Home Food Delivery for Diabetes Management in Patients of Rural Clinics

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. 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.

Conditions

• Diabetes Mellitus, Type 2
• Diet, Healthy

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Arkansas

  lead OTHER

Principal Investigators

• Pearl A McElfish, PhD · University of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-22

Primary Completion

2025-02-06

Completion

2025-12-18

Countries

• United States

Study Locations