Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876053
• Other study ID #: 261074
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: University of Arkansas
• Contact: Kelsey R Bounds, BS
• Phone: 4793320204
• Email: krbounds[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet, Healthy

Intervention

Behavioral:
• Healthy Food Delivery Intervention
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.

Locations

Country	Name	City	State
United States	UAMS - North Central	Batesville	Arkansas
United States	UAMS - East	Helena	Arkansas
United States	UAMS - Northeast	Jonesboro	Arkansas
United States	UAMS - South	Magnolia	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.	from Baseline to 12 months