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11 February 2012
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| [ Print-friendly version ] |
| Improving behavioural support for reducing smoking among those who want to cut down |
| ISRCTN | ISRCTN13837944 |
| ClinicalTrials.gov identifier | |
| Public title | Improving behavioural support for reducing smoking among those who want to cut down |
| Scientific title | An exploratory trial to evaluate the effects of a physical activity intervention as a smoking cessation induction and cessation aid among the ‘hard to reach’ |
| Acronym | EARS (Exercise Assisted Reduction then Stop) |
| Serial number at source | HTA 07/78/02 |
| Study hypothesis |
Primary objective:
To develop a multi-component physical activity (PA) intervention aimed at helping smokers (not intending to quit in the next month), among 'hard to reach' groups, to cut down. Secondary objectives: 1. To assess via interview the acceptability of such a PA intervention as an aid to cutting down, among 'hard to reach' smokers 2. To assess via interview the acceptability of recruitment, assessment and randomisation procedures within a pilot pragmatic randomised controlled trial to compare the effects of a PA intervention versus brief advice (usual care) on quitting, among 'hard to reach' smokers 3. To obtain an estimate of the intervention (PA versus brief advice) effect size, relative risk and its precision to inform sample size calculations for a fully powered trial, from a pilot randomised trial to assess carbon monoxide confirmed abstinence at 4 weeks post-quit date 4. To assess process measures at 4, 8 and 16 weeks post-baseline including: 4.1. Self-reported cigarettes smoked 4.2. Number of quit attempts 4.3. Self-reported quality of life 4.4. Mood and physical symptoms 4.5. Cravings 4.6. PA by self-report and accelerometer (in a sub-sample) 4.7. Pharmacological and behavioural support used 4.8. Weight 5. To estimate the resource use and costs associated with delivery of the intervention, and to pilot methods for determining future cost-effectiveness analyses |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Smoking reduction and cessation |
| Participants - inclusion criteria |
1. Written informed consent
2. People who are currently smoking at least 15 cigarettes a day and have done for a minimum of 3 years 3. Are at least 18 years of age, either sex 4. Are not motivated to quit smoking in the next month but do wish to cut down the number of cigarettes they do smoke |
| Participants - exclusion criteria |
1. Contra-indicated for moderate physical activity
2. Have an injury or illness that might be exacerbated by exercise 3. Pregnant |
| Anticipated start date | 01/09/2010 |
| Anticipated end date | 01/11/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 120 |
| Interventions |
Brief advice:
Written and verbal information on NHS Stop Smoking Service (SSS) with information on the benefits of quitting and how to quit provided at baseline. Those expressing a desire to make a quit attempt will subsequently be referred to NHS SSS. PA intervention: Written and verbal information on NHS SSS with information on the benefits of quitting and how to quit provided at baseline. Smokers will select one of three strategies for smoking reduction and receive weekly support to attain this. Face to face physical activity support sessions will be conducted at weeks 1, 4, and 8 along with supportive phone calls in each intermediate week. The communications will involve tailored physical activity counselling, guidance on using a free pedometer to achieve SMART goals, and signposting to local exercise opportunities with subsidised access as required, with the aim of increasing the amount of regular physical activity completed by each participant for both implicit and explicit purposes as an aid to quit. Those expressing a desire to make a quit attempt will subsequently be referred to NHS SSS. Added 14/07/2010: Please note that this trial is recruiting only in Plymouth, specifically in Stonehouse and Devonport areas of the city, where smoking prevalence is more than twice the national, regional and citywide average. |
| Primary outcome measure(s) | Prolonged abstinence at 4 weeks post-quit. |
| Secondary outcome measure(s) |
1. Weight and height (body mass index [BMI]), measured at baseline, 8 weeks and 16 weeks
2. Self reported cigarettes, pipes, and cigars smoked, measured at baseline and weekly thereafter 3. Readiness to quit smoking, measured at baseline 4. Cigarettes smoked in past week, measured at baseline and weekly thereafter 5. Urge to smoke (single item), measured at baseline and weekly thereafter 6. Mood and Physical Symptom Scores (MPSS, 7 items), measured at baseline and weekly thereafter 7. Physical Symptom Scores (PSS), measured at baseline and weekly thereafter 8. Self reported and accelerometer assessed PA, measured at baseline and weekly thereafter 9. Alcohol consumption 10. 36-item short form health survey (SF36), measured at baseline, 8 weeks and 16 weeks 11. Self reported use of nicotene replacement therapy (NRT) products or smoking related aids, measured at baseline and weekly thereafter |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Adrian Taylor |
| Address |
School of Sport & Health Sciences
University of Exeter St. Luke's Campus Heavitree Road |
| City/town | Exeter |
| Zip/Postcode | EX1 2LU |
| Country | United Kingdom |
| Tel | +44 (0)1392 264 747 |
| a.h.taylor@ex.ac.uk | |
| Sponsor | University of Exeter (UK) |
| Address |
c/o Helen Loughlin
Innovation Centre Streatham Campus |
| City/town | Exeter |
| Zip/Postcode | EX4 4QJ |
| Country | United Kingdom |
| Sponsor website: | http://www.exeter.ac.uk/ |
| Date applied | 05/07/2010 |
| Last edited | 23/08/2011 |
| Date ISRCTN assigned | 06/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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