Weight Loss and Exercise for Communities With Arthritis in North Carolina

NCT02577549 | Completed Results DMC

• 2 other identifiers: IRB00033618.WE-CANU01AR068658
• Study Type: interventional
• Target: 823
• Locations: 1 country
• Sites: 3

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 both urban and rural communities 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.

Conditions

Osteoarthritis

Keywords

Knee Pain; Exercise; Diet; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Knee Pain

  To determine whether a pragmatic, community-based, 18-month diet-induced weight-loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain \[as measured by the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale\] in overweight and obese adults with knee Osteoarthritis (OA) compared to an attention-control group - test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4) - Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations - The WOMAC measures five items for pain (score range 0-20). Measure Description: Range, 0 to 20 (0, no pain; 2 to 8, mild; \>8 to 14, moderate; and \>14 to 20, severe); between-group MCID = 1.6, calculated as half the SD.

  18 months

Secondary Outcomes (3)

• Function

  18 months

• Health Related Quality of Life (SF-36) Physical Subscale

  18 months

• Mobility (Six Minute Walk)

  18 months

Other Outcomes (1)

• Cost-effectiveness

  18 months

Study Arms (2)

Diet & Exercise

EXPERIMENTAL

Participants will attend an exercise class 3 days/week for 18 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's minimum weight loss goal will be 10% of baseline body weight.

Behavioral: Diet & Exercise

Attention Control

ACTIVE COMPARATOR

The attention control intervention will cover an 18-month period. There will be five total face to face group meetings over the 18 months, with one meeting each at months 1, 3, 6, 9, and 15; and during the other months (months 2-5, 7-11, 13-17) participants will receive a combination of informational packets, webinars, phone sessions, and/or emails based on continued monitoring of participant needs and delivered via their preferred mode of contact.

Behavioral: Attention Control

Interventions

Diet & Exercise BEHAVIORAL

Participants will attend exercise and diet classes.

Diet & Exercise

Attention Control BEHAVIORAL

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

Attention Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 50
• Knee Pain plus American College of Rheumatology (ACR) Criteria for Knee Osteoarthritis
• BMI = 27 ≥ kg/m2

You may not qualify if:

• 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 18-month study or unlikely to be compliant (Planning to leave area \> 2 month during the next 18 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
• 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)

Sponsors & Collaborators

• Wake Forest University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

Johnston County - UNC Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Haywood County - Haywood Regional Medical Center

Waynesville, North Carolina, 28721, United States

Location

Forsyth County - Wake Forest University/Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (3)

• Messier SP, Callahan LF, Beavers DP, Queen K, Mihalko SL, Miller GD, Losina E, Katz JN, Loeser RF, Quandt SA, DeVita P, Hunter DJ, Lyles MF, Newman J, Hackney B, Jordan JM. Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 22;18(1):91. doi: 10.1186/s12891-017-1441-4.

  PMID: 28228115 BACKGROUND

• Messier SP, Beavers DP, Queen K, Mihalko SL, Miller GD, Losina E, Katz JN, Loeser RF, DeVita P, Hunter DJ, Newman JJ, Quandt SA, Lyles MF, Jordan JM, Callahan LF. Effect of Diet and Exercise on Knee Pain in Patients With Osteoarthritis and Overweight or Obesity: A Randomized Clinical Trial. JAMA. 2022 Dec 13;328(22):2242-2251. doi: 10.1001/jama.2022.21893.

  PMID: 36511925 RESULT

• Messier SP, Gill ME, Mihalko SL, Beavers DP, Queen K, Miller GD, Losina E, Katz JN, Loeser RF, DeVita P, Hunter DJ, Quandt SA, Lyles MF, Hudson D, Callahan LF. Clinical, Health-Related Quality of Life, and Gait Differences Among Obesity Classes in Adults With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2024 Apr;76(4):503-510. doi: 10.1002/acr.25265. Epub 2024 Jan 16.

  PMID: 37885103 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Weight Loss

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Stephen Messier
• Organization: Wake Forest University

messier@wfu.edu

336-758-5849

Study Officials

• Stephen P Messier, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Leigh Callahan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: January 1, 2016
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: June 27, 2023
• Results First Posted: March 15, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)