SmokingNCT06095999
Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity
A study testing Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity in people with Smoking and Low Physical Activity Level, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Low Physical Activity Level
- What is being tested?
- Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2023to 22 Jul 2025
- 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
- 18 years or older
- Current smoker (cigarette, cigar, or rolling tobacco)
- Intention to quit smoking between now and 6 weeks
- Being able to walk without pain complaints
- Being able to understand and read Dutch (B1 level)
- Having access to the internet and a smartphone
Show all 10Show fewer
- In addition, at least 50% of sample has ≥10% risk of CVD (Nederlands Huisartsen Genootschap, 2019), estimated on basis of:
- Being female and 55+ years old OR male and 50+ years old
- Finally, at least 75% of sample is:
- Living in region Leiden (region between Leiden/Amsterdam/Utrecht)
Who cannot join
- Being involved in smoking cessation therapy/counseling at the start of the intervention.
- Has undergone major lower extremity surgery in the past year (to prevent giving PA advice that contradicts medical guidance).
- Taking antipsychotics or having a serious psychiatric illness (e.g., schizophrenia/psychosis, bipolar disorder, major depression).
- Being pregnant.
- Not able to wear the smartwatch throughout the day (e.g., when individuals are not allowed to wear a watch at work)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333 RC
About this study
Official title: Perfect Fit: A Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity
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
- Smoking, Low Physical Activity Level
- Being tested
- Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity
- Keywords
- Smoking, Smoking Cessation, Physical Activity, Virtual Coach, Chatbot, Relapse Prevention, eHealth, low physical activity
- Medical subject headings
- Smoking, Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 'Perfect Fit' virtual coaching intervention | Experimental | Due to the single-arm design, all participants will receive the Perfect Fit intervention, a personalized eHealth intervention that supports them to stop smoking and increase their PA using a virtual coach (i.e., chatbot). Receives: Behavioral: Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach
Assess feasibility of the Perfect Fit intervention using:
- usage data on which components of the intervention (i.e., chat conversations, exercises, informational videos) are completed at certain timepoints (measured from baseline to post-intervention, T1). Users who complete all the preparation phase dialogs, complete at least one dialog per week during the execution phase of the intervention, and complete the closing dialogue, will be marked as adherent users.
- a self-report question about the frequency of contact with the virtual coach; Users will be asked to indicate how many times a week they had contact with their virtual coach during the Perfect Fit intervention.
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Acceptability of the Perfect Fit intervention assessed by the CSQ-8
Participants' satisfaction with the Perfect Fit intervention and the chat function of the NiceDay app (the app that is used for chat interaction between the user and the virtual coach) will be measured with the Dutch translation of the 8-item Client Satisfaction Questionnaire (CSQ-8; De Wilde \& Hendriks, 2005; Larsen, 1979). An example of an item is: "To what extent has our service [the Perfect Fit program] met your needs?". The items are scored on 4-point Likert scales with different labels (e.g., from 1 (quite dissatisfied) to 4 (very satisfied)) and the total score ranges from 8 to 32, with a higher score indicating greater satisfaction.
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Usability of the Perfect Fit intervention assessed by the SUS
The usability of the Perfect Fit intervention and the chat function of the NiceDay app will be measured with a Dutch translation of the System Usability Scale (SUS; Brooke, 1996). The total questionnaire consists of ten items with items such as "I think the virtual coach is unnecessary complex" and "I found the various functions in this system were well integrated". The items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Attitudes to the virtual coach assessed by satisfaction and relationship with, usability of and adherence to the virtual coach
Acceptance of the virtual coach will be assessed using a Dutch translation of a set of six items that measure the evaluation of the coach in terms of satisfaction, usability, continuation of collaboration, relationship, preference for a program with or without coach and adherence to advice from the coach. The questionnaire has been used in other studies evaluating virtual agents (Bickmore et al., 2010; Provoost et al., 2020). Two example items are: "How satisfied were you with the virtual coach?" and "How easy was it talking to the virtual coach?". Answers are given on a 7-point Likert scale with different labels (e.g., from 1 (not at all satisfied) to 7 (very satisfied)).
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Qualitative data on primary outcome measures
Qualitative individual semi-structured interviews with participants will complement the quantitative data and provide more in-depth insight into acceptability, feasibility, preliminary effectiveness, and requirements for implementation of the Perfect Fit intervention.
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Secondary outcomes (12)
Preliminary effectiveness of the Perfect Fit intervention: Self-reported smoking abstinence
To assess prolonged smoking abstinence at multiple timepoints after the Perfect Fit intervention, a combination of continuous abstinence and 7-day point prevalence abstinence will be used (Secades-Villa et al., 2016; Velicer \& Prochaska, 2004; West et al., 2005). Participants will be asked if they have smoked since the end of the Perfect Fit intervention (yes/no; i.e., continuous abstinence). In case their answer is 'yes', participants will be asked if they have smoked the seven days prior to the assessment (yes/no; i.e., 7-day point prevalence abstinence). In case their answer to this question is 'no', two other follow-up questions will be asked, namely: "How long ago did you smoke your last cigarette, cigar or rolling tobacco?" and "How many cigarettes, cigars or rolling tobacco did you smoke?'.
Measured: Assessed four times during the study: at post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Self-reported level of PA
Self-reported level of PA will be measured with a Dutch translation of the 3-item Godin-Shephard Leisure-Time PA questionnaire (GSLTPAQ; Amireault \& Godin, 2015; Godin, 2011). Participants are asked how many times on average, during a typical week, they do strenuous, moderate or mild exercise for more than 15 minutes. The total score of the questionnaire is calculated by multiplying the number of times per week strenuous exercise by nine, multiplying the number of times per week moderate exercise by five, multiplying the number of times per week mild exercise by three, and taking the sum of this (i.e., (9 x times/wk strenuous) + (5 x times/wk moderate) + (3 x times/wk mild)). A total score of 24 or more is defined as 'active', a total score of 14 to 23 is defined as 'moderately active' and a score of less than 14 is defined as 'insufficiently active' (Godin, 2011).
Measured: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: non-smoker self-identity
Non-smoker self-identity will be assessed using seven items (Meijer et al., 2016), of which three are adapted from the Abstainer Self-Concept scale and three are adapted from the Smoker Self-Concept Scale (Shadel \& Mermelstein, 1996) by replacing 'smoking' with 'not smoking'. In addition, the item "I would like to be a non-smoker" will be added (adapted from Tombor et al., 2013). All items are translated to Dutch and can be answered on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher total scores indicate stronger non-smoker self-identity.
Measured: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: PA self-identity
PA self-identity will be measured with a Dutch translation of the adapted version (Strachan et al., 2010) of the 9-item Exercise Identity Questionnaire (Anderson \& Cychosz, 1994). PA identity will be measured rather than exercise identity since being physically active entails a broader array of physical activities (Strachan et al., 2010). As the Perfect Fit intervention aims to enhance PA by increasing the amount of steps, this includes not only sports/exercise, but also daily physical activities like household chores. An example item is: "I consider myself a physically active person". Answers are given on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree) and the total score ranges from 9 to 63, with a higher score indicating stronger identity.
Measured: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Smoking abstinence self-efficacy
Smoking abstinence self-efficacy will be assessed with a single item (adapted from Loprinzi et al., 2015), translated in Dutch. Participants will be asked: "Overall, how confident are you that you are able not to smoke ?". Abstinence self-efficacy has been shown to be associated with smoking cessation (Spek et al., 2013). Answers are given on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (extremely confident), with a higher score indicating higher abstinence self-efficacy.
Measured: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: PA self-efficacy
To assess self-efficacy for PA the same Dutch single item (adapted from Loprinzi et al., 2015) will be used as for assessing smoking abstinence self-efficacy, but the item will be adjusted to PA behavior: "Overall, how confident are you that you are able to be sufficiently physically active?". An instruction will be provided before the question is presented, explaining the definition of PA (i.e., exercise, but also physical activities like walking to the supermarket) and the recommended levels of PA according to the WHO guidelines (World Health Organisation, 2022). PA self-efficacy has been shown to be associated with actual PA behavior (McAuley \& Blissmer, 2000). Answers are given on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (extremely confident), with a higher score indicating higher self-efficacy for PA.
Measured: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Objective level of PA
The average number of steps per day will be measured with the smartwatch participants are wearing during the study and collected using the sensor data collector app. The sensor data will be collected during the Perfect Fit intervention.
Measured: Assessed during the intervention: from baseline (week 0, T0) to post-intervention (week 16, T1)
Feasibility of the study: Recruitment, response and consent rate
Feasibility of the study will be assessed in terms of recruitment, response and consent rate using participant screening and inclusion logfile data. The following information will be logged: the time between the start of patient recruitment and the day on which the final participant is recruited (i.e., recruitment rate); proportion of interested participants who completed screening questionnaire (i.e., response rate); and number of eligible participants who consented to take part in study (i.e., consent rate).
Measured: Assessed from the start of the recruitment till inclusion of final participant
Feasibility of the study: Recruitment strategies
To gain more insight in the effectiveness of different recruitment strategies, participants will be asked at baseline how they heard about the study. They can indicate which recruitment strategy was used (e.g., recruited directly by a researcher, via social media post). This will provide insight in effective recruitment strategies for future research, which is especially interesting in the case of participants with a lower SEP as they are often underrepresented in research.
Measured: Assessed before the intervention, at baseline (week 0, T0)
Feasibility of the study: Adherence
Users' adherence to the study will be assessed using participant log data. Adherence will be examined in terms of the number of participants who completed the Perfect Fit intervention and the study, the number of participants lost to follow-up over time (dropouts), and the number of participants who do not drop out from the study, i.e. still filling in questionnaires, but who are no longer using the app (nonusers; Eysenbach, 2005). Adherence will be monitored during the full study duration by keeping a participant screening and inclusion logfile and will also be assessed with the earlier mentioned usage data and self-report question (see primary outcome 'Feasibility of the Perfect Fit intervention').
Measured: Assessed from the start of the recruitment to the end (week 64, T4) of the study
Feasibility of the study: Intervention completion after 16 weeks
At the start of the post-intervention questionnaire, users will be asked if they completed the intervention (i.e., completed the final closing dialog with the virtual coach) or not. In case they did not complete the intervention yet, they are asked in which week of the execution phase of the Perfect Fit intervention they are at that moment. This way it can be assessed if participants fill out the post-intervention questionnaire while having completed the whole intervention or not. It also provides information on how many people complete the intervention in 16 weeks or less.
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Qualitative data on secondary outcome measures
Qualitative individual semi-structured interviews with participants will complement the quantitative data and provide more in-depth insight into acceptability, feasibility, preliminary effectiveness, and requirements for implementation of the Perfect Fit intervention.
Measured: Assessed after the intervention, at week 16 (post-intervention, T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Sep 2023
- Primary completion28 Jun 2024
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A mixed-method single-arm pre-post intervention study will be used. Baseline questionnaires (T0) measure demographic, PA and smoking-characteristics. Post-intervention questionnaires (T1) measuring feasibility of the study and Perfect Fit intervention, acceptability of the Perfect Fit intervention and virtual coach, and preliminary effectiveness of the Perfect Fit intervention will be administered 16 weeks after the start of the intervention (i.e., expected end of intervention). Participants who consent to take part in the semi-structured individual interview will be invited for this interview also around 16 weeks after the start of the intervention. Finally, follow-up questionnaires measuring preliminary effectiveness of the Perfect Fit intervention will be administered 24 (T2), 40 (T3), and 64 (T4) weeks after the start of the intervention (i.e., respectively 2, 6 and 12 months after expected end of the intervention).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aversluis, Leiden University Medical Center
- Investigators
- Anke Versluis, Dr., Principal investigator, Leiden University Medical CenterEline Meijer, Dr., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095999
- Sponsor's protocol ID
- N23.045 METC-LDD
- Other IDs
- 628.011.211
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data will be made available for reuse at the end of the project. Certain demographic characteristics might have to be removed from the data set, to prevent traceability of individual participants. It has yet to be decided whether data can best be made available through a repository or through reasonable request.
Publications
van Vliet MHM, Meijer E, Albers N, Penfornis KM, Baccinelli W, Scheltinga BL, van Eersel RA, Chavannes NH, Versluis A; Perfect Fit Consortium. Evaluation of the Feasibility and Acceptability of Perfect Fit, a Virtual Coach-Based mHealth Intervention for Smoking Cessation and Physical Activity in Adults: Mixed Methods Study. JMIR Hum Factors. 2026 Jul 14;13:e83456. doi: 10.2196/83456.
PubMed 42447467
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfect Fit: A Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity
- ClinicalTrials.gov ID
- NCT06095999
- Acronym / sponsor ID
- N23.045 METC-LDD
- Conditions
- Smoking, Low Physical Activity Level
- Keywords
- Smoking, Smoking Cessation, Physical Activity, Virtual Coach, Chatbot, Relapse Prevention, eHealth, low physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 23 Oct 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed-method single-arm pre-post intervention study will be used. Baseline questionnaires (T0) measure demographic, PA and smoking-characteristics. Post-intervention questionnaires (T1) measuring feasibility of the study and Perfect Fit intervention, acceptability of the Perfect Fit intervention and virtual coach, and preliminary effectiveness of the Perfect Fit intervention will be administered 16 weeks after the start of the intervention (i.e., expected end of intervention). Participants who consent to take part in the semi-structured individual interview will be invited for this interview also around 16 weeks after the start of the intervention. Finally, follow-up questionnaires measuring preliminary effectiveness of the Perfect Fit intervention will be administered 24 (T2), 40 (T3), and 64 (T4) weeks after the start of the intervention (i.e., respectively 2, 6 and 12 months after expected end of the intervention).
| Arm | Type | Receives |
|---|---|---|
| 'Perfect Fit' virtual coaching intervention | Experimental | Behavioral: Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activityDue to the single-arm design, all participants will receive the Perfect Fit intervention, a personalized eHealth intervention that supports them to stop smoking and increase their PA using a virtual coach (i.e., chatbot). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older
- Current smoker (cigarette, cigar, or rolling tobacco)
- Intention to quit smoking between now and 6 weeks
- Being able to walk without pain complaints
- Being able to understand and read Dutch (B1 level)
Key exclusion criteria (5 listed)
- Being involved in smoking cessation therapy/counseling at the start of the intervention.
- Has undergone major lower extremity surgery in the past year (to prevent giving PA advice that contradicts medical guidance).
- Taking antipsychotics or having a serious psychiatric illness (e.g., schizophrenia/psychosis, bipolar disorder, major depression).
- Being pregnant.
- Not able to wear the smartwatch throughout the day (e.g., when individuals are not allowed to wear a watch at work)
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 |
|---|---|---|
| Perfect 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. | Behavioural | 'Perfect Fit' virtual coaching intervention |
Primary outcome
Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
Assess feasibility of the Perfect Fit intervention using: 1. usage data on which components of the intervention (i.e., chat conversations, exercises, informational videos) are completed at certain timepoints (measured from baseline to post-intervention, T1). Users who complete all the preparation phase dialogs, complete at least one dialog per week during the execution phase of the intervention, and complete the closing dialogue, will be marked as adherent users. 2. a self-report question about the frequency of contact with the virtual coach; Users will be asked to indicate how many times a week they had contact with their virtual coach during the Perfect Fit intervention.
Acceptability of the Perfect Fit intervention assessed by the CSQ-8
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
Participants' satisfaction with the Perfect Fit intervention and the chat function of the NiceDay app (the app that is used for chat interaction between the user and the virtual coach) will be measured with the Dutch translation of the 8-item Client Satisfaction Questionnaire (CSQ-8; De Wilde \& Hendriks, 2005; Larsen, 1979). An example of an item is: "To what extent has our service [the Perfect Fit program] met your needs?". The items are scored on 4-point Likert scales with different labels (e.g., from 1 (quite dissatisfied) to 4 (very satisfied)) and the total score ranges from 8 to 32, with a higher score indicating greater satisfaction.
Usability of the Perfect Fit intervention assessed by the SUS
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
The usability of the Perfect Fit intervention and the chat function of the NiceDay app will be measured with a Dutch translation of the System Usability Scale (SUS; Brooke, 1996). The total questionnaire consists of ten items with items such as "I think the virtual coach is unnecessary complex" and "I found the various functions in this system were well integrated". The items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Attitudes to the virtual coach assessed by satisfaction and relationship with, usability of and adherence to the virtual coach
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
Acceptance of the virtual coach will be assessed using a Dutch translation of a set of six items that measure the evaluation of the coach in terms of satisfaction, usability, continuation of collaboration, relationship, preference for a program with or without coach and adherence to advice from the coach. The questionnaire has been used in other studies evaluating virtual agents (Bickmore et al., 2010; Provoost et al., 2020). Two example items are: "How satisfied were you with the virtual coach?" and "How easy was it talking to the virtual coach?". Answers are given on a 7-point Likert scale with different labels (e.g., from 1 (not at all satisfied) to 7 (very satisfied)).
Qualitative data on primary outcome measures
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
Qualitative individual semi-structured interviews with participants will complement the quantitative data and provide more in-depth insight into acceptability, feasibility, preliminary effectiveness, and requirements for implementation of the Perfect Fit intervention.
12 secondary outcomes
Preliminary effectiveness of the Perfect Fit intervention: Self-reported smoking abstinence
Time frame: Assessed four times during the study: at post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Self-reported level of PA
Time frame: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: non-smoker self-identity
Time frame: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: PA self-identity
Time frame: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Smoking abstinence self-efficacy
Time frame: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: PA self-efficacy
Time frame: Assessed five times during the study: at baseline (week 0, T0), post-intervention (week 16, T1), 2-month follow-up (week 24, T2), 6-month follow-up (week 40, T3), and 12-month follow-up (week 64, T4).
Preliminary effectiveness of the Perfect Fit intervention: Objective level of PA
Time frame: Assessed during the intervention: from baseline (week 0, T0) to post-intervention (week 16, T1)
Feasibility of the study: Recruitment, response and consent rate
Time frame: Assessed from the start of the recruitment till inclusion of final participant
Feasibility of the study: Recruitment strategies
Time frame: Assessed before the intervention, at baseline (week 0, T0)
Feasibility of the study: Adherence
Time frame: Assessed from the start of the recruitment to the end (week 64, T4) of the study
Feasibility of the study: Intervention completion after 16 weeks
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
Qualitative data on secondary outcome measures
Time frame: Assessed after the intervention, at week 16 (post-intervention, T1)
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 11 Sep 2025.
- Derived from this study: PubMed 42447467van Vliet MHM, Meijer E, Albers N, Penfornis KM, Baccinelli W, Scheltinga BL, van Eersel RA, Chavannes NH, Versluis A; Perfect Fit Consortium. Evaluation of the Feasibility and Acceptability of Perfect Fit, a Virtual Coach-Based mHealth Intervention for Smoking Cessation and Physical Activity in Adults: Mixed Methods Study. JMIR Hum Factors. 2026 Jul 14;13:e83456. doi: 10.2196/83456.
- Individual participant dataSharing planned: Yes. Pseudonymized data will be made available for reuse at the end of the project. Certain demographic characteristics might have to be removed from the data set, to prevent traceability of individual participants. It has yet to be decided whether data can best be made available through a repository or through reasonable request.
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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.
Anke Versluis, Dr. principal investigator
Leiden University Medical Center
Eline Meijer, Dr. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity in people with Smoking and Low Physical Activity Level, run by Leiden University Medical Center at 1 site in Netherlands.
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 10 inclusion and 5 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 11 Sep 2025. 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 Netherlands. 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?
Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach (time frame: Assessed after the intervention, at week 16 (post-intervention, T1)). 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?
On the ClinicalTrials.gov record for NCT06095999, which also lists 1 linked publication.
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 11 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.