Starting a Weekday Outdoor Walking (WOW) Routine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Inactivity
• Intervention / Treatment: Behavioral: Personalized Two-Week Email-Based Program

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua C Hollingsworth, PharmD, PhD; Phone Number: 334-442-4041; Email: jhollingsworth@auburn.vcom.edu

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36832
      • Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)
      • Contact: Joshua C Hollingsworth, PharmD, PhD; Phone Number: 228-623-8106; Email: jhollingsworth@auburn.vcom.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: No-Coach; 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.	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.
Experimental: Coached; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Edward Via Virginia College of Osteopathic Medicine
• Investigators: Principal Investigator: Joshua C Hollingsworth, PharmD, PhD, Assistant Professor at VCOM-Auburn

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Implementation intentions; Health behavior change; Behavioral health; Habit formation
• Other Study ID Numbers: 2023-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No