Home Food Delivery for Diabetes Management in Patients of Rural Clinics

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. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM.

   Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved:

   H1- glycemic control as measured by HbA1c; H2- cardio-metabolic risk factors: body mass index (BMI), blood pressure, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, blood glucose; H3- diabetes management self-efficacy; H4- diabetes-related distress.

2. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM.

   Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved:

   H1- Healthy Eating Index 2015 (HEI-2015) scores; H2- fruit and vegetable consumption as measured by Veggie Meter scores.

3. Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only.

Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diet, Healthy
• Intervention / Treatment: Behavioral: CDCES Consultation Only; Behavioral: Healthy Food Delivery Intervention

Detailed Description

Type 2 diabetes mellitus (T2DM) is a growing public health concern affecting 37.3 million people (11.3%) in the United States (US). At the same time, 13.5 million (10.2%) US households experience food insecurity. People living in rural areas are particularly challenged by the intersection of food insecurity and T2DM - both food insecurity and T2DM prevalence in rural areas are higher than metropolitan areas. Arkansas has the sixth highest proportion of rural population (44.5%) of all US states, with rates of food insecurity and T2DM of 14.7% and 12.5%, respectively. Rurality and food insecurity are associated with social determinants of health that impede diabetes management (e.g., limited transportation, longer distance to healthcare clinics, lack of access to healthy food options). People experiencing food insecurity have poor diet quality (e.g., high intake of sugar-sweetened beverages and red/processed meat, low intake of fruits and vegetables), which is a key risk factor for unmanaged T2DM. Unmanaged T2DM can lead to increased risk of serious complications. Improved diet quality is a crucial factor to enhance T2DM management. Millions of people with T2DM experiencing food insecurity turn to food pantries for food; however, food pantries are not a long-term solution to improve health for rural people with T2DM experiencing food insecurity. Certified Diabetes Care and Education Specialists (CDCES; i.e., diabetes educators) have expertise in working with patients to instill knowledge and skills necessary to live an active and healthy lifestyle with T2DM.

This study used a two-arm randomized controlled comparative effectiveness design to compare the effectiveness of a Healthy Food Delivery Intervention (HFDI) plus a consultation with a CDCES Consultation Only in improving diabetes-related outcomes among rural people with T2DM experiencing food insecurity. We hypothesized HFDI to be comparatively more effective in improving HbA1c and other outcomes for rural people with T2DM experiencing food insecurity.

The primary outcome was change in hemoglobin A1c (HbA1c) between baseline and post-intervention. Secondary outcomes included diet quality (Healthy Eating Index-2015 and Veggie meter scores), body mass index, blood pressure, lipids, glucose, diabetes management self-efficacy and diabetes-related distress. We also examined the duration of treatment effects by comparing outcomes at 6 months post-intervention and 12 months post-intervention.

Participants were randomly assigned to either the HFDI arm or the CDCES Consultation Only arm. Participants randomized to the CDCES Consultation Only study arm received the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a CDCES and a food pantry resource guide specific to their community. In addition to standard of care and the CDCES consultation, participants randomized to the HFDI arm received 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.

Participants were initially recruited only from family medicine clinics within the University of Arkansas for Medical Sciences (UAMS) network that serve the highest percentage of rural patients with T2DM. Additional clinics and Federally Qualified Health Centers were added as recruitment sites in order to meet study recruitment goals.

Inclusion criteria included: 1) 18 years of age or older; 2) food insecure (Hunger Vital Sign™ 2-item screener); 3) HbA1c ≥ 6.5%; 4) speak English or Spanish; and 5) live at a rural address. Note: the food insecurity and rural residence criteria were removed during the course of the study in order to meet study recruitment goals.

Exclusion criteria included: 1) having 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; 2) pregnant; 3) only one adult with T2DM per household was allowed to enroll.

Investigators worked with clinical stakeholders at each clinic site to ensure the study was integrated into existing workflows. Study flyers were placed throughout the clinics, in the exam rooms, and in the clinic waiting areas. All clinics had electronic health record systems that were queried monthly for recruitment. Research coordinators at each clinic site identified potential participants by reviewing monthly patient queries and daily clinic schedules. The research coordinators provided study information to potential participants in a pre-visit call or during the clinical visit. If the patient was interested, the research coordinator scheduled a 30-minute meeting to discuss the study and conduct eligibility screening in a private room in the clinic. Research staff were trained to flag potential participants that may not meet eligibility, which were then sent to the study physician for medical determination. Those deemed eligible to participate reviewed study information with the research coordinator, were given the chance to ask questions, and signed an informed consent. All recruitment and consent information was available in English and Spanish.

Randomization was conducted by the study biostatistician, who had no interactions with potential participants and no supervisory role with study staff responsible for recruiting, consent, and intervention processes. Stratified random assignment using permuted blocks of size 2, 4, and 6 was used to randomize participants 1:1 to the treatment arms using lists created with the blockrand R package. Strata of participant sex, level of T2DM control (6.5-9.0%; >9.0%), and age group (18-64; 65+ years) were used to ensure that similar numbers within each characteristic are assigned 1:1 to the treatment arms.

Data collection occurred in-person at the clinic from which participants were recruited, co-occurring with participants' primary care provider visits when possible. Biometric and survey measure outcomes were collected at baseline (pre-intervention), immediate post-intervention (approximately 18 weeks after baseline), 6 months post-intervention, and 12 months post-intervention.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Batesville, Arkansas, United States, 72501
      • UAMS - North Central
    • Corning, Arkansas, United States, 72422
      • Pocahontas Medical Center
    • Eureka Springs, Arkansas, United States, 72632
      • Washington Regional Medical Center
    • Fayetteville, Arkansas, United States, 72703
      • Washington Regional Medical Center
    • Fayetteville, Arkansas, United States, 72703
      • UAMS - Northwest
    • Fort Smith, Arkansas, United States, 72901
      • UAMS - West
    • Harrison, Arkansas, United States, 72601
      • Washington Regional Medical Center
    • Helena, Arkansas, United States, 72390
      • UAMS - East
    • Jonesboro, Arkansas, United States, 72401
      • UAMS - Northeast
    • Magnolia, Arkansas, United States, 71753
      • UAMS - South
    • Marianna, Arkansas, United States, 72360
      • Lee County Cooperative Clinic
    • Marshall, Arkansas, United States, 72650
      • Boston Mountain Rural Health Center
    • Pocahontas, Arkansas, United States, 72455
      • Pocahontas Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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
• Only one adult with T2DM per household will be enrolled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CDCES Consultation Only; 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; 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.
Experimental: Healthy Food Delivery Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (HbA1c)	Finger stick blood collection will be used to test HbA1c using a Siemens DCA Vantage analyzer.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Quality: Healthy Eating Index-2015 Score	Diet quality was assessed with a 24-hour dietary recall interview using the Nutrition Data System for Research (NDSR) software. The Healthy Eating Index-2015 (HEI) was applied to the dietary recall data to measure the extent that dietary intake among participants met the Dietary Guidelines for Americans 2015-2020 recommendations. HEI-2015 consists of 13 individual components. HEI-2015 scores have a possible range of 0-100, with higher numbers indicating better diet quality.	Baseline; Immediate post-intervention
Diet Quality: Veggie Meter Score	Skin carotenoid level was measured using a Veggie Meter optical skin scanner, which uses Raman Spectroscopy. The Veggie Meter assesses frequency changes in reflected light to calculate carotenoid presence in the skin and has been validated as a non-self-report, non-invasive measure associated with serum carotenoid levels and self-report measures of fruit and vegetable consumption. Each participant's index finger was scanned three times and the mean of the three measures was recorded for use in data analysis. Veggie Meter scores have a possible range of 0-800, with higher scores indicating better diet quality.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Body Mass Index (BMI)	Participant height (without shoes) was collected using a stadiometer and participant weight (without shoes) was collected using a calibrated digital scale. Height and weight were used to compute a continuous measure of BMI (kilograms per square meter).	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Systolic Blood Pressure (SBP)	Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. If there was a >5mmHg difference between the first and second reading, an additional two measurements were taken. The mean of the two (or four) measurements was recorded and used in analysis.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Diastolic Blood Pressure (DBP)	Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. If there was a >5mmHg difference between the first and second reading, an additional two measurements were taken. The mean of the two (or four) measurements was recorded and used in analysis.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Total Cholesterol	Through finger prick blood collection, point of care tests were used to collect lipids using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
High-Density Lipoproteins (HDL)	Through finger prick blood collection, point of care tests were used to collect HDL using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Low-Density Lipoproteins (LDL)	Through finger prick blood collection, point of care tests were used to collect LDL using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Triglycerides	Through finger prick blood collection, point of care tests were used to collect triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Glucose	Through finger prick blood collection, point of care tests were used to collect random (non-fasting) blood glucose.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Diabetes Self-Efficacy (DMSES)	The Diabetes Management Self-Efficacy Scale (DMSES) was used to measure patient's confidence in managing their diabetes. The DMSES assesses self-reported confidence in managing multiple aspects of their diabetes. The item reponses range from 1 (not at all confident) to 10 (totally confident) and are averaged to generate composite scores, with higher scores indicating higher levels of self-efficacy.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Diabetes-Related Distress (PAID-5)	The Problem Areas in Diabetes scale (PAID-5) was used to measure diabetes-related distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Item responses range from 0 (not a problem) to 4 (serious problem) and are summed to produce an overall composite score, with a total score of 8 or higher indicating possible diabetes-related emotional distress.	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
Food Insecurity	Food insecurity was assessed using the 2-item Hunger Vital Sign. Affirmative answers ("Often True" or "Sometimes True") to either of the 2 screener items indicates food insecurity. Food insecurity was treated as a binary outcome (0=food secure, 1=food insecure).	Baseline; Immediate post-intervention; 6 months post-intervention; 12 months post-intervention

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Pearl A McElfish, PhD, University of Arkansas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): December 18, 2025

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Food Insecurity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 261074; 5R01NR019487 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No