Diabetes Mellitus
Conditions
Brief summary
The goal of this clinical trial is to learn if an educational intervention can affect clinical outcomes in adults with diabetes. The main question it aims to answer is: Can a Food Is Medicine intervention affect obesity and/or diabetes markers in adults? Researchers will compare a Food Is Medicine arm to a control arm to answer the research question. Participants will provide biometrics and questionnaire responses at three time points. Those in the Food Is Medicine arm will receive regular free meal kits combined with cooking and nutritional education.
Interventions
BEHAVIORALFood Is Medicine intervention
The intervention provides regular meal kits as well as cooking and nutritional education.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years, weight 100+ pounds, HbA1c \>7% in 2020
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants' diabetes level or severity | Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term) | Participants' glycated hemoglobin - Hemoglobin A1c (HbA1c) |
| Participants' obesity level or severity | Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term) | Body mass index (BMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary behaviors | Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term) | Self-reported food consumption frequencies |
Countries
United States
Outcome results
None listed