Cardiovascular Diseases, Hyperlipidemias, Type 2 Diabetes Mellitus in Obese
Conditions
Keywords
Community based participatory research, Asian Indian immigrants, Acculturation stress
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?
Interventions
BEHAVIORALCHAI 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;
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
Cluster randomized trial of 12 week intervention.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of CVD | 13 weeks | Measured by the QRISK3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 13 weeks | BMI (weight and height will be combined to report BMI in kg/m\^2) |
| 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 |
| Acculturation stress | 13 weeks | Measured by the Riverside Acculturation Stress Inventory |
| Perceived stress | 13 weeks | Measured by the Perceived Stress Scale |
| waist circumference | 13 weeks | Body composition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 13 weeks | NASA JSC physical activity scale |
| dietary intake | 13 weeks | 3 day dietary diary |
| Community support | 13 weeks | Perceived community support questionnaire |
| Salivary cortisol | 13 weeks | three specimens (upon rising, one-half hour later and at bedtime) |
Contacts
Primary ContactKaren T D'Alonzo, PhD
Backup ContactShailja Mathur, M.S., M.Ed.,
Outcome results
None listed