Food InsecurityNCT05972421
Enrollment in and Utilization of the Flex Nutrition Program
A study testing High Intensity Proactive Outreach and Low Intensity Proactive Outreach in people with Food Insecurity and Vulnerable Populations, run by Massachusetts General Hospital.
Trial summary
The goal of this clinical trial is to learn about the impact of proactive outreach on enrollment into and utilization of the Flexible Services Nutrition Program. The Flexible Services Nutrition Program increases access to healthy foods for patients with Medicaid ACO insurance, food insecurity and nutritionally… Read more about this study
- Who is it for?
- Ages 3 to 64 years
- Conditions the study is for
- Food Insecurity, Vulnerable Populations, Nutrition, Healthy
- What is being tested?
- High Intensity Proactive Outreach and Low Intensity Proactive Outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Feb 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 3 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Has Medicaid ACO as primary health insurance, confirmed food insecurity (defined as a positive screen on the Hunger Vital Sign, which is conducted in routine care within primary care) AND one of the following:
- a Complex Physical Health Need
- a Behavioral Health Need
- a High Risk Pregnancy or
- Repeated ED use.
- A Complex Physical Health Need is defined as having a diagnosis of one or more of the following:
Show all 36Show fewer
- Obesity (adults with BMI > 30, pediatrics with weight in 95-99 percentiles)
- Diabetes
- Hypertension
- Chronic kidney disease or end stage renal disease
- Chronic heart failure
- Adult or pediatric cancer diagnosis
- Malnutrition
- Failure to thrive
- Gastrointestinal disease (e.g. inflammatory bowel disease such as Crohn's or Ulcerative Colitis)
- Asthma and two or more uncontrolled exacerbations per year
- COPD and two or more exacerbations per year High cholesterol
- HIV / AIDs
- Vitamin D deficiency or receiving Vitamin D supplements
- A Behavioral Health Need is defined as one or more of the following:
- Major depressive disorder
- Generalized anxiety disorder
- Bipolar disorder
- Schizophrenia
- Mood disorder (pediatric)
- Developmental disorders (e.g. autism)
- Substance use disorders or
- (for adults) an individual with PHQ-9 score or GAD-7 score of 10 or greater.
- High Risk Pregnancy is defined as:
- High risk pregnant individual with a diagnosis of:
- hypertensive disorders of pregnancy
- pregestational or gestational diabetes
- a referral to or care with a Maternal Fetal Medicine specialist or
- other high-risk, high-acuity diagnoses that can benefit from meeting an unmet social need
- Repeated ED Use is defined as:
- 2+ ED visits in last 6 months or 4+ ED visits in last 12 months
Who cannot join
- Language other than English, Arabic, Spanish, or Creole.
- Language unknown
- Age> 64.5 years (patients age out of the Medicaid ACO at 65, and this is a 6 month intervention)
- Previous referral (already in database whether or not enrolled)
- Invalid address (e.g. exclude address="NPA")
- No phone number
- Same address as another patient in report (randomly select 1 to retain)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Proactive Outreach on Enrollment in and Utilization of the Flex Nutrition Program for Patients With Food Insecurity and Nutritionally Dependent Chronic Health Conditions
The goal of this clinical trial is to learn about the impact of proactive outreach on enrollment into and utilization of the Flexible Services Nutrition Program. The Flexible Services Nutrition Program increases access to healthy foods for patients with Medicaid ACO insurance, food insecurity and nutritionally dependent chronic health conditions.
The main questions the study aims to answer are:
Read more
- Does proactive outreach to eligible patients increase enrollment into the Medicaid ACO FLEX Nutrition Program, compared to usual care?
- Does high intensity outreach (letter +phone calls) increase enrollment more than low intensity outreach (letter only)?
The investigators will also conduct exploratory analyses to evaluate if proactive outreach has an effect on healthcare utilization (ED visits, unplanned hospitalizations, and outpatient no-show rate) and health outcomes (BMI for patients with overweight/obesity, a1c for patients with impaired fasting glucose/Diabetes, Blood Pressure for patients with Hypertension).
Read the detailed description
The Medicaid ACO Flexible Services Program is a pilot that allocates state funding to address certain health-related social needs, in the domains of food and housing, with the goal of improving health outcomes and reducing the total cost of health care for members. The Flex Nutrition Program specifically allows members with a health needs-based criteria (such as a complex physical health need, repeated Emergency Department use or a high-risk pregnancy) who are experiencing food insecurity (defined as a positive screening on the Hunger Vital Sign questionnaire) to receive nutritional support.
At MGH, the investigators have partnered with 3 Social Service Organizations (SSOs) to deliver 3 types of nutritional support. Community Servings provides medically tailored meals with nutritional counseling. Fresh Food Generation provides healthy food boxes. Fresh Connect provides debit cards with monthly allotments that can be used to purchase produce.
The current workflow for identifying and enrolling appropriate ACO members relies largely on referrals from Primary Care Teams. Role groups who respond to social needs within primary care, such as Community Health Workers, integrated Care Managers, Community Resource Navigators and Emergency Department Navigators (collectively herein referred to as Care Managers), have been trained on the program's eligibility requirements and encouraged to offer enrollment to the patients they are working with. However, this current method in inadequate to identify many eligible patients. Only a very small subset of patients (less than 10%) with social needs identified on their primary care screening questionnaire are referred to Care Managers. In addition, Care Managers do not have any consistent method for identifying patients and offering the Flex Nutrition Program.
For patients interested in enrollment, Care Managers refer to two dedicated FLEX staff. Upon receipt of a referral, these two staff complete a Verification, Planning and Referral (VPR) form in EPIC, which generates a referral for the appropriate SSO, who subsequently reaches out to enroll the patient.
The investigators seek to understand if proactive outreach to eligible patients increases enrollment into and utilization of the Medicaid ACO Flex Nutrition Program. To answer this question, the investigators will identify eligible members (patients in the Medicaid ACO with a positive food insecurity screening plus one or more defined health conditions, see Inclusion criteria for more details) via an EPIC Report and randomize them into 3 cohorts. Cohort A will receive high intensity proactive outreach via phone, Cohort B will receive low-intensity outreach via letter and Cohort C will receive usual care with no proactive outreach. The investigators will use an EPIC report to generate a list of eligible patients, defined as Adult and Pediatric patients cared for within MGH Primary Care in the Medicaid ACO with a health needs-based criteria and a positive screening for food insecurity. Patients already enrolled into the Flex Nutrition program will be excluded.
The rationale for randomization is that our 2 FLEX staff have limited bandwidth to proactively outreach to all eligible patients. Randomizing eligible patients will ensure their efforts are distributed fairly and also allow the investigators to evaluate the effectiveness of low intensity and high intensity outreach. The Flex Services Nutrition Program is incorporated into routine clinical care at MGH.
- Conditions
- Food Insecurity, Vulnerable Populations, Nutrition, Healthy
- Being tested
- High Intensity Proactive Outreach, Low Intensity Proactive Outreach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Proactive OutreachOther
phone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program
Low Intensity Proactive OutreachOther
mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Proactive Outreach | Experimental | Patients will receive a mailed letter as well as proactive outreach by phone. The objective of the letter and phone outreach is to describe the Flex Nutrition Program and offer enrollment.
Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed.
1 week following the mailing of the letter, patients will receive 3 phone calls within 10 business days, occurring at different times of day. Patients will be provided a call back number. Phone calls will be made to patients in their primary languages, with the use of Interpreters as needed. Receives: Other: High Intensity Proactive Outreach |
| Low Intensity Proactive Outreach | Experimental | Patients will receive a mailed letter. The objective of the letter is to describe the Flex Nutrition Program and offer enrollment.
Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed. Receives: Other: Low Intensity Proactive Outreach |
| No Outreach; Usual Care | No intervention | Patients will not receive any proactive outreach and will serve as a comparison group. These patients may be referred to the Flex Nutrition Program through their Care Managers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referred to Flex Nutrition Program
The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO)
Measured: 3 months after outreach is completed
Enrollment into the Flex Nutrition Program
The percentage of patients in each study arm who are enrolled into the FLEX Nutrition program (Enrolled with the SSO). We will utilize SSO rosters of enrolled patients as our data source.
Measured: 3 months after outreach is completed
Enrollment in the Flex Nutrition Program by Vendor
For patients enrolled into Flex Nutrition, the percentage breakdown by SSO vendor
- Community Servings
- Fresh Food Generation
- Fresh Connect We will utilize SSO rosters of enrolled patients as our data source.
Measured: 3 months after outreach is complete
Utilization of the Flex Nutrition Program
The percentage of patients in each study arm who used the FLEX Nutrition program at least once Numerator: patients with any positive utilization 3 mths after outreach is complete
- Community Servings: received at least 1 delivery
- Fresh Food Generation: received at least delivery
- Fresh Connect: have charged their card at least once We will utilize SSO rosters of patients receiving services as our data source.
Measured: 3 months after outreach is complete
Secondary outcomes (6)
Preventable ED visits
Number of ED visits that did not result in an admission 12 months pre-outreach compared to 12 months after outreach is completed
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
Avoidable Inpatient Hospitalizations
Unplanned inpatient hospitalizations 12 months pre-outreach compared to 12 months after outreach is completed
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
Outpatient no-show rate
No show rate during the 12 months pre-outreach period compared to 12 months after outreach is completed.
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
BMI for patients who are overweight/obese
Of patients with elevated BMI (defined as BMI>25 prior to outreach completed), change in pre-outreach BMI compared to 12 months after outreach is completed
BMI change for each patient: BMI pre-outreach (use last chronological value prior to outreach completed, within 12 months) - BMI 12 months after outreach is completed (If multiple values, use last chronological value post outreach, within 12 months)
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
A1c for patients with Impaired Fasting Glucose/Diabetes
Of patients with IFG/Diabetes (defined as Diagnosis of IFG/DM AND/OR a1c > 5.7 prior to outreach completed), change in pre-outreach a1c compared to 12 months after outreach is completed.
A1c change for each patient: a1c pre-outreach (If multiple values, use last chronological value prior to outreach completed, within 12 months) - a1c 12 months after outreach is completed (If multiple values, use last chronological value post outreach, within 12 months)
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
Blood Pressure for patients with HTN
Of patients with Hypertension (defined as Diagnosis of Hypertension AND/OR BP > 130/80 prior to outreach completed), change in pre-outreach Blood Pressure compared to 12 months after outreach is completed.
BP change for each patient: BP 12 mths pre-outreach (If multiple values, take mean of all values. If more than 1 value on one day, take the lowest value measured on that day) - BP during 12 months post-outreach period (If multiple values, take mean of all values. If more than 1 value on one day, take the lowest value measured on that day.)
Measured: 12 months pre-outreach compared to 12 months after outreach is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah A. Matathia, MD, MPH, Massachusetts General Hospital
- Investigators
- Sarah Matathia, MD MPH, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972421
- Sponsor's protocol ID
- 2022P002954
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matathia S, Alani S, Cheng D, Regan S, Marotta C, Risley K, Arauz Boudreau A, Brodney S, Thorndike AN. Higher and Lower Intensity Outreach to Increase Enrollment in a Medicaid Food Is Medicine Program: A Randomized Controlled Trial. J Gen Intern Med. 2026 Sep 3. doi: 10.1007/s11606-026-10558-5. Online ahead of print.
PubMed 42768178
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Proactive Outreach on Enrollment in and Utilization of the Flex Nutrition Program for Patients With Food Insecurity and Nutritionally Dependent Chronic Health Conditions
- ClinicalTrials.gov ID
- NCT05972421
- Acronym / sponsor ID
- 2022P002954
- Conditions
- Food Insecurity, Vulnerable Populations, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 2 Aug 2023 (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 goal of this clinical trial is to learn about the impact of proactive outreach on enrollment into and utilization of the Flexible Services Nutrition Program. The Flexible Services Nutrition Program increases access to healthy foods for patients with Medicaid ACO insurance, food insecurity and nutritionally dependent chronic health conditions.
The main questions the study aims to answer are:
- Does proactive outreach to eligible patients increase enrollment into the Medicaid ACO FLEX Nutrition Program, compared to usual care?
- Does high intensity outreach (letter +phone calls) increase enrollment more than low intensity outreach (letter only)?
The investigators will also conduct exploratory analyses to evaluate if proactive outreach has an effect on healthcare utilization (ED visits, unplanned hospitalizations, and outpatient no-show rate) and health outcomes (BMI for patients with overweight/obesity, a1c for patients with impaired fasting glucose/Diabetes, Blood Pressure for patients with Hypertension).
Detailed description
The Medicaid ACO Flexible Services Program is a pilot that allocates state funding to address certain health-related social needs, in the domains of food and housing, with the goal of improving health outcomes and reducing the total cost of health care for members. The Flex Nutrition Program specifically allows members with a health needs-based criteria (such as a complex physical health need, repeated Emergency Department use or a high-risk pregnancy) who are experiencing food insecurity (defined as a positive screening on the Hunger Vital Sign questionnaire) to receive nutritional support.
At MGH, the investigators have partnered with 3 Social Service Organizations (SSOs) to deliver 3 types of nutritional support. Community Servings provides medically tailored meals with nutritional counseling. Fresh Food Generation provides healthy food boxes. Fresh Connect provides debit cards with monthly allotments that can be used to purchase produce.
The current workflow for identifying and enrolling appropriate ACO members relies largely on referrals from Primary Care Teams. Role groups who respond to social needs within primary care, such as Community Health Workers, integrated Care Managers, Community Resource Navigators and Emergency Department Navigators (collectively herein referred to as Care Managers), have been trained on the program's eligibility requirements and encouraged to offer enrollment to the patients they are working with. However, this current method in inadequate to identify many eligible patients. Only a very small subset of patients (less than 10%) with social needs identified on their primary care screening questionnaire are referred to Care Managers. In addition, Care Managers do not have any consistent method for identifying patients and offering the Flex Nutrition Program.
For patients interested in enrollment, Care Managers refer to two dedicated FLEX staff. Upon receipt of a referral, these two staff complete a Verification, Planning and Referral (VPR) form in EPIC, which generates a referral for the appropriate SSO, who subsequently reaches out to enroll the patient.
The investigators seek to understand if proactive outreach to eligible patients increases enrollment into and utilization of the Medicaid ACO Flex Nutrition Program. To answer this question, the investigators will identify eligible members (patients in the Medicaid ACO with a positive food insecurity screening plus one or more defined health conditions, see Inclusion criteria for more details) via an EPIC Report and randomize them into 3 cohorts. Cohort A will receive high intensity proactive outreach via phone, Cohort B will receive low-intensity outreach via letter and Cohort C will receive usual care with no proactive outreach. The investigators will use an EPIC report to generate a list of eligible patients, defined as Adult and Pediatric patients cared for within MGH Primary Care in the Medicaid ACO with a health needs-based criteria and a positive screening for food insecurity. Patients already enrolled into the Flex Nutrition program will be excluded.
The rationale for randomization is that our 2 FLEX staff have limited bandwidth to proactively outreach to all eligible patients. Randomizing eligible patients will ensure their efforts are distributed fairly and also allow the investigators to evaluate the effectiveness of low intensity and high intensity outreach. The Flex Services Nutrition Program is incorporated into routine clinical care at MGH.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Proactive Outreach | Experimental | Other: High Intensity Proactive OutreachPatients will receive a mailed letter as well as proactive outreach by phone. The objective of the letter and phone outreach is to describe the Flex Nutrition Program and offer enrollment. Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed. 1 week following the mailing of the letter, patients will receive 3 phone calls within 10 business days, occurring at different times of day. Patients will be provided a call back number. Phone calls will be made to patients in their primary languages, with the use of Interpreters as needed. |
| Low Intensity Proactive Outreach | Experimental | Other: Low Intensity Proactive OutreachPatients will receive a mailed letter. The objective of the letter is to describe the Flex Nutrition Program and offer enrollment. Letters will be written in the primary language spoken by the patient. The letter will contain a call back phone number as well as a primary email contact. Patients will be provided with the phone number of Interpreter Services to utilize if needed. |
| No Outreach; Usual Care | No intervention | –Patients will not receive any proactive outreach and will serve as a comparison group. These patients may be referred to the Flex Nutrition Program through their Care Managers. |
Who may qualify
- Ages
- 3 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (36 listed)
- Has Medicaid ACO as primary health insurance, confirmed food insecurity (defined as a positive screen on the Hunger Vital Sign, which is conducted in routine care within primary care) AND one of the following:
- a Complex Physical Health Need
- a Behavioral Health Need
- a High Risk Pregnancy or
- Repeated ED use.
Key exclusion criteria (7 listed)
- Language other than English, Arabic, Spanish, or Creole.
- Language unknown
- Age> 64.5 years (patients age out of the Medicaid ACO at 65, and this is a 6 month intervention)
- Previous referral (already in database whether or not enrolled)
- Invalid address (e.g. exclude address="NPA")
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 |
|---|---|---|
| High Intensity Proactive Outreachphone calls + mailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program | Other | High Intensity Proactive Outreach |
| Low Intensity Proactive Outreachmailed letter to eligible patients to describe and offer enrollment into the FLEX Nutrition Program | Other | Low Intensity Proactive Outreach |
Primary outcome
Referred to Flex Nutrition Program
Time frame: 3 months after outreach is completed
The percentage of patients in each study arm who are referred to the FLEX Nutrition program (VPR form completed and sent to the SSO)
Enrollment into the Flex Nutrition Program
Time frame: 3 months after outreach is completed
The percentage of patients in each study arm who are enrolled into the FLEX Nutrition program (Enrolled with the SSO). We will utilize SSO rosters of enrolled patients as our data source.
Enrollment in the Flex Nutrition Program by Vendor
Time frame: 3 months after outreach is complete
For patients enrolled into Flex Nutrition, the percentage breakdown by SSO vendor 1. Community Servings 2. Fresh Food Generation 3. Fresh Connect We will utilize SSO rosters of enrolled patients as our data source.
Utilization of the Flex Nutrition Program
Time frame: 3 months after outreach is complete
The percentage of patients in each study arm who used the FLEX Nutrition program at least once Numerator: patients with any positive utilization 3 mths after outreach is complete 1. Community Servings: received at least 1 delivery 2. Fresh Food Generation: received at least delivery 3. Fresh Connect: have charged their card at least once We will utilize SSO rosters of patients receiving services as our data source.
6 secondary outcomes
Preventable ED visits
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
Avoidable Inpatient Hospitalizations
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
Outpatient no-show rate
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
BMI for patients who are overweight/obese
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
A1c for patients with Impaired Fasting Glucose/Diabetes
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
Blood Pressure for patients with HTN
Time frame: 12 months pre-outreach compared to 12 months after outreach is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 42768178Matathia S, Alani S, Cheng D, Regan S, Marotta C, Risley K, Arauz Boudreau A, Brodney S, Thorndike AN. Higher and Lower Intensity Outreach to Increase Enrollment in a Medicaid Food Is Medicine Program: A Randomized Controlled Trial. J Gen Intern Med. 2026 Sep 3. doi: 10.1007/s11606-026-10558-5. Online ahead of print.
- 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.
Sarah Matathia, MD MPH principal investigator
MGH
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Proactive Outreach and Low Intensity Proactive Outreach in people with Food Insecurity and Vulnerable Populations, run by Massachusetts General Hospital.
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 36 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saja Alani, MPH (617-726-1369, salani@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referred to Flex Nutrition Program (time frame: 3 months after outreach is completed). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972421, which also lists 1 linked publication.
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 2 Aug 2023; AzTrials last refreshed its copy on 4 Nov 2026.