HealthyPWBNCT03378505
Impact of Mobile App on Purpose and Well-Being Among College Students
A study testing Mobile App and Reflection in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mobile App and Reflection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Mobile App, Reflection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile AppBehavioural
Also called JOOL
Purposeful Living Mobile App JOOL to be used daily
ReflectionBehavioural
Bi-weekly online reflection question
| Study group | Role | What they receive |
|---|---|---|
| Mobile App | Experimental | Half of the students randomly assigned Receives: Behavioral: Mobile App |
| Reflection | Experimental | Half of the students randomly assigned Receives: Behavioral: Reflection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Behaviors
Expected increase in self-report of behaviors promoting academic achievement, physical health, well-being, and purpose from time of pre survey to post survey.
Measured: 14 weeks post start (1 semester)
Change in Resiliency
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.
Measured: 14 weeks post start (1 semester)
Change in Self-Regulation
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.
Measured: 14 weeks post start (1 semester)
Change in belief of ability to perform difficult tasks or cope with diversity
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.
Measured: 14 weeks post start (1 semester)
Change in Well-Being
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.
Measured: 14 weeks post start (1 semester)
Secondary outcomes (2)
Change in Health Behaviors
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.
Measured: 14 days (2 weeks) after end of study (16 weeks post start)
App Perceptions
Feedback on perceptions of the mobile app and information on continued use behaviors
Measured: 14 days (2 weeks) after end of study (16 weeks post start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start24 Jan 2018
- Primary completion21 May 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two conditions. Half of the participants will be required to use a daily check-in mobile app that promotes alignment of daily behaviors with their individualized life purpose. The other half of participants will complete brief bi-weekly reflections. Alternative assignment provided for non-participating students.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378505
- Sponsor's protocol ID
- 2017-1371
- Other IDs
- A271000, SOHE\CONSUMER SCIENCE\CONS SCI
- Acronym
- PWB
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2017
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared with researchers not directly associated with the study and/or listed on the IRB.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Purposefully: The Role of Mobile App JOOL in Promoting Well-being and Academic Success
- ClinicalTrials.gov ID
- NCT03378505
- Acronym / sponsor ID
- PWB / 2017-1371
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two conditions. Half of the participants will be required to use a daily check-in mobile app that promotes alignment of daily behaviors with their individualized life purpose. The other half of participants will complete brief bi-weekly reflections. Alternative assignment provided for non-participating students.
| Arm | Type | Receives |
|---|---|---|
| Mobile App | Experimental | Behavioral: Mobile AppHalf of the students randomly assigned |
| Reflection | Experimental | Behavioral: ReflectionHalf of the students randomly assigned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile AppAlso: JOOLPurposeful Living Mobile App JOOL to be used daily | Behavioural | Mobile App |
| ReflectionBi-weekly online reflection question | Behavioural | Reflection |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Health Behaviors
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: No. IDP will not be shared with researchers not directly associated with the study and/or listed on the IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Raison, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App and Reflection in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Behaviors (time frame: 14 weeks post start (1 semester)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.