Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-27 @ 7:40 AM
Study NCT ID:
NCT05190666
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2021-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Living After Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2021-12-28', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight at 6 months', 'timeFrame': '6 months', 'description': 'kg'}], 'secondaryOutcomes': [{'measure': 'Change in WOMAC pain subscale at 6 months', 'timeFrame': '6 months', 'description': 'WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)'}, {'measure': 'Change in WOMAC pain subscale at 12 months', 'timeFrame': '12 months', 'description': 'WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)'}, {'measure': 'Change in WOMAC pain subscale at 18 months', 'timeFrame': '18 months', 'description': 'WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)'}, {'measure': 'Change in Six Minute Walk Duration at 6 months', 'timeFrame': '6 months', 'description': 'Physical function assessed with the six minute walk test (feet)'}, {'measure': 'Change in Six Minute Walk Duration at 12 months', 'timeFrame': '12 months', 'description': 'Physical function assessed with the six minute walk test (feet)'}, {'measure': 'Change in Six Minute Walk Duration at 18 months', 'timeFrame': '18 months', 'description': 'Physical function assessed with the six minute walk test (feet)'}, {'measure': 'Change in Timed Up & Go at 6 months', 'timeFrame': '6 months', 'description': 'Physical function assessed with the Timed Up \\& Go Test (seconds)'}, {'measure': 'Change in Timed Up & Go at 12 months', 'timeFrame': '12 months', 'description': 'Physical function assessed with the Timed Up \\& Go Test (seconds)'}, {'measure': 'Change in Timed Up & Go at 18 months', 'timeFrame': '18 months', 'description': 'Physical function assessed with the Timed Up \\& Go Test (seconds)'}, {'measure': 'Change in Chair Stands at 6 months', 'timeFrame': '6 months', 'description': 'Physical function assessed with the Chair stand test (# of chair stands)'}, {'measure': 'Change in Chair Stands at 12 months', 'timeFrame': '12 months', 'description': 'Physical function assessed with the Chair stand test (# of chair stands)'}, {'measure': 'Change in Chair Stands at 18 months', 'timeFrame': '18 months', 'description': 'Physical function assessed with the Chair stand test (# of chair stands)'}, {'measure': 'Change in Moderate to vigorous intensity physical activity at 6 months', 'timeFrame': '6 months', 'description': 'Objectively measured by Actigraph accelerometer (\\>=2020 counts/min)'}, {'measure': 'Change in Moderate to vigorous intensity physical activity at 12 months', 'timeFrame': '12 months', 'description': 'Objectively measured by Actigraph accelerometer (\\>=2020 counts/min)'}, {'measure': 'Change in Moderate to vigorous intensity physical activity at 18 months', 'timeFrame': '18 months', 'description': 'Objectively measured by Actigraph accelerometer (\\>=2020 counts/min)'}, {'measure': 'Change in body weight at 12 months', 'timeFrame': '12 months', 'description': 'kg'}, {'measure': 'Change in body weight at 18 months', 'timeFrame': '18 months', 'description': 'kg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must:\n\n* have a body mass index between 25-45 kg/m2\n* have had a knee replacement (including primary, staged or independent bilateral, or revision) \\<6 months prior to baseline assessment\n* have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with Fitbit\n* completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall)\n* be English-speaking and able to read consent and study materials written in English\n* be willing to attend 4 in-person assessments.\n\nExclusion Criteria:\n\n* have any contraindications to diet or weight loss\n* undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months\n* have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke)\n* are taking anti-obesity medications\n* are enrolled in a formal weight loss program\n* had or are planning to have bariatric/gastric/lap band surgery\n* are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months.'}, 'identificationModule': {'nctId': 'NCT05190666', 'briefTitle': 'Healthy Living After Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Physical Activity and Weight Loss to Improve Function and Pain After Total Knee Replacement', 'orgStudyIdInfo': {'id': 'Pro00109459'}, 'secondaryIdInfos': [{'id': 'R01AG070004', 'link': 'https://reporter.nih.gov/quickSearch/R01AG070004', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PACE Weight Loss Program', 'description': '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.', 'interventionNames': ['Behavioral: PACE Weight Loss program']}, {'type': 'SHAM_COMPARATOR', 'label': 'Chronic Disease Self-Management Program', 'description': '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.', 'interventionNames': ['Behavioral: Chronic Disease Self-Management']}], 'interventions': [{'name': 'PACE Weight Loss program', 'type': 'BEHAVIORAL', 'description': '12 month phone-based behavioral weight loss program', 'armGroupLabels': ['PACE Weight Loss Program']}, {'name': 'Chronic Disease Self-Management', 'type': 'BEHAVIORAL', 'description': '12 month phone-based chronic disease self-management program', 'armGroupLabels': ['Chronic Disease Self-Management Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Pellegrini, PhD.', 'role': 'CONTACT', 'email': 'cpellegrini@sc.edu', 'phone': '803-777-0911'}, {'name': 'Christine Pellegrini, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'centralContacts': [{'name': 'Ellen Wingard', 'role': 'CONTACT', 'email': 'ewingard@mailbox.sc.edu', 'phone': '803-777-1889'}], 'overallOfficials': [{'name': 'Christine Pellegrini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '12 months after primary manuscript is published', 'ipdSharing': 'YES', 'description': 'We will also make de-identified study data available 12 months after the primary manuscript is published.', 'accessCriteria': 'Open'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christine A Pellegrini, PhD', 'investigatorAffiliation': 'University of South Carolina'}}}}