- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07009964
- Original Trial
An Exploratory Feasibility Study (Contextwell)
AI-Enhanced Educational Intervention to Support Contextual Well-being in Young Adults (ContextWell)
This study explores the feasibility of ContextWell, a well-being education programme that combines an online webinar with an AI-powered behavioural nudging system. The programme aims to support university students, particularly those in healthcare disciplines, in enhancing well-being and adopting healthier lifestyle habits.
The primary objective is to determine whether the programme can be feasibly delivered within university settings. A secondary objective is to assess its potential to improve student well-being and encourage behavioural changes aligned with lifestyle medicine principles.
The intervention builds on the understanding that healthcare professionals' lifestyle habits and well-being have a direct impact on patient care. Focusing on healthcare students helps advance the integration of lifestyle medicine within health education and clinical practice.
This single-group feasibility study delivers the full intervention to all participants. Students participate in an online well-being webinar and receive AI-generated behavioural prompts designed to promote self-awareness and healthier daily choices.
Key evaluation measures will indicated the feasibility of the programme among young adults in academic environments. Participant feedback and initial outcomes will support future development and inform larger-scale research.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yao Xie
- Phone Number: 0868928972
- Email: toyaoxie@gmail.com
Study Contact Backup
- Name: John Broughan
- Email: john.broughan@ucd.ie
Study Locations
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-
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Dublin, Ireland
- University College Dublin
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Contact:
- John Broughan
- Phone Number: 0868928972
- Email: john.broughan@ucd.ie
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Primarily healthcare students, young adults enrolled in higher education (18-30 years old)
Access to a computer or mobile device with an internet connection;
Willingness to participate in the educational webinar;
Willingness to complete AI-driven assignments;
Able to read and understand English.
Exclusion Criteria:
Are under the age of 18, or above 30;
Inability to access a computer or mobile device with internet connection;
Inability to read or understand English;
Unwillingness to participate in the webinar or complete assignments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: ContextWell Educational Programme
Participants will engage in the ContextWell programme, an online well-being education intervention that supports the development of core meta-skills such as self-awareness, reflective thinking, and value-based decision-making.
These skills help participants take ownership of their well-being and support their ability to independently pursue and apply knowledge that promotes health.
This includes, for example, adopting principles related to lifestyle medicine such as stress management, sleep improvement, nutrition, and physical activity.
The programme does not teach lifestyle medicine directly.
Instead, it builds the foundational mindset and capacities that enable participants to seek out and integrate such practices into their lives and future clinical roles.
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ContextWell Educational Programme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: Up to 4 weeks post-study launch (enrolment period).
|
Description: Proportion of eligible participants who enroll in the ContextWell Programme. Metric: % of enrolled participants out of those approached. Measurement Method: Screening and enrolment logs. |
Up to 4 weeks post-study launch (enrolment period).
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Retention Rate
Time Frame: Through study completion, an average of 5 weeks post-baseline.
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Proportion of enrolled participants completing the programme. Metric:
Measurement Method: Attendance records, programme tracking data, follow-up survey. |
Through study completion, an average of 5 weeks post-baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the Intervention
Time Frame: At 2 weeks post-intervention.
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Description: Participants' satisfaction with the content, format, and delivery. Metric: Mean satisfaction rating; qualitative feedback. Measurement Method: Post-intervention survey (Likert-scale + open-ended items). |
At 2 weeks post-intervention.
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Demand for the Programme
Time Frame: At 2 weeks post-intervention.
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Participants' expressed interest in continued use and peer recommendation. Metric: % intending to continue use or recommend. Measurement Method: Survey responses on future use/recommendation. |
At 2 weeks post-intervention.
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Implementation Feasibility
Time Frame: During intervention period, Weeks 1 to 3 post-baseline.
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Practicality of delivering the intervention as planned. Metric: Number of technical issues. % of content delivered as intended. Measurement Method: Researcher logs, participant feedback. |
During intervention period, Weeks 1 to 3 post-baseline.
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Perceived Impact on Well-Being
Time Frame: At 4 weeks post-baseline.
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Participants' perception of effects on well-being Metric: % reporting improved well-being. Measurement Method: follow-up survey (Likert-scale and reflections). |
At 4 weeks post-baseline.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Walter Prof. Cullen, MD, University College Dublin
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ContextWell-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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