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OpenTrials
Completed

NCT Number: NCT06503861

Community-designed Food Is Medicine for Adults With Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Indiana Community Health Care

Paoli, Indiana, 47454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Food Is Medicine intervention

Behavioral

The intervention provides regular meal kits as well as cooking and nutritional education.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: FarmtoHealth

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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