Clinical trial NCT06460272: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
Official title: NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Type2diabetes
Metabolic Syndrome
Obesity
Keywords: Hypertension
Type2diabetes
Metabolic Syndrome
Obesity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-06-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a human-centered three-arm design implementation trial to compare MTM only vs. MTM + SMA (weekly culinary and nutrition education and practice for 10 weeks) vs. a wait-list control group (MTM-Later). Meals will be provided at a frequency of 14 meals/week for 10 weeks. All intervention components will be designed and intended to be culturally congruent. Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction).

This study aims to distinguish an effective treatment (e.g., MTM only or MTM + SMAs) from a less effective or ineffective treatment. For this study, the investigators propose a three-arm (1:1:1) parallel-group randomized controlled trial (n = 75) powered to detect threshold levels of implementation and engagement. Intervention arms include, 1) MTM (only), 2) MTM +SMA, and a 3) Wait-list Control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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. Meals will be culturally tailored using methods used in the investigator's published pilot trial as well as data from other studies that have optimized cultural relevance of the Mediterranean diet for Black communities (e.g., meals that incorporate traditional staple foods). 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). Thus, participants will be directed to access South Pointe Hospital's bi-monthly fresh produce pantry, where fresh produce will be guaranteed and available to them for pick-up. 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.

Eligibility criteria: 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 within the past 6 months

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline through Week 10
measure: Retention Rate
timeFrame: Baseline through Week 10
measure: SMA Attendance
timeFrame: Baseline through Week 10
measure: MTMs Consumed
timeFrame: Baseline through Week 10
measure: Satisfaction of the Intervention
timeFrame: Baseline through Week 10
Secondary outcomes:
measure: Eating Behavior
timeFrame: Baseline and Week 10
measure: Body Weight
timeFrame: Baseline and Week 10
measure: Waist/Hip Circumference
timeFrame: Baseline and Week 10
measure: Systolic and Diastolic Blood Pressure (mmHg)
timeFrame: Baseline and Week 10
measure: Hemoglobin A1c (HbA1c, mmol/mol)
timeFrame: Baseline and Week 10
measure: Trimethylamine N-oxide (TMAO, uM)
timeFrame: Baseline and Week 10
measure: Uric Acid (mg/dL)
timeFrame: Baseline and Week 10
measure: Vitamin D 25 Hydroxy (ng/mL)
timeFrame: Baseline and Week 10
measure: High Sensitivity C-Reactive Protein (hsCRP, mg/dL)
timeFrame: Baseline and Week 10
Other outcomes:
measure: Qualitative characterization of participants' lived experiences and engagement
timeFrame: Week 10
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amanda Shallcross
role: PRINCIPAL_INVESTIGATOR
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