- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06643806
Implementering av en Peer Leader-faciliterad dyadisk intervention
Implementering av en peer Leader-faciliterad dyadisk intervention för att minska risken för hjärt-kärlsjukdomar bland första generationens asiatiska indiska invandrare
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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?
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- Rutgers, The State University of New Jersey
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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;
Andra namn:
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Aktiv komparator: 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;
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Risk of CVD
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Acculturation Stress
Tidsram: 10 weeks
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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
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Perceived Stress
Tidsram: 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
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Body Composition
Tidsram: 10 weeks
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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
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Waist Circumference
Tidsram: 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
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Hemoglobin A1c
Tidsram: 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
|
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Lipid Panel
Tidsram: 10 weeks
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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
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Inflammation
Tidsram: 10 weeks
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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
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Genetic Risk of CVD
Tidsram: 10 weeks
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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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Community Support
Tidsram: 10 weeks
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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
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Diurnal Salivary Cortisol
Tidsram: 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
|
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Physical Activity
Tidsram: 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
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Dietary Intake
Tidsram: 13 weeks
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3 day dietary diary- We encountered issues with data collection and are still analyzing this data. |
13 weeks
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Karen T D'Alonzo, PhD, Rutgers, The State University of New Jersey
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro2024002046
- 1P50MD017356-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individual participant data will be available after deidentification.
Tidsram för IPD-delning
Data will be available immediately after publication with no end date.
Kriterier för IPD Sharing Access
Data will be made available indefinitely at a specific link (to be determined)
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
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