Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

NCT06460272 | Completed

• 1 other identifier: 24-472
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Type2diabetes; Metabolic Syndrome; Obesity

Keywords

Hypertension; Type2diabetes; Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (9)

• Eating Behavior

  Baseline and Week 10

• Body Weight

  Baseline and Week 10

• Waist/Hip Circumference

  Baseline and Week 10

• Systolic and Diastolic Blood Pressure (mmHg)

  Baseline and Week 10

• Hemoglobin A1c (HbA1c, mmol/mol)

  Baseline and Week 10

Other Outcomes (1)

• Qualitative characterization of participants' lived experiences and engagement

  Week 10

Study Arms (3)

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.

Other: Medically Tailored Meals

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.

Other: Medically Tailored Meals

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.

Other: Medically Tailored Meals

Interventions

Medically Tailored Meals OTHER

Meals culturally tailored to provide essential nutrition

Medically Tailored Meals (MTMs); Medically Tailored Meals - Later (MTM-Later); Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identification as Black or African American
• Ability to speak and read English
• Age ≥ 18 years old
• 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)
• Access to a web-enabled device (phone, tablet, computer)
• Received care at Cleveland Clinic South Pointe Hospital or Main Campus within the past 6 months

You may not qualify if:

• Stage C and D heart failure
• Advanced valvular heart disease
• 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
• Insulin requiring type II diabetes mellitus
• Type I diabetes mellitus
• Advanced chronic kidney disease (≥ Stage 4)
• BMI \> 45 kg/m2
• Patients who are in another study or nutritional support program supplying meals
• Patients who are receiving a medically prescribed diet with a specific nutritional profile
• Receiving active cancer treatment, not including endocrine therapy
• Inability to participate in the demands and requirements of the trial
• Significant cognitive impairment

Sponsors & Collaborators

• Amanda Shallcross: lead
• American Heart Association: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

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MeSH Terms

Conditions

Hypertension; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Shallcross

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and the study statistician will be masked to treatment condition when conducting initial data analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Research and Training, Department of Wellness and Preventative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: July 30, 2024
• Primary Completion: February 27, 2025
• Study Completion: March 6, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: No later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first.
• Access Criteria: Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.

Locations

US (1)