ISRCTN ISRCTN45820471
DOI https://doi.org/10.1186/ISRCTN45820471
Secondary identifying numbers HTA 09/127/34, QMUL051211
Submission date
10/10/2012
Registration date
12/10/2012
Last edited
04/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
About 42% men and 32% women in England are overweight [body mass index (BMI) 25 kg/m2 or over] and some 24% are obese (BMI 30 kg/m2 or over). The prevalence (percentage of a population affected at a given time) of obesity has increased and is expected to rise further. Ill health resulting from obesity is responsible for about 10% of morbidity and mortality in the UK and costs the NHS about 7 billion pounds annually. Obesity is associated with a number of adverse health conditions including cardiovascular disease, Type 2 diabetes, osteoarthritis and a number of cancers. Weight loss has been shown to improve many of these illnesses, and reduce the risk of early death.
An increasing number of people are in need of interventions (treatment) to help them to lose weight. General Practitioners (GPs) are encouraged to measure BMI and monitor patients with a BMI of 30 kg/m2 or greater. Such patients are expected to be recommended healthy eating and physical activity, and to receive drug therapy and/or a referral to a practice nurse or dietician, if indicated. Current treatments have modest effects which can be beneficial, but are likely to be lost once the medication is stopped. Surgical interventions are more successful but are currently expensive and unsuitable for large scale use. Dietary interventions on their own have only uncertain effects and brief routine interventions within primary care have generally reported disappointing results. More intensive behavioural interventions generate a small but sustainable weight loss, which can have significant and clinically worthwhile long term health benefits. Such interventions however are normally limited to commercial or research context. Weight management in overweight individuals who seek help normally requires changes to their habitual lifestyle which are difficult to implement and maintain without specialist input, structure and support. The Weight Action Programme (WAP) is a weight loss intervention that was developed over several years through client feedback and testing in deprived communities. It provides people with tools to maintain a healthy lifestyle, with weekly individualized tasks, and peer support group sessions. The proposed study has been designed to establish whether WAP maintains its effects long term, and whether it helps people more than current best practice GP advice.

Who can participate?
Participants (330 overweight adults) will be referred from general practice.

What does the study involve?
Particpants will be randomly assigned to WAP or to a session with a trained nurse who will provide weight management advice modelled on the current best practice in primary care. The WAP will provide weekly sessions for 8 weeks, followed by monthly maintenance sessions for one year. The nurse will provide an initial 20 - 30 minute intervention followed by three further sessions over 8 weeks, accompanied by standard written materials and referrals to local physical activity programmes. Both the WAP and the nurse appointments will be run from GP surgeries. Weight loss over one year will be measured. Other measures concerning the participant’s health, exercise levels, and health behaviours will also be collected.

What are the possible benefits and risks of participating?
The main benefit to the participant is the chance to try a safe treatment that could enhance the likelihood of achieving and maintaining a beneficial weight loss. We do not forsee any potential risks to participants.

Where is the study run from?
The study is being conducted by researchers from Queen Mary University of London which includes experts who have extensive experience in developing and testing interventions to help people change their health behaviours.

When is the study starting and how long is it expected to run for?
The study recruitment started in September 2012 and recruitment is expected to finish in March 2014.

Who is funding the study
The study is being funded by the National Institute for Health Research - Health Technology Assessment Programme (NIHR-HTA).

Who is the main contact?
Dr Hayden McRobbie
h.j.mcrobbie@qmul.ac.uk

Contact information

Dr Hayden McRobbie
Scientific

55 Philpot Street
London
E1 2JH
United Kingdom

Phone +44 (0)207 882 8230
Email h.j.mcrobbie@qmul.ac.uk
Ms Sarrah Peerbux
Scientific

Health and Lifestyle Research Unit
55 Philpot Street
London
E1 2JH
United Kingdom

Email s.peerbux@qmul.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please contact k.myers@qmul.ac.uk to request a patient information sheet
Scientific titleA peer-support weight action programme to supplement brief advice in general practice
Study acronymSWAP
Study hypothesisThe proposed study will determine whether a promising group-based weight management program (Weight Action Programme; WAP) targeting underprivileged groups has a long-term effect that is over and above the effect of a 'best practice' weight management intervention that is provided in primary care by practice nurses.

More details can be found at http://www.hta.ac.uk/project/2552.asp
Protocol can be found at http://www.hta.ac.uk/protocols/200901270034.pdf
Ethics approval(s)NRES Committee London - Central, 03/02/2012, ref: 12/LO/0122
ConditionObesity/weight management
InterventionExperimental Group: The Weight Action Program (WAP)
WAP is a multi-modal health behavior modification intervention that has been modified and improved through client feedback over the past 5 years. It includes the standard elements of cognitive behavioural interventions, including information on healthy eating and caloric content of food, self-monitoring, cue management, provision of opportunities for exercise and close monitoring of exercise levels. Novel elements include a range of concrete and verifiable tasks agreed individually with each participant, and motivational interventions to ensure adherence to the new lifestyle changes. A range of guidelines for the treatment of obesity report that the best results are achieved with a combination of diet, physical activity and behavioural support. WAP combines all three components.

WAP comprises 8 weekly sessions, followed by monthly follow-up visits lasting up to 1 hour each. The target weight loss is one pound (0.45 kg) per week. Two advisors will be conducting WAP sessions in groups of 10 to 20 participants. Participants will be sent text messages to remind them of the session dates and times.

Control Group: Routine intervention as typically provided in primary care
The control intervention will be modelled on best-practice intervention in primary care, derived from discussions with GPs and Practice Nurses and incorporating national guidelines and NHS materials (e.g. Raising the issue of weight gain).

Participants will receive weight management intervention from a trained study nurse in 4 sessions delivered over 8 weeks. The initial session will take 20-30 minutes; the follow-up session may be briefer, as per usual practices.
Intervention typeBehavioural
Primary outcome measureChange in weight over 12 months from enrollment into the study. A researcher that is blind to treatment allocation will measure weight at 12 months.
Secondary outcome measures1. Change in BMI
2. Waist circumference
3. Proportion of participants losing at least 5% of baseline body weight
4. Changes in healthy eating
5. Changes in physical activity and changes in food craving

All measures at 12 months will be collected by a researcher that is blind to treatment allocation.
Overall study start date03/09/2012
Overall study end date06/02/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants330
Participant inclusion criteria1. Adults, aged 18 years and older
2. BMI of 30 kg/m2 or over, or BMI of 28 kg/m2 or over
3. Co-morbidities referred from general practice
Participant exclusion criteria1. Inability to read/write/understand English
2. BMI over 45
3. Lost more than 5% of their body weight in the previous 6 months
4. Women who are pregnant
5. Clients taking psychiatric medications (these medications can have a significant effect on weight and psychiatric illness also makes follow-up and adherence to long-term programs difficult)
6. Clients who are not registered with a GP
7. Currently involved in a research project
8. Clients who cannot speak or understand English
Recruitment start date24/09/2012
Recruitment end date28/01/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Health and Lifestyle Research Unit
55 Philpot Street
London
E1 2JH
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Joint research managment office
Queen Mary Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom

Phone +44 (0)20 7882 7260
Email sponsorsrep@bartshealth.nhs.uk
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2016 Yes No
Results article results 02/04/2019 04/04/2019 Yes No

Editorial Notes

04/04/2019: Publication reference added.
03/11/2016: Publication reference added.