The Osteoarthritis Prevention Study

Conditions

• Osteoarthritis, Knee

Eligibility Criteria

Sex

FEMALE

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Diet and Exercise — BEHAVIORAL
  Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.

Study Details

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.

Key Dates

Start date

Mar 21, 2024

Status verified

Jul 2025

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

1,230 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

• Jovita Newman
  336-758-3969
  [email protected]

Locations (3)

Find similar trials in Boston, MA

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