Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT)
| ISRCTN | ISRCTN25072883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25072883 |
| Protocol serial number | Version 4 |
| Sponsor | NHS South Birmingham (UK) |
| Funder | NHS South Birmingham (UK) |
- Submission date
- 19/01/2009
- Registration date
- 06/03/2009
- Last edited
- 20/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kate Jolly
Scientific
Scientific
Unit of Public Health, Epidemiology and Biostatistics
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 7552 |
|---|---|
| c.b.jolly@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT): a randomised controlled trial |
| Study acronym | Lighten Up |
| Study objectives | The weight loss programmes (Weight Watchers®, Slimming World, Rosemary Conley, NHS Size Down, pharmacy and general practice provision) will each achieve significantly greater weight loss at 3 months follow-up than the comparison group of exercise at a leisure centre. There will be no differences between the weight loss services in weight loss at 3 months. |
| Ethics approval(s) | South Birmingham Research Ethics Committee, approved on 19/12/2008 (ref: 08/H1207/331) |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Participants will be allocated to one of the following eight arms: 1. Commercial weight loss programme: Weight Watchers 2. Commercial weight loss programme: Slimming World 3. Commercial weight loss programme: Rosemary Conley 4. Size Down (NHS community-based group programme) 5. Pharmacy-led obesity services 6. General practice service 7. Choice of intervention (1 to 6 above) 8. Comparator: Exercise advice + membership to leisure centre (Participants in this group will not be provided with any specific exercise programme) Total duration of interventions: 12 weeks |
| Intervention type | Other |
| Primary outcome measure(s) |
Weight at 3 months follow-up |
| Key secondary outcome measure(s) |
1. Weight loss at 1 year |
| Completion date | 03/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 740 |
| Key inclusion criteria | 1. Aged at least 18 years, both males and females 2. Body mass index greater than or equal to 30 (based on data recorded via NHS Quality and Outcomes Framework [QoF]) 3. Identified by GP as medically competent to enter the programme evaluation |
| Key exclusion criteria | 1. Unable to understand English 2. Women who are known to be pregnant 3. Not willing to be randomised |
| Date of first enrolment | 26/01/2009 |
| Date of final enrolment | 03/01/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Unit of Public Health, Epidemiology and Biostatistics
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/11/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |