Recruiting

Observational Study

Sponsor:

Wake Forest University

Code:

NCT05946044

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Interventions

Diet and Exercise

Study Details

Brief summary:

The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.

Conditions

Osteoarthritis, Knee

Study ID

NCT05946044

Start date

Mar 21, 2024

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Female
  • BMI ≥ 30 kg/m2
  • An eligible knee will have no OA by xray and MRI
  • No or infrequent knee pain (< 15 days/month) in the same knee

Exclusion Criteria:

  • symptomatic or severe coronary artery disease
  • unable to walk without a device
  • blindness
  • type 1 diabetes
  • active treatment for cancer
  • during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair
  • knee injection during the past 6 months
  • bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2
  • bilateral knee OA by MRI
  • bilateral symptomatic knee OA (frequent bilateral knee pain > 15 days per month)
  • BMI< 30.0 kg/m2
  • male sex
  • claustrophobia
  • contraindication to MRI including body weight > 300 lbs or knee coil does not fit
  • unwillingness or inability to change eating and physical activity habits due to environment
  • cannot speak and read English
  • planning to leave area > 2 months during the 48-month intervention period

Study Design

Enrollment

1230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Attention Control

This comparison group provides attention, social interaction, and healthy lifestyle classes. There will be 4, 1-hour face-to-face group meetings per year featuring community health professionals, quarterly newsletters, and quarterly text messages.

experimental: Diet and Exercise

The dietary component of the weight loss intervention is characterized by the frequency of contacts, methods to induce dietary restriction, and behavioral therapy strategies. The first 6 months of the diet program is an energy-restricted diet with the option of using partial meal replacements and nutritious snacks (Rapid Nutrition, PLC). The weight loss goal for the diet and exercise group is a minimum of 10% of baseline body weight by the end of year 1. The weight loss phase is followed by 3 years of a weight-loss maintenance program, with the goal of sustaining the achieved weight loss. The exercise component includes 60-minute sessions 2 days per week for 48 months.

Interventions

Diet and Exercise

Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.

Primary outcome measure

  • Structural knee Osteoarthritis (OA) MRI change Scores [ Time Frame: Month 48 ]

Central Contacts and Locations

Central contacts

Jovita Newman

336-758-3969jollajk@wfu.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Paul Oh

617-525-8349paoh@bwh.harvard.edu

Principal Investigator:

Elena Losina, Ph.D.

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27109

Contacts

Jovita Newman

336-758-3969jollajk@wfu.edu

Principal Investigator:

Shannon Mihalko, Ph.D.

More Information

Sponsor

Wake Forest University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Knee Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University on 2026-07-23.