Implementation of a Peer Leader-facilitated Dyadic Intervention
- Conditions
- Cardiovascular DiseasesType 2 Diabetes Mellitus in ObeseHyperlipidemias
- Registration Number
- NCT06643806
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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.
- 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?
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Risk of CVD 13 weeks Measured by the QRISK3
- Secondary Outcome Measures
Name Time Method Acculturation stress 13 weeks Measured by the Riverside Acculturation Stress Inventory
Perceived stress 13 weeks Measured by the Perceived Stress Scale
Body composition 13 weeks BMI (weight and height will be combined to report BMI in kg/m\^2)
waist circumference 13 weeks Body composition
Hemoglobin A1c 13 weeks Measure of glucose control
Lipid panel 13 weeks Total cholesterol, HDL, LDL, triglycerides
Inflammation 13 weeks C-reactive protein
Genetic risk of CVD 13 weeks Lipoprotein a