Parkinson DiseaseNCT06170866
Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.
A study testing Socially supported physical activity in people with Parkinson Disease, run by UConn Health at 1 site in United States.
Trial summary
The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Socially supported physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Aug 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson disease,
- Able to walk without the assistance of another person for 10 minutes
- -≥ 29 on Telephone Interview for Cognitive Status (TICS)
- To have a close friend/family member over the age of 18 that would support the participant during the intervention
- -≥ 50 years of age
- Hispanic
Show all 9Show fewer
- To be willing to use an activity monitor and use a Fitbit and Fitbit application
- To be on a stable course of PD medications without any plans for change over the next 3 months
- To be able to speak, read and write in Spanish or English
Who cannot join
- Unstable cardiopulmonary, orthopedic, psychological or metabolic condition
- Atypical Parkinsonism Disorders
- A fall in the last 6 months (that was unrelated to an external force)
- Currently engaging in 150 minutes of mod-vigorous physical activity/week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease.
The main question[s] it aims to answer are:
Read more
- What is the feasibility of the peer partner training program?
- What is the feasibility of the peer-supported mobile health physical activity intervention?
- What are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy?
Participants will be asked to:
- Wear a research-grade activity monitor, Actigraph GT9X device for 10 days at the beginning and end of the study.
- Watch 11 educational videos about Parkinson´s disease and exercise and attend two virtual educational sessions.
- Connect with another person with Parkinson´s disease one time a week on a virtual meeting platform for 8 weeks.
- Use Fitbit activity monitors and connect with other participants through the Fitbit application for 8 weeks.
- Attend a weekly online exercise class for 8 weeks with other people with Parkinon´s disease.
- Conditions
- Parkinson Disease
- Being tested
- Socially supported physical activity
- Keywords
- Exercise, Peer Support, Hispanic, Parkinson´s Disease
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socially supported physical activityBehavioural
Use of a culturally and linguistically tailored intervention that uses mobile health technology plus social support to increase engagement in physical activity in the management of Parkinson´s disease.
| Study group | Role | What they receive |
|---|---|---|
| Social support for physical activity | Experimental | Socially supported (peer, family and group) physical activity group. Receives: Behavioral: Socially supported physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
A standardized measure of acceptability that indicates percent agreement with acceptability of the intervention ranging from 20-100%. Higher scores indicate agreement (better outcome) with the acceptability of the intervention.
Measured: After completion of the entire intervention (11 weeks)
Intervention Appropriateness Measure (IAM)
A standardized measure of appropriateness that indicates percent agreement with appropriateness of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the appropriateness of the intervention.
Measured: After completion of the entire intervention (11 weeks)
Feasibility of Intervention Measure (FIM)
A standardized measure of feasibility that indicates percent agreement with feasibility of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the feasibility of the intervention.
Measured: After completion of the entire intervention (11 weeks)
Secondary outcomes (4)
Objective Measurement of Physical Activity
Steps per day measured using a research-grade activity monitor will provide group mean change in physical activity from baseline to post-intervention.
Measured: 10 days at baseline and post-intervention (approximately 12 to 14 weeks)
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
The Behavioral Regulation in Exercise Questionnaire-2, Relative Autonomy Index, is a standardized, 19-item survey that evaluates motivation for exercise. The scores range from -24 to +20 with higher scores indicating increased motivation or better outcomes. The group mean change score is presented.
Measured: Baseline and post Intervention (approximately 12 to 14 weeks)
Parkinson's Disease Questionnaire-39 (PDQ-39)
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a 39-item, self-report survey that assess quality of life. The scores range from 0-100 and a decrease indicates an improvement in quality of life. The group mean change total scores will be evaluated.
Measured: Pre and post intervention (approximately 12 to 14 weeks)
Geriatric Depression Scale-Short Form
The Geriatric Depression Scale (GDS) -15, is a 15-item self-report measure of depression in older adults. The score ranges from 0-15 with higher scores indicating higher levels of depression (worse outcome). Group mean change scores related to depression are reported.
Measured: Pre and post intervention (approximately 12 to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2024
- Study completion30 Aug 2024
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 (32)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective feasibility trial, single group pre-posttest design and it aims to enroll 20 participants. For this feasibility study, the sample size is comparable to other feasibility trials in populations of individuals with Parkinson disease (Lima \& Rodrigues-de-Paula, 2013; Ellis et al., 2013, Colón-Semenza et al., 2018)17,19,20. This sample size will allow for a comparison in feasibility, acceptability, and appropriateness within and across groups. This sample will allow for identifying trends and preliminary efficacy for this intervention. This study will help to inform an appropriate sample size to adequately power larger samples in future studies
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Cristina Colón-Semenza, UConn Health
- Investigators
- Cristina Colón-Semenza, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170866
- Sponsor's protocol ID
- 23-117S-2
- Other IDs
- P30AG067988
- Status last verified
- Oct 2025
- First submitted
- 10 Nov 2023
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng EM, Tonn S, Swain-Eng R, Factor SA, Weiner WJ, Bever CT Jr; American Academy of Neurology Parkinson Disease Measure Development Panel. Quality improvement in neurology: AAN Parkinson disease quality measures: report of the Quality Measurement and Reporting Subcommittee of the American Academy of Neurology. Neurology. 2010 Nov 30;75(22):2021-7. doi: 10.1212/WNL.0b013e3181ff96dd.
PubMed 21115958Rogers G, Davies D, Pink J, Cooper P. Parkinson's disease: summary of updated NICE guidance. BMJ. 2017 Jul 27;358:j1951. doi: 10.1136/bmj.j1951. No abstract available.
PubMed 28751362Alberts JL, Rosenfeldt AB. The Universal Prescription for Parkinson's Disease: Exercise. J Parkinsons Dis. 2020;10(s1):S21-S27. doi: 10.3233/JPD-202100.
PubMed 32925109Johansson ME, Cameron IGM, Van der Kolk NM, de Vries NM, Klimars E, Toni I, Bloem BR, Helmich RC. Aerobic Exercise Alters Brain Function and Structure in Parkinson's Disease: A Randomized Controlled Trial. Ann Neurol. 2022 Feb;91(2):203-216. doi: 10.1002/ana.26291. Epub 2022 Jan 19.
PubMed 34951063Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
PubMed 29228079Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018.
PubMed 30003140Van Den Eeden SK, Tanner CM, Bernstein AL, Fross RD, Leimpeter A, Bloch DA, Nelson LM. Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003 Jun 1;157(11):1015-22. doi: 10.1093/aje/kwg068.
PubMed 12777365Damron L, Litvan I, Bayram E, Berk S, Siddiqi B, Shill H. Hispanic Perspectives on Parkinson's Disease Care and Research Participation. J Alzheimers Dis. 2021;81(2):809-819. doi: 10.3233/JAD-210231.
PubMed 33843687Fullard ME, Thibault DP, Hill A, Fox J, Bhatti DE, Burack MA, Dahodwala N, Haberfeld E, Kern DS, Klepitskava OS, Urrea-Mendoza E, Myers P, Nutt J, Rafferty MR, Schwalb JM, Shulman LM, Willis AW; Parkinson Study Group Healthcare Outcomes and Disparities Working Group. Utilization of rehabilitation therapy services in Parkinson disease in the United States. Neurology. 2017 Sep 12;89(11):1162-1169. doi: 10.1212/WNL.0000000000004355. Epub 2017 Aug 23.
PubMed 28835397Crespo CJ, Smit E, Andersen RE, Carter-Pokras O, Ainsworth BE. Race/ethnicity, social class and their relation to physical inactivity during leisure time: results from the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Prev Med. 2000 Jan;18(1):46-53. doi: 10.1016/s0749-3797(99)00105-1.
PubMed 10808982Mantri S, Fullard M, Gray SL, Weintraub D, Hubbard RA, Hennessy S, Willis AW. Patterns of Dementia Treatment and Frank Prescribing Errors in Older Adults With Parkinson Disease. JAMA Neurol. 2019 Jan 1;76(1):41-49. doi: 10.1001/jamaneurol.2018.2820.
PubMed 30285047Hooker SP, Wilcox S, Rheaume CE, Burroughs EL, Friedman DB. Factors related to physical activity and recommended intervention strategies as told by midlife and older African American men. Ethn Dis. 2011 Summer;21(3):261-7.
PubMed 21942156Griffith DM, Bergner EM, Cornish EK, McQueen CM. Physical Activity Interventions With African American or Latino Men: A Systematic Review. Am J Mens Health. 2018 Jul;12(4):1102-1117. doi: 10.1177/1557988318763647. Epub 2018 Mar 20.
PubMed 29557237Callahan LF, Rivadeneira A, Altpeter M, Vilen L, Cleveland RJ, Sepulveda VE, Hackney B, Reuland DS, Rojas C. Evaluation of the Arthritis Foundation's Camine Con Gusto Program for Hispanic Adults With Arthritis. Hisp Health Care Int. 2016 Sep;14(3):132-40. doi: 10.1177/1540415316665202. Epub 2016 Aug 23.
PubMed 27553228Ige-Elegbede J, Pilkington P, Gray S, Powell J. Barriers and facilitators of physical activity among adults and older adults from Black and Minority Ethnic groups in the UK: A systematic review of qualitative studies. Prev Med Rep. 2019 Jul 13;15:100952. doi: 10.1016/j.pmedr.2019.100952. eCollection 2019 Sep.
PubMed 31367514
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06170866
- Acronym / sponsor ID
- 23-117S-2
- Conditions
- Parkinson Disease
- Keywords
- Exercise, Peer Support, Hispanic, Parkinson´s Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease.
The main question[s] it aims to answer are:
- What is the feasibility of the peer partner training program?
- What is the feasibility of the peer-supported mobile health physical activity intervention?
- What are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy?
Participants will be asked to:
- Wear a research-grade activity monitor, Actigraph GT9X device for 10 days at the beginning and end of the study.
- Watch 11 educational videos about Parkinson´s disease and exercise and attend two virtual educational sessions.
- Connect with another person with Parkinson´s disease one time a week on a virtual meeting platform for 8 weeks.
- Use Fitbit activity monitors and connect with other participants through the Fitbit application for 8 weeks.
- Attend a weekly online exercise class for 8 weeks with other people with Parkinon´s disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective feasibility trial, single group pre-posttest design and it aims to enroll 20 participants. For this feasibility study, the sample size is comparable to other feasibility trials in populations of individuals with Parkinson disease (Lima \& Rodrigues-de-Paula, 2013; Ellis et al., 2013, Colón-Semenza et al., 2018)17,19,20. This sample size will allow for a comparison in feasibility, acceptability, and appropriateness within and across groups. This sample will allow for identifying trends and preliminary efficacy for this intervention. This study will help to inform an appropriate sample size to adequately power larger samples in future studies
| Arm | Type | Receives |
|---|---|---|
| Social support for physical activity | Experimental | Behavioral: Socially supported physical activitySocially supported (peer, family and group) physical activity group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Idiopathic Parkinson disease,
- Able to walk without the assistance of another person for 10 minutes
- -≥ 29 on Telephone Interview for Cognitive Status (TICS)
- To have a close friend/family member over the age of 18 that would support the participant during the intervention
- -≥ 50 years of age
Key exclusion criteria (4 listed)
- Unstable cardiopulmonary, orthopedic, psychological or metabolic condition
- Atypical Parkinsonism Disorders
- A fall in the last 6 months (that was unrelated to an external force)
- Currently engaging in 150 minutes of mod-vigorous physical activity/week
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 |
|---|---|---|
| Socially supported physical activityUse of a culturally and linguistically tailored intervention that uses mobile health technology plus social support to increase engagement in physical activity in the management of Parkinson´s disease. | Behavioural | Social support for physical activity |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: After completion of the entire intervention (11 weeks)
A standardized measure of acceptability that indicates percent agreement with acceptability of the intervention ranging from 20-100%. Higher scores indicate agreement (better outcome) with the acceptability of the intervention.
Intervention Appropriateness Measure (IAM)
Time frame: After completion of the entire intervention (11 weeks)
A standardized measure of appropriateness that indicates percent agreement with appropriateness of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
Time frame: After completion of the entire intervention (11 weeks)
A standardized measure of feasibility that indicates percent agreement with feasibility of the intervention ranging from 20-100%. Higher scores indicate more agreement (better outcome) with the feasibility of the intervention.
4 secondary outcomes
Objective Measurement of Physical Activity
Time frame: 10 days at baseline and post-intervention (approximately 12 to 14 weeks)
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2)
Time frame: Baseline and post Intervention (approximately 12 to 14 weeks)
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Pre and post intervention (approximately 12 to 14 weeks)
Geriatric Depression Scale-Short Form
Time frame: Pre and post intervention (approximately 12 to 14 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21115958Cheng EM, Tonn S, Swain-Eng R, Factor SA, Weiner WJ, Bever CT Jr; American Academy of Neurology Parkinson Disease Measure Development Panel. Quality improvement in neurology: AAN Parkinson disease quality measures: report of the Quality Measurement and Reporting Subcommittee of the American Academy of Neurology. Neurology. 2010 Nov 30;75(22):2021-7. doi: 10.1212/WNL.0b013e3181ff96dd.
- Background: PubMed 28751362Rogers G, Davies D, Pink J, Cooper P. Parkinson's disease: summary of updated NICE guidance. BMJ. 2017 Jul 27;358:j1951. doi: 10.1136/bmj.j1951. No abstract available.
- Background: PubMed 32925109Alberts JL, Rosenfeldt AB. The Universal Prescription for Parkinson's Disease: Exercise. J Parkinsons Dis. 2020;10(s1):S21-S27. doi: 10.3233/JPD-202100.
- Background: PubMed 34951063Johansson ME, Cameron IGM, Van der Kolk NM, de Vries NM, Klimars E, Toni I, Bloem BR, Helmich RC. Aerobic Exercise Alters Brain Function and Structure in Parkinson's Disease: A Randomized Controlled Trial. Ann Neurol. 2022 Feb;91(2):203-216. doi: 10.1002/ana.26291. Epub 2022 Jan 19.
- Background: PubMed 29228079Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
- Background: PubMed 30003140Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018.
- Background: PubMed 12777365Van Den Eeden SK, Tanner CM, Bernstein AL, Fross RD, Leimpeter A, Bloch DA, Nelson LM. Incidence of Parkinson's disease: variation by age, gender, and race/ethnicity. Am J Epidemiol. 2003 Jun 1;157(11):1015-22. doi: 10.1093/aje/kwg068.
- Background: PubMed 33843687Damron L, Litvan I, Bayram E, Berk S, Siddiqi B, Shill H. Hispanic Perspectives on Parkinson's Disease Care and Research Participation. J Alzheimers Dis. 2021;81(2):809-819. doi: 10.3233/JAD-210231.
- Background: PubMed 28835397Fullard ME, Thibault DP, Hill A, Fox J, Bhatti DE, Burack MA, Dahodwala N, Haberfeld E, Kern DS, Klepitskava OS, Urrea-Mendoza E, Myers P, Nutt J, Rafferty MR, Schwalb JM, Shulman LM, Willis AW; Parkinson Study Group Healthcare Outcomes and Disparities Working Group. Utilization of rehabilitation therapy services in Parkinson disease in the United States. Neurology. 2017 Sep 12;89(11):1162-1169. doi: 10.1212/WNL.0000000000004355. Epub 2017 Aug 23.
- Background: PubMed 10808982Crespo CJ, Smit E, Andersen RE, Carter-Pokras O, Ainsworth BE. Race/ethnicity, social class and their relation to physical inactivity during leisure time: results from the Third National Health and Nutrition Examination Survey, 1988-1994. Am J Prev Med. 2000 Jan;18(1):46-53. doi: 10.1016/s0749-3797(99)00105-1.
- Background: PubMed 30285047Mantri S, Fullard M, Gray SL, Weintraub D, Hubbard RA, Hennessy S, Willis AW. Patterns of Dementia Treatment and Frank Prescribing Errors in Older Adults With Parkinson Disease. JAMA Neurol. 2019 Jan 1;76(1):41-49. doi: 10.1001/jamaneurol.2018.2820.
- Background: PubMed 21942156Hooker SP, Wilcox S, Rheaume CE, Burroughs EL, Friedman DB. Factors related to physical activity and recommended intervention strategies as told by midlife and older African American men. Ethn Dis. 2011 Summer;21(3):261-7.
- 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.
Cristina Colón-Semenza, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socially supported physical activity in people with Parkinson Disease, run by UConn Health 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 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. 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 26 Nov 2025). 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?
Acceptability of Intervention Measure (AIM) (time frame: After completion of the entire intervention (11 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170866, which also lists 32 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 26 Nov 2025.