Healthy Food Delivery for Type 2 Diabetes Management

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byChristopher R Long, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher R Long, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for rural residents 18 or older with Type 2 Diabetes who report food insecurity and speak English or Spanish. They must have an HbA1c level of at least 6.5, indicating diabetes. It's not for pregnant individuals, those with terminal illness, severe mental illness, impaired vision/hearing, eating disorders, or plans to move away soon.

Inclusion Criteria

I am 18 years old or older.

My diabetes is confirmed with an HbA1c level of 6.5 or higher.

Tell us if you don't have enough food to eat.

See 3 more

Exclusion Criteria

I am able to follow the study's requirements without major health or personal obstacles.

Pregnant

Treatment Details

Interventions

Healthy Food Delivery Intervention (Behavioral Intervention)

Trial OverviewThe study tests if delivering healthy food to patients plus standard care improves diabetes management better than standard care alone in rural areas. It measures blood sugar control (HbA1c), heart risk factors (blood pressure/lipids/BMI), self-care behaviors/medication adherence and quality of life.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Food Delivery InterventionExperimental Treatment1 Intervention

9000 calorie / week food box

Group II: Standard CareActive Control1 Intervention