Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876053
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2021-04-30
Brief Title:
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Our long-term goal is to transform rural residents management of T2DM This studys objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants difficulties associated with completing existing interventions Our specific aims are
1 Compare the effectiveness of the Healthy Food Delivery Intervention HFDI plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM Hypothesis Compared with standard care alone patients receiving the HFDI plus standard care will demonstrate improved H1 glycemic control as measured by HbA1c H2 cardio-metabolic risk factors blood pressure fasting glucose fasting lipids and BMI H3 self-management self-efficacy adherence to self-management behaviors and medication adherence H4 patient-centered outcomes diabetes-related distress diabetes-related quality of life and diabetes-related complications
2 Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM Hypothesis Compared with standard care alone patients receiving the HFDI plus standard care will demonstrate improved H1 Healthy Eating Index 2015 HEI-2015 scores H2 fruit and vegetable consumption
3 Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone Hypothesis The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained
1 Compare the effectiveness of the Healthy Food Delivery Intervention HFDI plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM Hypothesis Compared with standard care alone patients receiving the HFDI plus standard care will demonstrate improved H1 glycemic control as measured by HbA1c H2 cardio-metabolic risk factors blood pressure fasting glucose fasting lipids and BMI H3 self-management self-efficacy adherence to self-management behaviors and medication adherence H4 patient-centered outcomes diabetes-related distress diabetes-related quality of life and diabetes-related complications
2 Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM Hypothesis Compared with standard care alone patients receiving the HFDI plus standard care will demonstrate improved H1 Healthy Eating Index 2015 HEI-2015 scores H2 fruit and vegetable consumption
3 Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone Hypothesis The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained
Detailed Description:
None
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