Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 4:23 PM
Study NCT ID:
NCT06991751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08-29', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To summarize socioecological characteristics of acculturation and cardiometabolic health from >=18-year-old adults United States Bhutanese living in Central Ohio.', 'timeFrame': '6-12 months', 'description': 'Summary on self-reported constructs of acculturation and acculturative stress, discrimination and stigma, health behaviors, medical history and health behaviors, mental health, sleep health, neighborhood social cohesion and community support, trauma, and medical history of cardiometabolic conditions.'}], 'secondaryOutcomes': [{'measure': 'To identify barriers and facilitators to biospecimen donation among United States Bhutanese adults living in Central Ohio.', 'timeFrame': '6-12 months', 'description': 'Description of barriers and facilitators to biospecimen donation from US Bhutanese participants identified by qualitative inquiry and analysis of beliefs on biospecimens and invasiveness.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bhutanese', 'South Asian', 'Community engaged', 'Biospecimen perceptions', 'Epidemiology', 'Syndemic'], 'conditions': ['Cardiometabolic Risk Factors', 'Mental Health']}, 'descriptionModule': {'briefSummary': 'Background:\n\nAs of 2021, almost 45 million people in the United States were foreign-born immigrants. South Asians, including people from Bhutan, are the fastest-growing immigrant subgroup in the US. Their income and education levels are higher than the US average. Yet they have worse physical and mental health outcomes than their White US-born counterparts. These risks include type 2 diabetes and obesity.\n\nObjective:\n\nThis natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US.\n\nEligibility:\n\nAdults aged 18 years or older who identify as Bhutanese and live in the US.\n\nDesign:\n\nParticipants will be recruited and screened by the Bhutanese Community of Central Ohio (BCCO). They will have 1 visit to the BCCO s Arogya Clinic in Reynoldsburg. The visit will last 2 hours.\n\nParticipants will take a survey; they may use either English or Nepali. They will answer questions about their background; their experiences living in the US; and how their customs and habits might have changed. They will also be asked about their experiences with discrimination; their mental health and well-being; their community; quality of life; and overall physical health. The survey will take 60 minutes.\n\nParticipants will also speak with a researcher. They will be asked how they feel about providing biological samples; these may include saliva, blood, and urine. Their answers will be audio recorded.', 'detailedDescription': 'Study Description:\n\nIn 2021 we completed a cross-sectional feasibility study to assess cardiometabolic health of the Bhutanese refugee community in central Ohio. This is a cross-sectional pilot to assess the feasibility of establishing a long-term cohort study among the Bhutanese community to provide representation of a hardly-reached demographic group, optimize collection of behavioral and biological data. Schedule of Activities, describes the study activities including a survey assessing the participants experiences and a brief qualitative assessment examining the feasibility of obtaining biological samples.\n\nObjectives:\n\nThe objectives are as follow:\n\nPrimary Objective: (Aim 1) To summarize socioecological characteristics of acculturation and cardiometabolic health from \\>=18-year-old adults United States Bhutanese living in Central Ohio.\n\nSecondary Objectives: (Aim 2) To identify barriers and facilitators to biospecimen donation among United States Bhutanese adults living in Central Ohio.\n\nEndpoints:\n\nPrimary Objective: (Aim 1) Summary on self-reported constructs of acculturation and acculturative stress, discrimination and stigma, health behaviors, medical history and health behaviors, mental health, sleep health, neighborhood social cohesion and community support, trauma, and medical history of cardiometabolic conditions.\n\nSecondary Objectives: (Aim 2) Description of barriers and facilitators to biospecimen donation from US Bhutanese participants identified by qualitative inquiry and analysis of beliefs on biospecimens and invasiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 18 years or older who identify as Bhutanese and live in the US, greater Ohio area.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nTo participate in this study all of the following criteria must be met:\n\n* Adults (aged 18 years and older) living in the United States\n* Identify as Bhutanese, which will be defined as those individuals that resided or had/have their closest relatives residing in the Kingdom of Bhutan\n* Bhutanese identity will also include those that self-identify as Bhutanese-Nepali or Bhutanese American\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any South Asian participants that do not identify as Bhutanese.\n* Pregnant at time of study or screening'}, 'identificationModule': {'nctId': 'NCT06991751', 'briefTitle': 'A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Bhutanese Community of Central Ohio Health Study to Identify Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating Health Disparities From a Cross-Sectional Study', 'orgStudyIdInfo': {'id': '10002248'}, 'secondaryIdInfos': [{'id': '002248-E'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'US Bhutanese', 'description': 'Those self-identifying as Bhutanese living in central Ohio.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43229', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Sudarshan Pyakurel', 'role': 'CONTACT', 'email': 'spyakurel@bccoh.org', 'phone': 'Not Listed'}], 'facility': 'Bhutanese Community of Central Ohio (BCCO)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Chandra L Jackson, Ph.D.', 'role': 'CONTACT', 'email': 'chandra.jackson@nih.gov', 'phone': '(984) 297-3701'}], 'overallOfficials': [{'name': 'Chandra L Jackson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Environmental Health Sciences (NIEHS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}