Clinical trial NCT04876053: Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Official title: Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diet, Healthy
Keywords: Food Insecurity
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline to immediate post-intervention (approx. 18 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Batesville
country: United States
facility: UAMS - North Central
state: Arkansas
city: Helena
country: United States
facility: UAMS - East
state: Arkansas
city: Jonesboro
country: United States
facility: UAMS - Northeast
state: Arkansas
city: Magnolia
country: United States
facility: UAMS - South
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Christopher R Long, PhD
role: PRINCIPAL_INVESTIGATOR
References: