Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Implementation of a Peer Leader-facilitated Dyadic Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation of a Peer Leader-facilitated Dyadic Intervention to Decrease Cardiovascular Disease Risk Among First Generation Asian Indian Immigrants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 feasibilityacceptability 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 feasibilityacceptability 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 feasibilityaccessibility 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
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 feasibilityacceptability 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 feasibilityaccessibility 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None