Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633939
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
The Okla Achokma Project
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Okla Achokma Project
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Okla Achokma
Brief Summary:
Deep South Native Americans disparately suffer from diabetes hypertension and obesity with only 5-10 of Native Americans living past age 65 compared to 15-17 of Whites Standard lifestyle interventions to improve diet and physical activity behaviors have shown improvement in weight and other cardiometabolic outcomes among Native Americans The impact of lifestyle interventions on preventable chronic diseases among Native Americans is limited by the exclusion of a multi-level approach with cultural and social enhancements that address the spiritual and social domains of physical health Therefore there is an urgent need to determine how spiritual and social domains of health at individual and family levels may advance lifestyle management interventions
Detailed Description:
The overall objective for this study is to determine the effectiveness of a more holistic intervention targeting the individual and family levels to enhance health outcomes and program engagement among Native Americans in the Deep South compared to standard approaches Our central hypothesis is that the integration of spiritual and social domains of health into the standard lifestyle intervention approach will significantly improve attendance retention and cardiometabolic profiles of Deep South Native Americans This hypothesis is supported by our own preliminary data that health behaviors of Deep South Native Americans are fostered by family support and hindered by fatalistic attitudes The rationale that underlies the proposed research is that demonstration of the feasibility and effectiveness of an intervention that integrates spiritual and social domains will provide new opportunities for its continued development as a strategy to improve disease managementprevention best practices in Deep South Native Americans
The specific aims for the study are to develop a conceptual model to define spiritual factors and spiritually- and socially-enhanced intervention components that could advance lifestyle management interventions among Native Americans in the Deep South and to determine feasibility of lifestyle intervention components and study instruments among Native Americans in the Deep South The plan is to to pilot recruitment methods standard lifestyle intervention components and implementation protocol and procedures to assess acceptability optimize population engagement and improve fidelity of delivery
The specific aims for the study are to develop a conceptual model to define spiritual factors and spiritually- and socially-enhanced intervention components that could advance lifestyle management interventions among Native Americans in the Deep South and to determine feasibility of lifestyle intervention components and study instruments among Native Americans in the Deep South The plan is to to pilot recruitment methods standard lifestyle intervention components and implementation protocol and procedures to assess acceptability optimize population engagement and improve fidelity of delivery
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