NCT06503861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

July 10, 2024

Last Update Submit

July 23, 2024

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Participants' diabetes level or severity

    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

    Body mass index (BMI)

    Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)

Secondary Outcomes (1)

  • Dietary behaviors

    Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)

Study Arms (2)

Food Is Medicine intervention

EXPERIMENTAL
Behavioral: Food Is Medicine intervention

Control

NO INTERVENTION

Interventions

Food Is Medicine interventionBEHAVIORAL

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

Food Is Medicine intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Indiana Community Health Care

Paoli, Indiana, 47454, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julia CD Valliant, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Scientist

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

June 15, 2020

Primary Completion

September 12, 2021

Study Completion

September 12, 2021

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)