Cardiometabolic Risk FactorsNCT06991751
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 ...
An observational study of Cardiometabolic Risk Factors and Mental Health, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: As 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiometabolic Risk Factors, Mental Health
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 31 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older who identify as Bhutanese and live in the US, greater Ohio area.
Who may be able to join
- To participate in this study all of the following criteria must be met:
- Adults (aged 18 years and older) living in the United States
- Identify as Bhutanese, which will be defined as those individuals that resided or had/have their closest relatives residing in the Kingdom of Bhutan
- Bhutanese identity will also include those that self-identify as Bhutanese-Nepali or Bhutanese American
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any South Asian participants that do not identify as Bhutanese.
- Pregnant at time of study or screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Bhutanese Community of Central Ohio (BCCO)
Columbus, Ohio, 43229
Sudarshan Pyakurel, Not Listed, spyakurel@bccoh.org
About this study
Official title: 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
Background:
As 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.
Read more
Objective:
This natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US.
Eligibility:
Adults aged 18 years or older who identify as Bhutanese and live in the US.
Design:
Participants 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.
Participants 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.
Participants 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.
Read the detailed description
Study Description:
In 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.
Objectives:
The objectives are as follow:
Primary Objective: (Aim 1) To summarize socioecological characteristics of acculturation and cardiometabolic health from >=18-year-old adults United States Bhutanese living in Central Ohio.
Secondary Objectives: (Aim 2) To identify barriers and facilitators to biospecimen donation among United States Bhutanese adults living in Central Ohio.
Endpoints:
Primary 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.
Secondary 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.
- Conditions
- Cardiometabolic Risk Factors, Mental Health
- Keywords
- Bhutanese, South Asian, Community engaged, Biospecimen perceptions, Epidemiology, Syndemic
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| US Bhutanese | Those self-identifying as Bhutanese living in central Ohio. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To summarize socioecological characteristics of acculturation and cardiometabolic health from >=18-year-old adults United States Bhutanese living in Central Ohio.
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.
Measured: 6-12 months
Secondary outcomes (1)
To identify barriers and facilitators to biospecimen donation among United States Bhutanese adults living in Central Ohio.
Description of barriers and facilitators to biospecimen donation from US Bhutanese participants identified by qualitative inquiry and analysis of beliefs on biospecimens and invasiveness.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start28 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chandra L Jackson, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991751
- Sponsor's protocol ID
- 10002248
- Other IDs
- 002248-E
- Status last verified
- 1 Oct 2026
- First submitted
- 23 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided