Trials / Completed
CompletedNCT06095999
Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity
Perfect Fit: A Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Leiden University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The leading cause of disease burden across the globe is cardiovascular disease (CVD). Important modifiable behavioral CVD risk factors include, amongst others, smoking and low physical activity (PA). Individuals with a low socioeconomic position (SEP) often have a less favorable profile of risk factors, resulting in a higher disease burden and premature death. There is a need for cost-effective multi-behavior interventions that target one or more risk factors. eHealth applications are increasingly being used to offer behavior change interventions. Potential benefits include accessibility, scalability, cost-effectiveness, and increased disease self-management. However, eHealth interventions are often static and thereby less effective, and also frequently developed without (sufficiently) engaging end-users. Involving end-users, including those from lower SEP groups, and other relevant stakeholders can help to optimize the adoption and adherence to the eHealth intervention and result in the maintenance of healthy behavior. The Perfect Fit intervention is the result of interdisciplinary collaboration, and the personalized eHealth intervention supports adult smokers to stop smoking and increase their PA using a virtual coach. We primarily aim to examine the feasibility, acceptability and preliminary effectiveness of the Perfect Fit intervention. A mixed-method single-arm pre-post intervention study will be used. The intervention, delivered through a virtual coach, has a personalized duration and intensity, but will last on average 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity | The intervention, delivered through a virtual coach, has a personalized duration and intensity, but will last on average 16 weeks. The intervention has three phases: preparation, execution (including \[re\]lapse) and closing. By having chat conversations with the Perfect Fit virtual coach (using the mobile application 'NiceDay'), the user will be guided through the different phases of the intervention. In each phase, the user has chat conversations with the virtual coach (e.g. about goal setting, weekly reflection) and, in addition, receives exercises and educational video material to support smoking cessation and PA promotion. Additionally, a smartwatch is used to objectively assess PA. It allows participants to monitor their PA and the data (on the number of steps) is used to give automatic, personalized PA advice to the user. |
Timeline
- Start date
- 2023-09-19
- Primary completion
- 2024-06-28
- Completion
- 2025-07-22
- First posted
- 2023-10-23
- Last updated
- 2025-09-11
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06095999. Inclusion in this directory is not an endorsement.