Bariatric SurgeryGOALSNCT04868032
Gaining Optimism After Weight Loss Surgery (GOALS) II
A study testing Positive Psychology-Motivational Interviewing in people with Bariatric Surgery, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Positive Psychology-Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult (age 18+)
- History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months
- Interest in increasing physical activity
- Low physical activity, defined as <200 minutes/week self-reported moderate- to-vigorous physical activity
- Access to telephone for study sessions
- Able to read and speak English
Who cannot join
- Cognitive deficits precluding participation or informed consent
- Illness likely to lead to death in the next 6 months
- Inability to be physically active (e.g., severe arthritis)
- Participation in another program targeting physical activity besides their standard offerings at the surgery center.
- Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.
Read the detailed description
This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.
- Conditions
- Bariatric Surgery
- Being tested
- Positive Psychology-Motivational Interviewing, Physical Activity Education Control
- Keywords
- Positive Psychology, Motivational Interviewing, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology-Motivational InterviewingBehavioural
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Physical Activity Education ControlBehavioural
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology-Motivational Interviewing Intervention | Experimental | Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. Receives: Behavioral: Positive Psychology-Motivational Interviewing |
| Physical Activity Education Control | Active comparator | Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. Receives: Behavioral: Physical Activity Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Intervention Sessions Completed
Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
Measured: 10 weeks
Intervention Acceptability
After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.
Measured: 10 weeks
Secondary outcomes (24)
Change in Moderate to Vigorous Physical Activity (MVPA)
We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Steps
Measured by Actigraph accelerometer, in number of steps per day.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Light Physical Activity
Measured by Actigraph accelerometer, in minutes per day.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Positive Affect
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Optimism
The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Depressive Symptoms
The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Anxiety
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise Identity
The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in General Self-Efficacy
Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise-specific Self-efficacy
Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Internalized Weight Bias
The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 1-7). Higher scores indicate greater internalized weight bias.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Self-Reported Physical Activity
The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Mass Index
Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Systolic Blood Pressure (Millimeters of Mercury)
Blood pressure will be measured by a nurse.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Aerobic Capacity and Endurance
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Composition
The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in A1C
Hemoglobin A1C will be measured via blood draw.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in HDL Cholesterol
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Inflammation
C-reactive protein will be measured via blood draw as a measure of inflammation.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Physical Activity Enjoyment
Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Diastolic Blood Pressure (Millimeters of Mercury)
Blood pressure will be measured by a nurse.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in LDL Cholesterol
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Triglycerides
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Measured: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Jul 2022
- Primary completion3 Feb 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Emily Feig, Ph.D., Massachusetts General Hospital
- Investigators
- Emily H Feig, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868032
- Sponsor's protocol ID
- 2021P001006b
- Other IDs
- 5K23HL148017
- Acronym
- GOALS
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feig EH, Harnedy LE, Thorndike AN, Psaros C, Healy BC, Huffman JC. A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 6;11(10):e39856. doi: 10.2196/39856.
PubMed 36201380
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04868032
- Acronym / sponsor ID
- GOALS / 2021P001006b
- Conditions
- Bariatric Surgery
- Keywords
- Positive Psychology, Motivational Interviewing, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.
Detailed description
This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology-Motivational Interviewing Intervention | Experimental | Behavioral: Positive Psychology-Motivational InterviewingParticipants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. |
| Physical Activity Education Control | Active comparator | Behavioral: Physical Activity Education ControlParticipants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (age 18+)
- History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months
- Interest in increasing physical activity
- Low physical activity, defined as <200 minutes/week self-reported moderate- to-vigorous physical activity
- Access to telephone for study sessions
Key exclusion criteria (5 listed)
- Cognitive deficits precluding participation or informed consent
- Illness likely to lead to death in the next 6 months
- Inability to be physically active (e.g., severe arthritis)
- Participation in another program targeting physical activity besides their standard offerings at the surgery center.
- Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
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 |
|---|---|---|
| Positive Psychology-Motivational InterviewingParticipants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics. | Behavioural | Positive Psychology-Motivational Interviewing Intervention |
| Physical Activity Education ControlParticipants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist. | Behavioural | Physical Activity Education Control |
Primary outcome
Number of Intervention Sessions Completed
Time frame: 10 weeks
Feasibility will be measured by examining the number of completed intervention sessions for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
Intervention Acceptability
Time frame: 10 weeks
After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.
24 secondary outcomes
Change in Moderate to Vigorous Physical Activity (MVPA)
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Steps
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Light Physical Activity
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Positive Affect
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Optimism
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Depressive Symptoms
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Anxiety
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise Identity
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in General Self-Efficacy
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise-specific Self-efficacy
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Internalized Weight Bias
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Self-Reported Physical Activity
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Mass Index
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Systolic Blood Pressure (Millimeters of Mercury)
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Aerobic Capacity and Endurance
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Composition
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in A1C
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in HDL Cholesterol
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Inflammation
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Physical Activity Enjoyment
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Diastolic Blood Pressure (Millimeters of Mercury)
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in LDL Cholesterol
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Triglycerides
Time frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36201380Feig EH, Harnedy LE, Thorndike AN, Psaros C, Healy BC, Huffman JC. A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 6;11(10):e39856. doi: 10.2196/39856.
- Individual participant dataSharing planned: No
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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.
Emily H Feig, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology-Motivational Interviewing in people with Bariatric Surgery, run by Massachusetts General Hospital 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 6 inclusion and 5 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 Mar 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?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Intervention Sessions Completed (time frame: 10 weeks). 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 NCT04868032, 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 27 Mar 2026.