The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee (Cherokee)

Cherokee Health for Elderly Residents With Osteoarthritis of the Knee in the Eastern Band

This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in Cherokee, North Caroling that will recruit American Indian participants; that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: Diet & Exercise; Behavioral: Attention Control

Detailed Description

Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non-pharmacologic treatment to reduce pain. Recently, the investigators determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to the investigators previous longterm weight loss and exercise trials of knee OA, the diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether the investigators results can be generalized to less rigorously monitored patient cohorts is unknown. Thus the challenge the investigators now face is to provide the practical means to implement this proven treatment in the community setting. This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities that can reduce pain and improve other clinical outcomes in knee OA patients.

Participants will be 30 ambulatory, community-dwelling, overweight and obese men and women who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a pragmatic, community-based 3-month diet-induced weight loss and exercise intervention implemented in Cherokee, North Carolina significantly decreases knee pain in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility. The investigators will also establish the cost-effectiveness of this pragmatic, community-based, multimodal diet-induced weight-loss and exercise program by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cherokee, North Carolina, United States, 28719
      • Ginger Welch Complex
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University/Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥ 50
• Knee Pain plus American College of Radiology (ACR) Criteria for Knee Osteoarthritis
• BMI = 25 ≥ kg/m2

Exclusion Criteria:

• Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
• Not sufficiently overweight or obese, BMI < 27 kg/m2
• Not having knee pain
• Inability to finish 3-month study or unlikely to be compliant (Planning to leave area > 1 month during the next 3 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
• Living > 30 minutes from the intervention site
• Age, age < 50
• Other conditions that may prohibit the effective delivery of the intervention (Unable to provide own transportation to exercise center; Unable to read or write)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet & Exercise; Participants will attend an exercise class 3 days/week for 3 months. 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. Participant's will also attend individual and group diet sessions. Each participant will be prescribed an individual walking prescription by the exercise leader, which will be adjusted accordingly, as each 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.	Behavioral: Diet & Exercise; Participants will attend exercise and diet classes.
Active Comparator: Attention Control; The attention control intervention will cover an 3 month period. There will be two face to face group meetings over the 3 months, with one meeting each at months 1 and 3; and during the other months (month 2) participants will receive a combination of text messages, emails, and phone calls based on continued monitoring of participant needs and delivered via their preferred mode of contact.	Behavioral: Attention Control; Participants will attend healthy living classes and receive phone calls/emails/texts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain	Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale in overweight and obese adults with knee OA compared to an attention-control group - The pain index assesses participants' pain on the same scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items. Normalized values are reported. To calculate, the mean score of the individual items of is divided by 4 (the highest possible score for a single answer option). The mean of the observed items is then multiplied by 100 and subtracted from 100. Total scores can range from 0-100, with larger scores indicating greater pain.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Function	Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) function subscale in overweight and obese adults with knee OA compared to an attention-control group - participants indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.	Month 3
Health Related Quality of Life (SF-36)	The physical dimension of the SF-36 is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. A higher score represents a more favorable health state.	Month 3
Distance Walked - Mobility (Six Minute Walk)	To determine whether a pragmatic, community-based, 3-month, diet-induced weight-loss and exercise intervention improves 6-minute walk distance (an accepted measure of mobility) in overweight and obese adults with knee OA compared to an attention control group.	Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 3
EuroQol Quality of Life	Evaluates the generic quality of life developed in Europe and widely used. The EuroQol Quality (EQ)-five dimensions (5D) descriptive system is a preference-based Health-related quality of life (HRQL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression	Baseline and Month 3
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	Baseline and Month 3
The Weight Efficacy Lifestyle Questionnaire (WEL)	A 20-item measure employed to assess self-efficacy for weight management - 10-point Likert scale ranging from 0 (not confident) to 9 (very confident) to resist the desire to eat.	Baseline and Month 3
The Perceived Stress Scale (PSS)	Will measure the degree to which people perceive their lives as stressful - PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Scores around 13 are considered average. Higher scores indicate higher stress.	Baseline and Month 3
Pain Catastrophizing Scale (PCS)	People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness	Baseline and Month 3
Intermittent and Constant Osteoarthritis Pain (ICOAP)	The ICOAP assesses pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences - the 11 items are scored from 0-4 with 0 being no pain and 4 being extreme pain - maximum score = 100	Baseline and Month 3
(DHQ) Dietary History Questionnaire	The diet history method is a detailed retrospective dietary assessment which obtains details of individual foods, and comprehensive information about foods eaten less regularly	Baseline and Month 3
Behavioral Risk Factor Surveillance System (BRFSS)	The BRFSS is a cross-sectional telephone survey that measures health literacy - the nation's premier system of health-related telephone surveys that collect state data about U.S. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services.	Baseline and Month 3
The Physical Activity Scale for the Elderly (PASE)	The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity -Total PASE scores are computed by multiplying activity weights by activity frequencies	Baseline and Month 3
The Montreal Cognitive Assessment (MOCA)	During the MOCA, a health professional asks a patient a series of questions designed to test a range of everyday mental skills. The maximum MOCA score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia	Baseline and Month 3
Center for Epidemiologic Studies Depression Scale	The score is the sum of the 20 questions. Possible range is 0-60. If more than four questions are missing answers, do not score the Center for Epidemiologic Studies Depression (CES-D) questionnaire. A score of 16 points or more is considered depressed	Baseline and Month 3
Physical Performance Battery (SPPB) - Balance	A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality	Baseline and Month 3
Physical Performance Battery (SPPB) - Walking Speed	A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality	Baseline and Month 3
Physical Performance Battery (SPPB) - Chair Rise	A score lower than 10 indicates one or more mobility limitations. A score lower than 10 is predictive of all-cause mortality	Baseline and Month 3
Physical Performance Battery (SPPB) - Stair Activity	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	Baseline and Month 3
The Walking Efficacy for Duration Scale	Duration is a measure to determine participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (5 to 40 minutes) at a moderately fast pace For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100	Baseline and Month 3
The Gait Efficacy/Environmental Efficacy Scale	Will ask the participants' confidence in performing certain activities	Baseline and Month 3
Satisfaction With Life Scale	Focused to assess global life satisfaction - Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree	Baseline and Month 3
The Adherence Self-efficacy Questionnaire	Assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies - This 12-item scale assessed patient confidence to carry out important treatment-related behaviors related to adhering to treatment plans, including medication regimen adherence and following plans for nutrition, exercise, etc, in the face of barriers - Higher scores indicate a greater level of self-efficacy	Baseline and Month 3
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) - the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems	Baseline and Month 3

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Stephen P Messier, PhD, Wake Forest University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Knee Pain; Weight Loss; Diet
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB00033618 - Cherokee; U01AR068658 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual data that has been collected during the trial after it has been deidentified will be available.
• IPD Sharing Time Frame: Data will become available 6 months after study analysis has been completed.
• IPD Sharing Access Criteria: Persons wishing to receive data must submit a formal request to the study team. Consultation with the leaders of tribe is required and approval must be given prior to data access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No