NCT05190666

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2022Jul 2027

First Submitted

Initial submission to the registry

December 28, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

December 28, 2021

Last Update Submit

January 13, 2026

Conditions

ArthroplastyOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in body weight at 6 months

    kg

    6 months

Secondary Outcomes (17)

  • Change in WOMAC pain subscale at 6 months

    6 months

  • Change in WOMAC pain subscale at 12 months

    12 months

  • Change in WOMAC pain subscale at 18 months

    18 months

  • Change in Six Minute Walk Duration at 6 months

    6 months

  • Change in Six Minute Walk Duration at 12 months

    12 months

  • +12 more secondary outcomes

Study Arms (2)

PACE Weight Loss Program

EXPERIMENTAL

Participants 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.

Behavioral: PACE Weight Loss program

Chronic Disease Self-Management Program

SHAM COMPARATOR

Participants 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.

Behavioral: Chronic Disease Self-Management

Interventions

PACE Weight Loss programBEHAVIORAL

12 month phone-based behavioral weight loss program

PACE Weight Loss Program
Chronic Disease Self-ManagementBEHAVIORAL

12 month phone-based chronic disease self-management program

Chronic Disease Self-Management Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Pellegrini, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 13, 2022

Study Start

January 4, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

We will also make de-identified study data available 12 months after the primary manuscript is published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 months after primary manuscript is published
Access Criteria
Open

Locations

US(1)