NCT04876053

Brief Summary

The goal of this randomized controlled trial was to determine the effectiveness of a Healthy Food Delivery Intervention (HFDI) on the outcomes of rural food insecure patients with type 2 diabetes mellitus (T2DM). Our specific aims were to:

  1. 1.Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM.
  2. 2.Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM.
  3. 3.Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 21, 2026

Completed
Last Updated

September 16, 2026

Status Verified

August 1, 2026

Enrollment Period

3.3 years

First QC Date

April 30, 2021

Results QC Date

July 29, 2026

Last Update Submit

August 21, 2026

Conditions

Diabetes Mellitus, Type 2Diet, Healthy

Keywords

Food Insecurity

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c)

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

    Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention

Secondary Outcomes (13)

  • Diet Quality: Healthy Eating Index-2015 Score

    Baseline; Immediate post-intervention (approx. 12 weeks)

  • Diet Quality: Veggie Meter Score

    Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention

  • Body Mass Index (BMI)

    Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention

  • Systolic Blood Pressure (SBP)

    Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention

  • Diastolic Blood Pressure (DBP)

    Baseline; Immediate post-intervention (approx. 12 weeks); 6 months post-intervention; 12 months post-intervention

  • +8 more secondary outcomes

Study Arms (2)

CDCES Consultation Only

ACTIVE COMPARATOR

Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.

Behavioral: CDCES Consultation Only

Healthy Food Delivery Intervention

EXPERIMENTAL

In addition to standard of care and the CDCES consultation, participants randomized to the Healthy Food Delivery arm receive weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).

Behavioral: Healthy Food Delivery Intervention

Interventions

Healthy Food Delivery InterventionBEHAVIORAL

Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.

Healthy Food Delivery Intervention
CDCES Consultation OnlyBEHAVIORAL

Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.

CDCES Consultation Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • HbA1c equal to or greater than 6.5
  • Speak English or Spanish

You may not qualify if:

  • 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
  • Only one adult with T2DM per household will be enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UAMS - North Central

Batesville, Arkansas, 72501, United States

Location

Pocahontas Medical Center

Corning, Arkansas, 72422, United States

Location

Washington Regional Medical Center

Eureka Springs, Arkansas, 72632, United States

Location

UAMS - Northwest

Fayetteville, Arkansas, 72703, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

UAMS - West

Fort Smith, Arkansas, 72901, United States

Location

Washington Regional Medical Center

Harrison, Arkansas, 72601, United States

Location

UAMS - East

Helena, Arkansas, 72390, United States

Location

UAMS - Northeast

Jonesboro, Arkansas, 72401, United States

Location

UAMS - South

Magnolia, Arkansas, 71753, United States

Location

Lee County Cooperative Clinic

Marianna, Arkansas, 72360, United States

Location

Boston Mountain Rural Health Center

Marshall, Arkansas, 72650, United States

Location

Pocahontas Medical Clinic

Pocahontas, Arkansas, 72455, United States

Location

Related Publications (1)

  • Short E, Selig JP, Felix HC, Painter J, McElfish PA, Rowland B, Ammerman AS, Bounds K, Henske J, Hudson JS, Li J, Young SG, Long CR. Healthy food delivery for type 2 diabetes management in rural clinics' patients: A comparative effectiveness randomized controlled trial protocol. Contemp Clin Trials. 2024 May;140:107491. doi: 10.1016/j.cct.2024.107491. Epub 2024 Mar 6.

    PMID: 38458560DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Pearl McElfish
Organization
University of Arkansas for Medical Sciences
pamcelfish@uams.edu
479-713-8102

Study Officials

  • Pearl A McElfish, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 6, 2021

Study Start

October 22, 2021

Primary Completion

February 6, 2025

Study Completion

December 18, 2025

Last Updated

September 16, 2026

Results First Posted

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(13)