Type 1 DiabetesActivateNCT05319600
Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes
A study testing Diabetes behavior change skills training and Physical activity promotion program in people with Type 1 Diabetes, run by University of Vermont at 1 site in United States.
Trial summary
This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Diabetes behavior change skills training and Physical activity promotion program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 21 Mar 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 13-17 years old
- At least 18 months post-diagnosis for type 1 diabetes
- Parent reported moderate to no physical activity for adolescent
- Ability to complete measures and intervention program in English
- Access to broadband or cellular internet
- Resides in and receives healthcare in the United States
Who cannot join
- Ward of state
- Active psychosis
- Severe medical or psychiatric illness that limit participation (including any contraindications for physical activity)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?
This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1 diabetes. The researchers have a recruitment goal of 30 participants, but will enroll beyond 30 to address any withdrawal and ensure sample size is met. A primary goal of the study is assessing the feasibility and acceptability of the program, which combines two previously piloted components. Then, the investigators will compare the 12-week Activate program to a treatment as usual control group on proximal outcomes of behavior-change skills and daily active minutes. The investigators will also explore the impact of the Activate program on secondary mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills training and physical activity intervention will be acceptable, and effective at improving behavior-change skills and daily active minutes, as well as other mechanisms and outcomes linked with later type 1 diabetes health disparities.
Read the detailed description
Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health disparities in glycemic outcomes in adolescence and cardiovascular disease and diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death. Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that adolescents face with achieving optimal glycemic levels (<20% nationally meet American Diabetes Association HbA1c targets), this is a critical population to support in health behavior change via psychosocial intervention during adolescence. Unfortunately, existing evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust multi-system approaches, have demonstrated limited efficacy for behavior change that results in improved glycemic outcomes and none have directly targeted cardiovascular health outside of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention innovation by testing a nationally-scalable diabetes behavior-change skills training and physical activity intervention program to improve glycemic outcomes and decrease cardiovascular disease risks for adolescents with type 1 diabetes including those with socioeconomic disadvantage .
In this study the researchers will conduct a two-arm randomized trial with 30 adolescents with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control group. This study has 2 primary aims. First, the investigators will assess acceptability of the Activate program by examining participant engagement with the Activate program components. To assess the preliminary efficacy of the Activate program the investigators will examine changes in proximal outcomes of behavior-change skills (goal setting, problem-solving, and coping skills), and active minutes compared between treatment and control groups from baseline to a 12-week follow-up assessment. Second, the investigators will explore the impact of the Activate program on secondary mechanisms and outcomes linked with longer-term type 1 diabetes health disparities.
- Conditions
- Type 1 Diabetes
- Being tested
- Diabetes behavior change skills training, Physical activity promotion program
- Keywords
- adolescents, physical activity intervention, diabetes self-management, behavior-change skills training
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes behavior change skills trainingBehavioural
Behavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting.
Physical activity promotion programBehavioural
The physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals. Receives: Behavioral: Diabetes behavior change skills training; Behavioral: Physical activity promotion program |
| Treatment as usual - Control | No intervention | This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Physical Activity
The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs.
Measured: daily for all days from week 1 through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start18 Apr 2022
- Primary completion20 Jul 2023
- Study completion21 Mar 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 (9)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adolescents (aged 13-17) diagnosed with type 1 diabetes will all complete a baseline assessment where they will be randomized to complete a 12-week physical activity and behavior-change skills training intervention, or to follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wrist watch to track their physical activity over the 12-week study period. Follow-up assessments for all participants will take place after 12 weeks.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Amy Hughes Lansing, University of Vermont
- Investigators
- Amy Hughes Lansing, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319600
- Sponsor's protocol ID
- STUDY00001482
- Other IDs
- P20GM103644
- Acronym
- Activate
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.
Publications
Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
PubMed 23340893Clements MA, Foster NC, Maahs DM, Schatz DA, Olson BA, Tsalikian E, Lee JM, Burt-Solorzano CM, Tamborlane WV, Chen V, Miller KM, Beck RW; T1D Exchange Clinic Network. Hemoglobin A1c (HbA1c) changes over time among adolescent and young adult participants in the T1D exchange clinic registry. Pediatr Diabetes. 2016 Aug;17(5):327-36. doi: 10.1111/pedi.12295. Epub 2015 Jul 8.
PubMed 26153338Menzin J, Korn JR, Cohen J, Lobo F, Zhang B, Friedman M, Neumann PJ. Relationship between glycemic control and diabetes-related hospital costs in patients with type 1 or type 2 diabetes mellitus. J Manag Care Pharm. 2010 May;16(4):264-75. doi: 10.18553/jmcp.2010.16.4.264.
PubMed 20433217Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
PubMed 8040759Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting components in pediatric type 1 diabetes: meta-analysis of their impact on glycemic control. Diabetes Care. 2010 Jul;33(7):1658-64. doi: 10.2337/dc09-2268.
PubMed 20587726Ellis DA, Templin T, Naar-King S, Frey MA, Cunningham PB, Podolski CL, Cakan N. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):168-74. doi: 10.1037/0022-006X.75.1.168.
PubMed 17295576Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005.
PubMed 30418521Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?
- ClinicalTrials.gov ID
- NCT05319600
- Acronym / sponsor ID
- Activate / STUDY00001482
- Conditions
- Type 1 Diabetes
- Keywords
- adolescents, physical activity intervention, diabetes self-management, behavior-change skills training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1 diabetes. The researchers have a recruitment goal of 30 participants, but will enroll beyond 30 to address any withdrawal and ensure sample size is met. A primary goal of the study is assessing the feasibility and acceptability of the program, which combines two previously piloted components. Then, the investigators will compare the 12-week Activate program to a treatment as usual control group on proximal outcomes of behavior-change skills and daily active minutes. The investigators will also explore the impact of the Activate program on secondary mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills training and physical activity intervention will be acceptable, and effective at improving behavior-change skills and daily active minutes, as well as other mechanisms and outcomes linked with later type 1 diabetes health disparities.
Detailed description
Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health disparities in glycemic outcomes in adolescence and cardiovascular disease and diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death. Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that adolescents face with achieving optimal glycemic levels (<20% nationally meet American Diabetes Association HbA1c targets), this is a critical population to support in health behavior change via psychosocial intervention during adolescence. Unfortunately, existing evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust multi-system approaches, have demonstrated limited efficacy for behavior change that results in improved glycemic outcomes and none have directly targeted cardiovascular health outside of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention innovation by testing a nationally-scalable diabetes behavior-change skills training and physical activity intervention program to improve glycemic outcomes and decrease cardiovascular disease risks for adolescents with type 1 diabetes including those with socioeconomic disadvantage .
In this study the researchers will conduct a two-arm randomized trial with 30 adolescents with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control group. This study has 2 primary aims. First, the investigators will assess acceptability of the Activate program by examining participant engagement with the Activate program components. To assess the preliminary efficacy of the Activate program the investigators will examine changes in proximal outcomes of behavior-change skills (goal setting, problem-solving, and coping skills), and active minutes compared between treatment and control groups from baseline to a 12-week follow-up assessment. Second, the investigators will explore the impact of the Activate program on secondary mechanisms and outcomes linked with longer-term type 1 diabetes health disparities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adolescents (aged 13-17) diagnosed with type 1 diabetes will all complete a baseline assessment where they will be randomized to complete a 12-week physical activity and behavior-change skills training intervention, or to follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wrist watch to track their physical activity over the 12-week study period. Follow-up assessments for all participants will take place after 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Diabetes behavior change skills training, Behavioral: Physical activity promotion programThis arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals. |
| Treatment as usual - Control | No intervention | –This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 13-17 years old
- At least 18 months post-diagnosis for type 1 diabetes
- Parent reported moderate to no physical activity for adolescent
- Ability to complete measures and intervention program in English
- Access to broadband or cellular internet
Key exclusion criteria (3 listed)
- Ward of state
- Active psychosis
- Severe medical or psychiatric illness that limit participation (including any contraindications for physical activity)
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 |
|---|---|---|
| Diabetes behavior change skills trainingBehavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting. | Behavioural | Intervention |
| Physical activity promotion programThe physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker. | Behavioural | Intervention |
Primary outcome
Change From Baseline in Physical Activity
Time frame: daily for all days from week 1 through week 12
The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23340893Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
- Background: PubMed 26153338Clements MA, Foster NC, Maahs DM, Schatz DA, Olson BA, Tsalikian E, Lee JM, Burt-Solorzano CM, Tamborlane WV, Chen V, Miller KM, Beck RW; T1D Exchange Clinic Network. Hemoglobin A1c (HbA1c) changes over time among adolescent and young adult participants in the T1D exchange clinic registry. Pediatr Diabetes. 2016 Aug;17(5):327-36. doi: 10.1111/pedi.12295. Epub 2015 Jul 8.
- Background: PubMed 20433217Menzin J, Korn JR, Cohen J, Lobo F, Zhang B, Friedman M, Neumann PJ. Relationship between glycemic control and diabetes-related hospital costs in patients with type 1 or type 2 diabetes mellitus. J Manag Care Pharm. 2010 May;16(4):264-75. doi: 10.18553/jmcp.2010.16.4.264.
- Background: PubMed 8040759Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 20587726Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting components in pediatric type 1 diabetes: meta-analysis of their impact on glycemic control. Diabetes Care. 2010 Jul;33(7):1658-64. doi: 10.2337/dc09-2268.
- Background: PubMed 17295576Ellis DA, Templin T, Naar-King S, Frey MA, Cunningham PB, Podolski CL, Cakan N. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):168-74. doi: 10.1037/0022-006X.75.1.168.
- Background: PubMed 30418521Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Individual participant dataSharing planned: No. Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.
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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.
Amy Hughes Lansing, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes behavior change skills training and Physical activity promotion program in people with Type 1 Diabetes, run by University of Vermont 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 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: finished, as of the sponsor's last update on 26 Mar 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 24 Dec 2024). 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?
Change From Baseline in Physical Activity (time frame: daily for all days from week 1 through week 12). 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 NCT05319600, which also lists 9 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 Mar 2025.