Cardiovascular DiseasesNCT05867433
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
A study testing STHS Intervention in people with Cardiovascular Diseases and Nutrition, run by Texas A&M University at 1 site in United States.
Trial summary
Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Nutrition, Physical Activity
- What is being tested?
- STHS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 15 Apr 2027
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
School Inclusion Criteria:
- > 50 6th and 7th grade students
- > 40% economically disadvantaged students
- > 40% Black and Hispanic students
School Exclusion Criteria:
Student Inclusion Criteria:
- 6th or 7th grade student
- Attend a Title 1 middle school that is participating in the STHS intervention
- Read and understand English
Student Exclusion Criteria:
- Participation in a weight loss program in the past 3 months
- Presence of a condition that prevents participation in physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas A&M AgriLife Dallas Center
Dallas, Texas, 75252
Jacob Szeszulski, PhD, 972-231-5362, jacob.szeszulski@ag.tamu.edu
Alexander MacMillan Uribe, PhD, 972-952-9275, lexi.macmillanuribe@ag.tamu.edu
About this study
Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.
Read the detailed description
The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.
Title 1 middle schools in Texas (n=20) with > 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).
The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.
- Conditions
- Cardiovascular Diseases, Nutrition, Physical Activity
- Being tested
- STHS Intervention, Usual Care
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STHS InterventionBehavioural
STHS program
The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors.
Usual CareBehavioural
No STHS program
The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.
| Study group | Role | What they receive |
|---|---|---|
| STHS Intervention | Experimental | Participants in this group (10 schools) will participate in the STHS program. Receives: Behavioral: STHS Intervention |
| Usual Care | Other | Participants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of metabolic syndrome (MetS)
MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels.
MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors)
Measures to determine MetS risk factors:
- Abdominal obesity: waist circumference >90th percentile for child's sex and age
- High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
- High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
- Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
- High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Change in the number of MetS risk factors
Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors)
Measures to determine MetS risk factors:
- Abdominal obesity: waist circumference >90th percentile for child's sex and age
- High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
- High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
- Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
- High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Positive Youth Development score
Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth.
The five dimensions measured are:
- Competence (sense of proficiency)
- Confidence (self-worth, self-efficacy)
- Character (adherence to societal and cultural rules)
- Connection (bonds with people and institutions)
- Caring (sympathy and empathy towards others)
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary outcomes (22)
Blood pressure level
Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of blood glucose
Glucose will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Waist circumference
Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of HDL cholesterol
HDL-C will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of serum triglycerides
Triglycerides will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Height
Height will be measured using a stadiometer in inches.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Weight
Weight will be measured with a scale in pounds.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Body mass index (BMI)
Weight will be measured with a scale, and height will be measured using a stadiometer. BMI will be calculated as BMI = (weight (lb)/height (inches)2) x 703.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of subdermal carotenoids
The concentration of subdermal carotenoids will assess the changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Accelerometer-derived physical activity estimation
Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.
Measured: Baseline to 9 months
Sedentary time
Sedentary time will be measured using Actigraph accelerometers.
Measured: Baseline to 9 months
Time spent sleeping
Sleep time will be measured using Actigraph accelerometers.
Measured: Baseline to 9 months
Physical fitness capacity estimation
Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.
Measured: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
School physical activity and nutrition environment assessment
The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey.
Measured: Baseline to 9 months
Assessment of perceptions of school environments and school-specific dietary intake patterns
Perceptions related to physical activity and nutrition within the school setting will be measured using the Perceptions of the Environment and Patterns of Diet at School (PEA-PODS) survey.
Measured: Baseline to 9 months
Assessment of perceived sociopolitical control
Perceived sociopolitical control will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' perceived sociopolitical control (i.e., participation in advocacy programs and optimism for change).
Measured: Baseline to 9 months
Assessment of assertiveness
Assertiveness will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' assertiveness (i.e., ability to engage with adults and peers).
Measured: Baseline to 9 months
Assessment of participatory competence and decision-making
Participatory competence and decision-making will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' participatory competence and decision-making (i.e., ability to influence group decision-making).
Measured: Baseline to 9 months
Assessment of advocacy outcome efficacy
Advocacy outcome efficacy will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' advocacy outcome efficacy (i.e., belief in their ability to work with others to improve the school's physical activity and nutrition environment).
Measured: Baseline to 9 months
Peer concentration of subdermal carotenoids
The concentration of subdermal carotenoids will assess peers' engagement in health behaviors changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.
Measured: Baseline to 9 months
Peer Body mass index (BMI)
Peers' engagement in health behaviors will be measured by the change in peers' BMI. Weight will be measured with a scale, and height will be measured using a stadiometer. Calculate BMI with the formula: BMI = (weight (lb)/height (inches)2) x 703.
Measured: Baseline to 9 months
Peer physical fitness capacity estimation
Peers' engagement in health behaviors will be measured by the change in peers' physical fitness. Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start27 Sep 2023
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- School-based cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867433
- Sponsor's protocol ID
- IRB2022-1159D
- Other IDs
- R01MD018214
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seguin-Fowler RA, Graham ML, Eldridge GD, Folta SC, Szeszulski J, MacMillan Uribe AL, Marshall GA, Villarreal DL, Volpe LC, Maddock JE, Nelson ME. Implementation of and Recommendations From the Change Club Civic Engagement Curriculum Targeting Health Behavior Improvement. Am J Health Promot. 2026 Aug 17:8901171261478393. doi: 10.1177/08901171261478393. Online ahead of print.
PubMed 42608888MacMillan Uribe AL, George A, McNeely A, Xin L, Largacha Cevallos E, Rethorst C, Seguin Fowler RA, Szeszulski J. Strong Teens for Healthy Schools: Protocol for evaluating a youth nutrition, physical activity, and civic engagement protocol. Front Public Health. 2025 Sep 17;13:1654678. doi: 10.3389/fpubh.2025.1654678. eCollection 2025.
PubMed 41041380
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
- ClinicalTrials.gov ID
- NCT05867433
- Acronym / sponsor ID
- IRB2022-1159D
- Conditions
- Cardiovascular Diseases, Nutrition, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 22 May 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.
Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.
Detailed description
The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.
Title 1 middle schools in Texas (n=20) with > 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).
The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- School-based cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| STHS Intervention | Experimental | Behavioral: STHS InterventionParticipants in this group (10 schools) will participate in the STHS program. |
| Usual Care | Other | Behavioral: Usual CareParticipants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| STHS InterventionSTHS program The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors. | Behavioural | STHS Intervention |
| Usual CareNo STHS program The usual care group will be offered the same activities as the intervention group after the conclusion of the research study. | Behavioural | Usual Care |
Primary outcome
Presence or absence of metabolic syndrome (MetS)
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels. MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors) Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference >90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Change in the number of MetS risk factors
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors) Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference >90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Positive Youth Development score
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth. The five dimensions measured are: 1. Competence (sense of proficiency) 2. Confidence (self-worth, self-efficacy) 3. Character (adherence to societal and cultural rules) 4. Connection (bonds with people and institutions) 5. Caring (sympathy and empathy towards others)
22 secondary outcomes
Blood pressure level
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of blood glucose
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Waist circumference
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of HDL cholesterol
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of serum triglycerides
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Height
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Weight
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Body mass index (BMI)
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Concentration of subdermal carotenoids
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Accelerometer-derived physical activity estimation
Time frame: Baseline to 9 months
Sedentary time
Time frame: Baseline to 9 months
Time spent sleeping
Time frame: Baseline to 9 months
Physical fitness capacity estimation
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
School physical activity and nutrition environment assessment
Time frame: Baseline to 9 months
Assessment of perceptions of school environments and school-specific dietary intake patterns
Time frame: Baseline to 9 months
Assessment of perceived sociopolitical control
Time frame: Baseline to 9 months
Assessment of assertiveness
Time frame: Baseline to 9 months
Assessment of participatory competence and decision-making
Time frame: Baseline to 9 months
Assessment of advocacy outcome efficacy
Time frame: Baseline to 9 months
Peer concentration of subdermal carotenoids
Time frame: Baseline to 9 months
Peer Body mass index (BMI)
Time frame: Baseline to 9 months
Peer physical fitness capacity estimation
Time frame: Baseline to 9 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 5 Oct 2026.
- Derived from this study: PubMed 42608888Seguin-Fowler RA, Graham ML, Eldridge GD, Folta SC, Szeszulski J, MacMillan Uribe AL, Marshall GA, Villarreal DL, Volpe LC, Maddock JE, Nelson ME. Implementation of and Recommendations From the Change Club Civic Engagement Curriculum Targeting Health Behavior Improvement. Am J Health Promot. 2026 Aug 17:8901171261478393. doi: 10.1177/08901171261478393. Online ahead of print.
- Derived from this study: PubMed 41041380MacMillan Uribe AL, George A, McNeely A, Xin L, Largacha Cevallos E, Rethorst C, Seguin Fowler RA, Szeszulski J. Strong Teens for Healthy Schools: Protocol for evaluating a youth nutrition, physical activity, and civic engagement protocol. Front Public Health. 2025 Sep 17;13:1654678. doi: 10.3389/fpubh.2025.1654678. eCollection 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STHS Intervention in people with Cardiovascular Diseases and Nutrition, run by Texas A&M University 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?
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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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 Jacob S Szeszulski, PhD (972-231-5362, jacob.szeszulski@ag.tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of metabolic syndrome (MetS) (time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention). 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?
On the ClinicalTrials.gov record for NCT05867433, which also lists 2 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 5 Oct 2026.