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

NCT ID: NCT04946344

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2023-04-20

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diet & Exercise

Intervention Type: BEHAVIORAL

Participants will attend exercise and diet classes.

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.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

Participants will attend healthy living classes and receive phone calls/emails/texts.

Interventions

Diet & Exercise

Participants will attend exercise and diet classes.

Intervention Type: BEHAVIORAL

Attention Control

Participants will attend healthy living classes and receive phone calls/emails/texts.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen P Messier, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

Ginger Welch Complex

Cherokee, North Carolina, United States

Wake Forest University/Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AR068658

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00033618 - Cherokee

Identifier Type: -

Identifier Source: org_study_id