Diabetes MellitusFiLMEDNCT06461273
Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome
A study testing Lifestyle Medicine Program and Medically Tailored Groceries in people with Diabetes Mellitus and Metabolic Syndrome, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Metabolic Syndrome, Obesity
- What is being tested?
- Lifestyle Medicine Program and Medically Tailored Groceries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2024to 11 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American Heart Association (AHA)
- Stage 1 Metabolic Syndrome: Excess and/or dysfunctional adiposity
- overweight/obesity - BMI ≥25 kg/m2 (or ≥23 kg/m2 if Asian ancestry)
- abdominal obesity - Waist circumference ≥88/102 cm in women/men (or if Asian ancestry, ≥80/90 cm in women/men) and/or
- dysfunctional adipose tissue
- Fasting blood glucose ≥100-124 mg/dL or HbA1c between 5.7% and 6.4%*
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- without the presence of other metabolic risk factors or chronic kidney disease (CKD)
- Stage 2 Metabolic Syndrome: Metabolic risk factors and CKD
- hypertriglyceridemia ≥135 mg/dL
- hypertension
- metabolic syndrome (MetS†)
- waist circumference ≥88 cm for women and ≥102 cm for men (if Asian ancestry, ≥80 cm for women and ≥90 cm for men)
- high-density cholesterol <40 mg/dL for men and <50 mg/dL for women
- triglycerides ≥150 mg/dL
- elevated blood pressure (BP) - systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mm Hg and/or use of antihypertensive medications
- fasting blood glucose ≥100 mg/dL
- Diabetes (HbA1c > 6.5%)
- CKD stage 1-3b
- Stage 3 Subclinical cardiovascular disease (CVD) in CKM
- Risk equivalents of subclinical CVD- High predicted 10-y CVD risk
- Stage 4 Clinical CVD in CKM
- Clinical CVD (coronary heart disease, heart failure, stroke, peripheral artery disease, atrial fibrillation) among individuals with excess/dysfunctional adiposity, other metabolic risk factors,
- Electronic access to MyDataHelps platform either through an internet connected device like a personal computer, Ipad, or their personal phone and consent to its use
- Must be patient of the NJ Family Practice Center at Rutgers Health/University Hospital
Who cannot join
- Cardiovascular and Pulmonary Conditions
- acute coronary syndrome with coronary artery bypass grafting in the past 3 months
- uncontrolled hypertension with systolic BP > 160 or diastolic BP > 100
- heart failure American College of Cardiology (ACC)/AHA Stage C and New York Heart Association (NYHA) > class II
- life threatening or uncontrolled arrhythmia
- hemodynamically relevant valvular heart disease
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- infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease
- genetic hypertrophic cardiomyopathy
- significant pericardial disease
- clinically significant congenital heart disease that may be cause of symptoms
- significant anemia (hemoglobin <9)
- severe chronic obstructive pulmonary disease (oxygen or steroid dependent)
- severe restrictive pulmonary disease
- Mental and Psychological Conditions
- active suicidal behavior
- substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months
- uncontrolled major psychiatric illness (schizophrenia, bipolar, dementia)
- history of drug or alcohol abuse or dependency within the past 12 months
- history of medical noncompliance
- Intellectual disability resulting in inability to make adult decisions
- Musculoskeletal conditions
- debility resulting in limited unassisted ambulation (being unable to walk 300 meters)
- inability to perform activities of daily living unassisted
- Other Major Organ System Conditions
- very high-risk CKD (Stage 4 or 5 CKD or very high risk per Kidney Disease Improving Global Outcomes (KDIGO) classification)
- significant hepatic dysfunction
- untreated hypothyroidism or hyperthyroidism
- cerebrovascular accident within past 6 months with functional residual deficits
- clinically relevant neuromuscular disease
- cancer or terminal illness with life expectancy < 3 years
- pregnant or may become pregnant in the next 6 months
- prior major organ transplant or intent to transplant (on the transplant list)
- Administrative
- participant in diabetes, nutrition, or weight research intervention in last 12 months
- another family member or household member is a study participant. Only one member of each household may take part in this study.
- individuals who have started treatment with a class of medications known as GLP-1 within 120 days of the program start
- individuals who have undergone bariatric surgery.
- participants without smartphone or web access
- individuals who are not proficient in English to a level that would allow for unassisted understanding of study materials and informed consent documentation, as well as effective communication with the research team
- individuals currently facing acute unresolved health-related social needs, including but not limited to, unstable housing, lack of reliable transportation, and unemployment
- These conditions are considered exclusion criteria due to the potential for it to significantly impact their ability to participate consistently in the study. It can affect the individual's ability to adhere to study protocols, attend follow-up appointments, or impact the generalizability of the study findings. The investigators recognize the importance of addressing these social determinants of health, typically in clinical practice the investigators focus on helping the patient stabilize and resolve health related social needs prior to engaging in a comprehensive therapeutic lifestyle change program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Health New Jersey Family Practice Center
Newark, New Jersey, 07103
About this study
Official title: Food is Medicine vs Lifestyle Medicine: A Community Based Pragmatic Randomized Control Trial for Patients With Cardiovascular Kidney Metabolic (CKM) Syndrome
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).
Read the 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 patient's 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 (e.g., 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).
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Hypertension,Essential, Hyperlipidemias, Cardiovascular Diseases
- Being tested
- Lifestyle Medicine Program, Medically Tailored Groceries
- Keywords
- Lifestyle Medicine, Food Is Medicine, Metabolic Syndrome, Lifestyle Related Diseases, Cardiovascular diseases, Type 2 Diabetes, Cardiovascular Kidney Metabolic Syndrome, Dietary Modification, Exercise, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Essential Hypertension, Hyperlipidemias, Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Medicine ProgramBehavioural
Participants will engage in culinary and nutrition education for 6 weeks curated by a professional chef working in conjunction with the project team from community partner Ethos Farm to Health. Lessons will be adapted from the American College of Lifestyle Medicine (ACLM) Culinary Medicine Curriculum
Participants will engage in exercise sessions on weeks without culinary and nutrition instruction for a total of 6 weeks. Exercise sessions will include a variety of activities to include calisthenics, weight training, walking, running, dance, and games delivered by the Rutgers physical therapy team.
Urban Agriculture lessons will occur longitudinally throughout the 12-week course. Participants will learn to cultivate a variety of crops in limited spaces, emphasizing sustainable practices and the importance of local food systems in urban communities.
Additionally, this arm will receive a supplemental food box weekly consistent with the dietary pattern set forth by ACLM.
Medically Tailored GroceriesBehavioural
Participants in the "Food is Medicine" arm will receive a supplemental food box weekly curated by a registered dietician and dietetics students. Each food box will contain seasonally available fruit and vegetables and other items including protein, dairy/cheese, and legumes that may be available at the time of the food box delivery. Each box will contain approximately 8 pounds of food and all participants in this group will receive the same food items. Classes and educational materials provided will be tailored to the specific foods contained in the weekly food box and will include simple preparation methods, recipes, nutrition information and grocery shopping tips.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Medicine | Experimental | 20 Patients will participate in a lifestyle medicine program that includes activities and lessons in urban agriculture, nutrition education, culinary education, and exercise with a team that includes a chef, physician, farmer, and physical therapist.
This group will meet one day per week for a 3-hour period for a total of 12-weeks. Receives: Behavioral: Lifestyle Medicine Program |
| Food is Medicine | Active comparator | As a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program. Receives: Behavioral: Medically Tailored Groceries |
| Usual Care | No intervention | The usual care arm will serve as the control group with a total of 20 patients. The control arm will undergo the standard of care and continue their current treatment plan as coordinated with their primary care physician throughout the course of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease reversal
Reduction of disease measures below the threshold for diagnosing the target disease/condition with an absence of medications or procedures known to affect those measures.
Measured: 12 weeks after start of intervention
Medication reduction
A decrease in the prescribed dose to the next appropriate dose of a specific agent for a specific condition
Measured: 12 weeks after start of intervention
Secondary outcomes (4)
Food Security
Defined as access by all members, at all times to have enough food for an active, healthy life
Measured: 12 weeks after start of intervention
Diet Quality
Diet quality is broadly defined as a dietary pattern or an indicator of variety across key food groups relative to those recommended in dietary guidelines. Diet quality is objectively measured using the Healthy Eating Index (HEI) 2020
Measured: 12 weeks after start of intervention
Culinary Attitudes and Behaviors
Assessed using the "Cooking With A Chef" survey instrument which consists of 8 scales assessing: 1. availability and accessibility of fruits and vegetables (AAFV), 2. cooking attitudes (CA) 3. cooking behaviors (CB), 4. produce consumption self efficacy (SEPC) , 5. cooking self-efficacy (SEC), 6. self-efficacy for using basic cooking techniques (SECT) and 7. self-efficacy for using fruit, vegetables, and seasonings (SEFVS) 8. knowledge of cooking terms and techniques.
Measured: 12 weeks after start of intervention
Physical Activity
Self-reported and measured duration and intensity of physical activity
Measured: 12 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start12 Oct 2024
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Ethos Farm to Health
- Responsible party
- Principal investigator, Andrew D. Lynch, PT, PhD, Rutgers, The State University of New Jersey
- Investigators
- Andrew Lynch, PT, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461273
- Sponsor's protocol ID
- Pro2024000459
- Acronym
- FiLMED
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food is Medicine vs Lifestyle Medicine: A Community Based Pragmatic Randomized Control Trial for Patients With Cardiovascular Kidney Metabolic (CKM) Syndrome
- ClinicalTrials.gov ID
- NCT06461273
- Acronym / sponsor ID
- FiLMED / Pro2024000459
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Obesity, Hypertension,Essential, Hyperlipidemias, Cardiovascular Diseases
- Keywords
- Lifestyle Medicine, Food Is Medicine, Metabolic Syndrome, Lifestyle Related Diseases, Cardiovascular diseases, Type 2 Diabetes, Cardiovascular Kidney Metabolic Syndrome, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Ethos Farm to Health
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's 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 (e.g., 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Medicine | Experimental | Behavioral: Lifestyle Medicine Program20 Patients will participate in a lifestyle medicine program that includes activities and lessons in urban agriculture, nutrition education, culinary education, and exercise with a team that includes a chef, physician, farmer, and physical therapist. This group will meet one day per week for a 3-hour period for a total of 12-weeks. |
| Food is Medicine | Active comparator | Behavioral: Medically Tailored GroceriesAs a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program. |
| Usual Care | No intervention | –The usual care arm will serve as the control group with a total of 20 patients. The control arm will undergo the standard of care and continue their current treatment plan as coordinated with their primary care physician throughout the course of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American Heart Association (AHA)
- Electronic access to MyDataHelps platform either through an internet connected device like a personal computer, Ipad, or their personal phone and consent to its use
- Must be patient of the NJ Family Practice Center at Rutgers Health/University Hospital
Key exclusion criteria (41 listed)
- Cardiovascular and Pulmonary Conditions
- Mental and Psychological Conditions
- Musculoskeletal conditions
- Other Major Organ System Conditions
- Administrative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Medicine ProgramParticipants will engage in culinary and nutrition education for 6 weeks curated by a professional chef working in conjunction with the project team from community partner Ethos Farm to Health. Lessons will be adapted from the American College of Lifestyle Medicine (ACLM) Culinary Medicine Curriculum Participants will engage in exercise sessions on weeks without culinary and nutrition instruction for a total of 6 weeks. Exercise sessions will include a variety of activities to include calisthenics, weight training, walking, running, dance, and games delivered by the Rutgers physical therapy team. Urban Agriculture lessons will occur longitudinally throughout the 12-week course. Participants will learn to cultivate a variety of crops in limited spaces, emphasizing sustainable practices and the importance of local food systems in urban communities. Additionally, this arm will receive a supplemental food box weekly consistent with the dietary pattern set forth by ACLM. | Behavioural | Lifestyle Medicine |
| Medically Tailored GroceriesParticipants in the "Food is Medicine" arm will receive a supplemental food box weekly curated by a registered dietician and dietetics students. Each food box will contain seasonally available fruit and vegetables and other items including protein, dairy/cheese, and legumes that may be available at the time of the food box delivery. Each box will contain approximately 8 pounds of food and all participants in this group will receive the same food items. Classes and educational materials provided will be tailored to the specific foods contained in the weekly food box and will include simple preparation methods, recipes, nutrition information and grocery shopping tips. | Behavioural | Food is Medicine |
Primary outcome
Disease reversal
Time frame: 12 weeks after start of intervention
Reduction of disease measures below the threshold for diagnosing the target disease/condition with an absence of medications or procedures known to affect those measures.
Medication reduction
Time frame: 12 weeks after start of intervention
A decrease in the prescribed dose to the next appropriate dose of a specific agent for a specific condition
4 secondary outcomes
Food Security
Time frame: 12 weeks after start of intervention
Diet Quality
Time frame: 12 weeks after start of intervention
Culinary Attitudes and Behaviors
Time frame: 12 weeks after start of intervention
Physical Activity
Time frame: 12 weeks after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Lynch, PT, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine Program and Medically Tailored Groceries in people with Diabetes Mellitus and Metabolic Syndrome, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease reversal (time frame: 12 weeks after start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.