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Healthy Food Delivery for Type 2 Diabetes Management

N/A
Recruiting
Led By Christopher R Long, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Reports T2D (confirmed by having an HbA1c equal to or greater than 6.5 at initial data collection immediately following consent)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an intervention that delivers healthy food to rural, food-insecure patients with type 2 diabetes improves their glycemic control, cardio-metabolic risk factors, self-management, patient-centered outcomes, and diet quality.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since the intervention involves healthy food delivery rather than medication, there are no direct side effects like you'd expect from drugs; however dietary changes may initially cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My diabetes is confirmed with an HbA1c level of 6.5 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am able to follow the study's requirements without major health or personal obstacles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HbA1c

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
495 Previous Clinical Trials
149,970 Total Patients Enrolled
Christopher R Long, PhDPrincipal InvestigatorUniversity of Arkansas
2 Previous Clinical Trials
11,637 Total Patients Enrolled

Media Library

Healthy Food Delivery Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04876053 — N/A
Type 2 Diabetes Research Study Groups: Standard Care, Healthy Food Delivery Intervention
Type 2 Diabetes Clinical Trial 2023: Healthy Food Delivery Intervention Highlights & Side Effects. Trial Name: NCT04876053 — N/A
Healthy Food Delivery Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04876053 — N/A
~0 spots leftby Dec 2024
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