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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MD017356-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Twenty 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. |
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| Control | Active Comparator | Twenty 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of CVD | Measured by the QRISK3 | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acculturation stress | Measured by the Riverside Acculturation Stress Inventory | 13 weeks |
| Perceived stress | Measured by the Perceived Stress Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Community support | Perceived community support questionnaire | 13 weeks |
| Salivary cortisol | three specimens (upon rising, one-half hour later and at bedtime) |
Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-report of gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen T D'Alonzo, PhD | Contact | (908)-963-7064 | kdalonzo@sn.rutgers.edu | |
| Shailja Mathur, M.S., M.Ed., | Contact | 908-692-5823 | mathur@njaes.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen T D'Alonzo, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
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Individual participant data will be available after deidentification.
Data will be available immediately after publication with no end date.
Data will be made available indefinitely at a specific link (to be determined)
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 26, 2026 | |
| Reset | Apr 14, 2026 | |
| Release | May 6, 2026 | |
| Unrelease | May 14, 2026 | |
| Release | May 15, 2026 | |
| Reset | Jun 10, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2026 | Apr 14, 2026 | |||
| May 6, 2026 | May 14, 2026 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Cluster randomized trial of 12 week intervention.
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We will attempt to enforce community level blinding/masking in this study, but other forms of blinding/masking are not entirely possible in a cluster randomized trial
| 13 weeks |
| Body composition | BMI (weight and height will be combined to report BMI in kg/m^2) | 13 weeks |
| waist circumference | Body composition | 13 weeks |
| Hemoglobin A1c | Measure of glucose control | 13 weeks |
| Lipid panel | Total cholesterol, HDL, LDL, triglycerides | 13 weeks |
| Inflammation | C-reactive protein | 13 weeks |
| Genetic risk of CVD | Lipoprotein a | 13 weeks |
| 13 weeks |
| Physical activity | NASA JSC physical activity scale | 13 weeks |
| dietary intake | 3 day dietary diary | 13 weeks |
| May 15, 2026 | Jun 10, 2026 |
| Jun 19, 2026 |