N/A
N=101
Delivering Health: Addressing Diabetes and Food Insecurity
Food Insecurity · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04831216 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Hemoglobin A1c (HbA1c), % — 9.87; 9.12 percentage of glycosylated hemoglobin — p=0.0107
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type 2 Diabetes Appropriate Food Boxes + Diabetes Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c), % |
9.87; 9.12 | 0.0107 sig |
| SECONDARY Diet Quality |
258.47; 261.65 | 0.7927 |
| SECONDARY Diet Quality (2) |
59.98; 58.61 | 0.4651 |
| SECONDARY Body Mass Index (BMI) |
33.42; 32.90 | 0.2439 |
| SECONDARY Chronic Diseases |
71; 12; 51; 8 | — |
| SECONDARY Type 2 Diabetes Self-Management Self-Efficacy |
6.88; 6.89 | 0.6794 |
| SECONDARY Oral Health |
36; 17; 10; 9; 16; 32 | 0.1043 |
| SECONDARY Type 2 Diabetes-related Distress |
7.63; 4.28 | <0.0001 sig |
| SECONDARY Food Security |
100; 1 | — |
| SECONDARY Food Pantry Utilization |
2.72; 2.48 | 0.5332 |
| SECONDARY Medication Adherence |
3.70; 3.07 | 0.0468 sig |
| SECONDARY Cooking Skills and Knowledge (1) |
92; 9; 0 | — |
| SECONDARY Cooking Skills and Knowledge (2) |
93; 8; 0 | — |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - General Diet |
2.32; 4.34 | <0.0001 sig |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Specific Diet |
3.83; 4.33 | 0.0649 |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Exercise |
2.07; 2.88 | 0.0049 sig |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Blood Glucose Testing |
3.39; 4.39 | 0.0086 sig |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Foot Care |
4.19; 4.72 | 0.0243 sig |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Smoking |
16; 85; 11; 58 | 0.2861 |
| SECONDARY Type 2 Diabetes Self-Management Behaviors - Medication Adherence |
2.43; 2.26 | 0.9933 |
Summary
The goal of this study was to develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Food insecure (confirmed with adapted 10-item screener)
- HbA1c levels of ≥7%
Exclusion Criteria
- Conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
- Pregnant
- Only one adult per household will be enrolled
Data sourced from ClinicalTrials.gov (NCT04831216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.