Community-designed Food Is Medicine for Adults With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT06503861
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-09-12
• Study Completion: 2021-09-12
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Age 18+ years, weight 100+ pounds, HbA1c >7% in 2020

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
Dietary behaviors	Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)	Self-reported food consumption frequencies

Trial Locations

Locations (1)

Southern Indiana Community Health Care; 🇺🇸 Paoli, Indiana, United States