Smoking cessation Respiratory Malignant neoplasms of respiratory and intrathoracic organs, Other forms of heart disease, Disorders related to length of gestation and fetal growth
Conditions
Interventions
Current intervention as of 31/07/2020:
Participants are individually randomised to either the intervention (health trainer support & support as usual) or control (support as usual) in a 1:1 ratio, usi
participants can choose to do as little or as much as is comfortable for them. If participants decide to try any hard physical activity, they are advised to talk to their doctor. We aim to look mainly
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult smokers wishing to reduce but not quit in the next month 2. Aged =18 years 3. =10 cigarettes per day (for at least 1 year). Irrespective of use of other nicotine containing products, for example, e-cigarettes and/or NRT products. 4. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to walk unaided for at least 15 minutes 2. Any illness or injury that might be exacerbated by moderate or vigorous Physical activity 3. Unable to engage in the intervention or trial procedures due to language or other reasons (eg, provide an unacceptable level of risk to the research team)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carbon monoxide (CO) verified prolonged abstinence over 6 months – Participants will be invited to have the carbon monoxide levels in their breath measured at 3 and 9 months, if they report a quit attempt upon completion of the 3 and 9 month questionnaire booklets. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/07/2020: 1. Biochemical verified point prevalence abstinence at 3, 9 and 15 months post-baseline by measurement of carbon monoxide (CO) in expired breath, or by saliva cotinine level as a contingency measure for follow-up during the coronavirus (COVID-19) outbreak. Only those reporting abstinence by mailed survey will be contacted for biochemical verification. 2. Additional prolonged biochemically verified abstinence over 6 months: 2.1 Prolonged biochemically verified abstinence over 6 months between 9 and 15 months post-baseline. 2.2 Prolonged biochemically abstinence over any 6 months (i.e. between 3 and 9 months or between 9 and 15 months post-baseline). 3. Additional prolonged biochemically verified abstinence for at least 12 months, i.e. between 3 and 15 months post-baseline (derived from biochemically confirmed abstinence at all three follow-up time points). 4. At least a 50% reduction in self-reported reported smoking between baseline and (i) 3 months and (ii) 9 months, derived from self-reported smoking status survey administered in postal questionnaires at baseline, 3 and 9 months. 5. Physical activity measures: 5.1 Self-reported physical activity derived from the 7-day physical activity recall survey administered in postal questionnaires at baseline, 3 and 9 months. 5.2 Objective measure of physical activity derived from accelerometer worn for 1 week by a sample of participants at 3 months. 6. Use of licenced nicotine containing products (LNCP), self-reported use in postal questionnaires at baseline, 3, 9 and 15 months. 7. Body Mass Index derived from self-reported height and weight in postal questionnaires at baseline, 3 and 9 months. 8. Economic evaluation: 8.1 Health related quality of life measured using EQ-5D-5L administered in postal questionnaire at baseline, 3 and 9 months. 8.2 Health service utilisation and costs derived from resource use survey administered in postal questionnaires at baseline, 3 and 9 | — |
Countries
England, United Kingdom
Contacts
Public ContactWendy Ingram
Outcome results
None listed