Slimming World in Stop Smoking Services

ISRCTN	ISRCTN65705512
DOI	https://doi.org/10.1186/ISRCTN65705512
Secondary identifying numbers	12683

Submission date: 25/07/2012
Registration date: 26/07/2012
Last edited: 04/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Deborah Lycett
Scientific

Primary Care Clinical Sciences School of Health and Population Sciences, Edgbaston
Birmingham
B15 2TT
United Kingdom

Study information

Study design	Randomised interventional phase II trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Slimming World in Stop Smoking Services (SWISSS)
Study acronym	SWISSS
Study hypothesis	Quitting smokers gain weight which puts some off attempting to quit, and seems to increase the risk of developing type 2 diabetes. Dieting is the main way to control weight but may worsen cigarette cravings and undermine cessation. A review of trials showed general healthy eating education does not reduce weight gain in quitting smokers and may hamper smoking cessation. However, planning diets to meet individual requirements, setting and reviewing weight targets does reduce weight gain; but whether this reduces the chance of successfully quitting is uncertain. Commercial weight management programmes (CWMPs) provide this type of individual dietary support and are available on prescription in most primary care trusts. Clinical trials show CWMPs lead to greater weight loss than other primary care interventions or dieting without support. The aim of this trial is to assess whether referral to a CWMP reduces weight gain on smoking cessation. If so, this would lead to a necessary much larger trial to see whether it did so at the expense of successfully quitting smoking. We will recruit patients from NHS stop smoking services, they must be smokers over 18 without any condition in which weight loss would be harmful. They will be randomised to either a CWMP during their quit attempt or usual care. All will receive usual stop smoking support and be weighed at the start, end of treatment and at six month follow-up.
Ethics approval(s)	First MREC, 29 June 2012 ref:12/SW/0159
Condition	Smoking and weight loss
Intervention	This will be the withdrawal orientated behavioural support provided by NHS stop smoking services which increase the chance of a successful quit attempt four-fold (West, 2010). This consists of weekly behavioural support typically for two weeks before and until four weeks after quit day focusing on key behavioural change techniques and nicotine replacement, varenicline, or bupropion are given to relieve withdrawal symptoms. Participants are encouraged to quit smoking first, before tackling weight; Usual care plus Slimming World, In addition to usual care, participants will be given a referral voucher for Slimming World when they attend their pre-quit visit. They will be booked in to attend weight management sessions from their quit day (or as near to that date as possible). They will attend SW for 12 weeks receiving support to lose or prevent weight gain. The choice of modest weight loss or weight gain prevention will depend upon whether an individual wants to lose weight or not and whether or not s/he is overweight or ; Follow Up Length: 5 month(s); Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Change in weight from baseline (one week before quit date) to twelve weeks
Secondary outcome measures	No secondary outcome measures
Overall study start date	24/09/2012
Overall study end date	06/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 320; Description: We will recruit 320 participants, 160 in each arm. With an alpha error rate of 5% and 90% power this will detect a 2kg (SD=2.5)
Total final enrolment	76
Participant inclusion criteria	1. Daily smokers with expired CO >10ppm 2. Aged 18 or over 3. Willing to be randomised to either the control or intervention arm and willing and able to comply with the intervention and all study procedures 4. Male & female participants
Participant exclusion criteria	1. Pregnant smokers 2. BMI<23 kg/m2. Mortality has been shown to be lowest in those with a 22>BMI<25 (Prospective studies collaboration, 2009) so preventing weight gain in those with lower BMIs is may not lead to health gain 3. Any medical condition in which weight loss would be contraindicated e.g. current course of chemotherapy
Recruitment start date	24/09/2012
Recruitment end date	06/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Primary Care Clinical Sciences School of Health and Population Sciences, Edgbaston

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Behavioural Brain Sciences Centre
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute of Health Research [NIHR] - National School for Primary Care Research (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	19/06/2013		Yes	No
Results article	results	26/01/2020	04/03/2021	Yes	No

Editorial Notes

04/03/2021: Publication reference and total final enrolment added.
26/09/2018: No publications found, verifying study status with principal investigator.