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Implementatie van een door peer-leiders gefaciliteerde dyadische interventie

22 september 2026 bijgewerkt door: Karen D'Alonzo, Rutgers, The State University of New Jersey

Implementatie van een door peer-leiders gefaciliteerde dyadische interventie om het risico op hart- en vaatziekten onder eerste generatie Aziatisch-Indische immigranten te verminderen

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.

Studie Overzicht

Gedetailleerde beschrijving

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 New Jersey (N.J.)? 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?

Studietype

Ingrijpend

Inschrijving (Werkelijk)

44

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New Jersey
      • New Brunswick, New Jersey, Verenigde Staten, 08901
        • Rutgers, The State University of New Jersey

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

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;

Andere namen:
  • CHAI for 2
Actieve vergelijker: 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.

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;

Andere namen:
  • CHAI for 2

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Risk of CVD
Tijdsspanne: 10 weeks

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acculturation Stress
Tijdsspanne: 10 weeks

Measured by the Riverside Acculturation Stress Inventory (RASI). The RASI is a 15 item scale that measures 5 domains of acculturative stress, including intercultural relations, language skills, discrimination, work challenges, and cultural/ethnic makeup of the community. Each item is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). In the RASI, higher scores reflect higher levels of acculturative stress, ranging from 15 to 75 points. Citation: Benet-Martinez V. The Riverside Acculturation Stress Inventory (RASI). Development and Psychometric Properties. Department of Psychology, University of California at Riverside; Riverside, CA, USA: 2003. Technical Report.

10 weeks
Perceived Stress
Tijdsspanne: 10 weeks

Measured by the Perceived Stress Scale (PSS-10). The PSS is a 10-item, 5 point Likert scale questionnaire that was designed to measure the degree to which situations in one's life are appraised as stressful. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of self-reported stress. There are two sub-scales on the PSS-10: Perceived helplessness (items 1, 2, 3, 6, 9, 10) and Lack of self-efficacy (items 4, 5, 7, 8). Citations: Cohen, S., Kamarch, T., & Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385; Lee, E.-H. (2012). Review of the psychometric evidence of the perceived stress scale. Asian Nursing Research, 6(4), 121-127. https://doi.org/10.1016/j.anr.2012.08.004.

10 weeks
Body Composition
Tijdsspanne: 10 weeks

BMI (weight and height will be combined to report BMI in Kg/m^2). Desirable BMI for Asian Indians is below 23 kg/m^2; overweight falls from 23 - 27.4 Kg/m^2 (25 - 30Kg/m^2 for other ethnicities) and 27.5 Kg/m^2and up is considered obese (30Kg/m^2 for other ethnicities).

10 weeks
Waist Circumference
Tijdsspanne: 10 weeks

Waist circumference as a measure of body composition. Desirable waist circumference measures in Asian Indian women are < 31 in. and for Asian Indian men, < 35 inches.

10 weeks
Hemoglobin A1c
Tijdsspanne: 10 weeks

Measure of glucose control- in the Asian Indian community, an A1C value of ≥6.0% is optimal for diagnosing diabetes with a very high level of accuracy

10 weeks
Lipid Panel
Tijdsspanne: 10 weeks

Cholesterol/HDL ratio- A cholesterol/HDL ratio of below 3.5 is optimal and indicates a very low risk for heart disease.

Ratios above 5 to 1 are considered high and may mean an elevated risk for heart disease

10 weeks
Inflammation
Tijdsspanne: 10 weeks

C-reactive protein is a generalized measure of inflammation; Levels of CRP less than 1 mg/L are desirable and reflect a low overall cardiovascular risk. Levels of CRP between 1 and 3 mg/L are indicative of moderate risk, while levels of CRP in excess of 3 mg/L suggest quite elevated vascular risk.

10 weeks
Genetic Risk of CVD
Tijdsspanne: 10 weeks

Lipoprotein a is a genetic risk for CVD. Approximately 25-50% of South Asians have elevated levels (>50mg/dL), contributing to a higher prevalence of and premature coronary disease, with higher levels often found in Indian individuals compared to other ethnicities. We drew lipoprotein a samples on June 27 and 28 and are awaiting the results.

10 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Community Support
Tijdsspanne: 10 weeks

Perceived community support questionnaire (PCSQ) is a 14-item 5 point Likert scale that includes three scales assessing three dimensions of community support. These dimensions are social integration in the community, participation in the community, and use of community organizations. Scores range from 14 (high community support) to 70 (low community support). Citation: Herrero, J. & Gracia, E. (2007). Measuring perceived community support: Factorial structure, longitudinal invariance, and predictive validity of the PCSQ (Perceived Community Support Questionnaire). Journal of Community Psychology, 35(2), 197 - 217

10 weeks
Diurnal Salivary Cortisol
Tijdsspanne: 10 weeks

Chronic psychological stress has been linked to elevated salivary cortisol levels and flattening of the circadian pattern. In this study, participants collect three specimens in a 24 hour period (upon rising, one-half hour later and at bedtime)

10 weeks
Physical Activity
Tijdsspanne: 10 weeks

The NASA/Johnson Space Center (JSC) Physical Activity Rating (PA-R) scale is an 8-point scale (0-7) used to estimate measure self-reported habitual physical activity over the previous 6 months. It categorizes individuals from sedentary (0) to highly active (7), with higher scores indicating higher levels of regular, intense exercise. Citation: Jackson et al., (1990). Prediction of functional aerobic capacity without exercise testing. Medicine and Science in Sports and Exercise, 22(6), 863-870.

10 weeks
Dietary Intake
Tijdsspanne: 13 weeks

3 day dietary diary- We encountered issues with data collection and are still analyzing this data.

13 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Karen T D'Alonzo, PhD, Rutgers, The State University of New Jersey

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 maart 2025

Primaire voltooiing (Werkelijk)

20 juni 2025

Studie voltooiing (Werkelijk)

28 juni 2026

Studieregistratiedata

Eerst ingediend

14 oktober 2024

Eerst ingediend dat voldeed aan de QC-criteria

15 oktober 2024

Eerst geplaatst (Werkelijk)

16 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Pro2024002046
  • 1P50MD017356-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Individual participant data will be available after deidentification.

IPD-tijdsbestek voor delen

Data will be available immediately after publication with no end date.

IPD-toegangscriteria voor delen

Data will be made available indefinitely at a specific link (to be determined)

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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