Tobacco SmokingNCT03716440
Effects of Nature Exposure on Smoking Behavior
A study testing Nature exposure and Non-nature exposure in people with Tobacco Smoking, run by University of Montana at 1 site in United States.
Trial summary
Smoking continues to be the leading cause of preventable death and disease in the U.S. While smoking is a significant threat to public health in the US in general, the negative effects of smoking disproportionately affect Americans with 12 or fewer years of education and those living below the poverty line. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Nature exposure and Non-nature exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 30 Jun 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Smoked at least two cigarettes per day for the last seven or more days
- Must be 18 years old or older
- Must have a smart cellular phone that can send and receive text messages and open web links
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Nature Exposure Research to Reduce Impulsivity in Smokers
Smoking continues to be the leading cause of preventable death and disease in the U.S. While smoking is a significant threat to public health in the US in general, the negative effects of smoking disproportionately affect Americans with 12 or fewer years of education and those living below the poverty line. Given these health disparities, it is vital to have widely-available treatments that can be applied in multiple contexts in a cost-efficient way. While numerous methodologies and intervention programs exist, there is a need for improved cessation programs targeted to smokers with low levels of education attainment and income, as these smokers tend to be less likely to receive cessation assistance from a health care provider or have sufficient resources to access treatments. Therefore, the present proposal aims to assess the feasibility of a tool that will improve smoking cessation programs in a short and cost-effective manner: a brief exposure to nature.
The health and wellbeing benefits of nature exposure have been well researched and are widely recognized, and research on the underlying mechanism for nature's positive impact on health has identified a reduction in impulsivity as a mediator of this effect. However, this work has never been directly translated to smoking outcomes, and thus the translational purpose of the present project is to assess the feasibility of a brief and cost-effective nature exposure intervention on smoking cessation outcomes. Prior work demonstrates the validity of the causal links in the nature -> impulsivity -> smoking cessation model. Research has shown that nature exposure reduces impulsivity for health-related outcomes, and found that increased impulsivity is linked to all stages of smoking. A necessary step in developing a practical application for this research is the aim of the present project.
Smokers will be recruited online and randomly assigned to either the Nature or Control condition. Participants in the Nature condition will be given a nature-based intervention, while participants in the Control condition will be given a non-nature-based intervention. Participants will be contacted via text message throughout the following 24 hours and asked to report their degree of urgency to smoke and number of cigarettes smoked. Participants will complete measurements of impulsivity, income, socio-economic status, and education, and additional smoking-related constructs.
- Conditions
- Tobacco Smoking
- Being tested
- Nature exposure, Non-nature exposure
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature exposureOther
Participants will view images of nature.
Non-nature exposureOther
Participants will view non-nature images.
| Study group | Role | What they receive |
|---|---|---|
| Nature group | Experimental | Nature exposure intervention. Receives: Other: Nature exposure |
| Non-nature group | Active comparator | Non-nature exposure intervention. Receives: Other: Non-nature exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-item Desire to Smoke Measure
Self reported rating of desire to smoke. This item is scored 1 - 10 (1 = no desire to smoke; 10 = craving to smoke is extreme).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start2 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucian Conway, University of Montana
- Investigators
- Luke Conway, PhD, Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716440
- Sponsor's protocol ID
- 44-17
- Status last verified
- Oct 2018
- First submitted
- 20 Feb 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Nature Exposure Research to Reduce Impulsivity in Smokers
- ClinicalTrials.gov ID
- NCT03716440
- Acronym / sponsor ID
- 44-17
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking continues to be the leading cause of preventable death and disease in the U.S. While smoking is a significant threat to public health in the US in general, the negative effects of smoking disproportionately affect Americans with 12 or fewer years of education and those living below the poverty line. Given these health disparities, it is vital to have widely-available treatments that can be applied in multiple contexts in a cost-efficient way. While numerous methodologies and intervention programs exist, there is a need for improved cessation programs targeted to smokers with low levels of education attainment and income, as these smokers tend to be less likely to receive cessation assistance from a health care provider or have sufficient resources to access treatments. Therefore, the present proposal aims to assess the feasibility of a tool that will improve smoking cessation programs in a short and cost-effective manner: a brief exposure to nature.
The health and wellbeing benefits of nature exposure have been well researched and are widely recognized, and research on the underlying mechanism for nature's positive impact on health has identified a reduction in impulsivity as a mediator of this effect. However, this work has never been directly translated to smoking outcomes, and thus the translational purpose of the present project is to assess the feasibility of a brief and cost-effective nature exposure intervention on smoking cessation outcomes. Prior work demonstrates the validity of the causal links in the nature -> impulsivity -> smoking cessation model. Research has shown that nature exposure reduces impulsivity for health-related outcomes, and found that increased impulsivity is linked to all stages of smoking. A necessary step in developing a practical application for this research is the aim of the present project.
Smokers will be recruited online and randomly assigned to either the Nature or Control condition. Participants in the Nature condition will be given a nature-based intervention, while participants in the Control condition will be given a non-nature-based intervention. Participants will be contacted via text message throughout the following 24 hours and asked to report their degree of urgency to smoke and number of cigarettes smoked. Participants will complete measurements of impulsivity, income, socio-economic status, and education, and additional smoking-related constructs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature group | Experimental | Other: Nature exposureNature exposure intervention. |
| Non-nature group | Active comparator | Other: Non-nature exposureNon-nature exposure intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Smoked at least two cigarettes per day for the last seven or more days
- Must be 18 years old or older
- Must have a smart cellular phone that can send and receive text messages and open web links
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature exposureParticipants will view images of nature. | Other | Nature group |
| Non-nature exposureParticipants will view non-nature images. | Other | Non-nature group |
Primary outcome
1-item Desire to Smoke Measure
Time frame: 1 day
Self reported rating of desire to smoke. This item is scored 1 - 10 (1 = no desire to smoke; 10 = craving to smoke is extreme).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Conway, PhD principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature exposure and Non-nature exposure in people with Tobacco Smoking, run by University of Montana at 1 site in United States.
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 3 inclusion and 1 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 30 Oct 2018. 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 United States. 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?
1-item Desire to Smoke Measure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2018.