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Physical ActivityNCT04223336

A Web-enabled Integrated Care Pathway (ICP) for Addressing Multiple Modifiable Risk Factors as a Part of Smoking Cessation Treatment in Primary Care Settings.

A study testing Brief physical activity and diet intervention in people with Physical Activity and Fruits and Vegetable Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Compared to non-smokers, smokers are significantly more likely to also engage in other chronic disease-related risk behaviours; which can be a barrier to quitting successfully. Therefore a holistic approach is needed for smoking cessation treatment. Read more about this study

Who is it for?
Any age
What is being tested?
Brief physical activity and diet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,331 participants
Where
1 siteCanada
Study dates
30 Nov 2019to 2 May 2021
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The sample of patients for the study will be recruited from 153 Family Health Teams (FHTs), 61 Community Health Centres (CHCs) and 18 Nurse Practitioner-Led Clinics (NPLCs) currently participating in the STOP program. The inclusion criteria are as follows:
  • An individual enrolling in the STOP program at a participating FHT, CHC, or NPLC.
  • Must have at least one of the following two modifiable risk factors: low levels of physical activity and/or low levels of fruits/vegetable consumption.
  • Enrollment into STOP program must be completed online on the STOP Portal, in real-time with the participant present.
  • Must have at least one piece of contact information (e.g. phone number or email address).

Who cannot join

  • An individual enrolling in the STOP program at a participating Addictions Agencies (AAs)
  • STOP enrollment conducted on paper, no contact information.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T1P7

Other trials in Canada

About this study

Compared to non-smokers, smokers are significantly more likely to also engage in other chronic disease-related risk behaviours; which can be a barrier to quitting successfully. Therefore a holistic approach is needed for smoking cessation treatment. The Smoking Treatment for Ontario Patients (STOP) program currently offers an online integrated care pathway (ICP) for addressing alcohol and mood as a part of smoking cessation treatment. Evidence also shows that smokers are also more likely to be physical inactive and not consume enough fruits/vegetables. These risk behaviours can further compound the negative health effects for smokers. However, it is remains unclear which and how many behaviours should be addressed simultaneously in smoking cessation treatment and what the impact on smoking cessation and care for STOP participants will be.

Through this study, the investigators will seek to:

  1. Determine whether the addition of an integrated care pathway for physical activity and fruits/vegetable consumption to the STOP program is associated with participants' quit prevalence at 6 month follow-up among STOP participants who are physically inactive and/or have low levels of fruits/vegetable consumption.
  2. Understand how the integrated care pathway for physical activity and fruits/vegetable consumption is implemented in primary care settings. In the process, we hope to generate insights on how this ICP can be most helpful to organizations, staff and patients.
Read the detailed description

Tobacco use, in particular, continues to be the leading cause of preventable death, with a recent review identifying strong associations between tobacco and other modifiable risk behaviours. Tobacco users tend to consume more alcohol, eat less fruits and vegetables and report less minutes of leisure physical activity as compared with non-tobacco users. The clustering of these modifiable risk behaviours among tobacco users not only translates a heightened risk for cardiovascular disease but may also negatively influence the likelihood of successful smoking cessation. Alcohol consumed even in small amounts, has been shown to increase cravings for smoking, thus increasing risk of relapse to smoking. Increasing physical activity levels can help to reduce tobacco withdrawal and cravings, as well as minimize the reward anticipation. Individuals also often misattribute the reversal of withdrawal symptoms (i.e. irritability) from smoking as relief from stress. This can also increase the risk of relapse when attempting to quit.

In addition to the more direct relationships between these health behaviours and smoking cessation, successfully changing one or more behaviours may also help to increase self-efficacy and self-confidence to change other health behaviours that individuals may be less motivated to act on. As a result, targeting multiple risk behaviours in smokers may help maximize health promotion efforts by augmenting smoking abstinence rates, improving overall health, and reducing healthcare-related costs. In order to address this, the Smoking Treatment for Ontario Patients (STOP) Program (REB#: 058-2011), a province-wide initiative that uses the existing healthcare infrastructure to provide smoking cessation support to smokers in Ontario, has been developed and is currently testing a web-enabled Integrated Care Pathways (ICP) for some of these behaviours. In 2016, the STOP program started offering specialized clinical pathways through the STOP Portal (a web-based platform and an online data collection/management tool used by the STOP practitioners to complete participant enrollment and record smoking status at each visit) for smokers who drink above Canadian Cancer Society guidelines (REB# 035-2015). In 2018, it added a specialized ICP for those who have mood disorders (REB#: 065-2016). However, there are currently no web-enabled tools in the STOP program that also address some of the other well-known modifiable risk factors such as: physical activity, and diet.

There is substantial high quality evidence that shows the effectiveness of screening for these behaviors, providing a brief intervention, and referral to treatment when needed for helping patients quit smoking as well as change other behaviours. Moreover, a recent systematic review of behaviour change techniques practitioners can use to promote health behaviour change in patients found that, relative to other techniques, 'risk communication' and 'self-monitoring of behaviour' are the most effective techniques.

As a result, we designed the intervention - an integrated care pathway that facilitates practitioners to deliver a brief intervention that includes risk communication, and provides tools for patients to monitor their health behaviours to STOP patients who have at least one of the following other modifiable risk factors at baseline: low levels of physical activity, and low levels of fruits/vegetable consumption. Low levels of physical activity will be defined as being below the Canadian national guidelines: less than 150 min per week of moderate-to-vigorous activity. Low fruits and vegetable is defined as being below the 2007 Canada's Food Guide: less than 7 servings (female) or 8 servings (male) of fruits/vegetable per day.

The specific components of the intervention are outlined below:

  1. Systematic screening through the STOP portal for STOP participants with at least one of the following risk factors: low levels of physical activity, and low fruits/vegetable consumption.
  2. Have computer prompts that advise the practitioner of patient's risk factors, and to provide a brief intervention that includes how the identified risk factors affect the patient's ability to quit successfully (Risk communication).
  3. Provision of self-monitoring tool(s) for monitoring physical activity and/or fruits/vegetable consumption levels.

This study aims to assess whether the addition of an ICP for physical activity and diet into Family Health Teams (FHTs), Community Health Centres (CHCs), and Nurse Practitioner-led Clinics (NPLCs) participating in the STOP program is associated with participants' quit rate at 6 month follow-up. Individuals enrolling into the STOP program through one of these organizations will be randomly allocated (1:1) to control vs intervention group. In addition, we hope to gather insights on how this ICP can be most helpful to organizations, staff and patients, thereby informing implementation processes in other primary care settings across Canada/ Ontario. Our evaluation includes patient, clinician, and organization-level outcomes. To organize this multifaceted evaluation, we use the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Being tested
Brief physical activity and diet intervention
Keywords
smoking cessation, physical activity, diet, primary care, screening, brief intervention, integrated care pathway
Medical subject headings
Motor Activity, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief physical activity and diet interventionBehavioural

    The intervention is an integrated care pathway that provides a computerized prompts for practitioners in the STOP program via their online portal. For a participant who is in the intervention group, the online portal will screen the participant for their physical activity and fruit/vegetable consumption and provide the practitioner (who is seeing this participant for their visit) with computerized alerts for physical activity and fruits/vegetable consumption. Specifically, the portal will prompt practitioners to provide a brief intervention for these two behaviours using risk communication and will also suggest brief intervention language designed based on the Elicit-Provide-Elicit framework. The portal will also have available a self-monitoring resource for physical activity and fruits/vegetable consumption and will prompt practitioners to provide this self-monitoring resource to the participant during their visit.

Study groups in NCT04223336
Study groupRoleWhat they receive
Control GroupNo interventionWhen a participant in the control group is identified via a mandatory baseline questionnaire as having low levels of physical activity and/or low levels of fruits/vegetable consumption, the practitioner seeing this participant during their visit will not receive any computer alerts for physical activity and fruits/vegetable consumption. However, practitioners will still have access to the physical activity and diet data as part of the baseline assessment (Screening). Practitioners will also continue to have access to all the same resources as they currently do (treatment as usual).
Intervention GroupExperimentalWhen a participant in the intervention group is identified via mandatory baseline questionnaire as having low levels of physical activity and/or low levels of fruits/vegetable consumption, the practitioner seeing this participant during their visit will receive computer alerts (screening), prompting to provide participant with a brief intervention (risk communication) and a self-monitoring resource for physical activity and/or fruits/vegetable consumption.
Receives: Behavioral: Brief physical activity and diet intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking cessation - self-report questionnaire

    The primary outcome of the study, measured at the patient level, is 7 day point prevalence of abstinence at 6 month follow-up. We will compare the proportion of intervention vs control group participants who report being quit at follow-up.

    Measured: 6-month follow-up

Secondary outcomes (2)
  1. Physical activity - self-report questionnaire

    The secondary outcome, also measured at the patient level, is change in physical activity levels from baseline to 6 months follow-up. We will compare the change in physical activity from baseline to 6 month follow-up in intervention vs control group participants.

    Measured: 6-month follow-up

  2. Fruits/vegetable consumption - self-report questionnaire

    The secondary outcome, also measured at the patient level, is change in fruits/vegetable consumption levels from baseline to 6 months follow-up. We will compare the change in fruits/vegetable consumption levels from baseline to 6 month follow-up in intervention vs control group participants.

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2020
  2. Study start30 Nov 2019
  3. Primary completion2 May 2021
  4. Study completion2 May 2021

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Individuals enrolling into the STOP program at a primary care organization (Family Health Team, Community Health Centre, or Nurse Practitioner-led Clinic) will be randomly allocated in a 1:1 allocation ratio to control or intervention group.
Masking
None (open label)
Enrolment
5,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04223336
Sponsor's protocol ID
119-2018
Status last verified
Aug 2021
First submitted
7 Jan 2020
Last updated
4 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Minian N, Mehra K, Lingam M, Dragonetti R, Veldhuizen S, Zawertailo L, deRuiter WK, Melamed OC, Moineddin R, Thorpe KE, Taylor VH, Hahn M, Selby P. Healthcare providers' perspectives on implementing a brief physical activity and diet intervention within a primary care smoking cessation program: a qualitative study. BMC Prim Care. 2024 Jan 6;25(1):16. doi: 10.1186/s12875-023-02259-3.

    PubMed 38184559
  • Minian N, Lingam M, Moineddin R, Thorpe KE, Veldhuizen S, Dragonetti R, Zawertailo L, Taylor VH, Hahn M, deRuiter WK, Melamed OC, Selby P. The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial. J Med Internet Res. 2022 Sep 30;24(9):e37900. doi: 10.2196/37900.

    PubMed 36178716
  • Minian N, Lingam M, Moineddin R, Thorpe KE, Veldhuizen S, Dragonetti R, Zawertailo L, Taylor VH, Hahn M, deRuiter WK, Melamed O, Selby P. Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation Treatment: Protocol for a Hybrid Type I Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 29;9(9):e19157. doi: 10.2196/19157.

    PubMed 32990250

Questions about this trial

What is this clinical trial studying?

A study testing Brief physical activity and diet intervention in people with Physical Activity and Fruits and Vegetable Consumption, run by Centre for Addiction and Mental Health at 1 site in Canada.

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 5 inclusion and 2 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 4 Aug 2021. 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 Canada. 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?

Smoking cessation - self-report questionnaire (time frame: 6-month follow-up). 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 NCT04223336, which also lists 3 linked publications.

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 4 Aug 2021.

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