Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Sponsor
University of Arkansas (Other)
Overall Status
Recruiting
CT.gov ID
NCT04876053
Collaborator
(none)
400
4
2
44.3
100
2.3

Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Food Delivery Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care

Experimental: Healthy Food Delivery Intervention

9000 calorie / week food box

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.

Outcome Measures

Primary Outcome Measures

  1. HbA1c [from Baseline to 12 months]

    Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UAMS - North Central Batesville Arkansas United States 72501
2 UAMS - East Helena Arkansas United States 72390
3 UAMS - Northeast Jonesboro Arkansas United States 72401
4 UAMS - South Magnolia Arkansas United States 71753

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Christopher R Long, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT04876053
Other Study ID Numbers:
  • 261074
First Posted:
May 6, 2021
Last Update Posted:
May 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arkansas
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022