Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALPerfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activityThe 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.