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

Amanda Shallcross

Status: Completed

Conditions: Hypertension; Type2diabetes; Obesity; Metabolic Syndrome

Treatments: Other: Medically Tailored Meals

Study type: Interventional

Funder types: Other

Identifiers

NCT06460272

24-472

Details and patient eligibility

About

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.

Full description

Subjects will be randomized into one of the three arms within the study:

Medically Tailored Meals (MTMs):

Collaborative agreements are in place with Performance Kitchen to prepare 2 meals/day for 7 days/week for 10 weeks at a discount for all participants (n =75) for this trial. Meals will be prepared based on evidence-based nutritional recommendations for the Mediterranean diet and that align with 2021 American Heart Association Dietary Guidance. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.

Medically Tailored Meals + Shared Medical Appointments (MTMs + SMAs):

Identical MTMs that are provided in the MTM only group will also be provided in the MTM + SMA group. The SMA will be delivered weekly for 10 weeks and will be modeled after the investigator's pilot study. This includes practice with behavior change principles (i.e., selection of healthy food options). The provider, dietician, chef, and health coach will be members of the Black community to ensure racial concordance between educators and participants, a critical feature that improves communication, trust, and health outcomes in behavioral health interventions. The provider, dietician, and health coach are professionals currently employed within the Department of Wellness and Preventive Medicine. Fidelity will be ensured by using a session fidelity checklist that will be completed by each facilitator. To maximize retention, during consent via (telephone or in-person the study coordinator will establish rapport and set study expectations, including what SMAs entail and the time commitment for the session to minimize attrition. SMA visit reminder emails will be sent to participants through their EHR portal and/or via email.

Medically Tailored Meals - Later (MTM-Later):

The inclusion of a MTM-Later arm will provide a rigorous test of outcomes and is necessary given limited data about MTM implementation, engagement, and clinical outcomes in Black, underserved communities. MTM-Later participants will receive MTMs (same quantity and frequency) as the two other groups after the completion of the post-intervention study assessment. To avoid differential drop-out and incomplete assessments in the MTM-Later group, this group will be offered culinary tools at the start of the intervention to build trust and confidence that they will indeed receive the meals and educational materials at the end of the study assessment period. This group will act as the Waitlist Control group.

All groups will receive a set of surveys to be given at baseline and weeks 5 and 10 for exploratory outcomes. All groups will also have labs drawn at baseline and week 10 to measure secondary outcomes such as change in HbA1c.

4 focus groups will also be conducted (2 groups from each treatment arm) to understand barriers and facilitators to engaging in each of the active treatments.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

75 participants in 3 patient groups

Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)

Experimental group

Description:

Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks.

Treatment:

Other: Medically Tailored Meals

Medically Tailored Meals (MTMs)

Active Comparator group

Description:

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.

Treatment:

Other: Medically Tailored Meals

Medically Tailored Meals - Later (MTM-Later)

Other group

Description:

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.

Treatment:

Other: Medically Tailored Meals