An Exploratory Feasibility Study (Contextwell)

June 18, 2025 updated by: University College Dublin

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
12

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

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

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: N/A
  • Interventional Model: Single Group 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.
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.
Other: ContextWell Educational Programme
ContextWell Educational Programme

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
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).
Retention Rate
Time Frame: Through study completion, an average of 5 weeks post-baseline.

Proportion of enrolled participants completing the programme.

Metric:

  1. % completing final follow-up.
  2. Count completing all study components.

Measurement Method: Attendance records, programme tracking data, follow-up survey.
Through study completion, an average of 5 weeks post-baseline.

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
Acceptability of the Intervention
Time Frame: At 2 weeks post-intervention.

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.
Demand for the Programme
Time Frame: At 2 weeks post-intervention.

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.
Implementation Feasibility
Time Frame: During intervention period, Weeks 1 to 3 post-baseline.

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.
Perceived Impact on Well-Being
Time Frame: At 4 weeks post-baseline.

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.

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 College Dublin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Imperial College London
University College Cork
UCD Clinical Research Centre, Ireland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Walter Prof. Cullen, MD, University College Dublin

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 (Estimated)

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.
November 1, 2025

Primary Completion (Estimated)

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.
December 1, 2025

Study Completion (Estimated)

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.
February 1, 2026

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).
May 7, 2025

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.
June 3, 2025

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.
June 8, 2025

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.
June 19, 2025

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.
June 18, 2025

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.
May 1, 2025

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.
  • ContextWell-2025

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

product manufactured in and exported from the U.S.

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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