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ArthroplastyNCT05190666

Healthy Living After Knee Replacement

A study testing PACE Weight Loss program and Chronic Disease Self-Management in people with Arthroplasty and Overweight and Obesity, run by University of South Carolina at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Arthroplasty, Overweight and Obesity
What is being tested?
PACE Weight Loss program and Chronic Disease Self-Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
1 siteUnited States
Study dates
4 Jan 2022to 30 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Participants must:
  • have a body mass index between 25-45 kg/m2
  • have had a knee replacement (including primary, staged or independent bilateral, or revision) <6 months prior to baseline assessment
  • have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit
  • completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)
  • be English-speaking and able to read consent and study materials written in English
  • be willing to attend 4 in-person assessments.

Who cannot join

  • have any contraindications to diet or weight loss
  • undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months
  • have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)
  • are taking anti-obesity medications
  • are enrolled in a formal weight loss program
  • had or are planning to have bariatric/gastric/lap band surgery
  • are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Carolina

    Columbia, South Carolina, 29208

Other trials in United States

About this study

Official title: Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

Read the detailed description

Participants will be randomized to either a weight loss program or chronic disease self-management program. Both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. Monthly calls with occur between months 13-18. Assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.

Being tested
PACE Weight Loss program, Chronic Disease Self-Management
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACE Weight Loss programBehavioural

    12 month phone-based behavioral weight loss program

  • Chronic Disease Self-ManagementBehavioural

    12 month phone-based chronic disease self-management program

Study groups in NCT05190666
Study groupRoleWhat they receive
PACE Weight Loss ProgramExperimentalParticipants randomized to this arm will receive personalized diet, activity, and weight loss goals as well as tools to self-monitor behaviors and weight. To facilitate changes, participants will receive coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.
Receives: Behavioral: PACE Weight Loss program
Chronic Disease Self-Management ProgramSham comparatorParticipants randomized to this arm will receive a chronic disease self-management program including a self-management book. Participants will receive regular calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.
Receives: Behavioral: Chronic Disease Self-Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight at 6 months

    kg

    Measured: 6 months

Secondary outcomes (17)

  1. Change in WOMAC pain subscale at 6 months

    WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

    Measured: 6 months

  2. Change in WOMAC pain subscale at 12 months

    WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

    Measured: 12 months

  3. Change in WOMAC pain subscale at 18 months

    WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

    Measured: 18 months

  4. Change in Six Minute Walk Duration at 6 months

    Physical function assessed with the six minute walk test (feet)

    Measured: 6 months

  5. Change in Six Minute Walk Duration at 12 months

    Physical function assessed with the six minute walk test (feet)

    Measured: 12 months

  6. Change in Six Minute Walk Duration at 18 months

    Physical function assessed with the six minute walk test (feet)

    Measured: 18 months

  7. Change in Timed Up & Go at 6 months

    Physical function assessed with the Timed Up \& Go Test (seconds)

    Measured: 6 months

  8. Change in Timed Up & Go at 12 months

    Physical function assessed with the Timed Up \& Go Test (seconds)

    Measured: 12 months

  9. Change in Timed Up & Go at 18 months

    Physical function assessed with the Timed Up \& Go Test (seconds)

    Measured: 18 months

  10. Change in Chair Stands at 6 months

    Physical function assessed with the Chair stand test (# of chair stands)

    Measured: 6 months

  11. Change in Chair Stands at 12 months

    Physical function assessed with the Chair stand test (# of chair stands)

    Measured: 12 months

  12. Change in Chair Stands at 18 months

    Physical function assessed with the Chair stand test (# of chair stands)

    Measured: 18 months

  13. Change in Moderate to vigorous intensity physical activity at 6 months

    Objectively measured by Actigraph accelerometer (>=2020 counts/min)

    Measured: 6 months

  14. Change in Moderate to vigorous intensity physical activity at 12 months

    Objectively measured by Actigraph accelerometer (>=2020 counts/min)

    Measured: 12 months

  15. Change in Moderate to vigorous intensity physical activity at 18 months

    Objectively measured by Actigraph accelerometer (>=2020 counts/min)

    Measured: 18 months

  16. Change in body weight at 12 months

    kg

    Measured: 12 months

  17. Change in body weight at 18 months

    kg

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2022
  2. Study start4 Jan 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05190666
Sponsor's protocol ID
Pro00109459
Other IDs
R01AG070004
Status last verified
Apr 2026
First submitted
28 Dec 2021
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will also make de-identified study data available 12 months after the primary manuscript is published.

Questions about this trial

What is this clinical trial studying?

A study testing PACE Weight Loss program and Chronic Disease Self-Management in people with Arthroplasty and Overweight and Obesity, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05190666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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