Implementation of a Peer Leader-facilitated Dyadic Intervention

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Hyperlipidemias; Type 2 Diabetes Mellitus in Obese
• Intervention / Treatment: Behavioral: CHAI dyad study

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 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?

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen T D'Alonzo, PhD; Phone Number: (908)-963-7064; Email: kdalonzo@sn.rutgers.edu
• Study Contact Backup: Name: Shailja Mathur, M.S., M.Ed.,; Phone Number: 908-692-5823; Email: mathur@njaes.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: CHAI dyad study; 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;
Active Comparator: Control; 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.	Behavioral: CHAI dyad study; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of CVD	Measured by the QRISK3	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acculturation stress	Measured by the Riverside Acculturation Stress Inventory	13 weeks
Perceived stress	Measured by the Perceived Stress Scale	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

Other Outcome Measures

Outcome Measure	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)	13 weeks
Physical activity	NASA JSC physical activity scale	13 weeks
dietary intake	3 day dietary diary	13 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Karen T D'Alonzo, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Community based participatory research; Asian Indian immigrants; Acculturation stress
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hyperlipidemias
• Other Study ID Numbers: Pro2024002046; 1P50MD017356-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available after deidentification.
• IPD Sharing Time Frame: Data will be available immediately after publication with no end date.
• IPD Sharing Access Criteria: Data will be made available indefinitely at a specific link (to be determined)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No