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NCT Number: NCT06643806

Implementation of a Peer Leader-facilitated Dyadic Intervention

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 NJ? 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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CHAI dyad study

Behavioral

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;

Primary outcomes

  1. Risk of CVD

    Time frame: 13 weeks

    Measured by the QRISK3

Secondary outcomes

  1. Acculturation stress

    Time frame: 13 weeks

    Measured by the Riverside Acculturation Stress Inventory

  2. Perceived stress

    Time frame: 13 weeks

    Measured by the Perceived Stress Scale

  3. Body composition

    Time frame: 13 weeks

    BMI (weight and height will be combined to report BMI in kg/m^2)

  4. waist circumference

    Time frame: 13 weeks

    Body composition

  5. Hemoglobin A1c

    Time frame: 13 weeks

    Measure of glucose control

  6. Lipid panel

    Time frame: 13 weeks

    Total cholesterol, HDL, LDL, triglycerides

  7. Inflammation

    Time frame: 13 weeks

    C-reactive protein

  8. Genetic risk of CVD

    Time frame: 13 weeks

    Lipoprotein a

Other outcomes

  1. Community support

    Time frame: 13 weeks

    Perceived community support questionnaire

  2. Salivary cortisol

    Time frame: 13 weeks

    three specimens (upon rising, one-half hour later and at bedtime)

  3. Physical activity

    Time frame: 13 weeks

    NASA JSC physical activity scale

  4. dietary intake

    Time frame: 13 weeks

    3 day dietary diary

Study contacts

Contact information is provided by the study sponsor or research team.

Karen T D'Alonzo, PhD

CONTACT

[email protected]

(908)-963-7064

Shailja Mathur, M.S., M.Ed.,

CONTACT

[email protected]

908-692-5823

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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