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

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Smoking; Low Physical Activity Level

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06095999

628.011.211 (Other Grant/Funding Number)

N23.045 METC-LDD

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

'Perfect Fit' virtual coaching intervention

Experimental group

Description:

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).

Treatment:

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