- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06643806
동료 리더가 주도하는 Dyadic 개입 구현
1세대 아시아 인디언 이민자들의 심혈관 질환 위험을 줄이기 위해 동료 리더가 주도하는 일제적 개입 시행
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.
연구 개요
상세 설명
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?
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- Rutgers, The State University of New Jersey
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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;
다른 이름들:
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활성 비교기: 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;
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Risk of CVD
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acculturation Stress
기간: 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
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Perceived Stress
기간: 10 weeks
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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
기간: 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
기간: 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
기간: 10 weeks
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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
기간: 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
|
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Inflammation
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Community Support
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen T D'Alonzo, PhD, Rutgers, The State University of New Jersey
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pro2024002046
- 1P50MD017356-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will be available after deidentification.
IPD 공유 기간
Data will be available immediately after publication with no end date.
IPD 공유 액세스 기준
Data will be made available indefinitely at a specific link (to be determined)
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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