Clinical trial NCT06095999: Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity
Official title: Perfect Fit: a Mixed-methods Evaluation of a Virtual Coach Using Personalized Real-time Feedback to Promote Smoking Cessation and Physical Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking
Low Physical Activity Level
Keywords: Smoking
Smoking Cessation
Physical Activity
Virtual Coach
Chatbot
Relapse Prevention
eHealth
low physical activity
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of the Perfect Fit intervention assessed by completed intervention components and frequency of contact with the coach
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
measure: Acceptability of the Perfect Fit intervention assessed by the CSQ-8
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
measure: Usability of the Perfect Fit intervention assessed by the SUS
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
measure: Attitudes to the virtual coach assessed by satisfaction and relationship with, usability of and adherence to the virtual coach
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
measure: Qualitative data on primary outcome measures
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
Secondary outcomes:
measure: Preliminary effectiveness of the Perfect Fit intervention: Self-reported smoking abstinence
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: Self-reported level of PA
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: non-smoker self-identity
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: PA self-identity
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: Smoking abstinence self-efficacy
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: PA self-efficacy
timeFrame: 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).
measure: Preliminary effectiveness of the Perfect Fit intervention: Objective level of PA
timeFrame: Assessed during the intervention: from baseline (week 0, T0) to post-intervention (week 16, T1)
measure: Feasibility of the study: Recruitment, response and consent rate
timeFrame: Assessed from the start of the recruitment till inclusion of final participant
measure: Feasibility of the study: Recruitment strategies
timeFrame: Assessed before the intervention, at baseline (week 0, T0)
measure: Feasibility of the study: Adherence
timeFrame: Assessed from the start of the recruitment to the end (week 64, T4) of the study
measure: Feasibility of the study: Intervention completion after 16 weeks
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
measure: Qualitative data on secondary outcome measures
timeFrame: Assessed after the intervention, at week 16 (post-intervention, T1)
Other outcomes:
measure: Demographic characteristics
timeFrame: Assessed before the intervention, at baseline (week 0, T0)
measure: Intention to quit smoking
timeFrame: Assessed before the intervention, at baseline (week 0, T0)
measure: Physical nicotine dependence
timeFrame: Assessed before the intervention, at baseline (week 0, T0)
measure: Intention to become more physically active
timeFrame: Assessed before the intervention, at baseline (week 0, T0)
measure: Use of additional aids/support for smoking cessation or PA enhancement
timeFrame: 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).
measure: Self-reported (re)lapses during intervention after quit date
timeFrame: Assessed during the intervention, from the moment the quit date is set (around week 2-4) till post-intervention (week 16, T1)
measure: Smoking e-cigarettes
timeFrame: 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).
measure: Self-reported level of occupational PA
timeFrame: 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).
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center (LUMC)
name: Anke Versluis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center (LUMC)
name: Eline Meijer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: