Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

Description

This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.

Conditions

Hypertension, Type2diabetes, Metabolic Syndrome, Obesity

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Study Overview

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Study Details

Study overview

This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.

NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 within the past 6 months
  • 1. Pre-hypertension
  • 2. Stage C and D heart failure
  • 3. Advanced valvular heart disease
  • 4. 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
  • 5. Insulin requiring type II diabetes mellitus
  • 6. Type I diabetes mellitus
  • 7. Advanced chronic kidney disease (≥ Stage 4)
  • 8. Severe obesity (Grade III or above) as defined by BMI \> 40 kg/m2
  • 9. Patients who are in another study or nutritional support program supplying meals
  • 10. Advanced co-morbidity with diminished life expectancy \< 2 years
  • 11. Co-morbidity requiring immunosuppressive, immunotherapy, chemotherapy, chronic antibiotic therapy
  • 12. Inability to participate in the demands and requirements of the trial
  • 13. Significant cognitive impairment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amanda Shallcross,

Amanda Shallcross, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-12-19