Community-designed Food Is Medicine for Adults With Diabetes

NCT ID: NCT06503861

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-09-12

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Food Is Medicine intervention

Group Type EXPERIMENTAL

Food Is Medicine intervention

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Food Is Medicine intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Julia Valliant

Assistant Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia CD Valliant, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Southern Indiana Community Health Care

Paoli, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IU-IIR-FARM2HEALTH

Identifier Type: OTHER

Identifier Source: secondary_id

2002563351

Identifier Type: -

Identifier Source: org_study_id

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