Clinical trial NCT05980676: Starting a Weekday Outdoor Walking (WOW) Routine
Official title: Starting a Weekday Outdoor Walking (WOW) Routine: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Keywords: Behavioral health
Health behavior change
Habit formation
Implementation intentions
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in average daily step count
timeFrame: Four weeks
Secondary outcomes:
measure: Instigation habit strength
timeFrame: Four weeks
measure: Change in sleep quality
timeFrame: Four weeks
measure: Change in general self-efficacy
timeFrame: Four weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)
state: Alabama
Study officials:
affiliation: Assistant Professor at VCOM-Auburn
name: Joshua C Hollingsworth, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: