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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06460272
Other study ID # 24-472
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 19, 2024
Est. completion date December 19, 2025

Study information

Verified date June 2024
Source The Cleveland Clinic
Contact Narissa McCarty
Phone 2167801931
Email mccartn3@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date December 19, 2025
Est. primary completion date December 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Medically Tailored Meals
Meals culturally tailored to provide essential nutrition

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Amanda Shallcross American Heart Association

References & Publications (32)

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Berkowitz SA, Shahid NN, Terranova J, Steiner B, Ruazol MP, Singh R, Delahanty LM, Wexler DJ. "I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. BMC Endocr Disord. 2020 Jan 20;20(1):10. doi: 10.1186/s12902-020-0491-z. — View Citation

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Gardiner P, McGonigal L, Villa A, Kovell LC, Rohela P, Cauley A, Rinker D, Olendzki B. Our Whole Lives for Hypertension and Cardiac Risk Factors-Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial. JMIR Form Res. 2022 May 16;6(5):e29227. doi: 10.2196/29227. — View Citation

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Lara-Breitinger KM, Medina Inojosa JR, Li Z, Kunzova S, Lerman A, Kopecky SL, Lopez-Jimenez F. Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT (Eating Assessment Tool). J Am Heart Assoc. 2023 Jan 3;12(1):e025064. doi: 10.1161/JAHA.121.025064. Epub 2022 Dec 30. — View Citation

Lichtenstein AH, Appel LJ, Vadiveloo M, Hu FB, Kris-Etherton PM, Rebholz CM, Sacks FM, Thorndike AN, Van Horn L, Wylie-Rosett J. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association. Circulation. 2021 Dec 7;144(23):e472-e487. doi: 10.1161/CIR.0000000000001031. Epub 2021 Nov 2. — View Citation

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Moore C, Coates E, Watson A, de Heer R, McLeod A, Prudhomme A. "It's Important to Work with People that Look Like Me": Black Patients' Preferences for Patient-Provider Race Concordance. J Racial Ethn Health Disparities. 2023 Oct;10(5):2552-2564. doi: 10.1007/s40615-022-01435-y. Epub 2022 Nov 7. Erratum In: J Racial Ethn Health Disparities. 2023 Oct;10(5):2614. doi: 10.1007/s40615-022-01489-y. — View Citation

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Rohela P, Olendzki B, McGonigal LJ, Villa A, Gardiner P. A Teaching Kitchen Medical Groups Visit with an eHealth Platform for Hypertension and Cardiac Risk Factors: A Qualitative Feasibility Study. J Altern Complement Med. 2021 Nov;27(11):974-983. doi: 10.1089/acm.2021.0148. Epub 2021 Aug 5. — View Citation

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* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative characterization of participants' lived experiences and engagement 4 focus groups (n=5 in each group, 2 groups from each treatment arm - MTM and MTM + SMA) will be conducted to understand barriers and facilitators to engaging in each of the active treatments. Week 10
Primary Recruitment Rate Recruitment is a measure of treatment implementation. Recruitment rate will be measured by # of participants enrolled in study/# passed eligibility screening. Baseline through Week 10
Primary Retention Rate Retention is a measure of treatment implementation. Retention rate will be measured by # of completed assessments at week 10/# randomized to treatment arm. Baseline through Week 10
Primary SMA Attendance Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period. Baseline through Week 10
Primary MTMs Consumed Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed. Baseline through Week 10
Primary Satisfaction of the Intervention Satisfaction of MTM vs. MTM + SMA will be assessed using the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors) Baseline through Week 10
Secondary Eating Behavior Changes in eating behavior will be measured using the Mini-EAT (Eating Assessment Tool) and Fast Food/Restaurant Frequency Questionnaires. Baseline and Week 10
Secondary Body Weight Body weight will be measured in pounds. Baseline and Week 10
Secondary Waist/Hip Circumference Waist/Hip circumference will be expressed as a ratio. Baseline and Week 10
Secondary Systolic and Diastolic Blood Pressure (mmHg) Systolic and diastolic blood pressure will be measured and expressed as mmHg. Baseline and Week 10
Secondary Hemoglobin A1c (HbA1c, mmol/mol) Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control. Baseline and Week 10
Secondary Trimethylamine N-oxide (TMAO, uM) Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk. Baseline and Week 10
Secondary Uric Acid (mg/dL) Uric Acid will be evaluated through peripheral blood draw to assess cardiovascular disease and diabetes risk. Baseline and Week 10
Secondary Vitamin D 25 Hydroxy (ng/mL) Vitamin D 25 Hydroxy will be evaluated through peripheral blood draw to asses for Vitamin D deficiency. Baseline and Week 10
Secondary High Sensitivity C-Reactive Protein (hsCRP, mg/dL) High Sensitivity C-Reactive Protein will be evaluated through peripheral blood draw to assess inflammation. Baseline and Week 10
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