Community-designed Food Is Medicine for Adults With Diabetes (FarmtoHealth)

July 23, 2024 updated by: Julia Valliant, Indiana University

Southern Indiana Farm to Health Initiative: Evaluation of Produce Prescription Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Paoli, Indiana, United States, 47454
        • Southern Indiana Community Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Food Is Medicine intervention
Behavioral: Food Is Medicine intervention
The intervention provides regular meal kits as well as cooking and nutritional education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' diabetes level or severity
Time Frame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Participants' glycated hemoglobin - Hemoglobin A1c (HbA1c)
Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Participants' obesity level or severity
Time Frame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Body mass index (BMI)
Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary behaviors
Time Frame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Self-reported food consumption frequencies
Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Julia CD Valliant, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

September 12, 2021

Study Completion (Actual)

September 12, 2021

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2002563351
  • IU-IIR-FARM2HEALTH (Other Identifier: IU Office of Clinical Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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