Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461273
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-04
Brief Title:
Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic CKM Syndrome
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Food is Medicine vs Lifestyle Medicine A Community Based Pragmatic Randomized Control Trial for Patients With Cardiovascular Kidney Metabolic CKM Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FiLMED
Brief Summary:
The investigators are piloting a 3 month community-based lifestyle medicine program that incorporates experiences and education in urban agriculture nutrition culinary arts and physical fitness to test the hypothesis whether this improves clinical and socio-behavioral outcomes of participants with Cardiovascular Kidney Metabolic CKM syndrome high blood pressure diabetes high cholesterol heart disease and obesity in comparison to the current medical care model usual care or providing healthy produce medically tailored groceries
Detailed Description:
Many chronic conditions can be prevented treated and improved or even reversed through lifestyle modification The practice and application of lifestyle medicine offers tremendous potential to restore health and reduce healthcare costs Lifestyle Medicine is the use of evidence-based lifestyle therapeutic intervention-including a whole-food plant-predominant eating pattern regular physical activity restorative sleep stress management avoidance of risky substances and positive social connection-as a primary modality delivered by clinicians trained and certified in this specialty to prevent treat and often reverse chronic disease Lifestyle Medicine interventions have been applied in clinical community and workplace settings to drive health restoration and disease prevention
In recent times there has been tremendous interest in the development and study of Food Is Medicine interventions as evidenced by the creation of a Food is Medicine initiative and inaugural Food is Medicine Summit by the Department of Health and Human Services HHS in fiscal year 2023 Historically Food is Medicine interventions have been applied using 3 modalities
Produce Prescriptions Vouchers or restricted debit cards that can be redeemed for produce or direct distributions of produce that are made available to recipients based on a health condition or risk Produce prescriptions are sometimes paired with services provided by RDNs such as nutrition education nutrition resources supermarket tours cooking classes and medical nutrition therapy
Medically Tailored Groceries Distributions of unprepared or lightly processed foods that recipients are meant to prepare for consumption at home the contents are sufficient to prepare nutritionally complete meals or provide a significant portion of the ingredients for such meals including produce whole grains and legumes and lean proteins
Medically Tailored Meals Fully prepared meals made available through a referral from a medical professional or healthcare plan that are tailored to the medical needs of the recipient by a Registered Dietitian Nutritionist RDN Nutrition assessment nutrition counseling and medical nutrition therapy are offered along with the meal program
Food is medicine interventions suggest there is promise in improving not only food security but health outcomes associated with diet related diseases Addressing food insecurity with healthful food improving nutrition security is important however Food Is Medicine interventions may not achieve the expected improvements in health outcomes if patients lifestyle behaviors are not targeted comprehensively within their unique circumstances This clinical aspect is often missing from the conversation in terms of chronic disease Relative to Food is Medicine interventions lifestyle medicine interventions are comprehensive expanding beyond nutrition encompassing physical activity stress management smoking cessation alcohol moderation adequate sleep and social connectivity to treat disease and drive health restoration
The investigators research question is Does a comprehensive lifestyle medicine intervention involving culinary education health education physical activity and urban agriculture more effectively improve cardiometabolic risk factors in participants compared to those who only receive produce food boxes or usual care
In a pilot pragmatic randomized control trial pRCT the investigators hypothesize that a comprehensive lifestyle medicine intervention can improve clinical outcomes eg blood pressure cholesterol levels blood sugar levels body mass index of people are living with a lifestyle-related non-communicable disease such as obesity heart disease or diabetes compared to a medically tailored groceries cohort and usual care acting as a control
In recent times there has been tremendous interest in the development and study of Food Is Medicine interventions as evidenced by the creation of a Food is Medicine initiative and inaugural Food is Medicine Summit by the Department of Health and Human Services HHS in fiscal year 2023 Historically Food is Medicine interventions have been applied using 3 modalities
Produce Prescriptions Vouchers or restricted debit cards that can be redeemed for produce or direct distributions of produce that are made available to recipients based on a health condition or risk Produce prescriptions are sometimes paired with services provided by RDNs such as nutrition education nutrition resources supermarket tours cooking classes and medical nutrition therapy
Medically Tailored Groceries Distributions of unprepared or lightly processed foods that recipients are meant to prepare for consumption at home the contents are sufficient to prepare nutritionally complete meals or provide a significant portion of the ingredients for such meals including produce whole grains and legumes and lean proteins
Medically Tailored Meals Fully prepared meals made available through a referral from a medical professional or healthcare plan that are tailored to the medical needs of the recipient by a Registered Dietitian Nutritionist RDN Nutrition assessment nutrition counseling and medical nutrition therapy are offered along with the meal program
Food is medicine interventions suggest there is promise in improving not only food security but health outcomes associated with diet related diseases Addressing food insecurity with healthful food improving nutrition security is important however Food Is Medicine interventions may not achieve the expected improvements in health outcomes if patients lifestyle behaviors are not targeted comprehensively within their unique circumstances This clinical aspect is often missing from the conversation in terms of chronic disease Relative to Food is Medicine interventions lifestyle medicine interventions are comprehensive expanding beyond nutrition encompassing physical activity stress management smoking cessation alcohol moderation adequate sleep and social connectivity to treat disease and drive health restoration
The investigators research question is Does a comprehensive lifestyle medicine intervention involving culinary education health education physical activity and urban agriculture more effectively improve cardiometabolic risk factors in participants compared to those who only receive produce food boxes or usual care
In a pilot pragmatic randomized control trial pRCT the investigators hypothesize that a comprehensive lifestyle medicine intervention can improve clinical outcomes eg blood pressure cholesterol levels blood sugar levels body mass index of people are living with a lifestyle-related non-communicable disease such as obesity heart disease or diabetes compared to a medically tailored groceries cohort and usual care acting as a control
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