Impact of Mobile App on Purpose and Well-Being Among College Students (PWB)

December 5, 2019 updated by: University of Wisconsin, Madison

Living Purposefully: The Role of Mobile App JOOL in Promoting Well-being and Academic Success

This study will examine the impact of a mobile app (JOOL) focused on promoting purposeful living on student health behaviors, academic performance, self-regulation, well-being, resiliency, and self-efficacy.

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

Participants will be recruited from a large undergraduate classroom. Participants will be randomly assigned to one of two conditions and asked to complete either online reflections or engage with a mobile app over the course of the semester. Students who elect to not participate will be provided an alternate assignment to complete, to be coordinated by their teaching assistant. Participants will additionally be asked to complete (1) a pre-survey, (2) post-survey, and follow-up survey 14 days after the class concludes. The study will examine changes in health-related behaviors, resiliency, well-being, and self-efficacy reported between the start and conclusion of semester/study.

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.
112

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • School of Human Ecology

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum age of 18 years
  • Enrolled in Consuming Happiness course during the Spring 2017-18 semester.
  • Must have access to WiFi, cellular service or computer with internet connection and web browser.

Exclusion Criteria:

  • None

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: Basic Science
  • 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.
Experimental: Mobile App
Half of the students randomly assigned
Behavioral: Mobile App
Purposeful Living Mobile App JOOL to be used daily
Other Names:
  • JOOL
Experimental: Reflection
Half of the students randomly assigned
Behavioral: Reflection
Bi-weekly online reflection question

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
Change in Health Behaviors
Time Frame: 14 weeks post start (1 semester)
Expected increase in self-report of behaviors promoting academic achievement, physical health, well-being, and purpose from time of pre survey to post survey.
14 weeks post start (1 semester)
Change in Resiliency
Time Frame: 14 weeks post start (1 semester)
Brief Resiliency Scale (BRS) used to measure resiliency, or ""the ability to bounce back or recover from stress" (Smith et al., 2008). 6 items using Likert scale strongly disagree (1) to strongly agree (5). Score will be summed for one total score and can range from 6 to 30, with 6 indicating low resilience and 30 indicating high resilience. No clinical cut off. Expected increase no change in scores from pre and post.
14 weeks post start (1 semester)
Change in Self-Regulation
Time Frame: 14 weeks post start (1 semester)
Self-Regulation Scale (SRQ) short form used to measure self-regulation, or ""the ability to develop, implement, and flexibly maintain planned behavior in order to achieve one's goal" (Brown, Miller, & Lawendowski, 1999). 31 items using a Likert scale strongly disagree (1) to strongly agree (5), with 14 reverse coded. Scores will be summed for one total score ranging from 31 to 155. 31 indicates low self-regulation and 155 indicates high self-regulation. No clinical cut off. Expected increase or no change in scores from pre and post.
14 weeks post start (1 semester)
Change in belief of ability to perform difficult tasks or cope with diversity
Time Frame: 14 weeks post start (1 semester)
Generalized Self-Efficacy Scale used to measure self-efficacy, or "the optimistic self-belief that one can perform novel or difficult tasks or cope with diversity" (Schwarzer, 1992). 10 items on a Likert scale from Not true at all (1) to Exactly true (4). Responses will be summed for one total score, ranging from 10 to 40. 10 indicates low self-efficacy, 40 indicates high self-efficacy. No clinical cut off. Expected increase or no change in scores from pre and post.
14 weeks post start (1 semester)
Change in Well-Being
Time Frame: 14 weeks post start (1 semester)
The WHO (Five) Well-Being Index (WHO-5) measures well-being, defined as the subjective quality of life based on positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interest (being interested in things). 5 items on a Likert scale ranging from all of the time (5) to at no time (1). Responses will be summed for one total score ranging from 0 to 25. 0 indicates low well-being and 5 indicates high well-being. Score below 13 indicates poor well-being. Expected increase or no change in scores from pre and post.
14 weeks post start (1 semester)

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
Change in Health Behaviors
Time Frame: 14 days (2 weeks) after end of study (16 weeks post start)
Expected increase or no change in reported health behaviors around academic achievement and well-being from time of post survey. To be completed 2 weeks after post-survey.
14 days (2 weeks) after end of study (16 weeks post start)
App Perceptions
Time Frame: 14 days (2 weeks) after end of study (16 weeks post start)
Feedback on perceptions of the mobile app and information on continued use behaviors
14 days (2 weeks) after end of study (16 weeks post start)

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.
University of Wisconsin, Madison

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.
January 24, 2018

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.
May 21, 2018

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.
August 1, 2019

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).
December 4, 2017

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.
December 13, 2017

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.
December 19, 2017

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.
December 6, 2019

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.
December 5, 2019

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.
December 1, 2019

More Information

Terms related to this study

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.
  • 2017-1371
  • A271000 (Other Identifier: UW Madison)
  • SOHE\CONSUMER SCIENCE\CONS SCI (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IDP will not be shared with researchers not directly associated with the study and/or listed on the IRB.

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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