Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05856591
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-05-04
Brief Title:
Delivering Food Resources Kitchen Skills FoRKS to Adults With Food Insecurity and Hypertension
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Delivering Food Resources Kitchen Skills FoRKS to Adults With Food Insecurity and Hypertension An RCT
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:
FoRKS
Brief Summary:
The goal of this clinical trial is to determine the impact of a home-delivered foods and kitchen skills program on health and nutrition in adults with high blood pressure and food insecurity
Researchers will compare Food Resources Kitchen Skills FoRKS and Enhanced Usual Care EUC to evaluate the effects on mean systolic blood pressure SPB HbA1c food security and nutrition
Participants will complete 24-hr blood pressure monitoring standard blood pressure measurements weight blood draw and questionnaires
Researchers will compare Food Resources Kitchen Skills FoRKS and Enhanced Usual Care EUC to evaluate the effects on mean systolic blood pressure SPB HbA1c food security and nutrition
Participants will complete 24-hr blood pressure monitoring standard blood pressure measurements weight blood draw and questionnaires
Detailed Description:
This behavioral randomized controlled trial will evaluate nutritious food delivery and cooking classes FoRKS versus enhanced usual care EUC in adults with food insecurity and systolic blood pressure of 120 mm Hg This project seeks to evaluate the potential for hands-on training in food management skills to create lasting improvements in food security self-efficacy nutrition and risk factor reduction in persons with prevalent chronic disease
Adults who give informed consent will complete a 24-hour ambulatory blood pressure measure to confirm blood pressure eligibility Participants who meet criteria will complete a full baseline assessment consisting of questionnaires blood draw and weight before randomization to one of two arms
1 Enhanced Usual Care EUC consisting of access to existing usual primary care services such as social determinants of health screenings referrals to food pantries and assistance enrolling in food assistance programs They will be enrolled in a 5-week Hypertension Self-Management Education and Support SMES class which is an existing CDC-endorsed program offered at Eskenazi to provide information and skills for managing hypertension HTN
2 Food Resources Kitchen Skills FoRKS consisting of the same services as EUC plus home-delivered Mediterranean-style ingredient kits and virtual cooking classes for an additional 11 weeks with embedded lessons in kitchen organization tool use nutrition budgeting and shopping
Assessments will be completed around Week 16 as the primary endpoint and around Week 24 for maintenance evaluation
Adults who give informed consent will complete a 24-hour ambulatory blood pressure measure to confirm blood pressure eligibility Participants who meet criteria will complete a full baseline assessment consisting of questionnaires blood draw and weight before randomization to one of two arms
1 Enhanced Usual Care EUC consisting of access to existing usual primary care services such as social determinants of health screenings referrals to food pantries and assistance enrolling in food assistance programs They will be enrolled in a 5-week Hypertension Self-Management Education and Support SMES class which is an existing CDC-endorsed program offered at Eskenazi to provide information and skills for managing hypertension HTN
2 Food Resources Kitchen Skills FoRKS consisting of the same services as EUC plus home-delivered Mediterranean-style ingredient kits and virtual cooking classes for an additional 11 weeks with embedded lessons in kitchen organization tool use nutrition budgeting and shopping
Assessments will be completed around Week 16 as the primary endpoint and around Week 24 for maintenance evaluation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MD017961 | NIH | None | httpsreporternihgovquickSearchR01MD017961 |