Implementation of a Peer Leader-facilitated Dyadic Intervention

NCT06643806 | Not Yet Recruiting DMC

• 2 other identifiers: Pro20240020461P50MD017356-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 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

Cardiovascular Diseases; Type 2 Diabetes Mellitus in Obese; Hyperlipidemias

Keywords

Community based participatory research; Asian Indian immigrants; Acculturation stress

Outcome Measures

Primary Outcomes (1)

• Risk of CVD

  Measured by the QRISK3

  13 weeks

Secondary Outcomes (8)

• Acculturation stress

  13 weeks

• Perceived stress

  13 weeks

• Body composition

  13 weeks

• waist circumference

  13 weeks

• Hemoglobin A1c

  13 weeks

Other Outcomes (4)

• Community support

  13 weeks

• Salivary cortisol

  13 weeks

• Physical activity

  13 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;

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

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen T D'Alonzo, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

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: Associate 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: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

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)