Starting a Weekday Outdoor Walking (WOW) Routine

Physical Inactivity Clinical Trial

Official title:

Starting a Weekday Outdoor Walking (WOW) Routine: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980676
• Other study ID #: 2023-014
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: October 2023

Study information

• Verified date: August 2023
• Source: Edward Via Virginia College of Osteopathic Medicine
• Contact: Joshua C Hollingsworth, PharmD, PhD
• Phone: 334-442-4041
• Email: jhollingsworth[@]auburn.vcom.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Personalized Two-Week Email-Based Program
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.

Locations

Country	Name	City	State
United States	Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Edward Via Virginia College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Four weeks
Secondary	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.	Four weeks
Secondary	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.	Four weeks
Secondary	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.	Four weeks