Food InsecurityPhase 2I-FRESHNCT06661538
Implementing Food Referrals for Equity and Sustained Health
A Phase 2 study testing Food Security Screening & Referral Program in people with Food Insecurity, run by University of California, San Diego at 2 sites in United States.
Trial summary
Food insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Food Security Screening & Referral Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2025to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- child attending Type 1 or Type 2 Diabetes clinics, Cardiology clinic, MASLD clinic, general GI clinic at RCHSD
- child age between 5-18 years old
- parent or caregiver who indicates that they are experiencing food insecurity and receives Medicaid or SNAP benefits
- family not moving out of the San Diego area within the time frame of the study
- Limited exclusion criteria will be applied in order to examine the impact of this program on a heterogenous group of people and increase generalizability. Of note, all genders and races/ethnicities will be allowed to participate.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
UC San Diego
La Jolla, California, 92093
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Kyung Rhee, MD, MS, MA, 8589665841, k1rhee@health.ucsd.edu
Kyung Rhee, MD, MS, MA
About this study
Official title: Addressing Food Insecurity in the Health Care Setting to Promote Health Equity
Food insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement. It also contributes to the development of adverse health outcomes such as obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Improving the diet quality of children (e.g., decreasing fat intake, increasing fruits and vegetables (FV) and fiber intake) has been associated with lower fasting serum glucose, insulin, LDL cholesterol, non-HDL cholesterol, and reduced risk of CVD later in life. Increasing awareness and access to programs that promote food equity by providing affordable healthy produce is a promising way to improve health outcomes and empower patients and communities to achieve better health and well-being. The goal of this proposal is to refine and optimize implementation strategies that connect families to community-based food security nutrition support programs through health care systems or medical clinics. The investigators will develop a multi-disciplinary, cross-sector collaboration to optimize current processes and workflows that integrate food security nutrition support programs into the healthcare system. The investigators will also work to develop a closed-loop communication system between the healthcare and healthy food access systems to support greater patient autonomy and self-efficacy to obtain, prepare, and consume healthy foods.
Read the detailed description
The investigators will conduct a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program using a Roll-Out Implementation Optimization (ROIO) design among families with children with nutrition-related illnesses who receive Medicaid or Supplemental Nutrition Assistance Program (SNAP) benefits. The I-FRESH program, the food security nutrition support program, will be refined prior to the first clinic roll-out based on input from several hospital, clinical, and community stakeholders. The program will involve 4 main components: screening and identification of families experiencing food insecurity (FI); social worker/care navigator-led discussions with families to determine need and readiness to receive support; referrals and assistance to engage with these programs; and follow-up assessments to determine fit, track utilization, and determine need for additional referrals. With each roll-out into a new clinic, modified implementation procedures and work-flows will be evaluated using implementation and effectiveness outcomes.
- Conditions
- Food Insecurity
- Being tested
- Food Security Screening & Referral Program
- Keywords
- Food Insecurity, Social Care, Screening, Type 2 Diabetes Mellitus, Cardiovascular Disease, Child Health, Nutrition, Fruit and Vegetables, Care Navigation, Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD, Nutrition Support Programs
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Security Screening & Referral ProgramBehavioural
The I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program is the food security nutrition support program that involves some combination and form of: 1) screening and identification of families experiencing food insecurity; 2) discussions with families to determine readiness to engage with nutrition support programs and other community resources; 3) referrals and support to engage with a program; and 4) conducting follow-up assessments to determine fit of program, track utilization, and assess need for additional referrals. The exact implementation and workflow for this program will be optimized for each clinic.
| Study group | Role | What they receive |
|---|---|---|
| Clinic 1: Type 2 Diabetes Clinic | Experimental | Families with children who attend the Type 2 Diabetes Clinic and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. Receives: Behavioral: Food Security Screening & Referral Program |
| Clinic 2: Obesity Clinic | Experimental | Families with children who attend the Obesity Clinic in Endocrinology and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. Receives: Behavioral: Food Security Screening & Referral Program |
| Clinic 3: Preventive Cardiology Clinic | Experimental | Families with children who attend the Preventive Cardiology Clinic for hypertension and/or high cholesterol and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. Receives: Behavioral: Food Security Screening & Referral Program |
| Clinic 4: Gastroenterology Clinic | Experimental | Families with children who attend the Gastroenterology Clinic for malnutrition or MASLD and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. Receives: Behavioral: Food Security Screening & Referral Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
4-item measure that assesses feasibility of implementing the program in that setting; score range (4-20) with higher scores referring to greater feasibility
Measured: 12 months
Acceptability of Intervention Measure (AIM)
4-item measure assessing the acceptability of the program by program staff and participants; score range (4-20) with higher scores referring to greater acceptability
Measured: 12 months
Implementation Fidelity
Percent of families with food insecurity that were called, percent of families that were referred to a program or provided with resources, percent of families that received follow-up phone calls, percent of families that needed additional resources/referrals
Measured: 12 months
Adoption
Percent of clinical settings approached that participate; characteristics of settings participating compared to non participating clinical settings
Measured: 12 months
Reach
Percent of families attending clinic that completed the food insecurity screener, number of families experiencing food insecurity in that clinic, percent of families that wanted and did not want referrals to a nutrition support program
Measured: 12 months
Secondary outcomes (7)
Change in Food Security levels over a 12 month period
U.S. Household Food Security Survey Module: Six-Item Short Form; Score range of 0-6, with higher scores indicating greater food insecurity
Measured: 12 months
Change in Weight Status over 12 months
Weight status may be measured by BMI percentile for age and sex, %BMIp95, %BMIp50, or BMI z-score
Measured: 12 months
Change in Blood Pressure over 12 months
Change in systolic and diastolic blood pressures
Measured: 12 months
Change in non-fasting and fasting Lipid levels over 12 months
Change in total cholesterol, non-HDL cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol
Measured: 12 months
Change in HbA1c over 12 months
change in HbA1c levels over a 12 month period
Measured: 12 months
Change in Liver Function Tests over 12 months
change in AST and ALT over a 12 month period
Measured: 12 months
Change in Quality of Life measure over 12 months
Parent reported Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL); Score range of 0 to 100, with higher scores indicating a higher quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start18 Aug 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 University of California, San DiegoThe 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 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH program using the Roll-out Implementation and Optimization (ROIO) design.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661538
- Sponsor's protocol ID
- IRB # 810869
- Other IDs
- R01DK140573
- Acronym
- I-FRESH
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make a complete description of our final study protocol available at the end of the study. We will provide details regarding our study population (inclusion and exclusion criteria as well as demographic information) and describe our strategy for engaging patients, clinicians, and other stakeholders in the design and implementation of this program. We will make available our workflows and specific measurement tools. The program protocol and implementation guide will be made available as well. The study coordinator will be responsible for creating these documents and maintaining them throughout the course of the study, with oversight from Dr. Rhee. External investigators interested in these materials can contact Dr. Rhee via email.
Publications
Becan JE, Bartkowski JP, Knight DK, Wiley TRA, DiClemente R, Ducharme L, Welsh WN, Bowser D, McCollister K, Hiller M, Spaulding AC, Flynn PM, Swartzendruber A, Dickson MF, Fisher JH, Aarons GA. A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study. Health Justice. 2018 Apr 13;6(1):9. doi: 10.1186/s40352-018-0068-3.
PubMed 29654518Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.
PubMed 34367671McCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, Frank JW, Hess PL, Burke RE, Battaglia CT. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019 Nov 25;9(6):1002-1011. doi: 10.1093/tbm/ibz085.
PubMed 31170296Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
PubMed 18468362Rhee KE, Hiller-Venegas S, Viglione C, Polich MA, Huang JS, Kim JJ, Bajwa MS, Zive M, Eichen DM, Strong DR, Stadnick NA, Brookman-Frazee L. Roll-Out Implementation Optimization (ROIO) trial to develop and test the implementation of a food security screening and referral process: a study protocol. Implement Sci Commun. 2026 Jun 19. doi: 10.1186/s43058-026-01025-7. Online ahead of print.
PubMed 42321957
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Food Insecurity in the Health Care Setting to Promote Health Equity
- ClinicalTrials.gov ID
- NCT06661538
- Acronym / sponsor ID
- I-FRESH / IRB # 810869
- Conditions
- Food Insecurity
- Keywords
- Food Insecurity, Social Care, Screening, Type 2 Diabetes Mellitus, Cardiovascular Disease, Child Health, Nutrition, Fruit and Vegetables
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rady Children's Hospital, San Diego
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Oct 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.
Food insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement. It also contributes to the development of adverse health outcomes such as obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Improving the diet quality of children (e.g., decreasing fat intake, increasing fruits and vegetables (FV) and fiber intake) has been associated with lower fasting serum glucose, insulin, LDL cholesterol, non-HDL cholesterol, and reduced risk of CVD later in life. Increasing awareness and access to programs that promote food equity by providing affordable healthy produce is a promising way to improve health outcomes and empower patients and communities to achieve better health and well-being. The goal of this proposal is to refine and optimize implementation strategies that connect families to community-based food security nutrition support programs through health care systems or medical clinics. The investigators will develop a multi-disciplinary, cross-sector collaboration to optimize current processes and workflows that integrate food security nutrition support programs into the healthcare system. The investigators will also work to develop a closed-loop communication system between the healthcare and healthy food access systems to support greater patient autonomy and self-efficacy to obtain, prepare, and consume healthy foods.
Detailed description
The investigators will conduct a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program using a Roll-Out Implementation Optimization (ROIO) design among families with children with nutrition-related illnesses who receive Medicaid or Supplemental Nutrition Assistance Program (SNAP) benefits. The I-FRESH program, the food security nutrition support program, will be refined prior to the first clinic roll-out based on input from several hospital, clinical, and community stakeholders. The program will involve 4 main components: screening and identification of families experiencing food insecurity (FI); social worker/care navigator-led discussions with families to determine need and readiness to receive support; referrals and assistance to engage with these programs; and follow-up assessments to determine fit, track utilization, and determine need for additional referrals. With each roll-out into a new clinic, modified implementation procedures and work-flows will be evaluated using implementation and effectiveness outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH program using the Roll-out Implementation and Optimization (ROIO) design.
| Arm | Type | Receives |
|---|---|---|
| Clinic 1: Type 2 Diabetes Clinic | Experimental | Behavioral: Food Security Screening & Referral ProgramFamilies with children who attend the Type 2 Diabetes Clinic and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. |
| Clinic 2: Obesity Clinic | Experimental | Behavioral: Food Security Screening & Referral ProgramFamilies with children who attend the Obesity Clinic in Endocrinology and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. |
| Clinic 3: Preventive Cardiology Clinic | Experimental | Behavioral: Food Security Screening & Referral ProgramFamilies with children who attend the Preventive Cardiology Clinic for hypertension and/or high cholesterol and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. |
| Clinic 4: Gastroenterology Clinic | Experimental | Behavioral: Food Security Screening & Referral ProgramFamilies with children who attend the Gastroenterology Clinic for malnutrition or MASLD and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- child attending Type 1 or Type 2 Diabetes clinics, Cardiology clinic, MASLD clinic, general GI clinic at RCHSD
- child age between 5-18 years old
- parent or caregiver who indicates that they are experiencing food insecurity and receives Medicaid or SNAP benefits
- family not moving out of the San Diego area within the time frame of the study
- Limited exclusion criteria will be applied in order to examine the impact of this program on a heterogenous group of people and increase generalizability. Of note, all genders and races/ethnicities will be allowed to participate.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Food Security Screening & Referral ProgramThe I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program is the food security nutrition support program that involves some combination and form of: 1) screening and identification of families experiencing food insecurity; 2) discussions with families to determine readiness to engage with nutrition support programs and other community resources; 3) referrals and support to engage with a program; and 4) conducting follow-up assessments to determine fit of program, track utilization, and assess need for additional referrals. The exact implementation and workflow for this program will be optimized for each clinic. | Behavioural | Clinic 1: Type 2 Diabetes Clinic, Clinic 2: Obesity Clinic, Clinic 3: Preventive Cardiology Clinic, Clinic 4: Gastroenterology Clinic |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: 12 months
4-item measure that assesses feasibility of implementing the program in that setting; score range (4-20) with higher scores referring to greater feasibility
Acceptability of Intervention Measure (AIM)
Time frame: 12 months
4-item measure assessing the acceptability of the program by program staff and participants; score range (4-20) with higher scores referring to greater acceptability
Implementation Fidelity
Time frame: 12 months
Percent of families with food insecurity that were called, percent of families that were referred to a program or provided with resources, percent of families that received follow-up phone calls, percent of families that needed additional resources/referrals
Adoption
Time frame: 12 months
Percent of clinical settings approached that participate; characteristics of settings participating compared to non participating clinical settings
Reach
Time frame: 12 months
Percent of families attending clinic that completed the food insecurity screener, number of families experiencing food insecurity in that clinic, percent of families that wanted and did not want referrals to a nutrition support program
7 secondary outcomes
Change in Food Security levels over a 12 month period
Time frame: 12 months
Change in Weight Status over 12 months
Time frame: 12 months
Change in Blood Pressure over 12 months
Time frame: 12 months
Change in non-fasting and fasting Lipid levels over 12 months
Time frame: 12 months
Change in HbA1c over 12 months
Time frame: 12 months
Change in Liver Function Tests over 12 months
Time frame: 12 months
Change in Quality of Life measure over 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 29654518Becan JE, Bartkowski JP, Knight DK, Wiley TRA, DiClemente R, Ducharme L, Welsh WN, Bowser D, McCollister K, Hiller M, Spaulding AC, Flynn PM, Swartzendruber A, Dickson MF, Fisher JH, Aarons GA. A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study. Health Justice. 2018 Apr 13;6(1):9. doi: 10.1186/s40352-018-0068-3.
- Background: PubMed 34367671Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.
- Background: PubMed 31170296McCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, Frank JW, Hess PL, Burke RE, Battaglia CT. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019 Nov 25;9(6):1002-1011. doi: 10.1093/tbm/ibz085.
- Background: PubMed 18468362Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
- Derived from this study: PubMed 42321957Rhee KE, Hiller-Venegas S, Viglione C, Polich MA, Huang JS, Kim JJ, Bajwa MS, Zive M, Eichen DM, Strong DR, Stadnick NA, Brookman-Frazee L. Roll-Out Implementation Optimization (ROIO) trial to develop and test the implementation of a food security screening and referral process: a study protocol. Implement Sci Commun. 2026 Jun 19. doi: 10.1186/s43058-026-01025-7. Online ahead of print.
- Individual participant dataSharing planned: Yes. We will make a complete description of our final study protocol available at the end of the study. We will provide details regarding our study population (inclusion and exclusion criteria as well as demographic information) and describe our strategy for engaging patients, clinicians, and other stakeholders in the design and implementation of this program. We will make available our workflows and specific measurement tools. The program protocol and implementation guide will be made available as well. The study coordinator will be responsible for creating these documents and maintaining them throughout the course of the study, with oversight from Dr. Rhee. External investigators interested in these materials can contact Dr. Rhee via email.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Food Security Screening & Referral Program in people with Food Insecurity, run by University of California, San Diego at 2 sites 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kay Rhee, MD, MS, MA (858-534-6827, k1rhee@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) (time frame: 12 months). The study lists 5 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 NCT06661538, which also lists 5 linked publications.
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 19 Nov 2025.