Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obese people weigh more than is healthy for them. Losing weight can make a person healthier, feel better about themselves and improve quality of life. Studies show that being obese is more common in people with learning disabilities (LD) compared with the general population. However, most programmes designed to help people lose weight are not designed for people with LD. Working with the charity Weight Concern we developed a lifestyle programme (Shape Up) to help people lose weight. Shape Up is used throughout the UK and has now been adapted by learning disability (LD) specialists so that it can help people with LD. A small group tried out 'Shape Up-LD' and found it helped them lose weight and was enjoyable. The aim of this study is to see if we can design a bigger project to measure how well 'Shape Up-LD' works.

Who can participate?
People with mild to moderate LD who are overweight (and their carers).

What does the study involve?
Participants will be randomly allocated either to take part in the Shape Up-LD programme or to receive usual care.

What are the possible benefits and risks of participating?
'Shape Up-LD' may help participants to lose weight. If the results of this study are positive we will apply for funding for a larger study. We will change the Shape Up-LD materials in response to our findings, making them available to services. This study is important because evidence-based weight management services designed for people with LD are not currently available, and being obese can have a negative impact on health and quality of life.

Where is the study run from?
University College London (UK).

When is the study starting and how long is it expected to run for?
The study started in June 2012 and will run until November 2014.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Rebecca Beeken

Trial website

Contact information



Primary contact

Dr Rebecca Beeken


Contact details

Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
University College London
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

'Shape Up-LD': A randomised pilot study of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities


Shape Up-LD

Study hypothesis

“Shape Up”, a weight management programme specifically designed for adults with learning disabilities (LD) is feasible and a more effective than usual care in helping overweight and obese service users with mild-moderate LD reduce body weight.

More details can be found at

Ethics approval

NRES Committee South West- Cornwall & Plymouth, Proportionate Review Sub-Committee; First MREC approval date 05/04/2012, ref: 12/SW/0089

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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


Topic: Mental Health Research Network, Metabolic and Endocrine; Subtopic: Learning difficulties development disorders, Metabolic and Endocrine (all Subtopics); Disease: Learning difficulties, Metabolic & Endocrine (not diabetes)


Participants are randomised to Shape Up-LD or usual care.

Shape Up-LD: A LD tailored version of Shape-Up; a manualised healthy lifestyle programme that helps service users learn new behaviours to manage their weight. This population-specific version of Shape Up was developed through a partnership between local users with LD, specialist dietitians and other LD professionals within the PCT, and a psychologist and a dietitian from Weight Concern. The original Shape Up programme ran for 8 weeks, however based on field testing and prior experience of interventions in LD; the programme has been extended to 12 weeks. Follow Up Length: 6 month(s)

Intervention type



Not Applicable

Drug names

Primary outcome measures

Feasibility outcomes at 12 weeks

Secondary outcome measures

1. Attitudes to healthy behaviours at baseline, 12 weeks, 6 months
2. Blood pressure at baseline, 12 weeks, 6 months
3. Body Fat at baseline, 12 weeks, 6 months
4. Costs at baseline, 12 weeks
5. Knowledge & behaviour change at baseline, 12 weeks, 6 months
6. Mental health at baseline, 12 weeks, 6 months
7. Quality of life at baseline, 12 weeks, 6 months
8. Self esteem at baseline, 12 weeks, 6 months
9. Waist circumference at baseline, 12 weeks, 6 months
10. Weight at baseline, 12 weeks, 6 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. LD in mild to moderate range (assessed by a scoring system for Ability & Development scale (Cooper, 1997)
2. Overweight, Body Mass Index (BMI>25)
3. Adults, male and female, upper age limit 100 years, lower age limit 18 years
4. Living in the community
5. If receiving regular care, then the presence of a carer (paid or informal) who is willing to participate in the intervention
6. Ability to attend the weekly Shape-Up sessions

Participant type


Age group




Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Acute mental illness requiring hospitalisation
2. Severe LD
3. Substance misuse
4. A confirmed diagnosis of Prader-Willi syndrome
5. Not living in the community

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Health Behaviour Research Centre
United Kingdom

Sponsor information


Camden and Islington NHS Foundation Trust (UK)

Sponsor details

R&D Room 3-17
3rd Floor West Wing
St Pancras Hospital St Pancras Way
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in:

Publication citations

  1. Protocol

    Beeken RJ, Spanos D, Fovargue S, Hunter R, Omar R, Hassiotis A, King M, Wardle J, Croker H, Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial., Trials, 2013, 14, 71, doi: 10.1186/1745-6215-14-71.

Additional files

Editorial Notes