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Behavioural Intervention

Medically Tailored Meals for Metabolic Health (NOURISH HEARTS Trial)

N/A

Recruiting

Research Sponsored by Amanda Shallcross

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve 75 participants from a predominantly Black community with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. The study will compare the effects of receiving Medically Tailored Meals

Who is the study for?

This trial is for Black or African American adults over 18 with hypertension, type 2 diabetes, metabolic syndrome, or obesity. They must have been treated at Cleveland Clinic South Pointe Hospital recently and be able to use a web-enabled device in English.

What is being tested?

The study compares three groups: one receiving Medically Tailored Meals (MTM) only, another getting MTM plus Shared Medical Appointments (SMA), and a wait-list control group. It aims to see how well these interventions work in a community setting.

What are the potential side effects?

Since the intervention involves medically tailored meals and shared medical appointments rather than medication, there are no typical drug side effects; however, dietary changes may cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTMs Consumed

Recruitment Rate

Retention Rate

+2 more

Secondary study objectives

Body Weight

Eating Behavior

Hemoglobin A1c (HbA1c, mmol/mol)

+6 more

Other study objectives

Qualitative characterization of participants' lived experiences and engagement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)Experimental Treatment1 Intervention

Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks. Participants will also have access to bi-monthly fresh produce pantry, where fresh produce will be guaranteed and available to them for pick-up.

Group II: Medically Tailored Meals - Later (MTM-Later)Experimental Treatment1 Intervention

Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and educational materials (e.g., relevant handouts from the SMA) after the completion of the post intervention study assessment. This group will act as our Waitlist Control group.

Group III: Medically Tailored Meals (MTMs)Active Control1 Intervention

Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.

0 / 1Eligibility criteria met