Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity

Study Overview
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Brief Summary
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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.

Official Title
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Perfect Fit: A Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity

Conditions
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Physical Inactivity, Smoking

Intervention / Treatment
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* Behavioral: Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Perfect Fit' virtual coaching intervention<br>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). | Behavioral: Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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)). | 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. | Assessed after the intervention, at week 16 (post-intervention, T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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?'. | 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). | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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'). | 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. | 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. | Assessed after the intervention, at week 16 (post-intervention, T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Virtual Coach, Smoking Cessation, Physical Inactivity, Physical Activity, Chatbot, Relapse Prevention, eHealth