Home Food Delivery for Diabetes Management in Patients of Rural Clinics

University of Arkansas

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2; Diet, Healthy

Treatments: Behavioral: Healthy Food Delivery Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04876053

261074

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

415 participants in 2 patient groups

Standard Care

No Intervention group

Healthy Food Delivery Intervention

Experimental group

Description:

9000 calorie / week food box

Treatment:

Behavioral: Healthy Food Delivery Intervention