Middle AgedPhase 1MASTERYNCT04849052
Text Messaging to Increase Activity in Midlife
A Phase 1 study testing MASTERY in people with Middle Aged, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Middle Aged
- What is being tested?
- MASTERY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 16 Sep 2024
- Phase
- Phase 1
- 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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Midlife status (age 45-64 at enrollment).
- Low baseline physical activity (≤150 minutes/week of MVPA]) as initially self-reported via the well-validated IPAQ and then confirmed via accelerometer after 7 days of wear.
Who cannot join
- Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
- An unrelated condition limiting physical activity (e.g., ambulation with a cane or walker, recent or planned surgery, or other condition such that ability to increase moderate to physical activity would be limited).
- Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
- A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
- Inability to speak/write fluently in English.
- No access to a text message-capable phone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults
This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. The MASTERY intervention utilizes two-way text message sessions once-weekly for 12 weeks focusing on performing activities to enhance well being, setting physical activity goals, and learning techniques to reduce midlife-specific stress.
Read the detailed description
This is a randomized controlled pilot trial of a multipronged intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. The messages will focus on 3 distinct areas in the same order each week: (1) well-being-based skills and assigned activities, customized for midlife adults, (2) physical activity content focused on setting and reaching weekly activity goals, and (3) specific skills to manage midlife-related stressors that act as barriers to activity. The primary outcome is objectively measured moderate to vigorous physical activity (MVPA). Secondary outcomes include feasibility and acceptability and other activity-related, psychological, and functional outcomes at 12 weeks.
- Conditions
- Middle Aged
- Being tested
- MASTERY, Attentional Control
- Keywords
- Text Message, Physical Activity, Stress Reduction, Positive Psychology, Well-being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASTERYBehavioural
In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. Furthermore, study trainers will conduct 4 brief calls with participants (Weeks 1, 4, 7, and 12) to introduce the program, assess progress, answer questions, and provide support.
Attentional ControlBehavioural
Participants in the control condition will also receive text messages once per week. To ensure time matching, the program will have 4 phone check-ins (on physical activity) as in MASTERY.
| Study group | Role | What they receive |
|---|---|---|
| MASTERY Intervention | Experimental | Participants will complete a positive psychology activity, work towards a physical activity goal, and use a stress reduction technique, then will complete weekly text message sessions. In the first six weeks, participants will review the activities they performed the prior week, be introduced to new material, choose activities to perform that week, and set a new physical activity goal during the text message sessions. In the final 6 weeks, participants will review progress towards prior goals, set new physical activity goals, and choose positive psychology and stress reduction skills to use that week. Finally, over the course of the program participants will complete three brief calls with a study trainer to discuss progress. Receives: Behavioral: MASTERY |
| Attentional control | Active comparator | Participants will receive the same physical activity component noted in MASTERY along with added messages providing education and guidance about physical activity, from our past work. Control participants will not receive PP or midlife-related content. Receives: Behavioral: Attentional Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moderate-Vigorous Physical Activity [MVPA]
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of MVPA performed per day.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (23)
Proportion of Text Message Sessions Completed
To assess the feasibility of the MASTERY intervention the automated platform will record rates of the proportion of text message sessions in which participants respond and set a physical activity goal. The "proportion of text message sessions completed" will be calculated by dividing the number of sessions in which participants respond and set a physical activity goal by the total number of sessions initiated by the text message program.
Measured: Weekly over 12 weeks.
Mean Utility Ratings of Positive Psychology Text Messages
Participants will rate the utility of the positive psychology text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
Measured: 6 weeks; 12 weeks
Mean Utility Ratings of Physical Activity Text Messages
Participants will rate the utility of the physical activity text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
Measured: 6 weeks; 12 weeks
Mean Utility Ratings of Stress Reduction Text Messages
Participants will rate the utility of the stress reduction text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful). The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
Measured: 6 weeks; 12 weeks
Mean Utility Ratings of Phone Check-ins
Participants will rate the utility of the phone sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
Measured: 12 weeks
Change in Overall Physical Activity
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of steps per day.
Measured: Baseline, 6 weeks, 12 weeks
Change in Sedentary Time
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of sedentary time per day.
Measured: Baseline, 6 weeks, 12 weeks
Change in Self-reported Physical Activity
The International Physical Activity Questionnaire (IPAQ) 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, and change will be assessed by subtracting the baseline score from the 6- and 12-week scores.
Measured: Baseline, 6 weeks, 12 weeks
Change in Positive Affect (Positive Affect Items of the Positive and Negative Affect Schedule [PANAS])
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). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of positive affect.
Measured: Baseline, 6 weeks, 12 weeks
Change in Optimism (Life Orientation Test - Revised [LOT-R])
The Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of optimism.
Measured: Baseline, 6 weeks, 12 weeks
Change in Life Satisfaction (Satisfaction With Life Scale [SWLS])
The Satisfaction with Life Scale is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (Range: 5-35). Higher scores reflect higher levels of life satisfaction. Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Measured: Baseline, 6 weeks, 12 weeks
Change in Depressive Symptoms (Hospital Anxiety and Depression Scale Depression Subscale [HADS-D])
The Hospital Anxiety and Depression Scale depression subscale (HADS-D) 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). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of depression.
Measured: Baseline, 6 weeks, 12 weeks
Change in Anxiety (Hospital Anxiety and Depression Scale Anxiety Subscale [HADS-A])
The Hospital Anxiety and Depression Scale (HADS)-anxiety 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). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of anxiety.
Measured: Baseline, 6 weeks, 12 weeks
Change in Exercise Self-efficacy (Self-efficacy for Exercise Scale [SES])
The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. (Range: 0-90). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of self-efficacy.
Measured: Baseline, 6 weeks, 12 weeks
Change in Perceived Constraints (Perceived Constraints Subscale of the MIDUS Sense of Control Measure)
The 8-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - perceived constraints (Range: 8-56). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Lower scores indicate higher levels of perceived constraints.
Measured: Baseline, 6 weeks, 12 weeks
Change in Personal Mastery (Personal Mastery Subscale of the MIDUS Sense of Control Measure)
The 4-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - personal mastery (Range: 4-28). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of personal mastery.
Measured: Baseline, 6 weeks, 12 weeks
Change in Function (General Health Questionnaire-12 [GHQ-12])
The General Health Questionnaire-12 consists of 12 items and assesses function (Range: 0-36). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate worse functional status.
Measured: Baseline, 6 weeks, 12 weeks
Change in Mental Health Related Quality of Life (Medical Outcomes Study Short Form-12 Mental Component Score [SF-12 MCS])
Mental health related quality of life will be assessed via the mental component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.
Measured: Baseline, 6 weeks, 12 weeks
Change in Physical Health Related Quality of Life (Medical Outcomes Study Short Form-12 Physical Component Score [SF-12 PCS])
Physical health related quality of life will be assessed via the physical component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.
Measured: Baseline, 6 weeks, 12 weeks
Change in Body Weight
Body weight (in kilograms) will be measured by nurses. Change will be calculated by subtracting the weight at baseline from the weight at 6 and 12 weeks.
Measured: Baseline, 6 weeks, 12 weeks
Change in Body Mass Index (in Kilograms Per Square Meter)
Height and weight will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Measured: Baseline, 6 weeks, 12 weeks
Change in Waist Circumference (in Centimeters)
Waist circumference will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Measured: Baseline, 6 weeks, 12 weeks
Change in Systolic Blood Pressure (Millimeters of Mercury)
Blood pressure will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Sep 2021
- Primary completion16 Sep 2024
- Study completion16 Sep 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.
- Other trials for Middle AgedStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-blinded study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849052
- Sponsor's protocol ID
- 2021P000881
- Other IDs
- P30AG048785
- Acronym
- MASTERY
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2021
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults
- ClinicalTrials.gov ID
- NCT04849052
- Acronym / sponsor ID
- MASTERY / 2021P000881
- Conditions
- Middle Aged
- Keywords
- Text Message, Physical Activity, Stress Reduction, Positive Psychology, Well-being
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. The MASTERY intervention utilizes two-way text message sessions once-weekly for 12 weeks focusing on performing activities to enhance well being, setting physical activity goals, and learning techniques to reduce midlife-specific stress.
Detailed description
This is a randomized controlled pilot trial of a multipronged intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. The messages will focus on 3 distinct areas in the same order each week: (1) well-being-based skills and assigned activities, customized for midlife adults, (2) physical activity content focused on setting and reaching weekly activity goals, and (3) specific skills to manage midlife-related stressors that act as barriers to activity. The primary outcome is objectively measured moderate to vigorous physical activity (MVPA). Secondary outcomes include feasibility and acceptability and other activity-related, psychological, and functional outcomes at 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blinded study
| Arm | Type | Receives |
|---|---|---|
| MASTERY Intervention | Experimental | Behavioral: MASTERYParticipants will complete a positive psychology activity, work towards a physical activity goal, and use a stress reduction technique, then will complete weekly text message sessions. In the first six weeks, participants will review the activities they performed the prior week, be introduced to new material, choose activities to perform that week, and set a new physical activity goal during the text message sessions. In the final 6 weeks, participants will review progress towards prior goals, set new physical activity goals, and choose positive psychology and stress reduction skills to use that week. Finally, over the course of the program participants will complete three brief calls with a study trainer to discuss progress. |
| Attentional control | Active comparator | Behavioral: Attentional ControlParticipants will receive the same physical activity component noted in MASTERY along with added messages providing education and guidance about physical activity, from our past work. Control participants will not receive PP or midlife-related content. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Midlife status (age 45-64 at enrollment).
- Low baseline physical activity (≤150 minutes/week of MVPA]) as initially self-reported via the well-validated IPAQ and then confirmed via accelerometer after 7 days of wear.
Key exclusion criteria (6 listed)
- Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
- An unrelated condition limiting physical activity (e.g., ambulation with a cane or walker, recent or planned surgery, or other condition such that ability to increase moderate to physical activity would be limited).
- Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
- A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
- Inability to speak/write fluently in English.
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 |
|---|---|---|
| MASTERYIn MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. Furthermore, study trainers will conduct 4 brief calls with participants (Weeks 1, 4, 7, and 12) to introduce the program, assess progress, answer questions, and provide support. | Behavioural | MASTERY Intervention |
| Attentional ControlParticipants in the control condition will also receive text messages once per week. To ensure time matching, the program will have 4 phone check-ins (on physical activity) as in MASTERY. | Behavioural | Attentional control |
Primary outcome
Change in Moderate-Vigorous Physical Activity [MVPA]
Time frame: Baseline, 6 weeks, 12 weeks
ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of MVPA performed per day.
23 secondary outcomes
Proportion of Text Message Sessions Completed
Time frame: Weekly over 12 weeks.
Mean Utility Ratings of Positive Psychology Text Messages
Time frame: 6 weeks; 12 weeks
Mean Utility Ratings of Physical Activity Text Messages
Time frame: 6 weeks; 12 weeks
Mean Utility Ratings of Stress Reduction Text Messages
Time frame: 6 weeks; 12 weeks
Mean Utility Ratings of Phone Check-ins
Time frame: 12 weeks
Change in Overall Physical Activity
Time frame: Baseline, 6 weeks, 12 weeks
Change in Sedentary Time
Time frame: Baseline, 6 weeks, 12 weeks
Change in Self-reported Physical Activity
Time frame: Baseline, 6 weeks, 12 weeks
Change in Positive Affect (Positive Affect Items of the Positive and Negative Affect Schedule [PANAS])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Optimism (Life Orientation Test - Revised [LOT-R])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Life Satisfaction (Satisfaction With Life Scale [SWLS])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Depressive Symptoms (Hospital Anxiety and Depression Scale Depression Subscale [HADS-D])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Anxiety (Hospital Anxiety and Depression Scale Anxiety Subscale [HADS-A])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Exercise Self-efficacy (Self-efficacy for Exercise Scale [SES])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Perceived Constraints (Perceived Constraints Subscale of the MIDUS Sense of Control Measure)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Personal Mastery (Personal Mastery Subscale of the MIDUS Sense of Control Measure)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Function (General Health Questionnaire-12 [GHQ-12])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Mental Health Related Quality of Life (Medical Outcomes Study Short Form-12 Mental Component Score [SF-12 MCS])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Physical Health Related Quality of Life (Medical Outcomes Study Short Form-12 Physical Component Score [SF-12 PCS])
Time frame: Baseline, 6 weeks, 12 weeks
Change in Body Weight
Time frame: Baseline, 6 weeks, 12 weeks
Change in Body Mass Index (in Kilograms Per Square Meter)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Waist Circumference (in Centimeters)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Systolic Blood Pressure (Millimeters of Mercury)
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeff C Huffman, MD 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 Phase 1 study testing MASTERY in people with Middle Aged, 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 2 inclusion and 6 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 2 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 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?
Change in Moderate-Vigorous Physical Activity [MVPA] (time frame: Baseline, 6 weeks, 12 weeks). 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 2 Sep 2026.