Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962372
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-07-14
Brief Title:
Culturally Adapted Dietary Clinical Trial in PR
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Culturally Adapted Dietary Clinical Trial in PR Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition PRECISION
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISION
Brief Summary:
This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors This will help define a culturally-appropriate feasible and sustainable diet intervention aimed at reducing cardiovascular type 2 diabetes and obesity outcomes
Detailed Description:
This intervention will culturally tailor a diet to the adult population in Puerto Rico based on staple foods as well as culturally appropriate strategies to reduce cardiometabolic risk factors Based on preliminary results from studies on the island investigators will conduct a 24-month 2-arm intervention among 250-350 adults 125-175 per arm ages 30-65 living in Puerto Rico with at least 1 of 5 cardiometabolic risk factors The two arms are 1 intervention group with culturally-tailored portion-control Mediterranean Diet-like advice through monthly individual counseling for 12 months reinforced with daily text messages for 12 months and a monthly household supply of legumes vegetable oils and locally sourced assorted fruit and vegetables for 18 months 2 control arm with portion-control standard non-tailored nutritional counseling in monthly individual sessions for 12 months reinforced with daily text messages for 12 months and monthly supermarket vouchers for 18 months From months 18-24 we will monitor behavior maintenance no foodvoucher or counseling with support from the nutritionist and cues-to-action texts Investigators will measure changes in cardiometabolic risk factors and metrics of eating behaviors and psychological factors The two co-primary outcomes are changes in ASCVD score and cardiometabolic improvement score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None