ObesityWISE HealthNCT06284681
Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults
A study testing Weight-focused health coaching, Weight-neutral health coaching and Intensify lifestyle approach in people with Obesity and Prehypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Prehypertension, Hypertension
- What is being tested?
- Weight-focused health coaching, Weight-neutral health coaching and Intensify lifestyle approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or African American Race
- ≥18 years
- BMI ≥27 kg/m2 plus a diagnostic history of 1 or more of the following:
- Prehypertension or hypertension
- Prediabetes or type 2 diabetes
- Dyslipidemia
Show all 11Show fewer
- Has a primary care provider who is willing to participate in enhanced medical management condition as needed
- Access and ability to use a device with reliable internet connectivity
- Able to converse and read English
- Willingness to enroll in any possible intervention conditions
- Willingness to engage in post-intervention focus group
Who cannot join
- Presence of any condition precluding engagement in the prescribed diet or exercise interventions
- Currently engaged in a structured lifestyle-based or weight loss intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Weight-focused vs. Weight-neutral Adaptive Biobehavioral Strategies for Improving Metabolic Health in Black Adults With Stage 1 Obesity: A Pilot Sequential Multiple Assignment Randomized Trial
The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit).
- Conditions
- Obesity, Prehypertension, Hypertension, PreDiabetes, Type 2 Diabetes, Dyslipidemia
- Being tested
- Weight-focused health coaching, Weight-neutral health coaching, Intensify lifestyle approach, Augment with enhanced medical management
- Medical subject headings
- Obesity, Prehypertension, Hypertension, Prediabetic State, Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-focused health coachingBehavioural
Following the definition of structured lifestyle interventions within the current obesity clinical practice guidelines, the weight-focused health coaching intervention will be delivered as a multi-component behavior change intervention intended to produce clinically-important weight loss through consuming a healthy, energy-restricted diet and increasing physical activity.
Weight-neutral health coachingBehavioural
Dietary and physical activity prescriptions for the weight-neutral health coaching intervention will be similar to the weight-focused intervention except the diet prescription will be designed to fully meet daily estimated energy requirements rather than creating a negative energy balance and producing weight loss. Health coaches will not emphasize changes in body weight as an explicit goal or as a mediator of improved cardiometabolic health. Rather, health coaches will emphasize achieving diet and exercise behavioral goals as a direct means to improving cardiometabolic health independently of changes in body weight.
Intensify lifestyle approachBehavioural
Participants identified as non-responders to initial health coaching interventions may be re-randomized to receive a 4-month membership to the local YMCA and health coaches will assist participants in identifying and enrolling in at least 2 weekly group fitness classes at the YMCA.
Augment with enhanced medical managementOther
Participants identified as non-responders to initial health coaching interventions may be re-randomized to meet with the primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active comparator | Participants will start with weight-focused health coaching for 7 weeks and individuals achieving <3% weight loss will be given a 4-month membership to the YMCA and enrolled in group fitness classes. Receives: Behavioral: Weight-focused health coaching; Behavioral: Intensify lifestyle approach |
| Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active comparator | Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving <150 minutes of moderate physical activity will be given a 4-month membership to the YMCA and enrolled in group fitness classes. Receives: Behavioral: Weight-neutral health coaching; Behavioral: Intensify lifestyle approach |
| Weight-Focused Health Coaching with Enhanced Medical Management | Active comparator | Participants will start with weight-focused health coaching for 7 weeks and individuals achieving <3% weight loss will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions. Receives: Behavioral: Weight-focused health coaching; Other: Augment with enhanced medical management |
| Weight-Neutral Health Coaching with Enhanced Medical Management | Active comparator | Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving <150 minutes of moderate physical activity will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions. Receives: Behavioral: Weight-neutral health coaching; Other: Augment with enhanced medical management |
| Weight-Focused Health Coaching Only | Active comparator | This arm includes participants who responded to Weight-Focused Health Coaching in stage 1. Receives: Behavioral: Weight-focused health coaching |
| Weight-Neutral Health Coaching Only | Active comparator | This arm includes participants who responded to Weight-Neutral Health Coaching in stage 1. Receives: Behavioral: Weight-neutral health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Time required to meet recruitment goal
Measured: baseline
Retention rate
Number and proportion of participants completing the study
Measured: week 26
Response/Non-response rate to initial interventions
The proportion of participants meeting pre-specified response criteria initial interventions
Measured: week 8
Attendance to health coaching sessions
Number and proportion of health coaching sessions attended attendance
Measured: week 26
Treatment Credibility and Expectancy Questionnaire (CEQ)
The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.
Measured: baseline
Treatment Credibility and Expectancy Questionnaire (CEQ)
The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.
Measured: week 8
Treatment Preference
Measures the participant's preference for different treatments used in the study.
Measured: baseline
Treatment Preference
Measures the participant's preference for different treatments used in the study.
Measured: week 8
Family medicine clinic capacity for research
Measurement of family medicine clinic capacity for research
Measured: week 26
Study visit duration
Measurement of study visit duration
Measured: week 26
Time required for surveys completion
Measurement of time required for participants to complete the survey packet completion
Measured: week 26
Response to weight-focused health coaching
Weight loss measured using family medicine clinic. scale. Greater than or equal to 3 percent weight loss is the threshold for "response" for the weight focused condition.
Measured: Week 8
Response to weight-neutral health coaching measurement
Physical activity measured accelerometry (activPAL4). Greater than or equal to 150 weekly minutes of physical activity is the threshold for response for the weight-neutral condition.
Measured: Week 8
Secondary outcomes (10)
Change in blood pressure
Measured by mercury sphygmomanometer
Measured: Week 26
Change in glucose
Fasting blood draw
Measured: Week 26
Change in insulin
Fasting blood draw
Measured: Week 26
Change in insulin sensitivity
Measured by the quantitative insulin sensitivity check index (QUICKI). QUICKI is derived from measures of fasting insulin and fasting glucose, and a QUICKI score below 0.357 indicates low insulin sensitivity.
Measured: Week 26
Change in HbA1c
Fasting blood draw
Measured: Week 26
Change in total cholesterol
Fasting blood draw
Measured: Week 26
Change in LDL-cholesterol
Fasting blood draw
Measured: Week 26
Change in HDL-cholesterol
Fasting blood draw
Measured: Week 26
Change in triglycerides
Fasting blood draw
Measured: Week 26
Change in Metabolic Syndrome Severity Score
Metabolic Syndrome Severity Scores below zero indicate a lower degree of metabolic syndrome compared to the average adult, scores near zero indicate an average degree of metabolic syndrome, and scores above zero indicate an above average degree of metabolic syndrome and future disease risk.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Oct 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Drew Sayer, University of Alabama at Birmingham
- Investigators
- Drew Sayer, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284681
- Sponsor's protocol ID
- IRB-300012557
- Other IDs
- 3P50MD017338-03S1
- Acronym
- WISE Health
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded and cleaned scientific data - with all participant identifiers removed - from all time points and supporting information will be preserved and shared from resulting publication(s) to allow for validation and replication of the study. All participant identifying information (e.g., names, addresses, contact information) will be saved in a separate and secure file for future contact purposes via IRB-approved study personnel and protocols only. Study-related data will be available via PubMed Central following publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-focused vs. Weight-neutral Adaptive Biobehavioral Strategies for Improving Metabolic Health in Black Adults With Stage 1 Obesity: A Pilot Sequential Multiple Assignment Randomized Trial
- ClinicalTrials.gov ID
- NCT06284681
- Acronym / sponsor ID
- WISE Health / IRB-300012557
- Conditions
- Obesity, Prehypertension, Hypertension, PreDiabetes, Type 2 Diabetes, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 29 Feb 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.
The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active comparator | Behavioral: Weight-focused health coaching, Behavioral: Intensify lifestyle approachParticipants will start with weight-focused health coaching for 7 weeks and individuals achieving <3% weight loss will be given a 4-month membership to the YMCA and enrolled in group fitness classes. |
| Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders | Active comparator | Behavioral: Weight-neutral health coaching, Behavioral: Intensify lifestyle approachParticipants will start with weight-neutral health coaching for 7 weeks and individuals achieving <150 minutes of moderate physical activity will be given a 4-month membership to the YMCA and enrolled in group fitness classes. |
| Weight-Focused Health Coaching with Enhanced Medical Management | Active comparator | Behavioral: Weight-focused health coaching, Other: Augment with enhanced medical managementParticipants will start with weight-focused health coaching for 7 weeks and individuals achieving <3% weight loss will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions. |
| Weight-Neutral Health Coaching with Enhanced Medical Management | Active comparator | Behavioral: Weight-neutral health coaching, Other: Augment with enhanced medical managementParticipants will start with weight-neutral health coaching for 7 weeks and individuals achieving <150 minutes of moderate physical activity will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions. |
| Weight-Focused Health Coaching Only | Active comparator | Behavioral: Weight-focused health coachingThis arm includes participants who responded to Weight-Focused Health Coaching in stage 1. |
| Weight-Neutral Health Coaching Only | Active comparator | Behavioral: Weight-neutral health coachingThis arm includes participants who responded to Weight-Neutral Health Coaching in stage 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Black or African American Race
- ≥18 years
- BMI ≥27 kg/m2 plus a diagnostic history of 1 or more of the following:
- Has a primary care provider who is willing to participate in enhanced medical management condition as needed
- Access and ability to use a device with reliable internet connectivity
Key exclusion criteria (2 listed)
- Presence of any condition precluding engagement in the prescribed diet or exercise interventions
- Currently engaged in a structured lifestyle-based or weight loss intervention
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 |
|---|---|---|
| Weight-focused health coachingFollowing the definition of structured lifestyle interventions within the current obesity clinical practice guidelines, the weight-focused health coaching intervention will be delivered as a multi-component behavior change intervention intended to produce clinically-important weight loss through consuming a healthy, energy-restricted diet and increasing physical activity. | Behavioural | Weight-Focused Health Coaching Only, Weight-Focused Health Coaching with Enhanced Medical Management, Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders |
| Weight-neutral health coachingDietary and physical activity prescriptions for the weight-neutral health coaching intervention will be similar to the weight-focused intervention except the diet prescription will be designed to fully meet daily estimated energy requirements rather than creating a negative energy balance and producing weight loss. Health coaches will not emphasize changes in body weight as an explicit goal or as a mediator of improved cardiometabolic health. Rather, health coaches will emphasize achieving diet and exercise behavioral goals as a direct means to improving cardiometabolic health independently of changes in body weight. | Behavioural | Weight-Neutral Health Coaching Only, Weight-Neutral Health Coaching with Enhanced Medical Management, Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders |
| Intensify lifestyle approachParticipants identified as non-responders to initial health coaching interventions may be re-randomized to receive a 4-month membership to the local YMCA and health coaches will assist participants in identifying and enrolling in at least 2 weekly group fitness classes at the YMCA. | Behavioural | Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders, Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders |
| Augment with enhanced medical managementParticipants identified as non-responders to initial health coaching interventions may be re-randomized to meet with the primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions. | Other | Weight-Focused Health Coaching with Enhanced Medical Management, Weight-Neutral Health Coaching with Enhanced Medical Management |
Primary outcome
Recruitment rate
Time frame: baseline
Time required to meet recruitment goal
Retention rate
Time frame: week 26
Number and proportion of participants completing the study
Response/Non-response rate to initial interventions
Time frame: week 8
The proportion of participants meeting pre-specified response criteria initial interventions
Attendance to health coaching sessions
Time frame: week 26
Number and proportion of health coaching sessions attended attendance
Treatment Credibility and Expectancy Questionnaire (CEQ)
Time frame: baseline
The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.
Treatment Credibility and Expectancy Questionnaire (CEQ)
Time frame: week 8
The CEQ measures how much the participant believes in the rationale for the study treatments and how much they expect the treatments to improve their health.
Treatment Preference
Time frame: baseline
Measures the participant's preference for different treatments used in the study.
Treatment Preference
Time frame: week 8
Measures the participant's preference for different treatments used in the study.
Family medicine clinic capacity for research
Time frame: week 26
Measurement of family medicine clinic capacity for research
Study visit duration
Time frame: week 26
Measurement of study visit duration
Time required for surveys completion
Time frame: week 26
Measurement of time required for participants to complete the survey packet completion
Response to weight-focused health coaching
Time frame: Week 8
Weight loss measured using family medicine clinic. scale. Greater than or equal to 3 percent weight loss is the threshold for "response" for the weight focused condition.
Response to weight-neutral health coaching measurement
Time frame: Week 8
Physical activity measured accelerometry (activPAL4). Greater than or equal to 150 weekly minutes of physical activity is the threshold for response for the weight-neutral condition.
10 secondary outcomes
Change in blood pressure
Time frame: Week 26
Change in glucose
Time frame: Week 26
Change in insulin
Time frame: Week 26
Change in insulin sensitivity
Time frame: Week 26
Change in HbA1c
Time frame: Week 26
Change in total cholesterol
Time frame: Week 26
Change in LDL-cholesterol
Time frame: Week 26
Change in HDL-cholesterol
Time frame: Week 26
Change in triglycerides
Time frame: Week 26
Change in Metabolic Syndrome Severity Score
Time frame: Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Coded and cleaned scientific data - with all participant identifiers removed - from all time points and supporting information will be preserved and shared from resulting publication(s) to allow for validation and replication of the study. All participant identifying information (e.g., names, addresses, contact information) will be saved in a separate and secure file for future contact purposes via IRB-approved study personnel and protocols only. Study-related data will be available via PubMed Central following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drew Sayer, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-focused health coaching, Weight-neutral health coaching and Intensify lifestyle approach in people with Obesity and Prehypertension, run by University of Alabama at Birmingham 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 11 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: baseline). The study lists 13 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 27 Feb 2026.