Cherokee Health for Elderly Residents With Osteoarthritis of the Knee in the Eastern Band
Phase: NA
Conditions: Osteoarthritis
Sponsor: Wake Forest University

 
Cherokee Health for Elderly Residents with OsteoarthriƟs of the Knee 
in the Easter band. The Cherokee Study (WE CAN Pilot) 
 
 
STUDY PROTOCOL 
 
 
9.9.2022 

Submission Date: 9.9.22 
 
 
STUDY PROTOCOL 
 
Project Description: 
The global prevalence of knee osteoarthritis (OA) is estimated at greater than 250 million 
persons or 3.6% of the world population, ranking 23rd on the list of the most common sequelae 
[1]. Knee OA is the most prevalent cause of mobility dependency and disability, with the time 
spent living with symptoms averaging 26 years [2].  Two in three people who are obese will 
develop symptomatic knee OA in their lifetime [3].   
 
In 2004 we reported that a 5% weight loss, when combined with exercise, resulted in a 30% 
decrease in pain and a 24% improvement in function [4]. Our recently completed trial entitled 
Intensive Diet and Exercise for Arthritis (IDEA) sought to improve on our work with a more 
intensive weight loss intervention, 2 to 3 times the weight loss we had recently achieved [5].  
IDEA compared intensive diet (D) and exercise (E) interventions, separately and in combination, 
across an 18-month intervention period in 454 overweight and obese older adults with 
radiographic knee OA. An intent-to-treat analysis revealed that after 18 months the D+E group 
reduced pain by 51% compared to 25% and 28% for the D only and E only groups, respectively. 
The D+E group was also superior to the E group on self-reported physical function, health 
related quality of life, and walking speed, and had significantly lower knee joint loading and 
serum levels of IL-6, a pro-inflammatory cytokine.  On average, our D+E intervention was twice 
as effective at relieving pain as previous long-term OA trials. We concluded that wider adoption 
of intensive weight loss with a goal of at least 10% of baseline body weight combined with 
exercise could reduce the burden of disability related to knee OA.   
 
IDEA was an efficacy study with impressive results, a trial designed to determine the effects of 
intensive diet and exercise under ideal circumstances.  However, a common concern from 
physicians who treat people with knee OA is lack of practical means to implement this treatment 
in the clinical environment.  Indeed, there is no evidence regarding how this efficacious 
intervention could be successfully adapted to be effective in real world clinical and community 
settings and also be cost effective.   
 
Participants (age ≥ 50 years; BMI ≥ 25 kg/m2 ) will be randomized to one of 2 groups: diet-
induced weight loss and exercise or an attention control group.  The sample will consist of 30 
ambulatory, community-dwelling persons that meet the ACR clinical criteria for knee 
osteoarthritis.  
 
Primary Hypothesis and Aim  
Hypothesis 1. The study will demonstrate the feasibility of conducting a trial similar to WE-
CAN in Cherokee, NC that will recruit American Indian participants.  It will leverage the 
organizational structure and expertise of the parent WE-CAN pragmatic, community-based trial.   
 
Aim 1. To conduct a trial in Cherokee, NC that will be comprised of (a) 90% participants who 
self-identify as American Indian,, including but not limited to the Eastern Band Cherokee Indian 
Tribe, and who are older, overweight or obese with symptomatic knee OA; (b) the executive 
clinical director of Cherokee Indian Hospital to act as site PI and co-investigator of the parent 

Submission Date: 9.9.22 
 
 
trial; (c) local community based American Indian staff trained by our coordinating center to 
deliver the intervention; and (d) an American Indian Community Advisory Board. 
 
Secondary Hypothesis and Aim 
Hypothesis 2. A subgroup analysis of the American Indian participants will provide pilot data of 
whether a pragmatic, diet-induced weight-loss and exercise intervention implemented by local 
American Indian personnel will reduce knee pain and improve self-reported function, mobility, 
and health-related quality of life compared to an attention control group. 
 
Aim 2. To determine whether a pragmatic, community-based 3-month, diet-induced weight-loss 
and exercise intervention reduces knee pain, measured by the Western Ontario McMasters 
Universities Osteoarthritis Index (WOMAC), and improves WOMAC self-reported function, 
health-related quality of life as measured by the physical subscale of the SF-36 questionnaire, 
and 6-minute walk distance (an accepted measure of mobility) in overweight and obese 
American Indian older adults with knee OA compared to an attention control group.   
 
Study Design 
We will randomize 30 overweight and obese (BMI 25 ≥ kg/m2), adults age ≥50 yrs knee OA into 
one of 2 groups: an intensive dietary restriction-plus-exercise (D+E) group or an attention 
control (nutrition and health) group.  Our minimum weight-loss goal for the weight-loss group 
will be 5% of body weight.  The exercise intervention will meet 3 days/wk at the clinical site.  
The intervention will be comprised of both aerobic and strength training exercises.  The nutrition 
and health group will meet 2 times over a 3 month period and will also receive a combination of 
text messages, emails (via personal email or Facebook), phone calls, and mailings for the 
remaining months.  Participants will be allowed to choose their preferred method.       
 
Measures 
 
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC).  We will measure 
self-reported physical function and pain using the WOMAC (scores will be pulled from the 
KOOS Questionnaire in which the WOMAC is embedded).  The LK version asks participants 
to indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the 
last week due to knee OA. Individual scores for the 17 items are totaled to generate a summary 
score that could range from 0-68, with higher scores indicating poorer function. The pain index 
assesses participants’ pain on the same scale, ranging from 0 (none) to 4 (extreme). The pain 
subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating 
greater dysfunction. This instrument has been validated and recommended by the Osteoarthritis 
Research Society as the health status measure of choice in older adults with knee OA.  In order 
to measure the minimal clinically improvement difference (MCID) participants will be asked to 
compare their knee pain to how it was at the beginning of the study.   
 
Mobility. Our primary mobility measure will be 6-minute walk distance. Participants are told to 
walk as far as possible in 6 minutes on an established course. No personal timing devices are 
permitted, and participants are not provided feedback during the test. Results are significantly 
correlated to treadmill time and symptom-limited maximal oxygen consumption (r = 0.52 and r 
= 0.53, respectively) and have a 3-month test-retest reliability of 0.86 (Pennix et al).  The Short 
Physical Performance Battery (SPPB) will also be used to measure mobility (Guralnik et al).  

Submission Date: 9.9.22 
 
 
The SPPB is comprised of the following tests (balance, walking speed, and chair rise).   A test 
of ascending and descending stair activity measured by the time (in seconds) it takes to ascend 
and descend a flight of 8 steps with 20cm (8 inch) step height and handrail will also be 
performed. 
 
Cost Effectiveness Resource utilization will be collected by questionnaire, with domains 
including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, 
injections, surgery, alternative therapies. The Work Productivity and Activity Impairment index 
(WPAI) will be used to assess absenteeism and reduced productivity while at work 
(presenteeism). 
 
Body weight, height, hip/waist circumference, BMI. Body weight and height will be obtained 
using standard techniques. Only persons with a BMI ≥ 25 kg/m2 will be eligible.  
Circumference measurements will be collected using standard techniques. 
 
Medical History, Medications, and Blood Pressure. Participants will be given forms to assess 
medical history and presence of comorbidities.  Participants will also be asked questions about 
their medical history during the phone screen so as to reduce participant burden by identifying 
potential exclusion criteria.  Participants will be administered a medication questionnaire 
adapted from the ARIC study and widely used in field research and in our prior studies at each 
testing visit (ARIC).  
 
It is designed to obtain information about all prescription and over-the-counter medicines and 
supplements used during the 2 weeks prior to the interview (home or clinic). The participants 
will be mailed the medication form to fill out at home and will return the form to the 
interviewer.  Participants may also be asked to provide the interviewer with all medicine 
containers so that the interviewer can transcribe the information.  In addition participants will 
be encouraged to notify the study staff of any medication changes during the course of the 
study. 
 
In addition to the medical history and medication questionnaires, participants will also be given a 
risk stratification questionnaire at the first screening visit.  The purpose of this questionnaire is to 
determine if participants will need medical clearance prior to enrolling into an exercise program.  
The determination is based on the presence/absence of cardiovascular/pulmonary/metabolic 
disease risk factors, sign and symptoms, and known medical history.  The following schematic 
demonstrates how medical clearance will be determined (Figure 1).  The American College of 
Sports Medicine recommends that all patients are first screened to determine if they are 
participate in regular exercise (defined as performing planned, structured physical activity at 
least 30 min at moderate intensity on at least 3 days per week for at least the last 3 months).  If 
the participant responds with no medical clearance will be not be needed for those who have not 
been diagnosed with any CV, Metabolic, or renal disease and are showing no signs/symptoms.  If 
the response is yes those who have not been diagnosed as well as those with a diagnosis and are 
asymptomatic will not need physician clearance [6].  Like the previous recommendations this is 
only for moderate intensity exercise.  Our exercise protocol falls within this moderate intensity 
range.  The original protocol called for participants to exercise in the range of 50-75% of their 
maximal heart rate reserve (i.e., moderate to high intensity).  The range was previously modified 

Submission Date: 9.9.22 
 
 
to 40-60% of maximal heart rate reserve (i.e., moderate intensity).  Hence, participants that have 
no diagnosis of CV, Metabolic, or renal disease or those that have been diagnosed but are 
asymptomatic will be enrolled without the need for physician clearance.  Those who have signs 
and symptoms or who have been diagnosed but do not meet the exercise criteria will require 
medical clearance from their physician.  Final approval and acceptance into the program for 
patients will be provided by our study physician.  It’s worth noting the risk of serious adverse 
events occurring during properly supervised exercise is extremely low (< 1 per 100,000 hours of 
exercise) even in older adults, with cardiovascular disease.  Blood pressure will also be 
measured. 
 
 
Figure 1: Exercise preparticipation health screening logic model for aerobic exercise 
participation [6] 
 
 
 
Measures of Quality of Life and Self-Efficacy. The SF-36 is the most widely used and carefully 
validated measure of health related quality of life and will be used to yield 2 broad summary 
scores: physical health and mental health [7–9].  The Eurqol Quality of Life will also be used to 
measure quality of life and health state [10].  The walking efficacy for duration scale measures 
one’s ability to walk/jog at a moderately fast pace for various durations [11].  The Positive and 
Negative Affect (PANAS) measures both positive and negative affect, leading to more insightful 
outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the 
intensity of how the participant "feels" right now [12].  The gait efficacy/environmental efficacy 

Submission Date: 9.9.22 
 
 
scale will ask the participants’ confidence in performing certain activities [13].  Among the 
various components of subjective well-being, the Satisfaction with life scale is focused to assess 
global life satisfaction [14].  The Weight Efficacy Lifestyle Questionnaire (WEL) is a 20-item 
measure employed to assess self-efficacy for weight management [15].  The Perceived Stress 
Scale (PSS) will measure the degree to which people perceive their lives as stressful [16].  The 
adherence self-efficacy questionnaire is designed to assess beliefs in one’s ability (confidence) to 
continue exercising at various intensities and frequencies [11].   
 
Pain Catastrophizing Scale (PCS).  The PCS questionnaire will be used to assess 
catastrophizing (rumination, magnification, and helplessness) [17]. 
 
Knee injury and Osteoarthritis Outcome Score (KOOS).  The KOOS questionnaire will be used 
to assess the patient’s opinion about their knee and associated problems. The KOOS evaluates 
both short-term and long-term consequences of knee injury and also consequences of primary 
osteoarthritis (OA) [18] 
 
Intermittent and Constant Osteoarthritis Pain (ICOAP).  The ICOAP assesses pain in 
individuals with knee osteoarthritis taking into account both constant and intermittent pain 
experiences [19]. 
 
Dietary Intake.  National Cancer Institute Modified Health Habits and History Questionnaire 
(HHHQ) provides nutrient assessment of dietary intake and has been shown to be reliable in 
American Indians [20].  The National Cancer Institute has developed a more recent 
questionnaire that is now being used DHQ (Dietary History Questionnaire).  
 
Health Literacy.     Behavioral Risk Factor Surveillance System measures health literacy [21].    
 
Physical Activity.  The Physical Activity Scale for the Elderly (PASE) has proven reliable in 
many of our clinical trials, including a group of 254 men and women aged ≥65 yrs [22]. 
 
Cognitive Functioning/Depression.  The Mini Mental State Exam (MMSE) will be used to 
measure cognitive function and has been measured in older American Indians [23].  Depression 
will be measured using the Center for Epidemiologic Studies Depression Scale [24].  This 
measure has previously been validated with older American Indians in the Great Lakes region 
[25].   
 
Inclusion/Exclusion Criteria   
Inclusion Criteria: 
(1) Age ≥ 50 years 
 
(2) Knee Pain plus ACR Criteria for Knee Osteoarthritis  
 
(3) BMI = 25 ≥ kg/m2 
 
Exclusion Criteria: 

Submission Date: 9.9.22 
 
 
1. Significant co-morbid disease that would threaten safety or impair ability to participate in 
interventions or testing (Method: Medical history; medications; physical exam; telephone 
pre-screen; risk stratification) 
a. Blindness 
b. Type 1 diabetes 
c. History or symptoms of coronary artery disease or pulmonary disease with no 
medical clearance (symptoms include angina, unreasonable breathlessness, 
dizziness/fainting/blackouts) 
d. Unable to walk without a device 
e. Lower extremity fracture (within previous 3 months) 
f. Joint Replacement (excluded if double KR or within previous 6 months) 
g. Knee injection or surgery (within previous  month) 
h. Lower extremity injury that affects activities of daily living 
2. Not sufficiently overweight or obese, BMI < 25 kg/m2  (Method: Ht/Wt)  
3. Not having knee pain: (Method:  < 1 on the pain scale, WOMAC and Telephone Screen) 
4. Inability to finish pilot study or unlikely to be compliant (Method: Telephone Screen, 
Screening Interviews) 
a. Planning to leave area > 1 month during the next 3 months 
b. Unwilling to change eating or physical activity habits 
c. Unwilling to attend exercise/diet sessions 
d. Participating in another intervention study (only if the other study has requested 
they not be enrolled) 
e. Living > 30 minutes from the intervention site 
5. Age, age < 50 (Method: Telephone Screen & Demographics Forms) 
6. Other conditions that may prohibit the effective delivery of the intervention (Method: 
Telephone Screen) 
a. Unable to provide own transportation to exercise center 
b. Unable to read or write, cannot speak or read English 
Community Advisory Board 
 
We created an American Indian Community Advisory Board as a part of the revision that was 
submitted to NIH.  The investigators plan to involve the community advisory board with the pilot 
study.  The board includes Dr. Ronny Bell, Chair of the North Carolina American Indian Health 
Board, Dr. Francis Owl-Smith, a pathologist and native Eastern Band Cherokee Indian and 
former board member of Cherokee Indian Health, and Sheena Kanott Lambert, program director 
of Cherokee Choices.  We also will be working with Turner Goins, professor at Western 
Carolina University, as a consultant for the study. 

Submission Date: 9.9.22 
 
 
 
Interventions 
Diet-induced weight loss plus exercise 
Month 1 
There will be two individual sessions per month and 2 group sessions per month. The 
behavioral sessions will focus on awareness of changing eating habits to lower caloric 
intake. Educational content information regarding what food changes to make, how to 
make them, and why they are important will be clearly explained and discussed with 
participants and significant others. Each group session will include problem solving, 
review of a specific food topic, and tasting of several well-balanced, low-fat, nutritious 
foods prepared with widely available ingredients. During the individual sessions, the 
counselor will review individual progress, solve problems, answer questions, and set 
goals.  During the initial individual session, the nutrition counselor will give the 
participant a weight history background questionnaire.  The major emphasis for Period 
1 is to enhance participant awareness of the importance and the need to change eating 
habits, i.e. lower caloric intake for weight loss.  Each participant should be given the 
opportunity to practice skills using goal setting in a stepwise approach.  Participants will 
follow a weekly menu plan which will incorporate meal replacements into their diet 
plan.  Lean Shakes, a General Nutrition Center (GNC), product will be the meal 
replacement used.  Participants may replace the Lean Shakes with a healthy, low-calorie 
meal of their choice, such as Lean Cuisine.  Motivation and encouragement through the 
combined efforts of the nutrition counselor, the participant, significant others and the 
nutrition staff will enhance adherence.   
Month 2 
In period 2 participants will focus on continued weight loss to reach the study weight 
loss goal of 5% of baseline weight.  Participants will follow a weekly menu plan with 
recipes using traditional foods and the option to incorporate meal replacements. The 
traditional meals will contain 400-600 kcals, be low in fat and added sugars, and high in 
vegetables, fruits, and whole grains. Snacks may be a bar, fruit, or vegetable providing 
~100-120 kcals. Daily caloric intake for each participant will be adjusted to his or her 
rate of weight change. Each group will be encouraged to take a daily 
multivitamin/mineral supplement containing no more than 100% of the Dietary 
Reference Intake for any particular nutrient.     
Month 3   
Period 3 will emphasize weight management over time.  Participants will continue to 
follow a weekly menu plan with recipes using traditional foods and the option to 
incorporate meal replacements.  
 
The exercise intervention will cover a 3-month period.  The exercise program will consist 
of a 15-minute aerobic phase, a 20-minute strength-training phase, a second 15-minute 
aerobic phase, and a 10-minute cool-down phase.  These sixty-minute exercise sessions 
will be conducted three days per week.  Each participant will be prescribed an individual 
walking prescription by the exercise leader, which will be adjusted accordingly, as each 

Submission Date: 9.9.22 
 
 
participant progresses throughout the 3 months.  The exercise will be of moderate 
intensity.  Alternate forms of aerobic exercise, such as but not limited to stationary bike, 
elliptical trainer, or treadmill walking, can be used in place of over-ground walking. This 
choice could be based on participant preference, the limitations of the exercise facility, or 
the participant’s pain level.   
 
Intervention Locations:  The diet and exercise classes will be held at the Ginger Welch 
Complex. 
 
All intervention staff in the WE-CAN study will be CPR certified.  The exercise 
coordinator, who is part of the coordinating center and is responsible for maintaining 
exercise protocol congruity, will train and supervise the intervention staff.  Intervention 
staff will meet monthly with the exercise coordinator to discuss any potential problems, 
risks, and concerns that have risen.  AEDs will be available at each location.  Emergency 
drills will be performed monthly in addition the AED will be checked monthly.   
 
Nutrition & Health Intervention 
The nutrition and health (attention control) intervention will cover a 3-month period.  There will 
be two total face to face group meetings over the 3 months, with one meeting each at months 1 
and 3; and during the other month (month 2) participants will receive a combination of text 
messages, emails, and phone calls.  Participants will be able to select their preferred method.  
Each group meeting will last approximately one hour and will be held at the Ginger Welch 
Complex in Cherokee, NC.   The sessions will be interactive and will provide useful information 
on nutrition and general health topics.  The Community Advisory Board will give input on the 
class sessions.   
 
 
 

Submission Date: 9.9.22 
 
 
Procedures-Screening and Follow-up Visits.  
           
Procedures-Screening and Follow-up Visits.   
Prescreening visit (PSV). Individuals who contact our recruitment office in response to 
advertising will be asked a series of brief questions that focus on major eligibility criteria.  A 
screening visit appointment will be made for participants who meet major eligibility criteria.  A 
medical history form and a medication form will be mailed to the participants for them to 
complete.   
 
Screening Visit One (SV1) SV1 includes an explanation of the study and obtaining informed 
consent.  Other assessments include medical history and medication use (previously mailed), 
cardiovascular risk, height and weight (to calculate BMI), hip/waist circumference 
Measurements 
PSV 
SV1 
RV 
FU3 
Explanation 
Informed Consent 
 
x 
 
 
 
Questionnaires 
Eligibility Questionnaire 
x 
 
 
 
To determine  eligibility 
Medical History/Med History 
FU 
xc 
x 
 
x 
For  eligibility and to document changes in health 
Risk Stratification 
xc 
x 
 
 
Used to screen cardiovascular risk 
Comorbidities Questionnaire 
 
x 
 
x 
 
Randomization 
 
x 
 
 
 
WOMAC 
 
x 
 
x 
Pain is primary and function secondary outcomes.  
Will be taken from the KOOS 
Knee Injury and Osteoarthritis 
Outcome Score (KOOS) 
 
x 
 
x 
Assesses patient’s opinion about their knee and 
associated problems 
PASE scale 
 
x 
 
x 
Physical Activity Scale for the Elderly 
MOCA 
 
x 
 
x 
Montreal Cognitive Assessment 
EuroQol Quality of Life(EQ5D) 
 
x 
 
x 
Quality of life measure 
Resource Utilization  
 
x 
 
x 
Visits to clinicians, tests, medications, injections, 
surgery, alternative therapies 
Work Productivity and Activity 
Impairment Index 
 
x 
 
x 
assesses absenteeism and presenteeism 
DHQ II 
 
x 
 
x 
NIH Diet History Questionnaire 
SF-36 
 
x 
 
x 
Health related quality of life (physical, mental) 
Health Literacy 
 
x 
 
x 
 
Adherence Self Efficacy 
 
x 
 
x 
Confidence in exercising at various intensities and 
frequencies 
Adherence for Duration 
 
x 
 
x 
Confidence in walking for different durations 
Gait Efficacy 
 
x 
 
x 
Confidence in completing tasks 
Demographics 
 
x 
 
 
 
Medication form 
 
x 
 
x 
Atherosclerosis Risk in Communities form 
Weight Efficacy Questionnaire 
 
x 
 
x 
Self-Efficacy for Weight Management 
PANAS 
 
x 
 
x 
Positive and Negative Affect Scale 
SWL 
 
x 
 
x 
Satisfaction with Life 
Perceived Stress 
 
x 
 
x 
Stress 
Pain Catastrophizing Scale 
 
x 
 
x 
Catastrophizing 
Intermittent and Constant 
Osteoarthritis Pain (ICOAP) 
 
x 
 
x 
Intermittent and Constant Pain 
CES-D 
 
x 
 
x 
Depression 
Transition Questionnaire 
 
 
 
x 
Knee pain 
Adverse Events  
 
 
 
x 
Also collected as they occur 
Physical Performance Tests/Knee Exam 
height 
xc 
x 
 
 
To determine BMI 
weight 
xc 
x 
 
x 
To determine BMI 
Knee exam 
 
x 
 
 
To determine  eligibility 
6 minute walk 
 
x 
 
x 
Measure of mobility 
Expanded Short Physical 
Performance Battery (SPPB) 
 
x 
 
x 
Gait speed, sit to stand, balance tests; predicts 
disability 
Randomization 
 
x 
x 
x 
mobility measures  

Submission Date: 9.9.22 
 
 
measurements, blood pressure, and a knee exam.  The MOCA & CES-D will be administered.  
The following questionnaires will be given:  demographics, cost effectiveness questionnaires, 
WOMAC, KOOS, Physical Activity Scale for the Elderly (PASE), Health-Related Quality of 
Life (HRQL), dietary intake questionnaires, health literacy, perceived stress, pain 
catastrophizing, and efficacy measures.  Physical performance measures include the SPPB, 6 
minute walk, GaitRite, and stair climb.  This screening visit will last approximately 3 - 4 hours.  
 
Randomization Visit (RV) At the RV an orientation to the group will be done. 
 
3-month Follow-up Data Collection Visit (FU3): Participants will return to repeat all measures 
collected at baseline (minus the knee exam and demographics).  The testing session will last 
approximately 2.5 – 3.5 hours.  At the end of 3 months the participants will have a mini session 
on what the other group received.    
Safety Monitoring Plan 
An internal safety committee has been established to monitor participant safety and to evaluate 
the progress of the study.   
 
Statistical Considerations 
Data Management 
The Data Management Group, part of the Coordinating Center, has primary responsibility for 
randomization and analyzing data generated by the clinical centers. Data will be collected on 
hard-copy forms at each site and transformed to an electronic database. Our web-based 
management system will assure integrity and validity. Dynamic reports and periodic statistical 
analyses will monitor quality. A participant-based inventory system will track recruitment, 
retention, adherence, and missing data from entry through exit, close-out, and lock-down of final 
datasets. Our team developed a similar database for the IDEA and START studies.   
Statistical Analyses  
Statistical analyses will be conducted according to intention-to-treat principles using SAS. 
 
 
 

Submission Date: 9.9.22 
 
 
References: 
1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with 
disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic 
analysis for the Global Burden of Disease Study 2010. Lancet Lond Engl. 2012;380:2163–96.  
2. Losina E, Burbine, Weinstein, AM, Reichmann WM, Rome BN, Collins JE, et al. Projecting 
the Future Public Health Impact of the Trend Toward Earlier Onset of Knee Osteoarthritis in the 
Past 20 Years. 2014;  
3. Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, et al. Lifetime risk of 
symptomatic knee osteoarthritis. Arthritis Rheum. 2008;59:1207–13.  
4. Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, et al. Exercise and 
dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, 
Diet, and Activity Promotion Trial. Arthritis Rheum. 2004;50:1501–10.  
5. Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, et al. Effects of 
intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among 
overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 
2013;310:1263–73.  
6. Riebe D, Franklin BA, Thompson PD, Garber CE, Whitfield GP, Magal M, et al. Updating 
ACSM’s Recommendations for Exercise Preparticipation Health Screening. Med Sci Sports 
Exerc. 2015;47:2473–9.  
7. Beals J, Welty TK, Mitchell CM, Rhoades DA, Yeh J-L, Henderson JA, et al. Different factor 
loadings for SF36: the Strong Heart Study and the National Survey of Functional Health Status. J 
Clin Epidemiol. 2006;59:208–15.  
8. Jiang L, Beals J, Whitesell NR, Roubideaux Y, Manson SM, AI-SUPERPFP Team. Health-
related quality of life and help seeking among American Indians with diabetes and hypertension. 
Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2009;18:709–18.  
9. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual 
framework and item selection. Med Care. 1992;30:473–83.  
10. Brooks R. EuroQol: the current state of play. Health Policy Amst Neth. 1996;37:53–72.  
11. McAuley E, Mihalko S. Measuring Exercise-Related Self-Efficacy. In: Advances in Sport  
and Exercise Psychology Measurement. Adv Sport Exerc Psychol Meas. edited by J.L.Duda. 
Morgantown, W.V: Fitness  Information Technology, Inc.,; 1998. p. 371–89.  
12. Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive 
and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063–70.  
13. McAuley E, Mihalko SL, Rosengren K. Self-Efficacy and Balance Correlates of Fear of 
Falling in the Elderly. J Aging Phys Act. 1997;5:329–40.  

Submission Date: 9.9.22 
 
 
14. Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers 
Assess. 1985;49:71–5.  
15. Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight 
management. J Consult Clin Psychol. 1991;59:739–44.  
16. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc 
Behav. 1983;24:385–96.  
17. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and 
validation. Psychol Assess. 1995;7:524–32.  
18. Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from 
joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.  
19. Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, et al. Development and 
preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. 
Osteoarthritis Cartilage. 2008;16:409–14.  
20. Murtaugh MA, Ma K, Greene T, Redwood D, Edwards S, Johnson J, et al. Validation of a 
dietary history questionnaire for American Indian and Alaska Native people. Ethn Dis. 
2010;20:429–36.  
21. Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test 
to measure functional health literacy. Patient Educ Couns. 1999;38:33–42.  
22. Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly 
(PASE): development and evaluation. J Clin Epidemiol. 1993;46:153–62.  
23. Ferraro FR, Trottier K. Gender and MMSE Performance in Native American Elderly. 
Psychol J. 2010;7:41–4.  
24. Burnam MA, Wells KB, Leake B, Landsverk J. Development of a brief screening instrument 
for detecting depressive disorders. Med Care. 1988;26:775–89.  
25. Schure M, Goins RT. Psychometric examination of the Center for Epidemiologic Studies 
Depression scale with older American Indians: The Native Elder Care Study. Am Indian Alsk 
Native Ment Health Res Online. 2017;24:1–17.