate value to impute.84 Missing values are imputed by drawing random samples, and the 
process is replicated to provide K data sets with pseudo-complete data. Estimates and 
corresponding confidence intervals will be plotted against K to determine the optimal K to use in 
subsequent sensitivity analyses. Mean weight loss is estimated for each data set, and the 
multiple imputation estimator is the average of the individual estimates. The variance of the 
estimator is estimated from between- and within-imputation variability.85 The SAS® procedure 
PROC MI provides four relevant options for imputation models and will be used in quantifying 
uncertainty due to missing data. 
Statistical summaries will be compiled on the number of patients overall and by arm and 
who completed study per protocol, did not complete study per protocol, and reasons for not 
completing. Patient characteristics (age, sex, race, BMI) will be summarized similarly. Multi-level 
logistic regression will be used to investigate the significance of correlates of failure to complete 
the study per protocol.      

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17. Trial Organization 
The Principal Investigator will oversee and monitor progress to reach the milestones with 
decisions concerning short-term goals and the evaluation of longer-term progress being 
discussed with the research staff via weekly meetings. Broader management of the project will 
be undertaken by the Project Management Committee, as described below. The research team 
will be organized into sub-teams of investigators and staff. The overall organizational structure 
will be reviewed and amended as required. 
Project Management Committee  
 
The Project Management Committee will be comprised of the Principal Investigator, selected 
co-investigators (i.e. Intervention Director, Assessment Director, and Community Engagement 
Co-Directors), Project Manager and two patient partners. The Project Management Committee 
will be responsible for overseeing the day-to-day management of the trial, and the Principal 
Investigator will make adjustments to the approach used by the team to achieve the milestones.  
 
Intervention Team 
 
The Intervention Director will lead the intervention team, which will consist of health psychology, 
health literacy, nutrition and physical activity experts who will develop the intervention materials, 
and the interventionists (health coaches) who will deliver the behavioral lifestyle intervention in 
primary care clinics. 
  
Assessment Team 
 
The Assessment Director will lead the assessment team, which will consist of data collection 
technicians trained by the assessment director and experts in anthropometry, questionnaire 
administration and health literacy. The assessment team will be responsible for collecting data 
on the outcome measures at screening, baseline, and at the 6, 12, 18 and 24 month visits.   
 
Education Team 
 
The Education Director and his/her team will be responsible for developing an educational 
program on obesity science and obesity management for PCPs in the intervention arm of the 
trial, and for developing a webinar and brochure for PCPs in the usual care arm on the current 
CMS reimbursement for obesity treatment. 
 

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18. Timeline 
The PROPEL trial is designed as a two-year intervention for patients. However, the trial itself is 
embedded within a broader timeline of research, consisting of two stages. Stage 1 involves 
establishing Patient Advisory Boards (quarterly meetings), a  Community Monitoring Board 
(yearly meetings), conducting focus groups, adapting intervention materials from Look AHEAD, 
development of a Manual of Procedures (MOP), and training of the health coaches and 
assessment team. Stage 2 involves the recruitment of patients and the execution of the trial 
itself. A detailed timeline for both stages of the research project is presented in Table 4 below. 
Table 4. Timeline of activities (by Quarter) for the PROPEL trial  
 
2015 
2016 
2017 
2018 
2019 
Stage/Activities 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q 
2 
Q 
3 
Q 
4 
Q 
1 
Q 
2 
Q 
3 
Q 
4 
Q 
1 
Q 
2 
Q 
3 
Q 
4 
Stage 1 
 
Patient Advisory Board 
Meetings (quarterly) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Community Monitoring Board 
(yearly) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Execution of Subcontractor 
Agreements 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB Submission/Approval for 
Focus Groups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Focus Groups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adaptation of Look AHEAD 
Materials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Development of Manual of 
Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB Submission/Approval for 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training of Health Coaches 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training of Outcomes 
Assessment Team 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Trial Registered at 
www.Clinicaltrials.gov 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stage 2 
 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis/Evaluation of the 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refinement of Intervention for 
Sustainability 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication of Results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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20. Appendices 
Appendix A: PROPEL Forms and Questionnaires 
Appendix B: Lifestyle Intervention 
Appendix C: PROPEL Recruitment Materials