NCT05980676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

July 28, 2023

Last Update Submit

September 8, 2025

Conditions

Keywords

Behavioral healthHealth behavior changeHabit formationImplementation intentions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Instigation habit strength

    Four weeks

  • Change in sleep quality

    Four weeks

  • Change in general self-efficacy

    Four weeks

Study Arms (3)

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.

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.

Behavioral: Personalized Two-Week Email-Based Program

Interventions

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.

CoachedNo-Coach

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)

Auburn, Alabama, 36832, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Joshua C Hollingsworth, PharmD, PhD

    Assistant Professor at VCOM-Auburn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician performing statistical analysis will be blinded to group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 8, 2023

Study Start

April 11, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations