Cardiovascular Risk FactorNCT04621045
Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease
A study testing The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet in people with Cardiovascular Risk Factor and Prediabetes, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Prediabetes, Overweight and Obesity
- What is being tested?
- The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2020to 12 Mar 2022
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-70 years old
- BMI≥25
- Have regular access to the internet (via computer or smart phone)
- Less than 90 mins of self-reported moderate to vigorous physical activity per week
- American Diabetes Association (ADA) risk ≥5
- Available for pre and post-intervention assessments.
Who cannot join
- Unstable conditions that may require supervised PA
- Physical limitations that may prohibit engagement in MVPA
- Pregnancy or intention to become pregnant during study, history of CVD
- Current participation in a PA study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primay Health Network
Beaver Falls, Pennsylvania, 15010
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Feasibility and Preliminary Efficacy of a Novel YouTube Based Physical Activity Intervention in Overweight and Obese Adults at High Risk of Type 2 Diabetes
Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental barriers to physical activity (PA) such as body image concerns and limited access to fitness facilities contribute to the low levels of PA observed in overweight/obese adults. Web-based PA programs have been developed to address these barriers, but the outcomes have been marginal. Qualitative studies suggest that individuals who are overweight/obese prefer PA programs that feature people they can relate to especially in body size, fitness status and age. Previously, the investigators have included these preferences in a technology-based Physical Activity for The Heart (PATH) intervention that leverages open source platforms, such as YouTube, to promote PA in any setting. In this application, the investigators propose to test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiometabolic risk in adults who are overweight/obese and at high risk of diabetes. In Aim 1 the investigators will conduct a 12-week randomized clinical trial including 52 adults who are overweight/obese and at high risk of diabetes to assess the feasibility and acceptability of PATH. In Aim 2 investigators will examine the trend in PA and cardiometabolic risk change from baseline to post-intervention. This approach is innovative because it leverages open source technologies to provide low-cost, action-oriented PA resources that match the preferences of adults who are overweight/obese. This contribution will be significant because PATH could offer a convenient, enjoyable and scalable program that features "similar others" to promote PA in overweight/obese adults at high risk of diabetes.
Read the detailed description
Currently, only 20% of American adults attain the minimum 150 mins/week of MVPA recommended by the 2018 PA Guidelines for Americans. The low levels of PA are associated with the rising prevalence of obesity and T2D. Individuals who are overweight/obese need a higher volume of PA (~200-300 mins of weekly MVPA) to mitigate cardiometabolic risk, but they face complex multifaceted barriers that decrease their engagement in PA. Multiple studies exploring barriers and facilitators of PA among these individuals have emphasized the need for interventions that address weight-related impediments (e.g., stigma, fitness) and environmental barriers such as limited access to fitness facilities. In the last 2 decades web-based PA programs have been developed to address these barriers and to provide more interactive resources than those typically mailed to participants in home-based programs. In a recent analytic review of web-based PA interventions, 44 out of 72 studies reported significant increases in PA. However, 10 out of 13 studies focusing on adults who are overweight/obese reported no significant improvements in PA. Most of these studies employed interventions that are typically used in the general population (e.g., learning modules, email feedback, chat sessions) without adapting them to address barriers that are unique to individuals who are overweight/obese. Formative studies and social cognitive theory supports the need for PA interventions that feature individuals who are overweight/obese engaging in PA to motivate action and demonstrate success. In recent years, Internet ubiquity and creation of YouTube has enabled fitness experts across the globe to develop and share a wide variety of high quality workout videos designed to make PA convenient and enjoyable for all demographics. The investigators leveraged these resources and the aforementioned preference data to design an action-oriented PATH program tailored for individuals who are overweight/obese. The workout videos curated on PATH website were vetted by the study team and stakeholders. The investigators contribution in this project is expected to be a detailed understanding of how open sourced resources in interventions like PATH are received and utilized by overweight/obese adults.
- Being tested
- The Physical Activity for The Heart (PATH) intervention, Be Active Your Way Booklet
- Keywords
- Physical activity, Web-based, YouTube
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Physical Activity for The Heart (PATH) interventionBehavioural
The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.
Be Active Your Way BookletBehavioural
Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
| Study group | Role | What they receive |
|---|---|---|
| PATH Treatment Group | Experimental | The PATH group will be granted password protected access to one of the 3 PATH levels based on their baseline fitness status. The intervention is designed to help participants increase their baseline PA via health coaching, self-monitoring and pragmatic workout videos that provide convenient options for overcoming socio-environmental barriers to PA. Receives: Behavioral: The Physical Activity for The Heart (PATH) intervention |
| Wait-list control group | Active comparator | Participants in this group will not have access to the PATH intervention until after 12 weeks when they cross over. After randomization, the control group will be provided with a copy of the Be Active Your Way booklet, developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. Receives: Behavioral: Be Active Your Way Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Will be indicated by ability to recruit, screen, and enroll the target sample within 6 months of commencing recruitment, and retention of ≥80% of the sample.
Measured: At the end of study approximately 48 weeks after commencement of the study
Feasibility of self-monitoring step count using wrist worn ActiGraph GT9X
will be indicated by the proportion of the sample with ≥4days per week of valid Actigraph wear time (≥10hrs) during the entire course of the study.
Measured: At the end of study approximately 52 weeks after commencement of the study
Acceptability of PATH intervention
Will be indicated by utilization data that will be collected via Web analytics, and a post-intervention survey will assess the intervention acceptability.
Measured: At the end of study approximately 52 weeks after commencement of the study
Secondary outcomes (11)
Change from baseline in body mass index (BMI) at 12 weeks
BMI will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their BMI and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change from baseline in body fat percentage at 12 weeks
Body fat percentage will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their body fat and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change from baseline in waist circumference at 12 weeks
Waist circumference will be measured using Perfect waist tape measure provided to the participant by the study team. The study team will guide the participants on how to take the measurement using a standard video and will be able to observe the outcome of the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change from baseline in blood pressure (BP) at 12 weeks
Both diastolic and systolic BP will be reported. The measurement will be done using automated OMRON BP machine provided to the participant by the study team. The study team will guide the participants on how to take blood pressure and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change from baseline in glycated hemoglobin (HbA1C) at 12 weeks
The sample for HbA1C will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols
Measured: Post-intervention at 12 weeks
Change from baseline in lipids at 12 weeks
The blood sample for lipids (LDL, HDL, and total cholesterol) will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols.
Measured: Post-intervention at 12 weeks
Change from baseline in the risk score for diabetes at 12 weeks
The risk score for diabetes will be measured via the American Diabetes Association (ADA) Risk Calculator. The scores range from 0 to 10 with higher scores indicating high risk for developing type 2 diabetes.
Measured: Post-intervention at 12 weeks
Change from baseline in step count at 12 weeks
Step count will be measured using a wrist worn ActiGraph GT9X link (about half the participants used Fitbit charge 2 due to device defects that we detected with Actigraph GT9X) during the entire study period. The study outcomes will focus on change from baseline to 12 weeks.
Measured: Post-intervention at 12 weeks
Change from baseline in light physical activity at 12 weeks
Light physical activity will be measured using a waist worn ActiGraph GT3X accelerometer.
Measured: Post-intervention at 12 weeks
Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks
MVPA will be measured using a waist worn ActiGraph GT3X accelerometer.
Measured: Post-intervention at 12 weeks
Change from baseline in Barriers Exercise Self-efficacy (BARSE) scale at 12 weeks
Participants will be asked to respond to the BARSE scale appraising their exercise self-efficacy. The scale range from 0 to 100, with higher scores indicating increased exercise self-efficacy.
Measured: Post-intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start27 Oct 2020
- Primary completion12 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize 52 participants to either the PATH treatment group or wait-list control group.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Kariuki, University of Pittsburgh
- Investigators
- Jacob Kariuki, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621045
- Sponsor's protocol ID
- STUDY19090134
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: t is our goal to make all data generated from this proposal available to other investigators without compromising the confidentiality of participants. Investigators who would like to do a secondary analysis of de-identified data can submit a formal request for the data including the proposal of their intended analysis to the PI at activeu@pitt.edu. The PI will review all requests and facilitate data access once approval is granted.
Publications
Kariuki JK, Sereika S, Erickson K, Burke LE, Kriska A, Cheng J, Milton H, Hirshfield S, Ogutu D, Gibbs B. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107318. doi: 10.1016/j.cct.2023.107318. Epub 2023 Aug 23.
PubMed 37625586
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Novel YouTube Based Physical Activity Intervention in Overweight and Obese Adults at High Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04621045
- Acronym / sponsor ID
- STUDY19090134
- Keywords
- Physical activity, Web-based, YouTube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 9 Nov 2020 (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.
Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental barriers to physical activity (PA) such as body image concerns and limited access to fitness facilities contribute to the low levels of PA observed in overweight/obese adults. Web-based PA programs have been developed to address these barriers, but the outcomes have been marginal. Qualitative studies suggest that individuals who are overweight/obese prefer PA programs that feature people they can relate to especially in body size, fitness status and age. Previously, the investigators have included these preferences in a technology-based Physical Activity for The Heart (PATH) intervention that leverages open source platforms, such as YouTube, to promote PA in any setting. In this application, the investigators propose to test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiometabolic risk in adults who are overweight/obese and at high risk of diabetes. In Aim 1 the investigators will conduct a 12-week randomized clinical trial including 52 adults who are overweight/obese and at high risk of diabetes to assess the feasibility and acceptability of PATH. In Aim 2 investigators will examine the trend in PA and cardiometabolic risk change from baseline to post-intervention. This approach is innovative because it leverages open source technologies to provide low-cost, action-oriented PA resources that match the preferences of adults who are overweight/obese. This contribution will be significant because PATH could offer a convenient, enjoyable and scalable program that features "similar others" to promote PA in overweight/obese adults at high risk of diabetes.
Detailed description
Currently, only 20% of American adults attain the minimum 150 mins/week of MVPA recommended by the 2018 PA Guidelines for Americans. The low levels of PA are associated with the rising prevalence of obesity and T2D. Individuals who are overweight/obese need a higher volume of PA (~200-300 mins of weekly MVPA) to mitigate cardiometabolic risk, but they face complex multifaceted barriers that decrease their engagement in PA. Multiple studies exploring barriers and facilitators of PA among these individuals have emphasized the need for interventions that address weight-related impediments (e.g., stigma, fitness) and environmental barriers such as limited access to fitness facilities. In the last 2 decades web-based PA programs have been developed to address these barriers and to provide more interactive resources than those typically mailed to participants in home-based programs. In a recent analytic review of web-based PA interventions, 44 out of 72 studies reported significant increases in PA. However, 10 out of 13 studies focusing on adults who are overweight/obese reported no significant improvements in PA. Most of these studies employed interventions that are typically used in the general population (e.g., learning modules, email feedback, chat sessions) without adapting them to address barriers that are unique to individuals who are overweight/obese. Formative studies and social cognitive theory supports the need for PA interventions that feature individuals who are overweight/obese engaging in PA to motivate action and demonstrate success. In recent years, Internet ubiquity and creation of YouTube has enabled fitness experts across the globe to develop and share a wide variety of high quality workout videos designed to make PA convenient and enjoyable for all demographics. The investigators leveraged these resources and the aforementioned preference data to design an action-oriented PATH program tailored for individuals who are overweight/obese. The workout videos curated on PATH website were vetted by the study team and stakeholders. The investigators contribution in this project is expected to be a detailed understanding of how open sourced resources in interventions like PATH are received and utilized by overweight/obese adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will randomize 52 participants to either the PATH treatment group or wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| PATH Treatment Group | Experimental | Behavioral: The Physical Activity for The Heart (PATH) interventionThe PATH group will be granted password protected access to one of the 3 PATH levels based on their baseline fitness status. The intervention is designed to help participants increase their baseline PA via health coaching, self-monitoring and pragmatic workout videos that provide convenient options for overcoming socio-environmental barriers to PA. |
| Wait-list control group | Active comparator | Behavioral: Be Active Your Way BookletParticipants in this group will not have access to the PATH intervention until after 12 weeks when they cross over. After randomization, the control group will be provided with a copy of the Be Active Your Way booklet, developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40-70 years old
- BMI≥25
- Have regular access to the internet (via computer or smart phone)
- Less than 90 mins of self-reported moderate to vigorous physical activity per week
- American Diabetes Association (ADA) risk ≥5
Key exclusion criteria (4 listed)
- Unstable conditions that may require supervised PA
- Physical limitations that may prohibit engagement in MVPA
- Pregnancy or intention to become pregnant during study, history of CVD
- Current participation in a PA study.
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 |
|---|---|---|
| The Physical Activity for The Heart (PATH) interventionThe web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle. | Behavioural | PATH Treatment Group |
| Be Active Your Way BookletBe Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do. | Behavioural | Wait-list control group |
Primary outcome
Recruitment feasibility
Time frame: At the end of study approximately 48 weeks after commencement of the study
Will be indicated by ability to recruit, screen, and enroll the target sample within 6 months of commencing recruitment, and retention of ≥80% of the sample.
Feasibility of self-monitoring step count using wrist worn ActiGraph GT9X
Time frame: At the end of study approximately 52 weeks after commencement of the study
will be indicated by the proportion of the sample with ≥4days per week of valid Actigraph wear time (≥10hrs) during the entire course of the study.
Acceptability of PATH intervention
Time frame: At the end of study approximately 52 weeks after commencement of the study
Will be indicated by utilization data that will be collected via Web analytics, and a post-intervention survey will assess the intervention acceptability.
11 secondary outcomes
Change from baseline in body mass index (BMI) at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in body fat percentage at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in waist circumference at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in blood pressure (BP) at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in glycated hemoglobin (HbA1C) at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in lipids at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in the risk score for diabetes at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in step count at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in light physical activity at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks
Time frame: Post-intervention at 12 weeks
Change from baseline in Barriers Exercise Self-efficacy (BARSE) scale at 12 weeks
Time frame: Post-intervention at 12 weeks
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 7 Oct 2022.
- Derived from this study: PubMed 37625586Kariuki JK, Sereika S, Erickson K, Burke LE, Kriska A, Cheng J, Milton H, Hirshfield S, Ogutu D, Gibbs B. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107318. doi: 10.1016/j.cct.2023.107318. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Yes. t is our goal to make all data generated from this proposal available to other investigators without compromising the confidentiality of participants. Investigators who would like to do a secondary analysis of de-identified data can submit a formal request for the data including the proposal of their intended analysis to the PI at activeu@pitt.edu. The PI will review all requests and facilitate data access once approval is granted.
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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.
Jacob Kariuki, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet in people with Cardiovascular Risk Factor and Prediabetes, run by University of Pittsburgh 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 6 inclusion and 4 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 7 Oct 2022. 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?
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 feasibility (time frame: At the end of study approximately 48 weeks after commencement of the study). 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 NCT04621045, which also lists 1 linked publication.
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 7 Oct 2022; AzTrials last refreshed its copy on 31 Oct 2026.