Physical InactivityVia HabitNCT07848178
Roybal Via Habit Formation
A study testing ViaHabit in people with Physical Inactivity and Sedentary Lifestlye, run by Louisiana State University and A&M College at 1 site in United States.
Trial summary
This pilot study will develop and evaluate ViaHabit, a personalized walking intervention designed to promote physical activity habit formation among sedentary midlife adults (ages 45-65). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Physical Inactivity, Sedentary Lifestlye
- What is being tested?
- ViaHabit
- 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 Oct 2026to 30 Jun 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 65 years.
- Reports no leisure-time physical activity during the past month and engages in <400 MET-minutes/week of physical activity as assessed by the IPAQ-Short Form.
- Has competing role demands, defined as ≥10 hours/week of paid work, caregiving, parenting, or volunteer activities.
- Owns an iPhone (iOS smartphone) with reliable internet access and is willing to use study-related mobile applications and wearable devices.
- Able to walk without assistance.
- Uses, or is willing to use, a digital calendar application and share de-identified event timing data with the study team.
- Able to understand study procedures and provide informed consent.
Who cannot join
- Plans to relocate or engage in extended travel during the next 3 months.
- Pregnant or planning to become pregnant during the study period.
- Currently participating in another physical activity or behavioral intervention study.
- Has a medical condition that may limit safe participation in walking, impair the ability to provide informed consent, or interfere with study adherence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberly Allen, MA contact
United States1 site
Louisiana State University School of Kinesiology
Baton Rouge, Louisiana, 70803
About this study
Official title: Automata Modeling Approach to Identify and Pilot-Test Receptive Windows for Physical Activity Habit Formation in Midlife Adults
This pilot study will develop and evaluate ViaHabit, a personalized walking intervention designed to promote physical activity habit formation among sedentary midlife adults (ages 45-65). During an initial 2-week observation period, participants' daily routines will be characterized using data collected from wearable devices, smartphones, and digital calendars. Personalized models will identify routine transitions, defined as periods between everyday activities, that may serve as receptive opportunities for initiating physical activity. Participants will then complete a 4-week intervention in which they create individualized "if-then" action plans linking routine transitions to a 15-minute brisk walk and receive automated smartwatch prompts at selected cue times. The study will assess the feasibility and acceptability of identifying routine transitions and delivering timely physical activity prompts, while exploring changes in walking behavior, habit strength, and physical activity engagement.
Read the detailed description
This pilot study will develop and evaluate ViaHabit, a personalized, cue-based walking intervention designed to promote physical activity habit formation among sedentary midlife adults. The study is based on the premise that routine transitions, defined as periods when one daily activity has ended and another has not yet begun, may represent receptive opportunities for initiating new health behaviors. The long-term goal is to increase physical activity during midlife, a critical period for reducing risk factors associated with cognitive decline and dementia.
The study will enroll approximately 10 adults aged 45 to 65 years who are physically inactive and experience competing work, caregiving, parenting, or other role demands. Participants must own or be willing to use an iPhone-compatible device and be able to walk without assistance.
The study uses a 12-week, single-arm, within-subject design consisting of two phases. During Phase 1 (2-week observation period), participants will use an Apple Watch, smartphone applications, and digital calendar tools to collect multimodal data on daily behavior, including physical activity, location patterns, calendar events, and contextual information. These data will be used to develop individualized computational models of participants' daily routines and identify recurring routine transitions that may serve as effective cues for physical activity initiation.
Following model development, participants will enter Phase 2 (4-week intervention period). In a virtual coaching session, participants will identify up to two routine transitions that can function as cues for walking and will create personalized "if-then" action plans linking those cues to a 15-minute brisk walk. Automated smartwatch notifications will be delivered when the selected routine transitions occur to increase cue salience and support initiation of physical activity. Walking behavior will be continuously monitored through wearable devices.
The primary objectives are to evaluate the feasibility of identifying individualized routine transitions from passive sensing data and the feasibility and acceptability of delivering a personalized, cue-based walking intervention anchored to those transitions. Secondary and exploratory outcomes include adherence to study procedures, walking behavior, cue-triggered behavioral enactment, habit strength, physical activity levels, and cognitive function. Habit strength will be assessed using measures of behavioral automaticity, while cognitive function will be evaluated through mobile cognitive assessments administered during the intervention period.
The findings will inform the development of scalable, data-driven interventions that leverage naturally occurring daily routines to support physical activity habit formation and healthy aging.
- Conditions
- Physical Inactivity, Sedentary Lifestlye
- Being tested
- ViaHabit
- Keywords
- Habit Formation, Physical Activity, Behavioral Intervention, Mobile Health (mHealth), Smartwatch, Physical Activity Promotion, Midlife Adults, Behavioral Automaticity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViaHabitBehavioural
ViaHabit is a personalized, cue-based walking intervention designed to promote physical activity habit formation in sedentary midlife adults. Following a 2-week observation period, individualized routine models are developed using data collected from wearable devices, smartphones, and digital calendars. Participants then complete a coaching session to identify up to two routine transitions that can serve as cues for physical activity and develop personalized if-then action plans linking each cue to a 15-minute brisk walk. During the 4-week intervention period, automated smartwatch notifications are delivered at the selected routine-transition cues to increase cue salience and support initiation of walking behavior. The intervention aims to strengthen cue-behavior associations through repeated pairing of routine completion cues with walking, thereby increasing behavioral automaticity and physical activity participation.
| Study group | Role | What they receive |
|---|---|---|
| ViaHabit Intervention | Experimental | Participants complete a 2-week observation period during which individualized routine models are developed using wearable, smartphone, and calendar data, followed by a 4-week ViaHabit intervention consisting of routine-transition cue selection, if-then action planning, and automated smartwatch prompts to support initiation of 15-minute brisk walks. Receives: Behavioral: ViaHabit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibliity of the ViaHabit Intervention - Recruitment
Feasibility will be assessed by participant recruitment rates.
Measured: Week 8 (end of intervention)
Feasibliity of the ViaHabit Intervention - Retention
Feasibility will be assessed by participant retention rates.
Measured: Week 8 (end of intervention)
Feasibliity of the ViaHabit Intervention - Data Collection
Feasibility will be assessed by participant completion of Phase 1 data collection.
Measured: Week 8 (end of intervention)
Secondary outcomes (1)
Habit Strength for Walking
Habit strength will be assessed using the 4-item Self-Reported Behavioral Automaticity Index (SRBAI), adapted to each participant's selected routine-transition cue. Higher scores indicate greater automaticity of walking behavior in response to the cue.
Measured: Baseline and weekly during the 4 week intervention period through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a personalized computational modeling approach to identify routine transitions that may serve as opportunities for physical activity habit formation. During a 2-week observation period, participants' behavioral and contextual data are collected using an Apple Watch, smartphone, and digital calendar. These data are used to develop an individualized routine automaton model that characterizes recurring daily routines and transitions between routine states. The model identifies periods when one routine has ended and another has not yet begun, which are hypothesized to be receptive windows for initiating walking behavior. During the intervention phase, participants select routine-transition cues and develop if-then action plans linking those cues to a 15-minute brisk walk. Automated smartwatch prompts are delivered at identified transition points to enhance cue salience and support habit formation through repeated cue-behavior pairing.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Shiyu Li, PhD, Louisiana State University and A&M College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848178
- Sponsor's protocol ID
- AM260787
- Other IDs
- AM260787
- Acronym
- Via Habit
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automata Modeling Approach to Identify and Pilot-Test Receptive Windows for Physical Activity Habit Formation in Midlife Adults
- ClinicalTrials.gov ID
- NCT07848178
- Acronym / sponsor ID
- Via Habit / AM260787
- Conditions
- Physical Inactivity, Sedentary Lifestlye
- Keywords
- Habit Formation, Physical Activity, Behavioral Intervention, Mobile Health (mHealth), Smartwatch, Physical Activity Promotion, Midlife Adults, Behavioral Automaticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
This pilot study will develop and evaluate ViaHabit, a personalized walking intervention designed to promote physical activity habit formation among sedentary midlife adults (ages 45-65). During an initial 2-week observation period, participants' daily routines will be characterized using data collected from wearable devices, smartphones, and digital calendars. Personalized models will identify routine transitions, defined as periods between everyday activities, that may serve as receptive opportunities for initiating physical activity. Participants will then complete a 4-week intervention in which they create individualized "if-then" action plans linking routine transitions to a 15-minute brisk walk and receive automated smartwatch prompts at selected cue times. The study will assess the feasibility and acceptability of identifying routine transitions and delivering timely physical activity prompts, while exploring changes in walking behavior, habit strength, and physical activity engagement.
Detailed description
This pilot study will develop and evaluate ViaHabit, a personalized, cue-based walking intervention designed to promote physical activity habit formation among sedentary midlife adults. The study is based on the premise that routine transitions, defined as periods when one daily activity has ended and another has not yet begun, may represent receptive opportunities for initiating new health behaviors. The long-term goal is to increase physical activity during midlife, a critical period for reducing risk factors associated with cognitive decline and dementia.
The study will enroll approximately 10 adults aged 45 to 65 years who are physically inactive and experience competing work, caregiving, parenting, or other role demands. Participants must own or be willing to use an iPhone-compatible device and be able to walk without assistance.
The study uses a 12-week, single-arm, within-subject design consisting of two phases. During Phase 1 (2-week observation period), participants will use an Apple Watch, smartphone applications, and digital calendar tools to collect multimodal data on daily behavior, including physical activity, location patterns, calendar events, and contextual information. These data will be used to develop individualized computational models of participants' daily routines and identify recurring routine transitions that may serve as effective cues for physical activity initiation.
Following model development, participants will enter Phase 2 (4-week intervention period). In a virtual coaching session, participants will identify up to two routine transitions that can function as cues for walking and will create personalized "if-then" action plans linking those cues to a 15-minute brisk walk. Automated smartwatch notifications will be delivered when the selected routine transitions occur to increase cue salience and support initiation of physical activity. Walking behavior will be continuously monitored through wearable devices.
The primary objectives are to evaluate the feasibility of identifying individualized routine transitions from passive sensing data and the feasibility and acceptability of delivering a personalized, cue-based walking intervention anchored to those transitions. Secondary and exploratory outcomes include adherence to study procedures, walking behavior, cue-triggered behavioral enactment, habit strength, physical activity levels, and cognitive function. Habit strength will be assessed using measures of behavioral automaticity, while cognitive function will be evaluated through mobile cognitive assessments administered during the intervention period.
The findings will inform the development of scalable, data-driven interventions that leverage naturally occurring daily routines to support physical activity habit formation and healthy aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a personalized computational modeling approach to identify routine transitions that may serve as opportunities for physical activity habit formation. During a 2-week observation period, participants' behavioral and contextual data are collected using an Apple Watch, smartphone, and digital calendar. These data are used to develop an individualized routine automaton model that characterizes recurring daily routines and transitions between routine states. The model identifies periods when one routine has ended and another has not yet begun, which are hypothesized to be receptive windows for initiating walking behavior. During the intervention phase, participants select routine-transition cues and develop if-then action plans linking those cues to a 15-minute brisk walk. Automated smartwatch prompts are delivered at identified transition points to enhance cue salience and support habit formation through repeated cue-behavior pairing.
| Arm | Type | Receives |
|---|---|---|
| ViaHabit Intervention | Experimental | Behavioral: ViaHabitParticipants complete a 2-week observation period during which individualized routine models are developed using wearable, smartphone, and calendar data, followed by a 4-week ViaHabit intervention consisting of routine-transition cue selection, if-then action planning, and automated smartwatch prompts to support initiation of 15-minute brisk walks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 45 to 65 years.
- Reports no leisure-time physical activity during the past month and engages in <400 MET-minutes/week of physical activity as assessed by the IPAQ-Short Form.
- Has competing role demands, defined as ≥10 hours/week of paid work, caregiving, parenting, or volunteer activities.
- Owns an iPhone (iOS smartphone) with reliable internet access and is willing to use study-related mobile applications and wearable devices.
- Able to walk without assistance.
Key exclusion criteria (4 listed)
- Plans to relocate or engage in extended travel during the next 3 months.
- Pregnant or planning to become pregnant during the study period.
- Currently participating in another physical activity or behavioral intervention study.
- Has a medical condition that may limit safe participation in walking, impair the ability to provide informed consent, or interfere with study adherence.
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 |
|---|---|---|
| ViaHabitViaHabit is a personalized, cue-based walking intervention designed to promote physical activity habit formation in sedentary midlife adults. Following a 2-week observation period, individualized routine models are developed using data collected from wearable devices, smartphones, and digital calendars. Participants then complete a coaching session to identify up to two routine transitions that can serve as cues for physical activity and develop personalized if-then action plans linking each cue to a 15-minute brisk walk. During the 4-week intervention period, automated smartwatch notifications are delivered at the selected routine-transition cues to increase cue salience and support initiation of walking behavior. The intervention aims to strengthen cue-behavior associations through repeated pairing of routine completion cues with walking, thereby increasing behavioral automaticity and physical activity participation. | Behavioural | ViaHabit Intervention |
Primary outcome
Feasibliity of the ViaHabit Intervention - Recruitment
Time frame: Week 8 (end of intervention)
Feasibility will be assessed by participant recruitment rates.
Feasibliity of the ViaHabit Intervention - Retention
Time frame: Week 8 (end of intervention)
Feasibility will be assessed by participant retention rates.
Feasibliity of the ViaHabit Intervention - Data Collection
Time frame: Week 8 (end of intervention)
Feasibility will be assessed by participant completion of Phase 1 data collection.
1 secondary outcome
Habit Strength for Walking
Time frame: Baseline and weekly during the 4 week intervention period through Week 8
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 29 Sep 2026.
- 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.
Kimberly Allen, MA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViaHabit in people with Physical Inactivity and Sedentary Lifestlye, run by Louisiana State University and A&M College 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 7 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: opening soon, as of the sponsor's last update on 29 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.
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 Shiyu Li, PhD (225-578-0977, sli40@lsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibliity of the ViaHabit Intervention - Recruitment (time frame: Week 8 (end of intervention)). 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?
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 29 Sep 2026.