Implementation of a Peer Leader-facilitated Dyadic Intervention

NCT06643806 | Completed Results DMC

• 2 other identifiers: Pro20240020461P50MD017356-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hyperlipidemias; Cardiovascular Diseases; Type 2 Diabetes Mellitus in Obese

Keywords

Community based participatory research; Asian Indian immigrants; Acculturation stress

Outcome Measures

Primary Outcomes (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

  10 weeks

Secondary Outcomes (8)

• Acculturation Stress

  10 weeks

• Perceived Stress

  10 weeks

• Body Composition

  10 weeks

• Waist Circumference

  10 weeks

• Hemoglobin A1c

  10 weeks

Other Outcomes (4)

• Community Support

  10 weeks

• Diurnal Salivary Cortisol

  10 weeks

• Physical Activity

  10 weeks

Study Arms (2)

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

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.

Behavioral: CHAI dyad study

Interventions

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;

Also known as: CHAI for 2

Control; Experimental

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Participant eligibility is based on self-report of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

1. The original proposal called for a 12 -week intervention, but due to delays in the IRB process, we shortened it to a 10 week intervention, to accommodate the participants. All of the dyads completed the 10 week intervention. 2. We had difficulty collecting the dietary diary data from participants, so we are still trying to analyze this now. 3. We had difficulty arranging with the laboratory for the lipoprotein a analysis- we are still trying to arrange this now.

Results Point of Contact

• Title: Karen T. D'Alonzo
• Organization: Rutgers University

kdalonzo@sn.rutgers.edu

18489320879

Study Officials

• Karen T D'Alonzo, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized trial of 12 week intervention.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 28, 2026
• Last Updated: September 24, 2026
• Results First Posted: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available immediately after publication with no end date.
• Access Criteria: Data will be made available indefinitely at a specific link (to be determined)

Locations

US (1)