Physical Activity and Social-media Support (PASS)

July 26, 2023 updated by: Zakkoyya Lewis-Trammell, California State Polytechnic University, Pomona
This study is a 3-arm randomized intervention to provide exercise education through Instagram. The primary outcome is trust in the content presented.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Social media is an interpersonal-level technology that can provide physical activity support through social support and behavioral education. One popular social media platform is Instagram. However, there is limited data on whether participants trust the content delivered through this platform. There is also limited information on whether the social-media account holder plays a role in the acceptance of the content. The purpose of the proposed study is to determine participants perceptions of physical activity related information and social media account. The design for this study is a 3-arm randomized intervention through Instagram. Participants (n=60) will be randomized to one of three Instagram accounts (control, student, and scientist). Recruitment will be on a rolling basis for 2 months; once participants are deemed eligible, they will be enrolled for 4-weeks and will receive a weekly questionnaire to determine their perceptions. Participants will also be encouraged to participate in follow-up questionnaires at 2 and 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91768
        • California State Polytechnic University, Pomona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years and older
  • less than 150 minutes of moderate-to-vigorous exercise per week
  • active Instagram account

Exclusion Criteria:

  • physical activity is inadvisable based on the PAR-Q+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
Participants randomized to this group will follow a public Instagram account. This account was chosen because they have a strong following (over 600,000 followers) and it is a public account that anyone can follow. The content shared on this page is motivational and community driven. There is a focus of healthy living with an emphasis on exercise. Additionally, there are no paid sponsorships or radical exercise advice, which is common on other influencer pages. The Co-PIs determined that this page accurately represents the exercise-related content that is readily available on Instagram. The research team will not have control over the content of this account, but the account holder will be notified about the study.
Behavioral: Influencer Instagram account
Participants randomized to this group will follow a public Instagram account. This account was chosen because they have a strong following (over 600,000 followers) and it is a public account that anyone can follow. The content shared on this page is motivational and community driven. There is a focus of healthy living with an emphasis on exercise. Additionally, there are no paid sponsorships or radical exercise advice, which is common on other influencer pages. The Co-PIs determined that this page accurately represents the exercise-related content that is readily available on Instagram. The research team will not have control over the content of this account, but the account holder will be notified about the study.
Experimental: Student
Student Co-PI will manage this Instagram account created for the study. Although the student is a Kinesiology student and works within the health field, she will not disclose this information on the account. Instead, she will present herself as a general college student. By withholding her major and career aspirations, we hope to get unbiased feedback on what participants think about the content being presented. The content presented will be identical to study arm #3.
Behavioral: Research study Instagram account
Intervention arms will deliver the same exercise-related content on the same schedule on the intervention Instagram accounts. The arms will deliver 13-weeks worth of content which goes through the last possible day of the intervention. The structure was based on feedback from stakeholders in a formative focus group. All of the content delivered through the accounts is evidence-based and referenced from reputation organizations/agencies such as the American College of Sports Medicine, American Heart Association, Center for Disease Control, and World Health Organization. Each Co-PI will post videos to answer participant questions. To ensure that the content between both groups is the same, the Co-PIs will meet to determine which questions to answer and draft the response.
Experimental: Scientist
The PI will manage this Instagram account created for the study. The PI is a certified exercise physiologist and holds a PhD in Rehabilitation Sciences. She will disclose this information on the account. This group is the study's "gold standard" because it will provide evidence-based content delivered by an exercise scientist.
Behavioral: Research study Instagram account
Intervention arms will deliver the same exercise-related content on the same schedule on the intervention Instagram accounts. The arms will deliver 13-weeks worth of content which goes through the last possible day of the intervention. The structure was based on feedback from stakeholders in a formative focus group. All of the content delivered through the accounts is evidence-based and referenced from reputation organizations/agencies such as the American College of Sports Medicine, American Heart Association, Center for Disease Control, and World Health Organization. Each Co-PI will post videos to answer participant questions. To ensure that the content between both groups is the same, the Co-PIs will meet to determine which questions to answer and draft the response.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported trust in Instagram content assessed with a likert scale
Time Frame: 4-weeks
Participant trust in the content presented on the Instagram account using a 10-point scale where 1 is low trust and 10 is high trust
4-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity measured by the IPAQ
Time Frame: 4-weeks
self-reported total physical activity MET*minutes/week
4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California State Polytechnic University, Pomona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-21-8

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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