'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
Secondary identifying numbers	11973

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Rebecca Beeken
Scientific

Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
University College London
London
WC1E 7HB
United Kingdom

Email	r.beeken@ucl.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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 study start date	01/06/2012
Completion date	01/11/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 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

England
United Kingdom

Study participating centre

University College London

London
WC1E 7HB
United Kingdom

Sponsor information

Camden and Islington NHS Foundation Trust (UK)
Hospital/treatment centre

R&D Room 3-17
3rd Floor West Wing
St Pancras Hospital St Pancras Way
London
NW1 OPE
United Kingdom

Email	angela.williams9@nhs.ne
"ROR"	https://ror.org/03ekq2173

Funders

Funder type

Government

Research for Patient Benefit Programme
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	12/03/2013		Yes	No
Results article	results	01/02/2019		Yes	No

Editorial Notes

27/03/2019: Publication reference added.
03/10/2018: No publications found, verifying study status with principal investigator.