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Can free healthy meals and group support lower heart risks in black communities?

NCT ID NCT06460272

Disease control Sponsor: Amanda Shallcross 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether providing medically tailored meals, with or without weekly group support sessions, helps Black adults with high blood pressure, type 2 diabetes, obesity, or metabolic syndrome improve their health. 75 participants received either meals alone, meals plus group support, or meals later. The study focused on whether people would join, stay, and be satisfied with the program.

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

75 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2025

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-identification as Black or African American 2. Ability to speak and read English 3. Age ≥ 18 years old 4. Diagnosis of any of the following: a) Hypertension (\>130/80), and ever treated for hypertension; b) Type 2 Diabetes Mellitus (HgbA1c ≥ 8%); c) Metabolic Syndrome; d) Obesity (BMI ≥ 30) 5. Access to a web-enabled device (phone, tablet, computer) 6. Received care at Cleveland Clinic South Pointe Hospital or Main Campus within the past 6 months Exclusion Criteria: 1. Stage C and D heart failure 2. Advanced valvular heart disease 3. Advanced heart failure class D defined as heart failure symptoms impairing daily quality of life and/or resulting in recurrent hospitalizations (\>1) per previous 12 months 4. Insulin requiring type II diabetes mellitus 5. Type I diabetes mellitus 6. Advanced chronic kidney disease (≥ Stage 4) 7. BMI \> 45 kg/m2 8. Patients who are in another study or nutritional support program supplying meals 9. Patients who are receiving a medically prescribed diet with a specific nutritional profile 10. Receiving active cancer treatment, not including endocrine therapy 11. Inability to participate in the demands and requirements of the trial 12. Significant cognitive impairment

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome hypertensive disorder metabolic syndrome X Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Hypertension Metabolic syndrome Obesity TYPE2DIABETES

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

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