Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590649
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Household Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PILI Āina 2 Household Participants
Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Native Hawaiians traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants which stand in stark contrast to the disproportionately high prevalence of diet-related cardiometabolic diseases they experience today In this project the investigators will adapt and test an evidence-based multilevel intervention entitled PILI Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations The objectives of this project are to optimize the effectiveness and sustainability of PILI Āina improve diet quality cardiometabolic markers promote traditional Native Hawaiian diets and improve social cohesion
Detailed Description:
The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition Type 2 diabetes pre-diabetes hypertension pre-hypertension dyslipidemia These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group Data collection will occur at baseline and 3 9 and 12 months Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects
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