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Food boxes and health coaching aim to tame diabetes in the deep south

NCT ID NCT05288452

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests whether delivering healthy food boxes, remote health monitoring, and one-on-one coaching can help low-income Black adults with type 2 diabetes better control their blood sugar. The trial enrolls 304 participants in the Deep South and tracks changes in HbA1c levels over 6 to 12 months. The goal is to address social barriers like food insecurity and limited healthcare access.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Food box delivery, digital health coaching, and remote patient monitoring
What this could lead to
If successful, this could provide a practical, scalable way to help low-income Black adults better manage their type 2 diabetes and lower blood sugar levels.
What could go wrong
This is a behavioral and dietary intervention study, not a drug trial. Results may vary by individual, and long-term adherence outside the study is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Self-identified as Black/African American 2. ICD diagnosis of T2DM 3. ≥18 years of age 4. Ongoing insulin treatment 5. HbA1c ≥8% within 6 weeks of study screening 6. has the ability to converse in and read English 7. must provide written informed consent prior to enrollment Exclusion criteria: 1. Current enrollment in any diabetes-related interventional study 2. Cognitive impairment 3. End-stage kidney disease (CKD-5) 4. Pregnant or plans to become pregnant within 12 months 5. Currently enrolled in a structured lifestyle change program 6. Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention HIV Cohort Criteria Inclusion Criteria 1. ≥ 18 years of age 2. ICD diagnosis of T2DM 3. HbA1c ≥ 7% 4. Confirmed HIV+ diagnosis 5. Prescribed HIV ART therapy as part of care Exclusion Criteria 1. Current enrollment in any diabetes-related interventional study or structured lifestyle change program 2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention 3. Cognitive impairment 4. End-stage kidney disease (CKD-5) 5. Pregnant or plans to become pregnant within 12 months

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Conditions

The condition(s) this trial relates to.

HIV infectious disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • UAB Hospital and UMMC Cardiology Clinics

    Birmingham, Alabama, 35205, United States

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Other studies related to the condition(s) this trial covers.