Hypertension, Metabolic Syndrome, Obesity, Type2diabetes
Conditions
Keywords
Hypertension, Type2diabetes, Metabolic Syndrome, Obesity
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. 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.
Interventions
Meals culturally tailored to provide essential nutrition
Sponsors
American Heart Association
Amanda Shallcross
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI and the study statistician will be masked to treatment condition when conducting initial data analysis.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the Intervention | Baseline through Week 10 | 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) |
| Recruitment Rate | Baseline through Week 10 | Recruitment is a measure of treatment implementation. Recruitment rate will be measured by # of participants enrolled in study/# passed eligibility screening. |
| Retention Rate | Baseline through Week 10 | Retention is a measure of treatment implementation. Retention rate will be measured by # of completed assessments at week 10/# randomized to treatment arm. |
| SMA Attendance | Baseline through Week 10 | Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period. |
| MTMs Consumed | Baseline through Week 10 | Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trimethylamine N-oxide (TMAO, uM) | Baseline and Week 10 | Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk. |
| Uric Acid (mg/dL) | Baseline and Week 10 | Uric Acid will be evaluated through peripheral blood draw to assess cardiovascular disease and diabetes risk. |
| Eating Behavior | Baseline and Week 10 | Changes in eating behavior will be measured using the Mini-EAT (Eating Assessment Tool) and Fast Food/Restaurant Frequency Questionnaires. |
| High Sensitivity C-Reactive Protein (hsCRP, mg/dL) | Baseline and Week 10 | High Sensitivity C-Reactive Protein will be evaluated through peripheral blood draw to assess inflammation. |
| Vitamin D 25 Hydroxy (ng/mL) | Baseline and Week 10 | Vitamin D 25 Hydroxy will be evaluated through peripheral blood draw to asses for Vitamin D deficiency. |
| Body Weight | Baseline and Week 10 | Body weight will be measured in pounds. |
| Waist/Hip Circumference | Baseline and Week 10 | Waist/Hip circumference will be expressed as a ratio. |
| Systolic and Diastolic Blood Pressure (mmHg) | Baseline and Week 10 | Systolic and diastolic blood pressure will be measured and expressed as mmHg. |
| Hemoglobin A1c (HbA1c, mmol/mol) | Baseline and Week 10 | Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative characterization of participants' lived experiences and engagement | Week 10 | 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. |
Countries
United States
Outcome results
None listed