Type 2 DiabetesNCT06526273
PILI 'Āina Household
A study testing PILI 'Āina in people with Type 2 Diabetes and Hypertension, run by University of Hawaii at 2 sites in United States.
Trial summary
Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Dyslipidemias
- What is being tested?
- PILI 'Āina
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2025to 26 Feb 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ (looking for older adults)
- Native Hawaiian resident in a participating homestead
- Overweight or obese (BMI ≥ 25 kg/m^2)
- Prior diagnosis of T2D or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
- Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
- Willing and able to participate in all aspects of the individual and household-level intervention
- Fluent in written and spoken English
Who cannot join
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
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, 2 recruiting
- Recruiting
Kula no nā Po'e Hawai'i
Honolulu, Hawaii, 96813
Adrienne Y Dillard, PhD, (808) 520-8997, kula.papakolea@gmail.com
- Recruiting
Kapolei Community Development Corporation
Kapolei, Hawaii, 96707
Chantal Keli'iho'omalu, (808) 628-4626, info@kapoleiheritage.org
About this study
Official title: The PILI 'Āina Project
Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.
Read the detailed description
The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.
- Conditions
- Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity
- Being tested
- PILI 'Āina, Control
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILI 'ĀinaBehavioural
Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker. At 3 months, participants randomized to the PILI 'Āina intervention will receive a 6-month intervention centered around the use of a raised-bed home garden as the means of engaging household members to 1) increase their access to and intake of vegetables, 2) learn culturally relevant ways of preparing/cooking fresh vegetables through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. Participants will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. They will receive seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks).
ControlOther
Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker based on previously tested materials and protocols. At 3 months, participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers' markets, cultural events, and physical activity events.
| Study group | Role | What they receive |
|---|---|---|
| PILI 'Āina | Experimental | Participants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. At 3 months, participants randomized to the PILI 'Āina intervention will receive a 6-month intervention centered around the use of a raised-bed home garden as the means of engaging household members to 1) increase their access to and intake of vegetables, 2) learn culturally relevant ways of preparing/cooking fresh vegetables through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. The participating households will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. The investigators will provide seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). All lessons will be delivered by a trained community health worker . Receives: Behavioral: PILI 'Āina |
| Control | Active comparator | Participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers markets, cultural events, and physical activity events. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality
To measure diet quality, research staff will collect participants' 24-hour dietary recall by using the Modified 3-Pass Method. They will record diet information, and analysis will be performed by the Pacific Tracker (PacTrac) Program, 4th edition, developed at the University of Hawaii Cancer Center to analyze diets common in Hawai'i. It generates a "healthy eating index" (from 0 = least healthy to 100 = healthiest) shown to have good validity and reliability. Continuous values of the overall score will constitute our primary outcome, but the investigators will also evaluate scores for subscales (diet adequacy, moderation). The investigators will also assess diet quality and patterns by comparing servings consumed for each food group (vegetables, fruits, grains, dairy, and protein) to the United States Department of Agriculture (USDA) dietary guidelines.
Measured: Baseline, 3 month, 9 month, 12 month
Weight
The investigators will measure weight (with clothing but without shoes) to the nearest 0.1 kilograms on an electric digital scale (Tanita model BSB800AS, Tokyo, Japan). Scales will be calibrated monthly.
Measured: Baseline, 3 month, 9 month, 12 month
Height
The investigators will use a portable stadiometer (SECA Road Rod) to record the average of 2 measurements of height to the nearest 0.1 cm. Scales will be calibrated monthly.
Measured: Baseline, 3 month, 9 month, 12 month
Blood pressure
Blood pressure will be collected with a mercury sphygmomanometer or with a portable automatic blood pressure device (Omron©HEM-907XL, Omron Healthcare) previously used with Native Hawaiians (NHs) to capture changes in blood pressure over time reliably. For both methods, study staff will be trained and certified with standard protocols that involve taking 3 measurements and using the last 2 to obtain each participant's average systolic and diastolic blood pressure (mm Hg). Systolic and diastolic blood pressure will be measured as continuous mm Hg and binary hypertension indicators (≥ 130 systolic or ≥ 80 mm Hg diastolic).
Measured: Baseline, 3 month, 9 month, 12 month
hemoglobin A1c
Hemoglobin A1c will be measured by DCA Vantage portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. A1c values will be recorded both as a continuous value (%) to the tenths digit and as a binary indicator of A1c < 8%.
Measured: Baseline, 3 month, 9 month, 12 month
Lipids
Lipids will be measured by Alere Cholestech LDX portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. Lipids (Low-Density Lipoproteins [LDL] and High-Density Lipoproteins [HDL]) will be measured as continuous mg/dL and as binary indicators of healthy cholesterol levels (LDL ≤ 130; HDL ≥ 40).
Measured: Baseline, 3 month, 9 month, 12 month
Secondary outcomes (8)
Food Insecurity
Food insecurity will be measured by the 10-item Household Food Security Survey Module, which captures the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members, and generates a binary indicator of food insecurity at the household level. The responses and scores range from 1-often true, 2-sometimes true, 3-never true. Higher scores indicate low food insecurity.
Measured: Baseline, 3 month, 9 month, 12 month
Food literacy
Food literacy, defined as the ability to make healthy food choices in different settings and situations, will be assessed by the 11-item self-perceived food literacy scale, which encompasses knowledge, skills, and behaviors pertinent to planning, selecting, preparing, and eating healthy food. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4- slightly agree, 5-yes/always. Higher scores indicate greater food literacy.
Measured: Baseline, 3 month, 9 month, 12 month
Nutrition Environment
The perceived 9-item nutrition environment will be measured by the Gustafson Perceived Nutrition Environment Measures questionnaire, which examines perceived access and availability of healthy foods within ~1 mile of the participant's home, and the availability and affordability of produce in the participant's primary food store. The responses and scores vary depending on the question including 0- disagree, 1-agree, and 0-not important, 1-slightly important, 2-moderately important, 3- important, 4-very important. Higher scores indicate higher perceived access and availability of food.
Measured: Baseline, 3 month, 9 month, 12 month
Household food patterns
Household food patterns will be measured by 4 questions that assess the frequency of meal planning, eating meals with household members, bringing prepared restaurant foods home, and preparing meals with household members. The responses and scores range from 1- 1 day, 2- 2-3 days, 3- 4-5 days, 4- 6 days, 5- 7 days. Higher scores indicate greater household food patterns.
Measured: Baseline, 3 month, 9 month, 12 month
Social support
Social support for a healthy diet will be measured as the perceived support that people who make dietary changes receive from family and friends. An 11-item questionnaire on social support will be used to ask participants' perceived level of support from friends and family regarding diet choices. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater social support.
Measured: Baseline, 3 month, 9 month, 12 month
Medications
Name and dosage for prescription medications for type 2 diabetes, hypertension, dyslipidemia, or cardiovascular disease will be recorded from containers brought to data collection visits.
Measured: Baseline, 3 month, 9 month, 12 month
Physical Activity
The 3-item Physical Activity Questionnaire, which has been used with Native Hawaiians, will assess exercise frequency during the past month. It contains 3 items that assess moderate and vigorous exercise and changes in activity levels. The responses and scores vary depending on the question, including 0- rarely or never, 1- 2-3 times over the month, 2- about once a week, 3- 2-4 times a week, 4- more than 4 times a week. Higher scores indicate greater physical activity.
Measured: Baseline, 3 month, 9 month, 12 month
Diet self-efficacy
The 11-item Diet Self Efficacy Scale will measure self-efficacy in avoiding tempting high caloric food and managing social and internal cues and negative emotions. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater self-efficacy with diet.
Measured: Baseline, 3 month, 9 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start12 Feb 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion26 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Claire Ing, DrPH, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526273
- Sponsor's protocol ID
- PILI 'Āina 2
- Other IDs
- R01HL168858
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2024
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PILI 'Āina Project
- ClinicalTrials.gov ID
- NCT06526273
- Acronym / sponsor ID
- PILI 'Āina 2
- Conditions
- Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 26 Feb 2029 (estimated)
- First posted
- 29 Jul 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.
Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.
Detailed description
The investigators will conduct a group-randomized controlled trial to test the effectiveness of PILI Aina for improving diet and health at the individual and household levels compared to a Diabetes Prevention Program Lifestyle Intervention only group. The investigators will enroll 180 Native Hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (Type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). These index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month PILI Aina intervention or to a control group. Data collection will occur at baseline and 3, 9, and 12 months. Other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PILI 'Āina | Experimental | Behavioral: PILI 'ĀinaParticipants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. At 3 months, participants randomized to the PILI 'Āina intervention will receive a 6-month intervention centered around the use of a raised-bed home garden as the means of engaging household members to 1) increase their access to and intake of vegetables, 2) learn culturally relevant ways of preparing/cooking fresh vegetables through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. The participating households will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. The investigators will provide seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). All lessons will be delivered by a trained community health worker . |
| Control | Active comparator | Other: ControlParticipants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers markets, cultural events, and physical activity events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18+ (looking for older adults)
- Native Hawaiian resident in a participating homestead
- Overweight or obese (BMI ≥ 25 kg/m^2)
- Prior diagnosis of T2D or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
- Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
Key exclusion criteria (3 listed)
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
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 |
|---|---|---|
| PILI 'ĀinaParticipants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker. At 3 months, participants randomized to the PILI 'Āina intervention will receive a 6-month intervention centered around the use of a raised-bed home garden as the means of engaging household members to 1) increase their access to and intake of vegetables, 2) learn culturally relevant ways of preparing/cooking fresh vegetables through hands-on cooking lessons with local experts, and 3) build family cohesion through family bonding activities. Participants will be given all the equipment and materials (e.g., soil, seeds, instructions, setup of equipment) needed to grow their vegetables using their raised-bed home garden box throughout the entire study. They will receive seeds for the vegetables that can grow in a relatively short period (i.e., within 6 weeks). | Behavioural | PILI 'Āina |
| ControlParticipants will receive the 3-month adapted Diabetes Prevention Program's Lifestyle Intervention. These lessons will be delivered by a trained community health worker based on previously tested materials and protocols. At 3 months, participants randomized to the control group will receive monthly untailored health education information and links to community resources from the community health worker via United States Postal Service or electronic messaging. Examples include information on food assistance programs, farmers' markets, cultural events, and physical activity events. | Other | Control |
Primary outcome
Diet Quality
Time frame: Baseline, 3 month, 9 month, 12 month
To measure diet quality, research staff will collect participants' 24-hour dietary recall by using the Modified 3-Pass Method. They will record diet information, and analysis will be performed by the Pacific Tracker (PacTrac) Program, 4th edition, developed at the University of Hawaii Cancer Center to analyze diets common in Hawai'i. It generates a "healthy eating index" (from 0 = least healthy to 100 = healthiest) shown to have good validity and reliability. Continuous values of the overall score will constitute our primary outcome, but the investigators will also evaluate scores for subscales (diet adequacy, moderation). The investigators will also assess diet quality and patterns by comparing servings consumed for each food group (vegetables, fruits, grains, dairy, and protein) to the United States Department of Agriculture (USDA) dietary guidelines.
Weight
Time frame: Baseline, 3 month, 9 month, 12 month
The investigators will measure weight (with clothing but without shoes) to the nearest 0.1 kilograms on an electric digital scale (Tanita model BSB800AS, Tokyo, Japan). Scales will be calibrated monthly.
Height
Time frame: Baseline, 3 month, 9 month, 12 month
The investigators will use a portable stadiometer (SECA Road Rod) to record the average of 2 measurements of height to the nearest 0.1 cm. Scales will be calibrated monthly.
Blood pressure
Time frame: Baseline, 3 month, 9 month, 12 month
Blood pressure will be collected with a mercury sphygmomanometer or with a portable automatic blood pressure device (Omron©HEM-907XL, Omron Healthcare) previously used with Native Hawaiians (NHs) to capture changes in blood pressure over time reliably. For both methods, study staff will be trained and certified with standard protocols that involve taking 3 measurements and using the last 2 to obtain each participant's average systolic and diastolic blood pressure (mm Hg). Systolic and diastolic blood pressure will be measured as continuous mm Hg and binary hypertension indicators (≥ 130 systolic or ≥ 80 mm Hg diastolic).
hemoglobin A1c
Time frame: Baseline, 3 month, 9 month, 12 month
Hemoglobin A1c will be measured by DCA Vantage portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. A1c values will be recorded both as a continuous value (%) to the tenths digit and as a binary indicator of A1c < 8%.
Lipids
Time frame: Baseline, 3 month, 9 month, 12 month
Lipids will be measured by Alere Cholestech LDX portable analyzers, using blood samples by fingerstick. Results are available in 5 minutes and will be returned to participants. Lipids (Low-Density Lipoproteins [LDL] and High-Density Lipoproteins [HDL]) will be measured as continuous mg/dL and as binary indicators of healthy cholesterol levels (LDL ≤ 130; HDL ≥ 40).
8 secondary outcomes
Food Insecurity
Time frame: Baseline, 3 month, 9 month, 12 month
Food literacy
Time frame: Baseline, 3 month, 9 month, 12 month
Nutrition Environment
Time frame: Baseline, 3 month, 9 month, 12 month
Household food patterns
Time frame: Baseline, 3 month, 9 month, 12 month
Social support
Time frame: Baseline, 3 month, 9 month, 12 month
Medications
Time frame: Baseline, 3 month, 9 month, 12 month
Physical Activity
Time frame: Baseline, 3 month, 9 month, 12 month
Diet self-efficacy
Time frame: Baseline, 3 month, 9 month, 12 month
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 4 Mar 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.
Claire Ing, DrPH principal investigator
University of Hawaii
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILI 'Āina in people with Type 2 Diabetes and Hypertension, run by University of Hawaii 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 7 inclusion and 3 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 4 Mar 2026. 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.
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 Claire Ing, DrPH (808-692-1042, clairemt@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality (time frame: Baseline, 3 month, 9 month, 12 month). The study lists 6 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 4 Mar 2026.