COMPLETED

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

Conditions

Hypertension Type2diabetes Metabolic Syndrome Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-30

Study Completion:2025-03-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06460272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Amanda Shallcross

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Amanda Shallcross

Amanda Shallcross, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30

Study Completion Date2025-03-06

Study Record Updates

Study Start Date2024-07-30

Study Completion Date2025-03-06

Terms related to this study

Keywords Provided by Researchers

Hypertension
Type2diabetes
Metabolic Syndrome
Obesity

Additional Relevant MeSH Terms

Hypertension
Type2diabetes
Metabolic Syndrome
Obesity