Diabetes MellitusFarmtoHealthNCT06503861
Community-designed Food Is Medicine for Adults With Diabetes
A study testing Food Is Medicine intervention in people with Diabetes Mellitus, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Food Is Medicine intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ years, weight 100+ pounds, HbA1c >7% in 2020
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Indiana Community Health Care
Paoli, Indiana, 47454
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Food Is Medicine intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Is Medicine interventionBehavioural
The intervention provides regular meal kits as well as cooking and nutritional education.
| Study group | Role | What they receive |
|---|---|---|
| Food Is Medicine intervention | Experimental | Not described Receives: Behavioral: Food Is Medicine intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' diabetes level or severity
Participants' glycated hemoglobin - Hemoglobin A1c (HbA1c)
Measured: 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)
Measured: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Secondary outcomes (1)
Dietary behaviors
Self-reported food consumption frequencies
Measured: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Jun 2020
- Primary completion12 Sep 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Valliant, Indiana University
- Investigators
- Julia CD Valliant, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503861
- Sponsor's protocol ID
- 2002563351
- Other IDs
- IU-IIR-FARM2HEALTH
- Acronym
- FarmtoHealth
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southern Indiana Farm to Health Initiative: Evaluation of Produce Prescription Intervention
- ClinicalTrials.gov ID
- NCT06503861
- Acronym / sponsor ID
- FarmtoHealth / 2002563351
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Is Medicine intervention | Experimental | Behavioral: Food Is Medicine intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18+ years, weight 100+ pounds, HbA1c >7% in 2020
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Is Medicine interventionThe intervention provides regular meal kits as well as cooking and nutritional education. | Behavioural | Food Is Medicine intervention |
Primary outcome
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)
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)
1 secondary outcome
Dietary behaviors
Time frame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia CD Valliant, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Is Medicine intervention in people with Diabetes Mellitus, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' diabetes level or severity (time frame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.