Life StyleNCT06404632
A Group Intervention for Promoting Health-related Habits (LEV-G)
A study testing Lev-g in people with Life Style and Health-Related Behavior, run by Region Stockholm at 1 site in Sweden.
Trial summary
Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Life Style, Health-Related Behavior, Disabilities Mental
- What is being tested?
- Lev-g
- 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 siteSweden
- Study dates
- 12 Apr 2024to 28 Feb 2027
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- both adults with and without disabilities recruited from different healthcare contexts.
Who cannot join
- Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
- Insufficient command of the Swedish language/ unable to understand the content.
- Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Stockholm
Stockholm, Stockholm, Sweden, 104 31
Douglas Sjöwall, PhD, +46 (0)739568658, douglas.sjowall@ki.se
About this study
Official title: A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities (LEV-G)
Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.
Read the detailed description
Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden.
Study 1: The feasibility trial investigates the following questions:
Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.
Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.
Do the intervention lead to adverse events? To what extent were individual goals met?
- Conditions
- Life Style, Health-Related Behavior, Disabilities Mental, Disability Physical, Acceptability of Health Care
- Being tested
- Lev-g
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lev-gBehavioural
Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others.
| Study group | Role | What they receive |
|---|---|---|
| Lev-g (group intervention) | Experimental | Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others. There is no control condition. Only one arm to test feasibility. Receives: Behavioral: Lev-g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate participants
How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 3 out of 4 session)
Measured: within 3-4 months
Secondary outcomes (22)
Level of treatment credibility participants
Was Lev perceived as creditable by participants using Treatment and Credibility Scale. Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Measured: Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months). I.e within 6 weeks
Level of treatment credibility healthcare workers
Was Lev perceived as creditable by healthcare workers using Treatment and Credibility Scale . Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Measured: Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months)I.e within 6 weeks
Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
After the meeting today, my knowledge of how I can change my lifestyle have increased.
I will benefit from what we talked about during the meeting today The content of the meeting felt relevant based on my own experiences I understood the advice and strategies I was given that will help my change mine lifestyle habits I feel confident in how to use the advice and strategies I will use the advice and strategies I was listened to, the therapist understood my situation I was involved and helped to come up with suggestions for how I can reach my goals Is there something else you would like to add?
Measured: After completing the first session in Lev. An average of 1-2 weeks from baseline
Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
After the meeting today, my knowledge of how I can change my lifestyle have increased.
I will benefit from what we talked about during the meeting today The content of the meeting felt relevant based on my own experiences I understood the advice and strategies I was given that will help my change mine lifestyle habits I feel confident in how to use the advice and strategies I will use the advice and strategies I was listened to, the therapist understood my situation I was involved and helped to come up with suggestions for how I can reach my goals Is there something else you would like to add?
Measured: After completing the second session in Lev. An average of 2-3 weeks from baseline
Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
After the meeting today, my knowledge of how I can change my lifestyle have increased.
I will benefit from what we talked about during the meeting today The content of the meeting felt relevant based on my own experiences I understood the advice and strategies I was given that will help my change mine lifestyle habits I feel confident in how to use the advice and strategies I will use the advice and strategies I was listened to, the therapist understood my situation I was involved and helped to come up with suggestions for how I can reach my goals Is there something else you would like to add?
Measured: After completing the third session in Lev. An average of 3-4 weeks from baseline
Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after booster session using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
After the meeting today, my knowledge of how I can change my lifestyle have increased.
I will benefit from what we talked about during the meeting today The content of the meeting felt relevant based on my own experiences I understood the advice and strategies I was given that will help my change mine lifestyle habits I feel confident in how to use the advice and strategies I will use the advice and strategies I was listened to, the therapist understood my situation I was involved and helped to come up with suggestions for how I can reach my goals Is there something else you would like to add?
Measured: After completing the booster session in Lev. An average of 3-4 month from baseline
Treatment satisfaction participants (the three sessions)
Treatment satisfaction will be evaluated after competing the three sessions using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
As a whole, the Lev has been clearly focused on how I can live healthier My knowledge of how I can have healthier habits has increased I can better deal with problems connected to my health-related habits I have had the opportunity to contribute opinions during the Lev I would consider participating in a similar interventions in the future The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Measured: Directly after completing the last treatment module in LEV (approximately at 3-4 weeks from baseline)]
Treatment satisfaction participants (the whole intervention including the booster session)
Treatment satisfaction will be evaluated after competing the whole intervention using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
As a whole, the Lev has been clearly focused on how I can live healthier My knowledge of how I can have healthier habits has increased I can better deal with problems connected to my health-related habits I have had the opportunity to contribute opinions during the Lev I would consider participating in a similar interventions in the future The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Measured: Directly after completing the last treatment module in LEV (approximately at 3-4 month from baseline)]
Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions:
I feel that participating in Lev helped me in these ways How could the Lev have been better? What could I have done differently myself? Is there anything else you would like to add? A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
I would consider participating in a similar interventions in the future The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Measured: Directly after completing the third session in LEV (approximately at 3-4 weeks from baseline)]
Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions:
I feel that participating in Lev helped me in these ways How could the Lev have been better? What could I have done differently myself? Is there anything else you would like to add? A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
I would consider participating in a similar interventions in the future.
The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Measured: Directly after completing the booster session in LEV (approximately at 3-4 month from baseline)]
Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
The content of this session feels relevant The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist Is there something else you would like to add?
Measured: After completing the first session in Lev. An average of 1-2 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
The content of this session feels relevant The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist Is there something else you would like to add?
Measured: After completing the first session in Lev. An average of 2-3 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
The content of this session feels relevant The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist Is there something else you would like to add?
Measured: After completing the first session in Lev. An average of 3-4 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after the booster session using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
The content of this session feels relevant The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist Is there something else you would like to add?
Measured: After completing the first session in Lev. An average of 3-4 months from baseline
Well-being before and after the intervention measures by The Evaluation Questionnaire
("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good)
Measured: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
Well-being before and after the intervention measures by The Evaluation Questionnaire
("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good)
Measured: Directly after completing the booster session module in LEV (approximately at 3-4 months)
Adverse events after the intervention
Adverse events will be defined as spontaneous oral complaints or instances when patients stated that they experienced negative or unwanted effects during the intervention period.
Serious adverse events will be defined as events that involved hospital care/hospitalization, etc. due to the intervention.
Measured: During the intervention up to week approximately 3-4 months
To what extent were individual goals met?
The healthcare worker assesses to what extent the goals have been met using the goal attainment scale. 5 point scale where high vales indicate that goals have been reached to a higher extent.
Measured: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
To what extent were individual goals met?
The healthcare worker assesses to what extent the goals have been met using the goal attainment scale. 5 point scale where high vales indicate that goals have been reached to a higher extent.
Measured: Directly after completing the booster session module in LEV (approximately at 3-4 months)
Self-efficacy for promoting health behaviors for their children
Participants are asked to assess self-efficacy for promoting health behaviors using the "Parental self-efficacy for healthy dietary and physical activity behaviors in preschool children (PDAP) including 24 items on a 0-10 point scale where high values indicate higher self-efficacy
Measured: Directly after completing the third session in LEV (approximately at 3-4 weeks)
Self-efficacy for promoting health behaviors for their children
Participants are asked to assess self-efficacy for promoting health behaviors using the "Parental self-efficacy for healthy dietary and physical activity behaviors in preschool children (PDAP) including 24 items on a 0-10 point scale where high values indicate higher self-efficacy
Measured: Directly after completing the booster session in LEV (approximately at 3-4 month)
Do Lev lead to healthier habits?
The Lev-s will be used to measure diet and physical activity before and after taking part in Lev. The scale includes 4 levels where higher levels indicate healthier habits.
Measured: Before and after taking part in Lev (after is after the third, 3-4 weeks, as wells as after the booster session, 3-4 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start12 Apr 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life StyleStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility trial with pre, peri, post and follow-up measurements
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Promobilia Foundation
- Responsible party
- Principal investigator, Douglas Sjowall, Region Stockholm
- Investigators
- Douglas Sjöwall, PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404632
- Sponsor's protocol ID
- The LEV Project (group)
- Status last verified
- Aug 2026
- First submitted
- 5 May 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Douglas Sjöwall will be responsible for granting access to data only to researchers who are participating in the publications
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities (LEV-G)
- ClinicalTrials.gov ID
- NCT06404632
- Acronym / sponsor ID
- The LEV Project (group)
- Conditions
- Life Style, Health-Related Behavior, Disabilities Mental, Disability Physical, Acceptability of Health Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, Promobilia Foundation
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.
Detailed description
Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden.
Study 1: The feasibility trial investigates the following questions:
Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.
Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.
Do the intervention lead to adverse events? To what extent were individual goals met?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility trial with pre, peri, post and follow-up measurements
| Arm | Type | Receives |
|---|---|---|
| Lev-g (group intervention) | Experimental | Behavioral: Lev-gLev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others. There is no control condition. Only one arm to test feasibility. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- both adults with and without disabilities recruited from different healthcare contexts.
Key exclusion criteria (3 listed)
- Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
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 |
|---|---|---|
| Lev-gLev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others. | Behavioural | Lev-g (group intervention) |
Primary outcome
Completion rate participants
Time frame: within 3-4 months
How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 3 out of 4 session)
22 secondary outcomes
Level of treatment credibility participants
Time frame: Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months). I.e within 6 weeks
Level of treatment credibility healthcare workers
Time frame: Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months)I.e within 6 weeks
Treatment satisfaction participants (individual sessions)
Time frame: After completing the first session in Lev. An average of 1-2 weeks from baseline
Treatment satisfaction participants (individual sessions)
Time frame: After completing the second session in Lev. An average of 2-3 weeks from baseline
Treatment satisfaction participants (individual sessions)
Time frame: After completing the third session in Lev. An average of 3-4 weeks from baseline
Treatment satisfaction participants (individual sessions)
Time frame: After completing the booster session in Lev. An average of 3-4 month from baseline
Treatment satisfaction participants (the three sessions)
Time frame: Directly after completing the last treatment module in LEV (approximately at 3-4 weeks from baseline)]
Treatment satisfaction participants (the whole intervention including the booster session)
Time frame: Directly after completing the last treatment module in LEV (approximately at 3-4 month from baseline)]
Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
Time frame: Directly after completing the third session in LEV (approximately at 3-4 weeks from baseline)]
Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants
Time frame: Directly after completing the booster session in LEV (approximately at 3-4 month from baseline)]
Treatment satisfaction healthcare workers (individual sessions)
Time frame: After completing the first session in Lev. An average of 1-2 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Time frame: After completing the first session in Lev. An average of 2-3 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Time frame: After completing the first session in Lev. An average of 3-4 weeks from baseline
Treatment satisfaction healthcare workers (individual sessions)
Time frame: After completing the first session in Lev. An average of 3-4 months from baseline
Well-being before and after the intervention measures by The Evaluation Questionnaire
Time frame: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
Well-being before and after the intervention measures by The Evaluation Questionnaire
Time frame: Directly after completing the booster session module in LEV (approximately at 3-4 months)
Adverse events after the intervention
Time frame: During the intervention up to week approximately 3-4 months
To what extent were individual goals met?
Time frame: Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
To what extent were individual goals met?
Time frame: Directly after completing the booster session module in LEV (approximately at 3-4 months)
Self-efficacy for promoting health behaviors for their children
Time frame: Directly after completing the third session in LEV (approximately at 3-4 weeks)
Self-efficacy for promoting health behaviors for their children
Time frame: Directly after completing the booster session in LEV (approximately at 3-4 month)
Do Lev lead to healthier habits?
Time frame: Before and after taking part in Lev (after is after the third, 3-4 weeks, as wells as after the booster session, 3-4 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Douglas Sjöwall will be responsible for granting access to data only to researchers who are participating in the publications
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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.
Douglas Sjöwall, PhD principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lev-g in people with Life Style and Health-Related Behavior, run by Region Stockholm at 1 site in Sweden.
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 3 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: looking for participants now, as of the sponsor's last update on 12 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 1 site in Sweden. 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?
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?
Contact Douglas Sjöwall, PhD (+46 (0)739568658, douglas.sjowall@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate participants (time frame: within 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.