OverweightPhase 2NCT05770570
Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
A Phase 2 study testing Counseling, Text Messages and Phone calls in people with Overweight and Overweight and Obesity, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Overweight and Obesity, Overweight or Obesity
- What is being tested?
- Counseling, Text Messages and Phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,889 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 11 Aug 2027
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For COMIDA participants only:
- Self-Identifies as Mexican American or Mexican
- Seeking services at the VDS of the Mexican Consulate
- Prefers to speak in Spanish
- All adults at least 18 years of age
- Screens as obese (an adult who has a Body Mass Index (BMI) 30 or higher) or overweight (an adult who has a BMI between 25 - 29.9)
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- Agrees to be audio recorded
- For SANOS focus group participants only:
- Self-identifies as Hispanic/Latino;
- Seeking services at VDS or VDS Mobile;
- Prefers to speak in Spanish;
- At least 18 years of age;
- Screens as obese (BMI ≥ 30 kg/m^2) or overweight (BMI of 25 - 29.9 kg/m^2);
- Agrees to be audio recorded
- For SANOS RCT participants only:
- Self-identifies as Hispanic/Latino;
- Seeking services at VDS or VDS Mobile;
- Prefers to speak in Spanish;
- At least 18 years of age;
- Screens as obese (BMI ≥ 30 kg/m^2) or overweight (BMI of 25 - 29.9 kg/m^2);
- Owns a cell phone capable of receiving text messages;
- Agrees to be audio recorded
- For Family COMIDA participants only:
- Self-Identifies as Hispanic/Latino
- Seeking services at the VDS (or has used VDS services in the past) of the Mexican - Consulate or VDS Mobile
- Prefers to speak in Spanish
- At least 18 years of age
- Has at least one child under age 18 living in the same household
- Owns a cell phone capable of receiving text messages
- Willing to receive text messages (3 texts per week for 3 months)
- Owns an internet connected device (eg, cell phone, tablet, etc) capable of conducting teleconference calls (eg, Zoom)
- For ROADmAP RCT participants only:
- At least 21 years of age
- Full-time (drives at least 35 hours per week) licensed taxi/FHV driver
- Driver for at least 6 months
- Seeking Health Fairs (or has used Health Fairs services in the past)
- Speaks English, French, Bengali, or Spanish
- Screens a as obese (BMI ≥ 30 kg/m2 [≥25 kg/m2 for South Asians]) or overweight (BMI of 25 - 29.9 kg/m2 s [23- 24.9 kg/m2 for South Asians])
- (BMI cut-offs are lower for South Asians, per WHO and American Diabetes Association recommendations)
- Owns a cell phone capable of receiving text messages
- Agrees to be audio-recorded
- For ROADmAP Phase 2 participants only:
- At least 21 years of age
- Driver who participated in ROADmAP RCT or manager at a taxi garage, Uber, Lyft or driver serving/union/organization
- Agrees to be audio-recorded
Who cannot join
- For COMIDA participants only:
- Will not be in the NYC area for the study duration (3-4 months) Is pregnant or might be pregnant
- Lactating women
- Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (Individuals with diabetes, lactose intolerance, and high blood pressure MAY still participate in the study)
- Has dietary restrictions (i.e. liquid diet)
- Does not have a phone that accepts text messages or unwilling to accept text messages
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- Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional"s judgment
- Has another family member already enrolled in COMIDA (as determined by patient report)
- For SANOS focus group participants only:
- Is pregnant or might be pregnant; lactating women;
- Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate);
- Has dietary restrictions (i.e. liquid diet);
- Has a household member who has already participated (or agreed to participate);
- For SANOS RCT participants only:
- Is pregnant or might be pregnant; lactating women; for the study duration (6 months)
- Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate); restricting diet;
- Currently has dietary restrictions (i.e. liquid diet);
- Has a household member who has already participated (or agreed to participate);
- Has already participated in the study
- Will not be in the NY Metropolitan area for the study duration (6 months) Works for or with the Mexican consulate (including employment and/or collaborative or volunteer services)
- For Family COMIDA participants only:
- Is pregnant or might be pregnant; lactating women for the study duration (3 months)
- Will not be in the NY Metropolitan area for the study duration (3 months) Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (Individuals with diabetes, lactose intolerance, and high blood pressure MAY still participate in the study)
- Has dietary restrictions (i.e. liquid diet)
- Has another family member who has already participated in COMIDA or SANOS
- Has already participated in the study
- Works for or with the Mexican consulate (including employment and/or collaborative or volunteer services)
- For ROADmAP RCT participants only:
- Is pregnant or might be pregnant; lactating women; for the study duration (12 months)
- Self-reported presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with HTN and DM may still participate) that may restrict diet
- Currently has dietary restrictions (i.e. liquid diet)
- Has a household member who has already participated (or agreed to participate)
- Has already participated in the study
- Will not be in the NY Metropolitan area for 6 months from study enrollment
- Is currently taking Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity Saxenda, Victoza, Phentermine (Adipex, Lomaira), Extended-release Phentermine/Topiramate (Qsymia), Extended-release Naltrexone/Bupropion (Contrave), Plenity, Orlistat (Xenical) or Other GLP-1 receptor agonist, or any other drug to treat obesity or there is less than 7 weeks since last dosage.
- Has undergone weight loss/bariatric surgery or is planning to undergo such surgery in the next 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francesca Gany, MD, MS contact
United States1 site, 1 recruiting
- Recruiting
Mexican Consulate's Ventanilla de Salud (VDS)
New York, New York, 10016
Jennifer Leng, MD, MPH, lengj@mskcc.org
About this study
The researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory [SCT]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation.
- Conditions
- Overweight, Overweight and Obesity, Overweight or Obesity, Obesity, Obese
- Being tested
- Counseling, Text Messages, Phone calls, Self-monitoring tools
- Keywords
- Focus Groups, Overweight, Overweight and Obesity, Overweight or Obesity, Obesity, Obese, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
In-person individual diet and physical activity (PA) counseling
Text MessagesBehavioural
Thrice-weekly diet/physical activity(PA) text messages
Phone callsBehavioural
Weekly telephone support
Self-monitoring toolsBehavioural
Self-monitoring tools
| Study group | Role | What they receive |
|---|---|---|
| ROADmAP schema | Experimental | Participants will be randomly assigned to one of eight study groups which will be one or a combination of 4 conditions: (1) in person individualized diet and exercise counseling (2) diet and exercise text messages (3) weekly telephone support and (4) self-monitoring tools for diet and weight. For the first part of the study, Survey, approximately 64 drivers and 36 management staff will take pate in the feedback questionnaire. For the second part of the study, Interview, approximately 8 drivers and 12 management staff may be invited to take part in an interview via phone, in person, or teleconference (Zoom). The audio files will be transcribed and translated by research staff and/or MSK-approved AI transcription tool, Azure Speech in Foundry Tools. Receives: Behavioral: Counseling; Behavioral: Text Messages; Behavioral: Phone calls; Behavioral: Self-monitoring tools |
| Consumo de Opciones Mas Ideales De Alimento (COMIDA) | Other | Participants will be placed in either individual or group interventions by convenience. Recruitment will be consecutive and participants will be placed in either intervention depending on what resource is available on a given day at the VDS, individual counselor or a group educator. Receives: Behavioral: Phone calls |
| SANOS | Other | Conducting SANOS Focus Groups. We will conduct 3-5 focus groups (in Spanish) with 6-10 participants each, until saturation. Bilingual study staff will approach individuals visiting the VDS and VDS Mobile for potential participation. A brief screening questionnaire will be administered, and a BMI assessment conducted, to ascertain eligibility. Focus groups will be scheduled at the VDS Mobile unit at times convenient to participants. Participants will be verbally consented in Spanish, and will be apprised that their participation is purely voluntary and that their names will not be included in the final narrative. The 6-month follow-up and my plate dietary surveys can be done over phone. Study staff will access step counts (or obtain it through phone via the pedometer manual provided to the participant) and upload data onto the REDCap tracking tool. Staff may ask participants to report step counts captured by their personal devices (i.e., phone or smartwatch). Receives: Behavioral: Self-monitoring tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in participant body weight from baseline to 12 months
Efficacy of intervention is achieved when participants have weight loss with a minimum threshold of 5% of overall body weight lost
Intervention components include:
- Initial in-person individual diet and physical activity (PA) counseling
- Thrice-weekly diet/PA text messages
- Weekly telephone support
- Self-monitoring tools.
Measured: 12-months post-intake
Estimate the cost and incremental cost-effectiveness of the obesity intervention components
Costs associated with each component include: 1) In-person counseling: personnel time, participant travel time, text messaging services; 3) Telephone support: personnel time; 4) Self-monitoring tools: food diaries and digital scales.
Measured: Up to 6 months
Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire
The ROADmAP Process Evaluation Questionnaire will be administered to all participants to gather data on implementation potential. Questions are on a Likert scale and will collect intervention delivery facilitators and barriers, intervention sustainability facilitators and barriers post-study completion. Feasibility will be indicated by extreme Likert scores (Strongly Agree, Neutral, Strongly Disagree).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start22 Dec 2022
- Primary completion26 Feb 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,889 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Leng, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770570
- Sponsor's protocol ID
- 15-088A(27)
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taxi ROADmAP (Realizing Optimization Around Diet And Physical Activity)
- ClinicalTrials.gov ID
- NCT05770570
- Acronym / sponsor ID
- 15-088A(27)
- Conditions
- Overweight, Overweight and Obesity, Overweight or Obesity, Obesity, Obese
- Keywords
- Focus Groups, Overweight, Overweight and Obesity, Overweight or Obesity, Obesity, Obese, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,889 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 15 Mar 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 researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory [SCT]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ROADmAP schema | Experimental | Behavioral: Counseling, Behavioral: Text Messages, Behavioral: Phone calls, Behavioral: Self-monitoring toolsParticipants will be randomly assigned to one of eight study groups which will be one or a combination of 4 conditions: (1) in person individualized diet and exercise counseling (2) diet and exercise text messages (3) weekly telephone support and (4) self-monitoring tools for diet and weight. For the first part of the study, Survey, approximately 64 drivers and 36 management staff will take pate in the feedback questionnaire. For the second part of the study, Interview, approximately 8 drivers and 12 management staff may be invited to take part in an interview via phone, in person, or teleconference (Zoom). The audio files will be transcribed and translated by research staff and/or MSK-approved AI transcription tool, Azure Speech in Foundry Tools. |
| Consumo de Opciones Mas Ideales De Alimento (COMIDA) | Other | Behavioral: Phone callsParticipants will be placed in either individual or group interventions by convenience. Recruitment will be consecutive and participants will be placed in either intervention depending on what resource is available on a given day at the VDS, individual counselor or a group educator. |
| SANOS | Other | Behavioral: Self-monitoring toolsConducting SANOS Focus Groups. We will conduct 3-5 focus groups (in Spanish) with 6-10 participants each, until saturation. Bilingual study staff will approach individuals visiting the VDS and VDS Mobile for potential participation. A brief screening questionnaire will be administered, and a BMI assessment conducted, to ascertain eligibility. Focus groups will be scheduled at the VDS Mobile unit at times convenient to participants. Participants will be verbally consented in Spanish, and will be apprised that their participation is purely voluntary and that their names will not be included in the final narrative. The 6-month follow-up and my plate dietary surveys can be done over phone. Study staff will access step counts (or obtain it through phone via the pedometer manual provided to the participant) and upload data onto the REDCap tracking tool. Staff may ask participants to report step counts captured by their personal devices (i.e., phone or smartwatch). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Self-Identifies as Mexican American or Mexican
- Seeking services at the VDS of the Mexican Consulate
- Prefers to speak in Spanish
- All adults at least 18 years of age
- Screens as obese (an adult who has a Body Mass Index (BMI) 30 or higher) or overweight (an adult who has a BMI between 25 - 29.9)
Key exclusion criteria (36 listed)
- Will not be in the NYC area for the study duration (3-4 months) Is pregnant or might be pregnant
- Lactating women
- Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (Individuals with diabetes, lactose intolerance, and high blood pressure MAY still participate in the study)
- Has dietary restrictions (i.e. liquid diet)
- Does not have a phone that accepts text messages or unwilling to accept text messages
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 |
|---|---|---|
| CounselingIn-person individual diet and physical activity (PA) counseling | Behavioural | ROADmAP schema |
| Text MessagesThrice-weekly diet/physical activity(PA) text messages | Behavioural | ROADmAP schema |
| Phone callsWeekly telephone support | Behavioural | Consumo de Opciones Mas Ideales De Alimento (COMIDA), ROADmAP schema |
| Self-monitoring toolsSelf-monitoring tools | Behavioural | ROADmAP schema, SANOS |
Primary outcome
Difference in participant body weight from baseline to 12 months
Time frame: 12-months post-intake
Efficacy of intervention is achieved when participants have weight loss with a minimum threshold of 5% of overall body weight lost Intervention components include: * Initial in-person individual diet and physical activity (PA) counseling * Thrice-weekly diet/PA text messages * Weekly telephone support * Self-monitoring tools.
Estimate the cost and incremental cost-effectiveness of the obesity intervention components
Time frame: Up to 6 months
Costs associated with each component include: 1) In-person counseling: personnel time, participant travel time, text messaging services; 3) Telephone support: personnel time; 4) Self-monitoring tools: food diaries and digital scales.
Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire
Time frame: Up to 12 months
The ROADmAP Process Evaluation Questionnaire will be administered to all participants to gather data on implementation potential. Questions are on a Likert scale and will collect intervention delivery facilitators and barriers, intervention sustainability facilitators and barriers post-study completion. Feasibility will be indicated by extreme Likert scores (Strongly Agree, Neutral, Strongly Disagree).
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 2 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Francesca Gany, MD, MS contact
Jennifer Leng, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counseling, Text Messages and Phone calls in people with Overweight and Overweight and Obesity, run by Memorial Sloan Kettering Cancer Center 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 45 inclusion and 36 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 2 Sep 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.
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 Jennifer Leng, MD,MPH (646-888-8057, lengj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in participant body weight from baseline to 12 months (time frame: 12-months post-intake). The study lists 3 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 2 Sep 2026.