Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 10:51 AM
Study NCT ID:
NCT05993169
Status:
TERMINATED
Last Update Posted:
2023-12-27
First Post:
2023-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Composition Optimization Intervention RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': ['CARE_PROVIDER'], 'maskingDescription': 'Primary care provider will be blind to subject arm,'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Lack of feasibility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (in kg)', 'timeFrame': '1 year', 'description': 'Patient weight will be recorded at each visit'}, {'measure': 'Height (in cm)', 'timeFrame': '1 year', 'description': 'Patient height will be recorded at each visit'}, {'measure': 'Body mass index', 'timeFrame': '1 year', 'description': 'Patient BMI will be calculated by (weight in kg/height in meters squared)'}, {'measure': 'Hand grip strength (measured in kg)', 'timeFrame': '1 year', 'description': 'Hand grip strength will be obtained at each visit'}, {'measure': 'Body fat mass', 'timeFrame': '1 year', 'description': 'Body fat mass will be obtained by an InBody machine at each visit'}, {'measure': 'Skeletal muscle mass', 'timeFrame': '1 year', 'description': 'Skeletal Muscle mass will be obtained by an InBody machine at each visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'This study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements.', 'detailedDescription': 'Obesity, at a BMI exceeding 40kg/m2 (class III) obesity, is a major risk factor for osteoarthritis (OA). In arthroplasty (joint replacement), patients in this population are routinely turned away due to surgeons refusing surgical treatment in patients above arbitrary BMI thresholds (typically 35 or 40 kg/m2). Due to this, patients often turn to simple weight loss to fall below these thresholds. Simple weight loss, which can include loss of muscle mass, has been proven ineffective, counterproductive, and to be an additional risk factor for surgery. To combat this, efforts in our dedicated bariatric clinic have been made to encourage muscle mass gain and body fat loss over simple weight loss methods where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers. Our department is a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA.\n\nThis study is a randomized controlled trial which aims to recruit adult patients with class III obesity who present to the bariatric arthroplasty clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass (as standard of care in this clinic), study participants will be randomly assigned to one of two cohorts: the study group who will receive nutritional and exercise consultation/intervention, or the control group who will only receive the individual body composition coaching that is standard practice at the bariatric clinic.\n\nThis study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adults, at or above 18 years of age\n* BMI over 40kg/m2\n* Presenting to arthroplasty-obesity clinic with desire for a total joint arthroplasty procedure\n\nExclusion criteria:\n\n* Has a pacemaker or other electronic pacemaker placement\n* Inability to stand unsupported for 60-90 seconds'}, 'identificationModule': {'nctId': 'NCT05993169', 'briefTitle': 'Body Composition Optimization Intervention RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Body Composition Optimization Intervention to Increase Conversion to Surgical Candidacy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202306474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Normal Care'}, {'type': 'EXPERIMENTAL', 'label': 'Nutritional consultation', 'description': 'Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.', 'interventionNames': ['Other: Body Composition optimization visits']}], 'interventions': [{'name': 'Body Composition optimization visits', 'type': 'OTHER', 'description': 'Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.', 'armGroupLabels': ['Nutritional consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacob M. Elkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jacob M. Elkins', 'investigatorAffiliation': 'University of Iowa'}}}}