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Cardiovascular DiseasesNCT06643806

Implementation of a Peer Leader-facilitated Dyadic Intervention

A study testing CHAI dyad study in people with Cardiovascular Diseases and Type 2 Diabetes Mellitus in Obese, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease cardiovascular disease (CVD) risk among… Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
What is being tested?
CHAI dyad study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
20 Mar 2025to 28 Jun 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • community-dwelling first generation Asian Indian (AI) immigrants (in marital dyads) between the ages of 18-70 years of age who can read and write English and are technology literate.

Who cannot join

  • AIs not in a marital dyad, those below the age of 20 or above 70 years or those born in the US or visiting the US from India.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers, The State University of New Jersey

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: Implementation of a Peer Leader-facilitated Dyadic Intervention to Decrease Cardiovascular Disease Risk Among First Generation Asian Indian Immigrants

This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease cardiovascular disease (CVD) risk among first generation AI immigrants; and 2) Assess the feasibility/acceptability of a full-scale intervention. Twenty marital dyads from the site randomly assigned as the intervention site will receive the 12- week peer leader-facilitated dyadic intervention, while 20 dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. Both groups will meet weekly (90 min. classes) for 12 weeks in a hybrid format (a combination of face to face and remote learning). The intervention is designed to address factors that we identified in our previous study as contributing to a syndemic of cardiovascular disease among AI immigrants including acculturation stress, family history and genetic risk, physical inactivity, as well as a high fat, high-carbohydrate, high-calorie diet.

Read the detailed description

Asian Indian (AI) immigrants, the second largest immigrant group in the US, have a high prevalence of abdominal obesity and premature cardiovascular disease (CVD). Despite ample epidemiological evidence of the need to reduce CVD risk in AIs, few published interventions have addressed this population, primarily focusing on dietary measures and promotion of physical activity, and none of these address immigrant AIs.

This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease CVD risk among first generation AI immigrants; and 2) Assess the feasibility/acceptability of a full-scale intervention. Twenty marital dyads from the site randomly assigned as the intervention site will receive the 12- week peer leader-facilitated dyadic intervention, while 20 dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. Both groups will meet weekly (90 min. classes) for 12 weeks in a hybrid format (a combination of face to face and remote learning). The intervention is designed to address factors that we identified in our previous study as contributing to a syndemic of cardiovascular disease among AI immigrants including acculturation stress, family history and genetic risk, physical inactivity, as well as a high fat, high-carbohydrate, high-calorie diet.

Unlike a hypothesis generating study, a pilot study is designed to assess the feasibility/accessibility of an approach to be used in a larger scale study. The following research questions are designed to address feasibility and accessibility of this pilot cluster randomized controlled trial intervention:

Q1 Can the target population of AI immigrant dyads be recruited from faith-based or AI community-based organizations in Central and Northern New Jersey (N.J.)? Q2 Can the target population of AI immigrant dyads be randomized in a cluster randomized controlled trial? Q3 Can the target population of AI immigrant dyads be retained? Q4 Can the treatments be delivered per protocol? Q5 Will AI immigrant dyads adhere to the treatment protocol? Q6 Are the treatment conditions of the intervention acceptable to AI immigrant dyads?

Being tested
CHAI dyad study
Keywords
Community based participatory research, Asian Indian immigrants, Acculturation stress
Medical subject headings
Cardiovascular Diseases, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHAI dyad studyBehavioural

    Also called CHAI for 2

    In the CHAI (Cardiovascular Health among Asian Indian immigrants) Dyad study, we plan to Implement and pilot test a peer leader-facilitated 12-week dyadic intervention to decrease CVD risk among first generation AI immigrants;

Study groups in NCT06643806
Study groupRoleWhat they receive
ExperimentalExperimentalTwenty marital dyads from the site randomly assigned as the intervention site(s) will receive the 12- week peer leader-facilitated dyadic intervention. Topics over the 12 week intervention will address stress management, family history and genetic risk, dietary habits, physical activity and social support/community engagement.
Receives: Behavioral: CHAI dyad study
ControlActive comparatorTwenty dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. This program will be similar to a classic cardiac rehabilitation program and will consist of diet, physical activity and medical management.
Receives: Behavioral: CHAI dyad study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk of CVD

    Measured by the QRISK3- The score estimates the likelihood (percentage) of a person developing CVD over the next 10 years. The higher the percentage, the greater the likelihood that they will suffer a heart attack or stroke in the next ten years. A 10-year risk <10% is considered low, 10-20% moderate, and >20% high. Collected data are entered into the QRISK3 calculator online Factors involved in the calculation include age, gender, ethnicity, smoking status, history of T2DM, history of hypertension, systolic BP, cholesterol/HDL. ratio, and BMI. Data are entered into Citation- Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study, BMJ 2017;357:j2099

    Measured: 10 weeks

Secondary outcomes (8)

  1. Acculturation Stress

    Measured by the Riverside Acculturation Stress Inventory (RASI). The RASI is a 15 item scale that measures 5 domains of acculturative stress, including intercultural relations, language skills, discrimination, work challenges, and cultural/ethnic makeup of the community. Each item is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). In the RASI, higher scores reflect higher levels of acculturative stress, ranging from 15 to 75 points. Citation: Benet-Martinez V. The Riverside Acculturation Stress Inventory (RASI). Development and Psychometric Properties. Department of Psychology, University of California at Riverside; Riverside, CA, USA: 2003. Technical Report.

    Measured: 10 weeks

  2. Perceived Stress

    Measured by the Perceived Stress Scale (PSS-10). The PSS is a 10-item, 5 point Likert scale questionnaire that was designed to measure the degree to which situations in one's life are appraised as stressful. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of self-reported stress. There are two sub-scales on the PSS-10: Perceived helplessness (items 1, 2, 3, 6, 9, 10) and Lack of self-efficacy (items 4, 5, 7, 8). Citations: Cohen, S., Kamarch, T., \& Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385; Lee, E.-H. (2012). Review of the psychometric evidence of the perceived stress scale. Asian Nursing Research, 6(4), 121-127. https://doi.org/10.1016/j.anr.2012.08.004.

    Measured: 10 weeks

  3. Body Composition

    BMI (weight and height will be combined to report BMI in Kg/m^2). Desirable BMI for Asian Indians is below 23 kg/m^2; overweight falls from 23 - 27.4 Kg/m^2 (25 - 30Kg/m^2 for other ethnicities) and 27.5 Kg/m^2and up is considered obese (30Kg/m^2 for other ethnicities).

    Measured: 10 weeks

  4. Waist Circumference

    Waist circumference as a measure of body composition. Desirable waist circumference measures in Asian Indian women are < 31 in. and for Asian Indian men, < 35 inches.

    Measured: 10 weeks

  5. Hemoglobin A1c

    Measure of glucose control- in the Asian Indian community, an A1C value of ≥6.0% is optimal for diagnosing diabetes with a very high level of accuracy

    Measured: 10 weeks

  6. Lipid Panel

    Cholesterol/HDL ratio- A cholesterol/HDL ratio of below 3.5 is optimal and indicates a very low risk for heart disease.

    Ratios above 5 to 1 are considered high and may mean an elevated risk for heart disease

    Measured: 10 weeks

  7. Inflammation

    C-reactive protein is a generalized measure of inflammation; Levels of CRP less than 1 mg/L are desirable and reflect a low overall cardiovascular risk. Levels of CRP between 1 and 3 mg/L are indicative of moderate risk, while levels of CRP in excess of 3 mg/L suggest quite elevated vascular risk.

    Measured: 10 weeks

  8. Genetic Risk of CVD

    Lipoprotein a is a genetic risk for CVD. Approximately 25-50% of South Asians have elevated levels (>50mg/dL), contributing to a higher prevalence of and premature coronary disease, with higher levels often found in Indian individuals compared to other ethnicities. We drew lipoprotein a samples on June 27 and 28 and are awaiting the results.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start20 Mar 2025
  3. Primary completion20 Jun 2025
  4. Study completion28 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial of 12 week intervention.
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06643806
Sponsor's protocol ID
Pro2024002046
Other IDs
1P50MD017356-01
Status last verified
Sep 2026
First submitted
14 Oct 2024
Last updated
24 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available after deidentification.

Questions about this trial

What is this clinical trial studying?

A study testing CHAI dyad study in people with Cardiovascular Diseases and Type 2 Diabetes Mellitus in Obese, run by Rutgers, The State University of New Jersey at 1 site 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Risk of CVD (time frame: 10 weeks). 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 NCT06643806.

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 24 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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