Digital Intervention for Physical Activity

NCT ID: NCT07130734

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are:

* Does a digitally-delivered intervention increase physical activity levels?
* Does a digitally-delivered intervention reduce symptoms of depression?

Researchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels.

Participants will:

* Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring
* Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group)
* Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Procedures include four laboratory visits: two visits before the intervention and two visits after the intervention.

Participants will be randomly assigned to either four weeks of a digital intervention that prompts participants to engage in physical activity or a waitlist (passive) control condition. Participants will be randomized using a stratified approach using depressive symptoms and physical activity measured at pre-intervention as strata.

The digital intervention group will be instructed to download a Pathverse mobile application on their Apple or Android smartphone device. The Pathverse mobile application will be used as a research delivery platform that can send participants daily push notifications to engage in physical activity of their choice. During the second pre-intervention visit, each participant will select approximately five types of physical activity they find enjoyable that they would like to engage in over the four-week intervention. Participants will report on the physical activity they completed, along with the duration and intensity of each activity. Participants will have the choice of time of day as to when they would like to receive daily notifications on their device.

Members of the passive control group will be informed that their mental health will be monitored over four weeks as a control condition. After the study, they will be offered the digital PA intervention, if desired.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression - Major Depressive Disorder Anxiety Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between-subjects randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigator and outcomes assessor will be unaware of group assignment; research staff working for the investigator will perform randomization. Participants will know whether they are assigned to the digital physical activity or passive control arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital Intervention Group

Participants allocated to this group will be instructed to download a Pathverse mobile application on their Apple or Android smartphone device. The Pathverse mobile application will be used to send participants daily push notifications to engage in physical activity of their choice. During on-boarding at pre-intervention, each participant will choose approximately five types of physical activity they find enjoyable that they would like to engage in throughout the four-week intervention. They will report on the physical activity they completed, along with the duration and intensity of each activity. Participants will have the choice of when they would like to receive their daily notifications on their smartphone device.

Group Type EXPERIMENTAL

Digital Physical Activity

Intervention Type BEHAVIORAL

The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of physical activity performed each day of the intervention.

Passive Control Group

Participants will be informed that their mental health will be monitored over four weeks as a control condition. After the study, they will be offered the digital PA intervention, if desired.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Physical Activity

The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of physical activity performed each day of the intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between the ages of 19 and 40 years
* Verbally fluent in English (i.e., must be able to speak or understand English)
* No uncorrected visual or hearing impairment
* Moderate depressive symptoms or greater of at least 10 or higher on the Patient Health Questionnaire-8 screening instrument
* Eligible to participate in physical activity
* Physically inactive (i.e., engaging in less than 150 min of weekly moderate-to-vigorous physical activity)
* Owns an Apple or Android mobile device, willing to download the Pathverse app , and willing to keep the device on during the study period
* Not currently pregnant
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Auburn University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christopher Brush

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kinesiology Building

Auburn, Alabama, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christopher J Brush, Ph.D.

Role: CONTACT

334-844-4483

Karly A Knudson, B.S.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Administrator, Business & Admin Services School of Kinesiology

Role: primary

334-844-1450

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00000675

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Physical Activity Program for TRD
NCT06404320 RECRUITING NA
Digital Physical Activity Program
NCT07179796 ENROLLING_BY_INVITATION
Web-based Physical Activity Program
NCT01218412 UNKNOWN PHASE1