'Shape Up-LD': Piloting a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities
| ISRCTN | ISRCTN39605930 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39605930 |
| Protocol serial number | 11973 |
| Sponsor | Camden and Islington NHS Foundation Trust (UK) |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 31/05/2012
- Registration date
- 31/05/2012
- Last edited
- 27/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | Shape Up-LD |
| Study objectives | 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. |
| Ethics approval(s) | NRES Committee South West- Cornwall & Plymouth, Proportionate Review Sub-Committee; First MREC approval date 05/04/2012, ref: 12/SW/0089 |
| Health condition(s) or problem(s) studied | 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 | Behavioural |
| Primary outcome measure(s) |
Feasibility outcomes at 12 weeks |
| Key secondary outcome measure(s) |
1. Attitudes to healthy behaviours at baseline, 12 weeks, 6 months |
| Completion date | 01/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/11/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
WC1E 7HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | Yes | No | |
| Protocol article | protocol | 12/03/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/03/2019: Publication reference added.
03/10/2018: No publications found, verifying study status with principal investigator.
