Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2026-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy Food Delivery Intervention

9000 calorie / week food box

Group Type EXPERIMENTAL

Healthy Food Delivery Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes