AtherosclerosisNCT02268513
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
An observational study of Atherosclerosis, run by Northwestern University at 2 sites in United States.
Trial summary
It has been argued that social relationships are important to health and well-being. This study will investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 775 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteer participants from the the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study cohort.
Who may be able to join
- Participants enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study.
Who cannot join
- People not enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of California at San Francisco
San Francisco, California, 94115
About this study
Official title: Social and Cultural Influences on Cardiovascular Disease Risk in South Asians
It has been argued that social relationships are important to health and well-being. This study will investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.
Read the detailed description
This study will use mixed-methods to investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.
- Conditions
- Atherosclerosis
- Keywords
- Cardiovascular Disease, Social network, South Asians
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
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 |
|---|---|---|
| MASALA study | Mediators of Atherosclerosis in South Asians Living in America (MASALA) study participants will be invited to participate in this ancillary study. Objective of MASALA study: The Mediators of Atherosclerosis in South Asians Living in America (MASALA) study is investigating the prevalence, correlates, and outcomes associated with subclinical CVD in a population-based sample of South Asian men and women age 40-79 years at 2 US clinical field centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MASALA participants with high kin density
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Namratha Kandula, Northwestern University
- Investigators
- Namratha R Kandula, MD,MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268513
- Sponsor's protocol ID
- STU00083722
- Other IDs
- R01HL120725
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2014
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bennett L, Rose D, Jackson A, Thomas S. Psychological and socio-medical aspects of HIV/AIDS: a reflection on publications in AIDS care (1989-1995). AIDS Care. 1998 Feb;10(1):115-21. doi: 10.1080/713612344.
PubMed 9536207Thanawala MS, Siddique J, Schneider JA, Kanaya AM, Cooper AJ, Dave SS, Lancki N, Kandula NR. Association of Social Networks and Physical Activity in South Asians: The Mediators of Atherosclerosis in South Asians Living in America Cohort Study. J Phys Act Health. 2020 Feb 1;17(2):149-155. doi: 10.1123/jpah.2019-0099.
PubMed 31810059Kandula NR, Cooper AJ, Schneider JA, Fujimoto K, Kanaya AM, Van Horn L, deKoning L, Siddique J. Personal social networks and organizational affiliation of South Asians in the United States. BMC Public Health. 2018 Feb 5;18(1):218. doi: 10.1186/s12889-018-5128-z.
PubMed 29402246
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Cultural Influences on Cardiovascular Disease Risk in South Asians
- ClinicalTrials.gov ID
- NCT02268513
- Acronym / sponsor ID
- STU00083722
- Conditions
- Atherosclerosis
- Keywords
- Cardiovascular Disease, Social network, South Asians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been argued that social relationships are important to health and well-being. This study will investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.
Detailed description
This study will use mixed-methods to investigate links between social networks and cardiovascular disease risk factors in South Asians, the second fastest growing ethnic group in the US and one with disparate rates of coronary heart disease. Identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASALA study | – | –Mediators of Atherosclerosis in South Asians Living in America (MASALA) study participants will be invited to participate in this ancillary study. Objective of MASALA study: The Mediators of Atherosclerosis in South Asians Living in America (MASALA) study is investigating the prevalence, correlates, and outcomes associated with subclinical CVD in a population-based sample of South Asian men and women age 40-79 years at 2 US clinical field centers. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer participants from the the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study cohort.
Key inclusion criteria (1 listed)
- Participants enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study.
Key exclusion criteria (1 listed)
- People not enrolled in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of MASALA participants with high kin density
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 9536207Bennett L, Rose D, Jackson A, Thomas S. Psychological and socio-medical aspects of HIV/AIDS: a reflection on publications in AIDS care (1989-1995). AIDS Care. 1998 Feb;10(1):115-21. doi: 10.1080/713612344.
- Derived from this study: PubMed 31810059Thanawala MS, Siddique J, Schneider JA, Kanaya AM, Cooper AJ, Dave SS, Lancki N, Kandula NR. Association of Social Networks and Physical Activity in South Asians: The Mediators of Atherosclerosis in South Asians Living in America Cohort Study. J Phys Act Health. 2020 Feb 1;17(2):149-155. doi: 10.1123/jpah.2019-0099.
- Derived from this study: PubMed 29402246Kandula NR, Cooper AJ, Schneider JA, Fujimoto K, Kanaya AM, Van Horn L, deKoning L, Siddique J. Personal social networks and organizational affiliation of South Asians in the United States. BMC Public Health. 2018 Feb 5;18(1):218. doi: 10.1186/s12889-018-5128-z.
- This is the link for the main MASALA study with information regarding the MASALA social network studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namratha R Kandula, MD,MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of MASALA participants with high kin density (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268513, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.