A trial of physical activity assisted reduction of smoking

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: During the intervention participants meet with a health trainer once a week for eight weeks. Meetings are a combination of face‐to‐face, at a convenient place for the participant, and telephone. The health trainer help participants to reduce the amount they smoke in a way that suits the individual participant. The health trainer also helps participants to do more physical activity or exercise, if they want to. This could include help in setting goals, access to exercise classes, and a free step counter. There is no set amount of physical activity in this study; 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. Hard physical activity can have risks. We aim to look mainly at moderate physical activity. If participants want further help from their local NHS Stop Smoking Service or GP the health trainer may be able to help with that. If a smoker wishes to quit at any time during theeight week intervention period, they are offered 6 weeks of additional behavioural and motivational support from the health trainer, as well as support to access services as part of usual care to stop smoking (as available at each location) if desired. All participants are followed up at three and nine months. Only those reporting a quit attempt at 9 months will be followed up at 15 months. CONDITION: Specialty: Primary Care, Primary sub‐specialty: Public Health; UKCRC code/ Disease: Respiratory/ Lung diseases due to external agents, Cancer/ Malignant neoplasms of respiratory and intrathoracic organs, Cardiovascular/ Other forms of heart disease, Reproductive Health and Childbirth/ Disorders related to length of gestation and fetal growth ; Respiratory ; Malignant neoplasms of respiratory and intrathoracic organs, Other forms of heart disease, Disorders related to length of gestation and fetal growth PRIMARY OUTCOME: 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. INCLUSION CRITERIA: 1. Adult smokers wishing to reduce but not quit in the next month 2. = 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 SECONDARY OUTCOME: 1. Point prevalence CO verified abstinence at three, nine and 15 months post baseline ‐ Only those reporting abstinence by mailed survey at 3 and 9 months will be contacted for CO verification. Only those abstinent at 9 months will be followed up at 15 months by mailed questionnaires and if abstinent by face‐to‐face assessment of expired CO.; 2. Self‐reported smoking and use of aids to reduce/quit smoking is assessed using self‐reporting on the number of cigarettes smoked and type of nicotine product, i.e. pipes, cigars and roll your own as well as reporting the use of e‐cigarettes and NRT (nicotine replacement therapy) products as part of the questionnaire booklets at baseline, 3, 9 and 15 months.; 3. Physical activity is measured using self‐reported seven‐day physical activity questions at baseline, three and nine months A sub set of all participants in the TARS study will be invited to wear an accelerometer for a 7 day period during the study. The accelerometer, and instructions for use will be mailed to selected participants at the 3 month time point from CTU, along with the 3 month questionnaire booklet. ; 4. Self‐reported height and weight is measured using Body Mass Index (BMI) questions that are part of the questionnaire booklet mailed to participants from CTU at baseline, three and nine months; 5. Health related quality of life (EQ‐5D‐5L & SF‐12) questions which are part of the questionnaire booklet at baseline, three and nine months; 6. Health economic outcomes are measured using a Health service utilisation and costs, including smoking related costs questions which are part of the questionnaire booklet at baseline, three and nine months; 7. Process measures ‐ The following process measures are also assessed as part of the self‐report questionnaire booklets issued to all participants by CTU at the baseline and three months:; 7.1. Importance and confidence in smoking reduction and cessation; 7.2. Importance and confidence in being physically active; 7.3. Availability of support to reduce smoking and increase physical activity; 7.4. Use of physical activity for smoking regulation; 7.5. Planning to change smoking ; 7.6. Planning to change physical activity; 7.7. Self‐monitoring of smoking; 7.8. Self‐monitoring of physical activity; 7.9. Urge & strength of urge to smoke;
Epistemonikos ID: ae1c611a650d75b8331e86f177c868b4aa31119f
First added on: Aug 01, 2020