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

Not Applicable

Completed

Conditions: Osteoarthritis

Interventions: Behavioral: Attention Control
Behavioral: Diet & Exercise

Registration Number: NCT04946344

Lead Sponsor: Wake Forest University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control	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.
Diet & Exercise	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Function	Month 3	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.
Distance Walked - Mobility (Six Minute Walk)	Month 3	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.
Health Related Quality of Life (SF-36)	Month 3	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.

Trial Locations

Locations (2): Wake Forest University/Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States
Ginger Welch Complex
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Cherokee, North Carolina, United States