Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT07049861
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing Biopsychosocial Care Training Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient percent overweight', 'timeFrame': 'Months 2-29 post-enrollment', 'description': 'Percent over the median body mass index (BMI) for sex and age.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Training', 'Implementation', 'Intensive Behavioral Treatment', 'Family-based Behavioral Treatment', 'Obesity', 'Obesity Care'], 'conditions': ['Weight Management', 'Obesity Prevention', 'Obesity and Obesity-related Medical Conditions', 'Obesity and Overweight', 'Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \\[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Study Eligibility Criteria - Provider Trainees:\n\n* Provider Trainees must be PCPs, BHPs, RDNs, or CHWs who work at participating clinics.\n\n * PCPs that are eligible to participate as Provider Trainees can be any of the following: Medical Doctors (MD), Doctor of Osteopathic Medicine (DO), Physician Assistants (PA), or Nurse Practitioners (NP). PCPs must see patients in a primary care setting and be capable of referring patients to IBT and MNT. PCPs must have already completed their residency (when applicable).\n * BHPs that are eligible to participate as Provider Trainees must be at least one of the following categories (listed with typical credentials): Licensed Clinical Social Worker (LCSW), Licensed Professional Counselor (LPC), Licensed Marriage and Family Therapist (LMFT), Psychologist (PhD/PsyD), Psychiatric Nurse Practitioner, Psychiatrist (MD).\n * RDNs that are eligible to participate as Provider Trainees must be Registered Dietitians/Registered Dietitian Nutritionists.\n * CHWs must work as Community Health Workers, or in functionally similar role, within participating clinics\n\nStudy Eligibility - EHR Patients: Benefit-Eligible Patients from Participating Clinics\n\n* Benefit-Eligible Patients from Participating Clinics can either be youth (ages 5-20) or adults (ages 21+) and must be recipients of Medicaid, eligible for the MO Medicaid benefit (i.e., Medicaid recipients with obesity), and have been seen at participating FQHC clinics.\n\nExclusion Criteria - Provider Trainees:\n\n* Not at a participating clinic\n* PCPs who do not have the ability to refer to IBT or MNT\n* Resident Doctors\n* A doctor specializing in reproductive health (or related fields)\n\nExclusion Criteria - Benefit-Eligible Patients from Participating Clinics:\n\n* Patients without obesity\n* Patients not on Medicaid\n* Youth under the age of 5\n* Not a patient at a participating clinic'}, 'identificationModule': {'nctId': 'NCT07049861', 'acronym': 'ABC Initiative', 'briefTitle': 'Advancing Biopsychosocial Care Training Initiative', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Increasing Access to USPSTF-Recommended Obesity Care for Youth and Adults Who Are Recipients of Medicaid: Evaluation of a Comprehensive Multidisciplinary Obesity Care Training Program in FQHCs', 'orgStudyIdInfo': {'id': '202406146'}, 'secondaryIdInfos': [{'id': '5R01DK134961', 'link': 'https://reporter.nih.gov/quickSearch/5R01DK134961', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CMOC', 'description': 'The Provider Trainees at the Federally Qualified Health Centers (FQHCs) assigned to the Comprehensive Multidisciplinary Obesity Care (CMOC) condition will receive the CMOC Training during the12-month training period (months 0-12) of the trial, followed by a 12-month (month 13-24) sustainability period.', 'interventionNames': ['Other: Comprehensive Multidisciplinary Obesity Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IAUC', 'description': 'The Provider Trainees at the Federally Qualified Health Centers (FQHCs) in the implementation as usual control (IAUC) condition will receive the IAUC Training during the12-month training period (months 0-12) of the trial, followed by a 12-month (month 13-24) sustainability period. Following the 12-month sustainability period, Provider Trainees will be offered the CMOC Training.', 'interventionNames': ['Other: Comprehensive Multidisciplinary Obesity Care', 'Other: Implementation as Usual Control']}], 'interventions': [{'name': 'Comprehensive Multidisciplinary Obesity Care', 'type': 'OTHER', 'otherNames': ['Core+'], 'description': 'CMOC is an innovative approach to obesity care delivery that leverages policy, clinical and community linkages, and digital technology for scalability. CMOC involves training providers (medical providers, registered dietitians, and behavioral health providers) to deliver guideline-based obesity care for youth and adults with obesity who receive Medicaid. Guidelines-based care involves screening, identification, weight counseling, and referral to intensive behavioral treatment by medical providers, and delivery of multicomponent intensive behavioral treatment by behavioral health providers and registered dietitians.', 'armGroupLabels': ['CMOC', 'IAUC']}, {'name': 'Implementation as Usual Control', 'type': 'OTHER', 'otherNames': ['Core'], 'description': 'The standard of care implemented in FQHCs in the absence of CMOC training.', 'armGroupLabels': ['IAUC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aubrie Hampp, MSc', 'role': 'CONTACT', 'email': 'ahampp@wustl.edu', 'phone': '314-662-2005'}, {'name': 'Corinne McMahon, MS, RDN, LD', 'role': 'CONTACT', 'email': 'cnmcmahon@wustl.edu'}, {'name': 'Denise Wilfley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Aubrie Hampp, MSc', 'role': 'CONTACT', 'email': 'ahampp@wustl.edu', 'phone': '314-662-2005'}, {'name': 'Corinne McMahon, MS, RDN, LD', 'role': 'CONTACT', 'email': 'cnmcmahon@wustl.edu'}], 'overallOfficials': [{'name': 'Denise Wilfley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, {'name': 'Missouri Institute of Mental Health', 'class': 'UNKNOWN'}, {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, {'name': 'The Missouri Department of Social Services, MO HealthNet Division, Office of Transformation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}