Body Weight ChangesNCT04201028
A Remote Delivered Lifestyle Therapeutics Program
A study testing Video Conferencing Health Coaching with devices and Video Conferencing Health Coaching with no devices in people with Body Weight Changes and Weight Loss, run by Coastal Carolina University at 1 site in United States.
Trial summary
Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Body Weight Changes, Weight Loss, Healthy Diet
- What is being tested?
- Video Conferencing Health Coaching with devices and Video Conferencing Health Coaching with no devices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 12 Feb 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English spoken and written at a high-school level, Obese according to body mass index (BMI) standards (> 30 kg/m2), Weigh less than 500 pounds, have access to an Apple® iPhone or Android® smart phone
Who cannot join
- Participants were excluded if they have stated having an Immunodeficiency disorder Kidney disease; Type II diabetes; Asthma, COPD, Heart attack or stroke within the past 12 months; Presence of a partial or full artificial limb; Known dementia, brain cancer, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition; Medications, dietary supplements, or substances advertised to modify metabolism or body weight; Undergone major surgery less than 4 weeks prior to enrollment in the study; or were actively losing weight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Remote Delivered Lifestyle Therapeutics Program: A Randomized Clinical Trial
Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Approximately 32% of the adult U.S. population has high blood pressure and 46% of them have uncontrolled hypertension. Successful management of high blood pressure and other cardiovascular risk is a complex process that requires significant lifestyle changes but adopting and adhering to these changes is challenging. A promise approach to overcoming these challenges is utilizing health coaching. The purpose of this research study is to compare at home devices for blood pressure and weight measurements (DEV) group compared to not using any at home devices Group (NODEV). Both groups will be supported throughout this study by meeting with obesity medicine doctor monthly in office and have a virtual health coaching visits throughout the study duration.
Read the detailed description
Baseline Assessment Participants attend a baseline assessment with a study Health Coach that includes an overview and explanation of the study, the completion of several surveys that involve questions related to your overall health and demographics (age, race, etc). In addition, body weight using a scale and resting blood pressure using a blood pressure cuff. During participants will be asked to download the DiscoverHealth app which will be used to track daily nutritional information (food and drinks) and for health coaching sessions.
Groups Participants will then be randomly assigned to a device group (DEV) or a no device group (NODEV).
Control Group If randomly assigned to the NO DEV Group, participants will be asked to download the DiscoverHealth® app and daily input their nutritional information into the app. This will occur at the baseline assessment. Monthly participants will be asked to attend the Sleep Health Clinic to obtain body weight and blood pressure.
Intervention Group
Regardless of randomization (NODEV OR DEV) participants will be be asked to input their daily nutritional information (food) into the DiscoverHealth® app which will be used by the medical doctor and health coach.
Physical Activity Recommendations:
They will be asked to exercise in accordance with obesity medicine doctors recommendations which may be recommendations like obtaining 20 minutes per day of walking with gradual progression to at least 60 minutes per day and achieve 10,000 steps/day. These recommendations are consistent with the guidelines of national organizations.
No Device Group (NODEV):
Medical Doctor Visits:
If participants are randomized to the NODEV group they will individually meet at the Sleep health Clinic and meet with the obesity medical doctor monthly (1-6) with each visit lasting approximately 15 - 45 minutes per visit. During the first visit each subject will be provided with individualized targets for the number of calories to consume per day and associated macronutrient ratios (i.e. percent of calories from protein, fat, and carbohydrates). They will be asked to follow diet recommendations which emphasizes fruits, vegetables, and low-fat dairy foods and reduced consumption of saturated fat, total fat, and cholesterol along with whole grains, poultry, fish, and nuts. The obesity medicine doctor will prescribe calories. At each visit body weight and blood pressure will be assessed and recorded, and the medical doctor will review and discuss each subject's current diet, physical activity plan, body weight and blood pressure changes.
Health Coaching Visits:
Months 1-3: Following the initial baseline visit they receive weekly individualized video health coaching sessions through the video conference feature of the DiscoverHealth® app on your Apple iPhone® or Android® smart phone. These health coaching sessions will be separate video conferences with the research team's Health Coach (HC). During these sessions, they will receive weekly educational online modules focusing on nutrition and fitness as well as education on way to manage your high blood pressure. Each week, the HC will review their progress including calories per day, macronutrient ratio, and make changes to your meal plan if needed. Additionally, the HC will discuss the physical activity program and progress it as needed (i.e. increase the number of steps per day). Each health coaching session will last approximately 20 minutes each resulting in a time subject commitment of 40 minutes per week. During all sessions, participants will have time to express any concerns or questions you may have.
Months 4-6: All health coaching session information and follow up will remain the with the health coach except participants will receive bi-weekly video health coaching sessions through the video conference feature of the DiscoverHealth® app on your Apple iPhone® or Android® smart phone. They will meet 6 times with the health coach during these months.
Device Group (DEV):
Months 1-3: Following the initial baseline visit participants will receive weekly video health coaching sessions through the video conference feature of the DiscoverHealth® app on their Apple iPhone® or Android® smart phone. These health-coaching sessions will be separate video conferences with the research team's HC. During these sessions, they will receive weekly educational online modules focusing on nutrition, fitness, behavior modification, and support building as well as education on ways to manage their blood pressure. Each week, they will be asked to weigh themselves and take their blood pressure using the devices provided, daily. They will meet with the HC each week to review your progress including calories per day, macronutrient ratio, and make suggestions to their meal plan if needed. Additionally, the HC will discuss the physical activity program and progress it as needed (i.e. increase the number of steps per day). Each health coaching session with HC will last approximately 20 minutes each resulting in a time subject commitment of 40 minutes per week. During all sessions, they will have time to express any concerns or questions you may have. They will meet 12 times with the registered dietitian during these months.
Months 4-6: All health coaching session information and follow up will remain the with the HC except they will receive bi-weekly individualized video health coaching sessions through the video conference feature of the DiscoverHealth® app on their Apple iPhone® or Android® smart phone. Each week, they will still be asked to weigh themselves and take their blood pressure using the devices provided, daily. They will meet 6 times with the health coach and during these months.
- Conditions
- Body Weight Changes, Weight Loss, Healthy Diet, Obesity
- Being tested
- Video Conferencing Health Coaching with devices, Video Conferencing Health Coaching with no devices
- Keywords
- telehealth, video conferencing, blood pressure, lipids, weight loss, usual care, obesity medicine
- Medical subject headings
- Body Weight Changes, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Conferencing Health Coaching with devicesBehavioural
Devices
Video Conferencing Health Coaching with no devicesBehavioural
No Devices
| Study group | Role | What they receive |
|---|---|---|
| Video Conferencing Health Coaching with devices | Experimental | The DEV group participants will meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) to discuss exercise and diet goals. Participants in this group were provided with a blood pressure and body weight scale which connected to the CoachCare App®. Receives: Behavioral: Video Conferencing Health Coaching with devices |
| Video Conferencing Health Coaching with no devices | Experimental | The NODEV group participants meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) for health coaching to discuss exercise and diet goals. Participants in this group did not receive devices. Receives: Behavioral: Video Conferencing Health Coaching with no devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Investigators examined body weight changes between groups baseline (week 0) and post intervention (week 26).
Measured: Change in weight between baseline (week 0) and post intervention (week 26) ]
Blood Pressure
Investigators examined blood pressure changes between groups baseline (week 0) and post intervention (week 26).
Measured: Change in blood pressure between baseline (week 0) and post intervention (week 26) ]
Secondary outcomes (2)
HbA1c
Investigators measured HbA1c via a blood test which was analyzed by Quest® laboratories.
Measured: Pre and Post (a 26 week study)
Lipid Panel
Investigators measured HDLs, LDLs, Cholesterol, and Triglycerides via a blood test which was analyzed by Quest® laboratories.
Measured: Pre and Post (a 26 week study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start6 Jan 2021
- Primary completion31 Jan 2022
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies 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
- Model description
- All participants were randomized in a balanced fashion and stratified by sex into either one of the two intervention groups no device (NODEV) group or a device (DEV) group.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coastal Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- inHealth Medical Services, Inc.
- Responsible party
- Principal investigator, Kelly Johnson, Coastal Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201028
- Sponsor's protocol ID
- 2021.96
- Status last verified
- Oct 2022
- First submitted
- 13 Dec 2019
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan DH, Ard J, Kennedy BM. Effects of dietary patterns on blood pressure: subgroup analysis of the Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial. Arch Intern Med. 1999 Feb 8;159(3):285-93. doi: 10.1001/archinte.159.3.285.
PubMed 9989541Alencar MK, Johnson K, Mullur R, Gray V, Gutierrez E, Korosteleva O. The efficacy of a telemedicine-based weight loss program with video conference health coaching support. J Telemed Telecare. 2019 Apr;25(3):151-157. doi: 10.1177/1357633X17745471. Epub 2017 Dec 3.
PubMed 29199544Johnson KE, Alencar MK, Coakley KE, Swift DL, Cole NH, Mermier CM, Kravitz L, Amorim FT, Gibson AL. Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Telemed J E Health. 2019 Feb;25(2):85-92. doi: 10.1089/tmj.2018.0002. Epub 2018 May 30.
PubMed 29847222American Heart Association; American College of Cardiology; Obesity Society. Reprint: 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. J Am Pharm Assoc (2003). 2014 Jan-Feb;54(1):e3. doi: 10.1331/japha.2014.14502. No abstract available.
PubMed 24898716
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Delivered Lifestyle Therapeutics Program: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04201028
- Acronym / sponsor ID
- 2021.96
- Conditions
- Body Weight Changes, Weight Loss, Healthy Diet, Obesity
- Keywords
- telehealth, video conferencing, blood pressure, lipids, weight loss, usual care, obesity medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coastal Carolina UniversityUniversity, hospital or other
- Collaborators
- inHealth Medical Services, Inc.
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 16 Dec 2019 (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.
Heart disease is the leading cause of death in the United States. The overall risk for heart disease is a composite measure of various modifiable factors including blood pressure, cholesterol, and tobacco use; which are exacerbated by a sedentary lifestyle, unhealthy diet, and being overweight. Approximately 32% of the adult U.S. population has high blood pressure and 46% of them have uncontrolled hypertension. Successful management of high blood pressure and other cardiovascular risk is a complex process that requires significant lifestyle changes but adopting and adhering to these changes is challenging. A promise approach to overcoming these challenges is utilizing health coaching. The purpose of this research study is to compare at home devices for blood pressure and weight measurements (DEV) group compared to not using any at home devices Group (NODEV). Both groups will be supported throughout this study by meeting with obesity medicine doctor monthly in office and have a virtual health coaching visits throughout the study duration.
Detailed description
Baseline Assessment Participants attend a baseline assessment with a study Health Coach that includes an overview and explanation of the study, the completion of several surveys that involve questions related to your overall health and demographics (age, race, etc). In addition, body weight using a scale and resting blood pressure using a blood pressure cuff. During participants will be asked to download the DiscoverHealth app which will be used to track daily nutritional information (food and drinks) and for health coaching sessions.
Groups Participants will then be randomly assigned to a device group (DEV) or a no device group (NODEV).
Control Group If randomly assigned to the NO DEV Group, participants will be asked to download the DiscoverHealth® app and daily input their nutritional information into the app. This will occur at the baseline assessment. Monthly participants will be asked to attend the Sleep Health Clinic to obtain body weight and blood pressure.
Intervention Group
Regardless of randomization (NODEV OR DEV) participants will be be asked to input their daily nutritional information (food) into the DiscoverHealth® app which will be used by the medical doctor and health coach.
Physical Activity Recommendations:
They will be asked to exercise in accordance with obesity medicine doctors recommendations which may be recommendations like obtaining 20 minutes per day of walking with gradual progression to at least 60 minutes per day and achieve 10,000 steps/day. These recommendations are consistent with the guidelines of national organizations.
No Device Group (NODEV):
Medical Doctor Visits:
If participants are randomized to the NODEV group they will individually meet at the Sleep health Clinic and meet with the obesity medical doctor monthly (1-6) with each visit lasting approximately 15 - 45 minutes per visit. During the first visit each subject will be provided with individualized targets for the number of calories to consume per day and associated macronutrient ratios (i.e. percent of calories from protein, fat, and carbohydrates). They will be asked to follow diet recommendations which emphasizes fruits, vegetables, and low-fat dairy foods and reduced consumption of saturated fat, total fat, and cholesterol along with whole grains, poultry, fish, and nuts. The obesity medicine doctor will prescribe calories. At each visit body weight and blood pressure will be assessed and recorded, and the medical doctor will review and discuss each subject's current diet, physical activity plan, body weight and blood pressure changes.
Health Coaching Visits:
Months 1-3: Following the initial baseline visit they receive weekly individualized video health coaching sessions through the video conference feature of the DiscoverHealth® app on your Apple iPhone® or Android® smart phone. These health coaching sessions will be separate video conferences with the research team's Health Coach (HC). During these sessions, they will receive weekly educational online modules focusing on nutrition and fitness as well as education on way to manage your high blood pressure. Each week, the HC will review their progress including calories per day, macronutrient ratio, and make changes to your meal plan if needed. Additionally, the HC will discuss the physical activity program and progress it as needed (i.e. increase the number of steps per day). Each health coaching session will last approximately 20 minutes each resulting in a time subject commitment of 40 minutes per week. During all sessions, participants will have time to express any concerns or questions you may have.
Months 4-6: All health coaching session information and follow up will remain the with the health coach except participants will receive bi-weekly video health coaching sessions through the video conference feature of the DiscoverHealth® app on your Apple iPhone® or Android® smart phone. They will meet 6 times with the health coach during these months.
Device Group (DEV):
Months 1-3: Following the initial baseline visit participants will receive weekly video health coaching sessions through the video conference feature of the DiscoverHealth® app on their Apple iPhone® or Android® smart phone. These health-coaching sessions will be separate video conferences with the research team's HC. During these sessions, they will receive weekly educational online modules focusing on nutrition, fitness, behavior modification, and support building as well as education on ways to manage their blood pressure. Each week, they will be asked to weigh themselves and take their blood pressure using the devices provided, daily. They will meet with the HC each week to review your progress including calories per day, macronutrient ratio, and make suggestions to their meal plan if needed. Additionally, the HC will discuss the physical activity program and progress it as needed (i.e. increase the number of steps per day). Each health coaching session with HC will last approximately 20 minutes each resulting in a time subject commitment of 40 minutes per week. During all sessions, they will have time to express any concerns or questions you may have. They will meet 12 times with the registered dietitian during these months.
Months 4-6: All health coaching session information and follow up will remain the with the HC except they will receive bi-weekly individualized video health coaching sessions through the video conference feature of the DiscoverHealth® app on their Apple iPhone® or Android® smart phone. Each week, they will still be asked to weigh themselves and take their blood pressure using the devices provided, daily. They will meet 6 times with the health coach and during these months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- All participants were randomized in a balanced fashion and stratified by sex into either one of the two intervention groups no device (NODEV) group or a device (DEV) group.
| Arm | Type | Receives |
|---|---|---|
| Video Conferencing Health Coaching with devices | Experimental | Behavioral: Video Conferencing Health Coaching with devicesThe DEV group participants will meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) to discuss exercise and diet goals. Participants in this group were provided with a blood pressure and body weight scale which connected to the CoachCare App®. |
| Video Conferencing Health Coaching with no devices | Experimental | Behavioral: Video Conferencing Health Coaching with no devicesThe NODEV group participants meet via the DiscoverHealth® app using their smartphone, and met 18 times with the registered dietitian (RD) for health coaching to discuss exercise and diet goals. Participants in this group did not receive devices. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fluent in English spoken and written at a high-school level, Obese according to body mass index (BMI) standards (> 30 kg/m2), Weigh less than 500 pounds, have access to an Apple® iPhone or Android® smart phone
Key exclusion criteria (1 listed)
- Participants were excluded if they have stated having an Immunodeficiency disorder Kidney disease; Type II diabetes; Asthma, COPD, Heart attack or stroke within the past 12 months; Presence of a partial or full artificial limb; Known dementia, brain cancer, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition; Medications, dietary supplements, or substances advertised to modify metabolism or body weight; Undergone major surgery less than 4 weeks prior to enrollment in the study; or were actively losing weight.
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 |
|---|---|---|
| Video Conferencing Health Coaching with devicesDevices | Behavioural | Video Conferencing Health Coaching with devices |
| Video Conferencing Health Coaching with no devicesNo Devices | Behavioural | Video Conferencing Health Coaching with no devices |
Primary outcome
Weight loss
Time frame: Change in weight between baseline (week 0) and post intervention (week 26) ]
Investigators examined body weight changes between groups baseline (week 0) and post intervention (week 26).
Blood Pressure
Time frame: Change in blood pressure between baseline (week 0) and post intervention (week 26) ]
Investigators examined blood pressure changes between groups baseline (week 0) and post intervention (week 26).
2 secondary outcomes
HbA1c
Time frame: Pre and Post (a 26 week study)
Lipid Panel
Time frame: Pre and Post (a 26 week study)
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 6 Oct 2022.
- Background: PubMed 9989541Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan DH, Ard J, Kennedy BM. Effects of dietary patterns on blood pressure: subgroup analysis of the Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial. Arch Intern Med. 1999 Feb 8;159(3):285-93. doi: 10.1001/archinte.159.3.285.
- Background: PubMed 29199544Alencar MK, Johnson K, Mullur R, Gray V, Gutierrez E, Korosteleva O. The efficacy of a telemedicine-based weight loss program with video conference health coaching support. J Telemed Telecare. 2019 Apr;25(3):151-157. doi: 10.1177/1357633X17745471. Epub 2017 Dec 3.
- Background: PubMed 29847222Johnson KE, Alencar MK, Coakley KE, Swift DL, Cole NH, Mermier CM, Kravitz L, Amorim FT, Gibson AL. Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Telemed J E Health. 2019 Feb;25(2):85-92. doi: 10.1089/tmj.2018.0002. Epub 2018 May 30.
- Background: PubMed 24898716American Heart Association; American College of Cardiology; Obesity Society. Reprint: 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. J Am Pharm Assoc (2003). 2014 Jan-Feb;54(1):e3. doi: 10.1331/japha.2014.14502. No abstract available.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Conferencing Health Coaching with devices and Video Conferencing Health Coaching with no devices in people with Body Weight Changes and Weight Loss, run by Coastal Carolina 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?
The sponsor lists 1 inclusion and 1 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 6 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 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?
Weight loss (time frame: Change in weight between baseline (week 0) and post intervention (week 26) ]). The study lists 2 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 NCT04201028, which also lists 4 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 6 Oct 2022.