Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT05444595
Status:
WITHDRAWN
Last Update Posted:
2025-04-27
First Post:
2022-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Plant-Based Dietary Intervention in Latinos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administrative reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'Percent change in body weight from baseline to post-intervention'}], 'secondaryOutcomes': [{'measure': 'Fat mass and fat free mass', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)'}, {'measure': 'β-cell function', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'β-cell function will be assessed from a modified 3-hour oral glucose tolerance test'}, {'measure': 'Insulin Clearance', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test'}, {'measure': 'Plasma Lipids', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'Fasting plasma lipid profile will be assessed by routine blood tests'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and immediately after the intervention at 6 months', 'description': 'Systolic and diastolic blood pressure will be measured'}, {'measure': 'Program acceptability from community health workers and study participants', 'timeFrame': 'Immediately after the intervention at 6 months', 'description': "Community health workers' and study participants' perceptions of program acceptability via questionnaire"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Latinos', 'Obesity', 'Plant-based diet'], 'conditions': ['Obesity', 'Metabolic Disease']}, 'descriptionModule': {'briefSummary': "The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive \\[based on previous literature and stakeholder input\\] lifestyle intervention program, that will be delivered by community health workers \\[CHWs\\], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity \\[20 control, 20 treatment\\] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported Hispanic and/or Latino heritage\n* Body Mass Index (BMI) 30-42 kg/m²\n* HbA1c ≤ 6.4%\n\nExclusion Criteria:\n\n* Previous diagnosis of diabetes\n* Unstable weight (≥4% during the last 2 months prior to study enrollment)\n* Severe cardiovascular disease within the 6 months prior to study enrollment\n* Severe organ system dysfunction\n* active substance abuse with alcohol or drugs\n* Severe anemia\n* Pregnant or breastfeeding\n* Use of medications that are known to affect the study outcome measures\n* Persons who are not able to grant voluntary informed consent'}, 'identificationModule': {'nctId': 'NCT05444595', 'acronym': 'SB Pilot', 'briefTitle': 'Behavioral Plant-Based Dietary Intervention in Latinos', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population', 'orgStudyIdInfo': {'id': '202308026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral and Plant-based Dietary Intervention', 'description': 'In this arm, participants will receive the behavioral plant-based intervention from community health workers.', 'interventionNames': ['Behavioral: Behavioral plant-based dietary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'In this arm, participants will receive the standard care intervention from community health workers.', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'Behavioral plant-based dietary intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will meet with community health workers to receive information focused on healthy eating and consuming a traditional plant-based diet in a group format for the first few months followed by individual check-ins.', 'armGroupLabels': ['Behavioral and Plant-based Dietary Intervention']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'Participants will meet with community health workers to receive general health information through individual check-ins.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}], 'overallOfficials': [{'name': 'Miriam Jacome Sosa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, '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': 'Sansum Diabetes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}