Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-05
Brief Title:
CHW Intervention to Improve Nutrition Security of Patients With Hypertension
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension
Status:
NOT_YET_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:
HeartWell
Brief Summary:
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker CHW intervention for primary care patients with nutrition insecurity and poorly controlled hypertension The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension Basic CHW program that provides hypertension education coaching about adherence to medications and primary care visits and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months
Detailed Description:
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced CHW intervention in primary care patients with nutrition insecurity and poorly controlled hypertension The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension Basic CHW that provides basic hypertension education coaching about adherence to medications and primary care visits and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months The CHW nutrition intervention curriculum is tailored to the needs and preferences of a food-insecure population with limited resources Nutrition education materials will be provided to participants including a booklet of nutrition information and a summarized version of key points on a brochure that they can use as a quick reference when grocery shopping Nutrition education will focus on reducing sodium saturated fats and added sugars and increasing fruits vegetables and whole grains Much of the educational material is based on a traffic-light system These topics are organized into four modules nutrition label reading grocery shopping meal-planning and healthy cooking
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