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A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers

A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers
A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers
Background

There have been few rigorous studies on the effects of behavioural support for helping smokers to reduce who do not immediately wish to quit. While reduction may not have the health benefits of quitting, it may lead smokers to want to quit. Physical activity (PA) helps to reduce cravings and withdrawal symptoms, and also reduces weight gain after quitting, but smokers may be less inclined to exercise. There is scope to develop and determine the effectiveness of interventions to support smoking reduction and increase physical activity, for those not ready to quit.

Objective

To conduct a pilot randomised controlled trial (RCT) [Exercise Assisted Reduction then Stop (EARS) smoking study] to (1) design and evaluate the feasibility and acceptability of a PA and smoking-reduction counselling intervention [for disadvantaged smokers who do not wish to quit but do want to reduce their smoking (to increase the likelihood of quitting)], and (2) to inform the design of a large RCT to determine the clinical effectiveness and cost-effectiveness of the intervention.

Design

A single-centre, pragmatic, pilot trial with follow-up up to 16 weeks. A mixed methods approach assessed the acceptability and feasibility of the intervention and trial methods. Smokers were individually randomised to intervention or control arms.

Setting

General practices, NHS buildings, community venues, and the Stop Smoking Service (SSS) within Plymouth, UK.

Participants

Aged > 18 years, smoking 10 cigarettes per day (for 2 years) who wished to cut down. We excluded individuals who were contraindicated for moderate PA, posed a safety risk to the research team, wished to quit immediately or use Nicotine Replacement Therapy, not registered with a general practitioner, or did not converse in English.

Intervention

We designed a client-centred, counselling-based intervention designed to support smoking reduction and increases in PA. Support sessions were delivered by trained counsellors either face to face or by telephone. Both intervention and control arms were given information at baseline on specialist SSS support available should they have wished to quit.

Main outcome measures

The primary outcome was 4-week post-quit expired air carbon monoxide (CO)-confirmed abstinence from smoking. Secondary outcomes included validated behavioural, cognitive and emotional/affective and health-related quality of life measures and treatment costs.

Results

The study randomised 99 participants, 49 to the intervention arm and 50 to the control arm, with a 62% follow-up rate at 16 weeks. In the intervention and control arms, 14% versus 4%, respectively [relative risk = 3.57; 95% confidence interval (CI) 0.78 to 16.35], had expired CO-confirmed abstinence at least 4 and up to 8 weeks after quit day; 22% versus 6% (relative risk = 3.74; 95% CI 1.11 to 12.60) made a quit attempt; 10% versus 4% (relative risk = 92.55; 95% CI 0.52 to 12.53) achieved point-prevalent abstinence at 16 weeks; and 39% versus 20% (relative risk = 1.94; 95% CI 1.01 to 3.74) achieved at least a 50% reduction in the number of cigarettes smoked daily. The percentage reporting using PA for controlling smoking in the intervention versus control arms was 55% versus 22%, respectively at 8 weeks and 37% versus 16%, respectively, at 16 weeks. The counsellors generally delivered the intervention as planned and participants responded with a variety of smoking reduction strategies, sometimes supported by changes in PA. The intervention costs were approximately £192 per participant. Exploratory cost-effectiveness modelling indicates that the intervention may be cost-effective.

Conclusions

The study provided valuable information on the resources needed to improve study recruitment and retention. Offering support for smoking reduction and PA appears to have value in promoting reduction and cessation in disadvantaged smokers not currently motivated to quit. A large RCT is needed to assess the clinical effectiveness and cost-effectiveness of the intervention in this population.
1366-5278
NIHR
Taylor, Adrian H.
fe15f27a-46ea-41bd-a31f-ac3a27299553
Thompson, Tom P.
8552b100-c2cc-42aa-be13-0d70e3135756
Greaves, Colin J.
d294c2c8-fa80-483e-bcd0-6971b52b3afe
Taylor, Rod S.
82254133-e8df-4e13-98d2-a556868d4d26
Green, Colin
c57c8e95-7870-4fb1-b3b1-6a2c7442cb30
Warren, Fiona C.
bab70ba8-cbd5-4419-a9b2-9b0d716d068e
Kandiyali, Rebecca
70758339-ee73-447d-980f-66dbc9157803
Aveyard, Paul
cb22de2b-29bc-4886-8a00-6e68aea59509
Ayres, Richard
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Byng, Richard
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Campbell, John L.
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Ussher, Michael H.
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Michie, Susan
47e0a907-79cb-47d5-b5a9-82d2afe1747a
West, Robert
de79ca55-bbe3-415f-bec6-a78f6ebb3d9f
Taylor, Adrian H.
fe15f27a-46ea-41bd-a31f-ac3a27299553
Thompson, Tom P.
8552b100-c2cc-42aa-be13-0d70e3135756
Greaves, Colin J.
d294c2c8-fa80-483e-bcd0-6971b52b3afe
Taylor, Rod S.
82254133-e8df-4e13-98d2-a556868d4d26
Green, Colin
c57c8e95-7870-4fb1-b3b1-6a2c7442cb30
Warren, Fiona C.
bab70ba8-cbd5-4419-a9b2-9b0d716d068e
Kandiyali, Rebecca
70758339-ee73-447d-980f-66dbc9157803
Aveyard, Paul
cb22de2b-29bc-4886-8a00-6e68aea59509
Ayres, Richard
8d05cabf-f778-4865-b2f2-1440c3177791
Byng, Richard
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Campbell, John L.
07cffd7d-3b19-409e-aabf-46531ac4c4de
Ussher, Michael H.
800e3c8b-d3fd-4ce3-bae0-3c7f2b7dca77
Michie, Susan
47e0a907-79cb-47d5-b5a9-82d2afe1747a
West, Robert
de79ca55-bbe3-415f-bec6-a78f6ebb3d9f

Taylor, Adrian H., Thompson, Tom P., Greaves, Colin J., Taylor, Rod S., Green, Colin, Warren, Fiona C., Kandiyali, Rebecca, Aveyard, Paul, Ayres, Richard, Byng, Richard, Campbell, John L., Ussher, Michael H., Michie, Susan and West, Robert (2014) A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers (Health Technology Assessment, , (doi:10.3310/hta18040), 18:4) Southampton, GB. NIHR 324pp.

Record type: Monograph (Project Report)

Abstract

Background

There have been few rigorous studies on the effects of behavioural support for helping smokers to reduce who do not immediately wish to quit. While reduction may not have the health benefits of quitting, it may lead smokers to want to quit. Physical activity (PA) helps to reduce cravings and withdrawal symptoms, and also reduces weight gain after quitting, but smokers may be less inclined to exercise. There is scope to develop and determine the effectiveness of interventions to support smoking reduction and increase physical activity, for those not ready to quit.

Objective

To conduct a pilot randomised controlled trial (RCT) [Exercise Assisted Reduction then Stop (EARS) smoking study] to (1) design and evaluate the feasibility and acceptability of a PA and smoking-reduction counselling intervention [for disadvantaged smokers who do not wish to quit but do want to reduce their smoking (to increase the likelihood of quitting)], and (2) to inform the design of a large RCT to determine the clinical effectiveness and cost-effectiveness of the intervention.

Design

A single-centre, pragmatic, pilot trial with follow-up up to 16 weeks. A mixed methods approach assessed the acceptability and feasibility of the intervention and trial methods. Smokers were individually randomised to intervention or control arms.

Setting

General practices, NHS buildings, community venues, and the Stop Smoking Service (SSS) within Plymouth, UK.

Participants

Aged > 18 years, smoking 10 cigarettes per day (for 2 years) who wished to cut down. We excluded individuals who were contraindicated for moderate PA, posed a safety risk to the research team, wished to quit immediately or use Nicotine Replacement Therapy, not registered with a general practitioner, or did not converse in English.

Intervention

We designed a client-centred, counselling-based intervention designed to support smoking reduction and increases in PA. Support sessions were delivered by trained counsellors either face to face or by telephone. Both intervention and control arms were given information at baseline on specialist SSS support available should they have wished to quit.

Main outcome measures

The primary outcome was 4-week post-quit expired air carbon monoxide (CO)-confirmed abstinence from smoking. Secondary outcomes included validated behavioural, cognitive and emotional/affective and health-related quality of life measures and treatment costs.

Results

The study randomised 99 participants, 49 to the intervention arm and 50 to the control arm, with a 62% follow-up rate at 16 weeks. In the intervention and control arms, 14% versus 4%, respectively [relative risk = 3.57; 95% confidence interval (CI) 0.78 to 16.35], had expired CO-confirmed abstinence at least 4 and up to 8 weeks after quit day; 22% versus 6% (relative risk = 3.74; 95% CI 1.11 to 12.60) made a quit attempt; 10% versus 4% (relative risk = 92.55; 95% CI 0.52 to 12.53) achieved point-prevalent abstinence at 16 weeks; and 39% versus 20% (relative risk = 1.94; 95% CI 1.01 to 3.74) achieved at least a 50% reduction in the number of cigarettes smoked daily. The percentage reporting using PA for controlling smoking in the intervention versus control arms was 55% versus 22%, respectively at 8 weeks and 37% versus 16%, respectively, at 16 weeks. The counsellors generally delivered the intervention as planned and participants responded with a variety of smoking reduction strategies, sometimes supported by changes in PA. The intervention costs were approximately £192 per participant. Exploratory cost-effectiveness modelling indicates that the intervention may be cost-effective.

Conclusions

The study provided valuable information on the resources needed to improve study recruitment and retention. Offering support for smoking reduction and PA appears to have value in promoting reduction and cessation in disadvantaged smokers not currently motivated to quit. A large RCT is needed to assess the clinical effectiveness and cost-effectiveness of the intervention in this population.

Full text not available from this repository.

More information

Published date: January 2014
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 369968
URI: http://eprints.soton.ac.uk/id/eprint/369968
ISSN: 1366-5278
PURE UUID: 2ff6d65f-ed2d-4a65-a5bc-bf4a16e0520f

Catalogue record

Date deposited: 10 Oct 2014 13:52
Last modified: 15 Jul 2019 21:41

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Contributors

Author: Adrian H. Taylor
Author: Tom P. Thompson
Author: Colin J. Greaves
Author: Rod S. Taylor
Author: Colin Green
Author: Fiona C. Warren
Author: Rebecca Kandiyali
Author: Paul Aveyard
Author: Richard Ayres
Author: Richard Byng
Author: John L. Campbell
Author: Michael H. Ussher
Author: Susan Michie
Author: Robert West

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