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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05946044




Registration number
NCT05946044
Ethics application status
Date submitted
6/07/2023
Date registered
14/07/2023

Titles & IDs
Public title
The Osteoarthritis Prevention Study
Scientific title
The Osteoarthritis Prevention Study
Secondary ID [1] 0 0
U01AR082121-01
Secondary ID [2] 0 0
IRB00080136
Universal Trial Number (UTN)
Trial acronym
TOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Diet and Exercise

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.


BEHAVIORAL: Diet and Exercise
Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Structural knee Osteoarthritis (OA) MRI change Scores
Timepoint [1] 0 0
Month 48
Secondary outcome [1] 0 0
Knee Pain Scores
Timepoint [1] 0 0
Month 48
Secondary outcome [2] 0 0
Mobility Scores
Timepoint [2] 0 0
Month 48
Secondary outcome [3] 0 0
Health-Related Quality of Life Scores
Timepoint [3] 0 0
Month 48

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
1230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Wake Forest University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Arthritis Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Center for Complementary and Integrative Health (NCCIH)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Office of Disease Prevention
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Office of Research on Women's Health (ORWH)
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
Office of Behavioral and Social Sciences Research (OBSSR)
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
Centers for Disease Control and Prevention
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Missouri-Columbia
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Rapid Nutrition PLC
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen P Messier, Ph.D.
Address 0 0
Wake Forest University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jovita Newman
Address 0 0
Country 0 0
Phone 0 0
336-758-3969
Fax 0 0
Email 0 0
jollajk@wfu.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after deidentification.

Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Immediately following publication. No end date.
Available to whom?
Investigators whose proposed use of the data has been approved by the study P\&P committee. Proposals should be directed to the study PI, Stephen Messier at messier@wfu.edu or the central contact.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05946044