Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Primary Purpose
Diabetes Mellitus, Type 2, Diet, Healthy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Food Delivery Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Food Insecurity
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- report food insecurity
- report T2D (confirmed by having an HbA1c equal to or greater than 6.5 at initial data collection immediately following consent)
- Speak English or Spanish
- Currently lives at a rural address
Exclusion Criteria:
- conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
- Pregnant
Sites / Locations
- UAMS - North CentralRecruiting
- UAMS - East
- UAMS - NortheastRecruiting
- UAMS - South
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Healthy Food Delivery Intervention
Arm Description
9000 calorie / week food box
Outcomes
Primary Outcome Measures
HbA1c
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04876053
Brief Title
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Official Title
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our long-term goal is to transform rural residents' management of T2DM. This study's 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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diet, Healthy
Keywords
Food Insecurity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Healthy Food Delivery Intervention
Arm Type
Experimental
Arm Description
9000 calorie / week food box
Intervention Type
Behavioral
Intervention Name(s)
Healthy Food Delivery Intervention
Intervention Description
Each weekly food box will include ~9,000 calories of food, equivalent to the amount the average household receives prorated per week from an average Arkansas food pantry. The boxes will be designed by a registered dietitian. The boxes will follow ADA's Create Your Plate method consistent with the meal pattern promoted in the American College of Physicians (ACP) DSMES. The foods will also reflect Feeding America's Detailed Foods to Encourage framework, developed by nutrition experts and food bank staff to represent USDA dietary guidelines with healthy food that can be made available by food banks.
Primary Outcome Measure Information:
Title
HbA1c
Description
Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.
Time Frame
from Baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
report food insecurity
report T2D (confirmed by having an HbA1c equal to or greater than 6.5 at initial data collection immediately following consent)
Speak English or Spanish
Currently lives at a rural address
Exclusion Criteria:
conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey R Bounds, BS
Phone
4793320204
Email
krbounds@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher R Long, PhD
Phone
4797138691
Email
crlong2@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Long, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS - North Central
City
Batesville
State/Province
Arkansas
ZIP/Postal Code
72501
Country
United States
Individual Site Status
Recruiting
Facility Name
UAMS - East
City
Helena
State/Province
Arkansas
ZIP/Postal Code
72390
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UAMS - Northeast
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Name
UAMS - South
City
Magnolia
State/Province
Arkansas
ZIP/Postal Code
71753
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
We'll reach out to this number within 24 hrs