Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460272
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
Nutrition Outreach and Understanding Research In Serving Hearts Through Healthy Eating And Tailored Support
Sponsor:
Amanda Shallcross
Organization:
The Cleveland Clinic
Study Overview
Official Title:
NOURISH HEARTS Nutrition Outreach and Understanding Research In Serving Hearts Through Healthy Eating And Tailored Support
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOURISH HEARTS
Brief Summary:
This study is a human-centered three-arm parallel-group randomized control implementation trial n75 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 andor metabolic syndrome All intervention components will be culturally congruent eg 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 Clinics 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 mealsday for 7 daysweek 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 investigators published pilot trial as well as data from other studies that have optimized cultural relevance of the Mediterranean diet for Black communities eg 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 investigators pilot study This includes practice with behavior change principles ie selection of healthy food options Thus participants will be directed to access South Pointe Hospitals 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 andor 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
Medically Tailored Meals MTMs
Collaborative agreements are in place with Performance Kitchen to prepare 2 mealsday for 7 daysweek 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 investigators published pilot trial as well as data from other studies that have optimized cultural relevance of the Mediterranean diet for Black communities eg 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 investigators pilot study This includes practice with behavior change principles ie selection of healthy food options Thus participants will be directed to access South Pointe Hospitals 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None