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Hematopoietic and Lymphoid Cell NeoplasmPhase 3NCT04089358

Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

A Phase 3 study testing Educational Intervention, FitBit and Goal Setting in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Children's Oncology Group at 116 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Read more about this study

Who is it for?
Ages 15 to 20 years
What is being tested?
Educational Intervention, FitBit and Goal Setting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
116 sitesin 2 countries
Study dates
7 Dec 2020to 30 Jun 2027
Phase
Phase 3
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 15 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
  • Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
  • Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
  • All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
  • Patients must have a life expectancy of > 1 year
  • Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
Show all 15Show fewer
  • Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
  • Ambulatory and no known medical contraindications to increasing physical activity
  • Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
  • No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
  • Able to read and write English
  • Note: For patients < 18 years, consenting parent/legal guardian does not have to be able to read and write English
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Who cannot join

  • Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
  • Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
  • Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
  • Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied

Trial locations and contacts

116 sites in 2 countries.

116 sites in 2 countries

United States114 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • Albany Medical Center

    Albany, New York, 12208

  • Texas Tech University Health Sciences Center-Amarillo

    Amarillo, Texas, 79106

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Michigan State University

    East Lansing, Michigan, 48823

  • El Paso Children's Hospital

    El Paso, Texas, 79905

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Mattel Children's Hospital UCLA

    Los Angeles, California, 90095

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

  • Palms West Radiation Therapy

    Loxahatchee Groves, Florida, 33470

  • Valley Children's Hospital

    Madera, California, 93636

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Vannie Cook Children's Clinic

    McAllen, Texas, 78503

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Banner Children's at Desert

    Mesa, Arizona, 85202

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • USA Health Strada Patient Care Center

    Mobile, Alabama, 36604

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Yale University

    New Haven, Connecticut, 06520

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Children's Hospital of Orange County

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

  • Nemours Children's Hospital

    Orlando, Florida, 32827

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • OSF Children's Hospital of Illinois

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Corewell Health Children's

    Royal Oak, Michigan, 48073

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

Canada2 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Official title: StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

SECONDARY OBJECTIVES:

  1. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

OUTLINE: Participants are randomized to 1 of 2 groups.

INTERVENTION GROUP: Participants receive educational materials about physical activity.

INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit.

MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges.

CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.

Being tested
Educational Intervention, FitBit, Goal Setting, Health Promotion and Education, Media Intervention
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive educational materials

  • FitBitDevice

    Wear a Fitbit

  • Goal SettingOther

    Set goals

  • Health Promotion and EducationOther

    Receive text message about goal setting

  • Media InterventionOther

    Follow Instagram group

  • Telephone-Based InterventionBehavioural

    Receive phone call about goal setting

Study groups in NCT04089358
Study groupRoleWhat they receive
Control Group (educational materials, Fitbit)Active comparatorParticipants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
Receives: Other: Educational Intervention; Device: FitBit
Intervention group (educational materials, goal set, Fitbit)ExperimentalSee outline
Receives: Other: Educational Intervention; Device: FitBit; Other: Goal Setting; Other: Health Promotion and Education; Other: Media Intervention; Behavioral: Telephone-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minutes of moderate-to-vigorous physical activity (MVPA) per day

    Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

Secondary outcomes (13)

  1. Cardiopulmonary fitness

    Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. Participants complete the 2-Minute Step Test at baseline and 12 months post-baseline. Steps are counted during the test. Will report the mean difference in steps from baseline to 12 months, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  2. Resting heart rate

    Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor prior to the participant initiating the 2-Minute Step Test at baseline and 12 months. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  3. Health-related quality of life (HRQOL) Global Functioning

    HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Global Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  4. Health-related quality of life (HRQOL) Physical Functioning

    HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Physical Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  5. Health-related quality of life (HRQOL) Social Functioning

    HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Social Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  6. Health-related quality of life (HRQOL) Fatigue

    HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Fatigue score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  7. Total cholesterol

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Total cholesterol will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  8. High density lipoprotein (HDL)

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  9. Low density lipoprotein (LDL)

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. LDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  10. Triglycerides

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Triglycerides will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  11. Insulin (HOMA-IR)

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HOMA-IR will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  12. Hemoglobin A1c (HbA1c)

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HbA1c will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

  13. High sensitivity C-reactive protein (CRP)

    A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. CRP will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start7 Dec 2020
  3. Primary completion31 Dec 2025
  4. Study completion30 Jun 2027 (estimated)

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089358
Sponsor's protocol ID
ALTE2031
Other IDs
NCI-2020-01916, ALTE2031, COG-ALTE2031, ALTE2031, U01CA246665, UG1CA189955
Status last verified
Aug 2026
First submitted
10 Sep 2019
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Beight LJ, Mendoza JA, Leisenring WM, Collier W, Olsen ME, Ross WL, Santiago-Rivera Y, Bryant S, Rotatori J, Ness KK, Hurtado-de-Mendoza A, Baker KS, Chow EJ, Kadan-Lottick NS. Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group. Contemp Clin Trials. 2024 Oct;145:107645. doi: 10.1016/j.cct.2024.107645. Epub 2024 Jul 28.

    PubMed 39079612

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Educational Intervention, FitBit and Goal Setting in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Children's Oncology Group at 116 sites in 2 countries.

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 15 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Minutes of moderate-to-vigorous physical activity (MVPA) per day (time frame: 12 months). 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 NCT04089358, 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 6 Aug 2026.

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