Condition category
Mental and Behavioural Disorders
Date applied
31/05/2012
Date assigned
31/05/2012
Last edited
15/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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
r.beeken@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Beeken

ORCID ID

Contact details

Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
University College London
London
WC1E 7HB
United Kingdom
r.beeken@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11973

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

Acronym

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 http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11973

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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)

Intervention

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

Other

Phase

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

01/06/2012

Overall trial end date

01/11/2014

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/06/2012

Recruitment end date

01/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Behaviour Research Centre
London
WC1E 7HB
United Kingdom

Sponsor information

Organisation

Camden and Islington NHS Foundation Trust (UK)

Sponsor details

R&D Room 3-17
3rd Floor West Wing
St Pancras Hospital St Pancras Way
London
NW1 OPE
United Kingdom
angela.williams9@nhs.ne

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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: http://www.ncbi.nlm.nih.gov/pubmed/23497560

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