Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/01/2018
Date assigned
01/02/2018
Last edited
31/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Referral to commercial open-group behavioural weight loss programmes (such as Weight Watchers) can help people to lose weight and reduces risk factors for diseases including diabetes, cardiovascular (heart) disease and some cancers. Modelling of the long-term impact of these programmes on illnesses and related treatment costs suggests that these programmes are likely to be cost-effective in the long term for adults who are overweight or obese. However, no studies of this type of intervention have measured outcomes beyond 2 years and uncertainty over the long-term impact of these programmes on body weight, diabetes, and other obesity-related conditions, limits the strength of evidence. It is important to reduce these uncertainties and provide a more precise estimate of longer-term impact. The Weight Loss Referrals for Adults in Primary Care (WRAP) study is one of only two studies of this type of programme that has measured weight at 2-year follow up and has measured diabetes-related outcomes. WRAP is also larger and has a considerably higher retention rate than the other trial at 2 years: 68% vs 26%. The aim of this study is to measure the effect of the weight loss programmes on body weight and diabetes risk after 5 and 10 years.

Who can participate?
Adults who are overweight or obese and who took part in the original WRAP study

What does the study involve?
Participants are contacted and invited to attend their 5-year and 10-year follow up visit at their GP surgery. Changes in weight, fat mass, blood HbA1C and lipid levels, blood pressure, diabetes status and modelled 10-year cardiovascular risk are all measured.

What are the possible benefits and risks of participating?
Participants receive a free weight management intervention as part of the original study. The knowledge gained in this study will help research into the prevention and treatment of obesity and type 2 diabetes. Participants will be part of a unique long-term weight loss study that has followed participants up for 5 years to date. The results from the visit will be reported back to the participant and their GP (if the participant has given consent). The results will be clearly explained and any results that are outside of the healthy range will be highlighted to both the GP and participant. Taking part in the study will not affect the participant’s usual standard of care. This is a low-risk study. The two follow-up assessment visits and the small number of blood samples have deliberately been chosen to reduce the burden on participants. Participants will have blood taken by venepuncture at both follow-up visits. Venepuncture can cause minor discomfort and bruising, but the effects are likely to be short lived. Fully trained and experienced practice/CRN nurses will carry out the sampling to minimise any potential risk. By analysing samples for lipids and blood glucose in house using standard scientific equipment, a smaller amount of blood will be required than would be needed in a hospital setting.

Where is the study run from?
University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
September 2017 to March 2024

Who is funding the study?
NIHR Programme Grants for Applied Research (UK)

Who is the main contact?
1. Jenny Woolston (public)
Jenny.Woolston@mrc-epid.cam.ac.uk
2. Dr Amy Ahern
Amy.Ahern@mrc-epid.cam.ac.uk

Trial website

http://www.mrc-epid.cam.ac.uk/research/studies/wrap/

Contact information

Type

Public

Primary contact

Mrs Jenny Woolston

ORCID ID

Contact details

MRC Epidemiology Unit
University of Cambridge
Box 285
Institute of Metabolic Sciences
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 769204
Jenny.Woolston@mrc-epid.cam.ac.uk

Type

Scientific

Additional contact

Dr Amy Ahern

ORCID ID

Contact details

MRC Epidemiology Unit
University of Cambridge
Box 285
Institute of Metabolic Sciences
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 769138
Amy.Ahern@mrc-epid.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG85078

Study information

Scientific title

Evaluation of the medium to long term impact of commercial open-group behavioural weight loss programmes on body weight and diabetes risk in adults with overweight and obesity: 5 & 10 year follow up of the WRAP trial

Acronym

WRAP Up

Study hypothesis

To evaluate the effect of open-group behavioural weight loss programmes of different lengths (12 weeks or 52 weeks) on 5 year (and 10 year) changes in body weight and diabetes risk, in adults with overweight or obesity (Body Mass Index; BMI≥28kg/m2).

Ethics approval

West Midlands - Coventry & Warwickshire Research Ethics Committee, 08/12/2017, ref: 17/WM/0432

Study design

5-year and 10-year follow up of participants from an existing parallel-group non-blinded multicentre randomised controlled trial

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Obesity, diabetes

Intervention

The interventions used in the original WRAP trial (ISRCTN82857232) included: brief intervention (brief advice and self-help materials; BI), referral to a commercial open-group behavioural programme (Weight Watchers) for 12 weeks (CP12), and referral to the same programme for 52 weeks (CP52). Participant details were entered into the trial database, which randomly assigned participants to one of three interventions (BI, CP12, CP52), based on a block randomisation sequence generated by the Trial Statistician with a 2:5:5 allocation stratified by centre and gender, with the sequence unknown to researchers and participants.

Participants who took part in the original WRAP study and consented for further follow up will be contacted and invited to attend their 5-year and 10-year follow up visit at their GP surgery, with all measurements carried out according to the protocol.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

5 year (and 10 year) changes in weight, adjusted for baseline. Participants will be weighed at their local GP surgery using calibrated scales. Where participants are unable/unwilling to attend a visit the trialists will obtain a weight measurement from NHS records and/or self-report.

Secondary outcome measures

5 year changes (and 10 year changes) in:
1. Fat mass, measured by Tanita body composition analyser
2. HbA1C and lipid profile, measured by blood sample and analysed used standardised methods
3. Blood pressure, measured using OMRON meter in a resting state
4. Diabetes status (normoglycaemia, non-diabetic hyperglycaemia and diabetes)
5. Modelled 10-year cardiovascular risk (Q-Risk)

Overall trial start date

01/09/2017

Overall trial end date

31/03/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Participants who took part in the original WRAP study and consented for further follow up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1040

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

22/01/2018

Recruitment end date

31/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Epidemiology Unit
University of Cambridge Box 285, Institute of Metabolic Sciences
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

University of Cambridge
School of Clinical Medicine
Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
United Kingdom
+44 (0)1223 769291
cad50@medschl.cam.ac.uk

Sponsor type

University/education

Website

Organisation

NHS Cambridgeshire and Peterborough CCG

Sponsor details

Lockton House
Clarendon Road
Cambridge
CB2 8FH
United Kingdom
+44 (0)1223 725400
capccg.contact@nhs.net

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Programme Grants for Applied Research (NIHR RP-PG-0216-20010)

Alternative name(s)

NIHR Programme Grants for Applied Research, PGfAR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Protocol and statistical analysis plan will be made available online. Planned publication of the study results in a high-impact peer reviewed journal. Publishing date: within 1 year of the completion of 5 year visits (31/03/2020) and 10 year visits (31/03/2025).

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2025

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes