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

NCT06095999 | Completed

• 2 other identifiers: N23.045 METC-LDD628.011.211
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Smoking; Low Physical Activity Level

Keywords

Smoking; Smoking Cessation; Physical Activity; Virtual Coach; Chatbot; Relapse Prevention; eHealth; low physical activity

Outcome Measures

Primary Outcomes (5)

• 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: 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.

  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 Outcomes (12)

• Preliminary effectiveness of the Perfect Fit intervention: Self-reported smoking abstinence

  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

  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

  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

  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

  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).

Other Outcomes (8)

• Demographic characteristics

  Assessed before the intervention, at baseline (week 0, T0)

• Intention to quit smoking

  Assessed before the intervention, at baseline (week 0, T0)

• Physical nicotine dependence

  Assessed before the intervention, at baseline (week 0, T0)

Study Arms (1)

'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).

Behavioral: Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity

Interventions

Perfect Fit intervention: virtual coaching intervention to quit smoking and increase physical activity BEHAVIORAL

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.

'Perfect Fit' virtual coaching intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333 RC, Netherlands

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Anke Versluis, Dr.

  Leiden University Medical Center (LUMC)

  PRINCIPAL INVESTIGATOR

• Eline Meijer, Dr.

  Leiden University Medical Center (LUMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A due to single-arm study.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. (Assistant professor)

Model Details: 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).

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: September 19, 2023
• Primary Completion: June 28, 2024
• Study Completion: July 22, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)