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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs) | Experimental | Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks. |
|
| Medically Tailored Meals (MTMs) | Active Comparator | 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. |
|
| Medically Tailored Meals - Later (MTM-Later) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medically Tailored Meals | Other | Meals culturally tailored to provide essential nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| SMA Attendance | Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period. | Baseline through Week 10 |
| MTMs Consumed | Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed. | Baseline through Week 10 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Body Weight | Body weight will be measured in pounds. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Shallcross | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19328255 | Background | Satia JA. Diet-related disparities: understanding the problem and accelerating solutions. J Am Diet Assoc. 2009 Apr;109(4):610-5. doi: 10.1016/j.jada.2008.12.019. No abstract available. | |
| Background | Eisenhauer E. In poor health: Supermarket redlining and urban nutrition. GeoJournal. 2001;53(2):125-133. doi:10.1023/A:1015772503007 | ||
| Background | Black/African American Health-Office of Minority Health. Accessed October 24, 2023. https://minorityhealth.hhs.gov/blackafrican-american-health | ||
| Background | FastStats- Leading Causes of Death. Centers for Disease Control and Prevention. Published January 18, 2023. Accessed October 24, 2023. https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm |
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Any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository.
No later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first.
Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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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.
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The PI and the study statistician will be masked to treatment condition when conducting initial data analysis.
| Baseline and Week 10 |
| Waist/Hip Circumference | Waist/Hip circumference will be expressed as a ratio. | Baseline and Week 10 |
| Systolic and Diastolic Blood Pressure (mmHg) | Systolic and diastolic blood pressure will be measured and expressed as mmHg. | Baseline and Week 10 |
| Hemoglobin A1c (HbA1c, mmol/mol) | Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control. | Baseline and Week 10 |
| Trimethylamine N-oxide (TMAO, uM) | Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk. | Baseline and Week 10 |
| Uric Acid (mg/dL) | Uric Acid will be evaluated through peripheral blood draw to assess cardiovascular disease and diabetes risk. | Baseline and Week 10 |
| 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 |
| 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 |
| 33471116 | Background | Benjamins MR, Silva A, Saiyed NS, De Maio FG. Comparison of All-Cause Mortality Rates and Inequities Between Black and White Populations Across the 30 Most Populous US Cities. JAMA Netw Open. 2021 Jan 4;4(1):e2032086. doi: 10.1001/jamanetworkopen.2020.32086. |
| 36192812 | Background | Belak L, Owens C, Smith M, Calloway E, Samnadda L, Egwuogu H, Schmidt S. The impact of medically tailored meals and nutrition therapy on biometric and dietary outcomes among food-insecure patients with congestive heart failure: a matched cohort study. BMC Nutr. 2022 Oct 3;8(1):108. doi: 10.1186/s40795-022-00602-y. |
| 30421335 | Background | Berkowitz SA, Delahanty LM, Terranova J, Steiner B, Ruazol MP, Singh R, Shahid NN, Wexler DJ. Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. 2019 Mar;34(3):396-404. doi: 10.1007/s11606-018-4716-z. Epub 2018 Nov 12. |
| 36251292 | Background | Hager K, Cudhea FP, Wong JB, Berkowitz SA, Downer S, Lauren BN, Mozaffarian D. Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. JAMA Netw Open. 2022 Oct 3;5(10):e2236898. doi: 10.1001/jamanetworkopen.2022.36898. |
| 31959176 | Background | 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. |
| 20046905 | Background | Winham DM. Culturally tailored foods and CVD prevention. Am J Lifestyle Med. 2009;3(1):64S-68S. doi: 10.1177/1559827609335552. |
| 35255887 | Background | Bharmal N, Beidelschies M, Alejandro-Rodriguez M, Alejandro K, Guo N, Jones T, Bradley E. A nutrition and lifestyle-focused shared medical appointment in a resource-challenged community setting: a mixed-methods study. BMC Public Health. 2022 Mar 7;22(1):447. doi: 10.1186/s12889-022-12833-6. |
| 35576575 | Background | 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. |
| 34357790 | Background | 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. |
| 34724806 | Background | 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. |
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| Background | Research methods: Is restricted randomisation necessary? Accessed June 1, 2021. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1482349/ |
| 10259963 | Background | Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x. |
| 36583423 | Background | 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. |
| Background | ASA24 Dietary Assessment Tool- EGRP/DCCPS/NCI/NIH. Accessed October 23, 2023. https://epi.grants.cancer.gov/asa24/ |
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| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |