Effectiveness of a community based weight management programme in North West England

ISRCTN	ISRCTN16647750
DOI	https://doi.org/10.1186/ISRCTN16647750
EudraCT/CTIS number	N/A
ClinicalTrials.gov number	N/A
Secondary identifying numbers	N/A

Submission date: 24/08/2018
Registration date: 05/09/2018
Last edited: 21/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
There is considerable research showing that being overweight or obese can lead to further health problems. In terms of helping people manage their weight, research also shows that local weight loss programmes, like Slimming World, can help people achieve their short and long-term weight loss goals. This study aims to identify whether the community weight loss programme in Wigan Borough is effective in helping people to lose weight.

Who can participate?
People aged over 16 who are overweight and obese who either live in Wigan or are registered with a Wigan Borough GP

What does the study involve?
Participants will be asked to attend a Slimming World class and an accompanying exercise lesson every week for 12 weeks. The programme is free of charge for participants for the 12 weeks and participants are expected to attend every session if they can, to help them achieve their weight loss goals. After 12 weeks, participants will be invited to continue with Slimming World classes (free of charge if they achieve their goal weight or £4 per session if not), along with attending the exercise support sessions at a reduced cost. Participants will have their weight measured before the study, at the end of the 12 week period, and 1 year following this.

What are the possible benefits and risks of participating in this study?
The possible benefits to participants taking part in this study include weight loss, and the individual benefits of physical activity even if no weight loss occurs, including a reduction in blood pressure and improved blood choelsterol. The possible risks of participating in this study include potential psychological harm through being classified as obese and potential disappointment about not losing weight. Additionally, physical activity can lead to musculoskeletal injury and cardiac events, but this risk is minimal, as all participants with 'at risk' conditions will have had a GP approved exercise referral.

Where is the study run from?
Inspiring Healthy Lifestyles, Wigan (UK)

When is the study starting and how long is it expected to run for?
June 2008 to August 2018

Who is funding the study?
University of Chester (UK)

Who is the main contact?
Orla Flannery
o.flannery@chester.ac.uk

Study website

Contact information

Mr Nick Colledge
Scientific

Department of Clinical Sciences and Nutrition
University of Chester
Parkgate Road
Chester
CH2 2AS
Chester
CH2 2AS
United Kingdom

Dr David Broom
Scientific

Academy of Sport and Physical Activity
Faculty of Health and Wellbeing
Sheffield Hallam University
Room A220, Collegiate Hall
Collegiate Crescent
Sheffield
S10 2BP
SHEFFIELD
S10 2BP
United Kingdom

ORCID ID	0000-0002-0305-937X
Phone	+44 (0)114 225 4369
Email	D.R.Broom@shu.ac.uk

Dr Orla Flannery
Scientific

Department of Clinical Sciences and Nutrition
University of Chester
Parkgate Road
Chester
CH2 2AS
CHESTER
CH2 2AS
United Kingdom

Phone	01244 513431
Email	o.flannery@chester.ac.uk

Study information

Study design	Interventional non-randomised retrospective analysis
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Three and twelve-month body mass outcomes after attendance at a community-based weight management intervention in North West England
Study acronym	N/A
Study objectives	Null hypothesis : There is no change in weight loss in the short term (3 months) or long term (12 months) amongst completers of a 3 month community based weight management programme.
Ethics approval(s)	Faculty of Medicine, Dentistry and Clinical Sciences Research Ethics Committee, University of Chester, 18/05/2016, Reference: 1166/16/NC/CSN
Health condition(s) or problem(s) studied	Overweight and obesity
Intervention	This study was a retrospective analysis of a multi-component tier 2 community weight management (CWM) service for adults commissioned locally as part of care pathway (LWFG) between January 2009 and November 2013. The CWM service was commissioned to provide a free 2 hour multi-component evidence-based programme over twelve weeks in line with NICE guidance (2014) offering support and advice around healthy eating, physical activity and behaviour change, as well as a 45 minute exercise session. The service was provided by Wigan Council’s leisure trust, Inspiring Healthy Lifestyles (formerly Wigan Leisure and Culture Trust) working in partnership with Slimming World. Eligible participants were triaged to the service by the separately commissioned telephone access hub. The Wigan CWM service was operated as a rolling programme with 56 weekly community-based sessions throughout the borough, giving new participants the opportunity to immediately book a place on a programme that suited them best in terms of both time and location. Participants were requested to attend every session of the Slimming World class and exercise component (provided by Inspiring Healthy Lifestyles). Those participants that attended at least 9 out of the 12 combined sessions were identified as a completer (arrangements could be made, in the event of illness or a planned holiday, to ‘authorise’ agreed absences, and to attend later sessions). After 12 weeks, participants were invited to continue with Slimming World classes (free of charge if goal weight was achieved, or £4 per session if not) and to attend the exercise support sessions with Inspiring healthy lifestyles at a reduced cost. Inspiring healthy lifestyles and Slimming World organised an annual fashion show event with previous successful participants to celebrate and inspire further success. Participants were measured at baseline and followed up at 3 and 12 months to report on key outcomes. There was no control group as part of this study.
Intervention type	Behavioural
Primary outcome measure	Body weight in kg, assessed using weighing scales at the baseline, after 12 weeks, and 1 year post-intervention completion
Secondary outcome measures	Participants achieving 5% weight loss at 1 year post-intervention, assessed as per primary outcome measure
Overall study start date	01/06/2008
Completion date	01/08/2018

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	Both
Target number of participants	Commissioners funded up to 4,000 new places on the community weight service per annum.
Key inclusion criteria	1. Aged 17 years or older 2. Overweight or obese 3. Self-referred to an access hub 4. One of the following: 4.1. BMI 25-39.9 kg/m² with or without co-morbidities 4.2. BMI 40-44.9 kg/m² without co-morbidities 5. Any of the following: 5.1. Living in Wigan borough 5.2. Registered with a local GP in the Wigan borough 5.3. Working within the Wigan borough
Key exclusion criteria	1. Serious uncontrolled disease i.e. angina, diabetes, asthma, COPD, heart failure 2. Recent complicated myocardial infarction and/or awaiting further investigation 3. Uncontrolled arrhythmia that compromises cardiac function 4. Blood pressure at rest above 180 mg systolic and 100 mg diastolic 5. Neuromuscular or rheumatoid disorders that are exacerbated by exercise 6. Unstable psychiatric disorder 7. Acute infection 8. Not medically fit to take part in 12 weeks of physical activity in doctor's opinion 9. Chronic back pain for over 6 months without a previous physiotherapy assessment 10. Eating disorder
Date of first enrolment	01/01/2009
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Inspiring Healthy Lifestyles (previously Wigan Leisure and Culture Trust)

Robin Park Sports Centre
Loire Drive
WIGAN
WN5 0UL
United Kingdom

Sponsor information

University of Chester
University/education

Department of Clinical Sciences and Nutrition
University of Chester
Parkgate Road
Chester
CH2 2AS
CHESTER
CH2 2AS
England
United Kingdom

Website	https://www.chester.ac.uk/csn
"ROR"	https://ror.org/01drpwb22

Funders

Funder type

Not defined

University of Chester
Private sector organisation / Universities (academic only)

Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The work has been presented at the European Congress of Obesity 2018 as a poster. The plan is to now publish this in a peer reviewed journal.
IPD sharing plan	The datasets generated during and analysed during the current study will be available upon request from Orla Flannery, o.flannery@chester.ac.uk, data is available as an SPSS file on request subject to the approval of a data sharing agreement). All data is anonymised and ethical approval was obtained.

Editorial Notes

21/05/2020: The intention to publish date has been changed from 21/11/2019 to 31/12/2020.
21/08/2019: The intention to publish date was changed from 01/02/2019 to 21/11/2019.