Physical InactivityNCT05980676
Starting a Weekday Outdoor Walking (WOW) Routine
A study testing Personalized Two-Week Email-Based Program in people with Physical Inactivity, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial summary
The purpose of this 4-week randomized study is to evaluate the effect of personalized plans plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily step count. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Personalized Two-Week Email-Based Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- Indicates desire to increases daily step count
- Indicates having a safe and convenient location to conduct outdoor walks
- Uses an iPhone
- Can upload step count screenshots
- Intends to bring their phone on their walks
- Has email address that they check ~daily
- Has an average daily step count for month prior to enrolling <5,000/day, as determined by phone step data (screenshot submitted for verification).
Who cannot join
- Any medical issues that could be worsened by walking. This will be assessed via the Physical Activity Readiness Questionnaire (PAR-Q), minus the question asking the participant if they take medication for blood pressure or a heart condition. Researchers feel this question is overly cautious and would exclude many individuals who would otherwise qualify and benefit from walking regularly.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)
Auburn, Alabama, 36832
About this study
Official title: Starting a Weekday Outdoor Walking (WOW) Routine: A Randomized Controlled Study
The purpose of this 4-week randomized study is to evaluate the effect of personalized plans plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150 participants will be recruited via paid ads on Facebook and Instagram. Participants will be randomized to a control group, an intervention group without eCoaching, and an intervention group with eCoaching. The control group will be told that they can work a WOW routine on their own, with the opportunity to take part in the intervention after completing the 4-week follow-up assessment. Both intervention groups will complete an activity that will guide the creation of habit plan (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The primary outcome of interest is change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups. It is hypothesized that the intervention groups will result in an increase in daily step count, as compared to the control group. Secondary outcomes include habit strength at one-month follow-up and change in self-reported sleep quality and self-efficacy from baseline to follow-up.
Read the detailed description
The purpose of this 4-week randomized study is to evaluate the effect of personalized implementation intentions plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150 participants will be recruited via paid ads on Facebook and Instagram. Participants will be randomized (1:1:1) to a control group, an intervention group without eCoaching, and an intervention group with eCoaching. The control group will be told that they can work a WOW routine on their own, with the opportunity to take part in the intervention after completing the 4-week follow-up assessment. Both intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The primary outcome of interest is change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups. It is hypothesized that the intervention groups will result in a statistically significant increase in daily step count, as compared to the control group. Secondary outcomes include instigation habit strength (via Self-Report Behavioral Automaticity Index) at one-month follow-up and change in self-reported sleep quality (via the Single Items Sleep Quality Scale) and general self-efficacy (via General Self-Efficacy Scale) from baseline to follow-up.
- Conditions
- Physical Inactivity
- Being tested
- Personalized Two-Week Email-Based Program
- Keywords
- Behavioral health, Health behavior change, Habit formation, Implementation intentions
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Two-Week Email-Based ProgramBehavioural
Both intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The Coached group will be able to reply to the emails to give feedback, ask questions, and receive additional support.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be told that they can work a WOW routine on their own, with the opportunity to complete the intervention after completing the 4-week follow-up assessment. |
| No-Coach | Experimental | This is a fully automated intervention. The No-Coach group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. They will not be able to reply to the emails for support. Receives: Behavioral: Personalized Two-Week Email-Based Program |
| Coached | Experimental | This is a semi-automated intervention. The Coached group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. Prompts will be added to the end of each email such that these participants can respond to give feedback, ask questions, and receive additional support from a (human) coach. Receives: Behavioral: Personalized Two-Week Email-Based Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily step count
Change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups.
Measured: Four weeks
Secondary outcomes (3)
Instigation habit strength
Instigation habit strength measured via Self-Report Behavioral Automaticity Index at one-month follow-up. Scores range from 4-20, with a higher score indicating greater habit strength.
Measured: Four weeks
Change in sleep quality
Change in self-reported sleep quality, measured via the Single Items Sleep Quality Scale, from baseline to follow-up. Scores range from 0=terrible sleep to 10=excellent sleep.
Measured: Four weeks
Change in general self-efficacy
Change in general self-efficacy, measured via the New General Self-Efficacy Scale from baseline to follow-up. Scores range from 8-40, with a higher score indicating higher general self-efficacy.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start11 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua C Hollingsworth, PharmD, PhD, Principal investigator, Assistant Professor at VCOM-Auburn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980676
- Sponsor's protocol ID
- 2023-014
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2023
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting a Weekday Outdoor Walking (WOW) Routine: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05980676
- Acronym / sponsor ID
- 2023-014
- Conditions
- Physical Inactivity
- Keywords
- Behavioral health, Health behavior change, Habit formation, Implementation intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 8 Aug 2023 (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.
The purpose of this 4-week randomized study is to evaluate the effect of personalized plans plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150 participants will be recruited via paid ads on Facebook and Instagram. Participants will be randomized to a control group, an intervention group without eCoaching, and an intervention group with eCoaching. The control group will be told that they can work a WOW routine on their own, with the opportunity to take part in the intervention after completing the 4-week follow-up assessment. Both intervention groups will complete an activity that will guide the creation of habit plan (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The primary outcome of interest is change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups. It is hypothesized that the intervention groups will result in an increase in daily step count, as compared to the control group. Secondary outcomes include habit strength at one-month follow-up and change in self-reported sleep quality and self-efficacy from baseline to follow-up.
Detailed description
The purpose of this 4-week randomized study is to evaluate the effect of personalized implementation intentions plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150 participants will be recruited via paid ads on Facebook and Instagram. Participants will be randomized (1:1:1) to a control group, an intervention group without eCoaching, and an intervention group with eCoaching. The control group will be told that they can work a WOW routine on their own, with the opportunity to take part in the intervention after completing the 4-week follow-up assessment. Both intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The primary outcome of interest is change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups. It is hypothesized that the intervention groups will result in a statistically significant increase in daily step count, as compared to the control group. Secondary outcomes include instigation habit strength (via Self-Report Behavioral Automaticity Index) at one-month follow-up and change in self-reported sleep quality (via the Single Items Sleep Quality Scale) and general self-efficacy (via General Self-Efficacy Scale) from baseline to follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be told that they can work a WOW routine on their own, with the opportunity to complete the intervention after completing the 4-week follow-up assessment. |
| No-Coach | Experimental | Behavioral: Personalized Two-Week Email-Based ProgramThis is a fully automated intervention. The No-Coach group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. They will not be able to reply to the emails for support. |
| Coached | Experimental | Behavioral: Personalized Two-Week Email-Based ProgramThis is a semi-automated intervention. The Coached group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. Prompts will be added to the end of each email such that these participants can respond to give feedback, ask questions, and receive additional support from a (human) coach. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-55 years of age
- Indicates desire to increases daily step count
- Indicates having a safe and convenient location to conduct outdoor walks
- Uses an iPhone
- Can upload step count screenshots
Key exclusion criteria (1 listed)
- Any medical issues that could be worsened by walking. This will be assessed via the Physical Activity Readiness Questionnaire (PAR-Q), minus the question asking the participant if they take medication for blood pressure or a heart condition. Researchers feel this question is overly cautious and would exclude many individuals who would otherwise qualify and benefit from walking regularly.
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 |
|---|---|---|
| Personalized Two-Week Email-Based ProgramBoth intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The Coached group will be able to reply to the emails to give feedback, ask questions, and receive additional support. | Behavioural | Coached, No-Coach |
Primary outcome
Change in average daily step count
Time frame: Four weeks
Change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups.
3 secondary outcomes
Instigation habit strength
Time frame: Four weeks
Change in sleep quality
Time frame: Four weeks
Change in general self-efficacy
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- 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.
Joshua C Hollingsworth, PharmD, PhD principal investigator
Assistant Professor at VCOM-Auburn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Two-Week Email-Based Program in people with Physical Inactivity, run by Edward Via Virginia College of Osteopathic Medicine 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 8 inclusion and 1 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 15 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 average daily step count (time frame: Four 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 15 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.