Waste the Waist: Pilot study for a randomised controlled trial of a pragmatic, primary care based intervention to support lifestyle change in the management of high cardiovascular risk
| ISRCTN | ISRCTN10707899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10707899 |
| Secondary identifying numbers | 9846 |
- Submission date
- 14/02/2012
- Registration date
- 14/02/2012
- Last edited
- 05/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Rachel Perry
Scientific
Scientific
The Department for Health
1 West 4.2a
University of Bath
Bath
BA2 7AY
United Kingdom
| Phone | +44 (0)1225 386696 |
|---|---|
| R.Perry@bath.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Waste the Waist: Pilot study for a randomised controlled trial of a pragmatic, primary care based intervention to support lifestyle change in the management of high cardiovascular risk |
| Study acronym | Waste the Waist |
| Study objectives | Primary Care Trusts in England need to commission services to promote healthy diet and physical activity for thousands of people who will be identified with high cardiovascular (CV) risk by the NHS Health Checks programme. The aim is to pilot, prior to a full trial evaluation, a practical, state-of-the-art intervention to promote healthy diet and physical activity for people with high cardiovascular risk, which has been adapted for use in UK primary care. The pilot aims to: 1. Assess recruitment, intervention concordance, study retention and measures-completion rates 2. Assess the acceptability of the intervention to participants 3. Assess the acceptability and feasibility of recruitment, measurement, randomisation and intervention delivery procedures which would be used in a future pragmatic randomised controlled trial 4. Estimate the resources and costs needed to deliver the intervention and conduct a full trial 5. Estimate the standard deviation of continuous outcomes (e.g. changes in participants weight). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | The sample size is calculated to provide realistic estimates (and confidence intervals (CIs)) for the recruitment and study completion rates. The resulting sample size will also allow realistic estimates of the intervention concordance rate and provide an ample pool of patients for qualitative sampling. From recent UK-based trials of interventions to support dietary /physical activity change in high CV risk populations,33-35 it is estimated that 25-40% of those contact Waste the waist The intervention group will receive the Waste the Waist intervention in local community venues (e.g. community halls). The intervention encourages increased physical activity and weight loss (by changing intake of total and saturated fat increasing fibre and other dietary changes). Targets will be set by participants, but the health benefits of 5% weight loss and of 150 mins per week of moderate (or 100 mins vigorous) activity will be presented and suggested as minimum long-term targets for heal. Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Recruitment rate measured at baseline |
| Secondary outcome measures | 1. All measures proposed for the main trial (e.g. weight) will be taken and variance explored at 0, 4, and 12 months 2. Intervention concordance (the proportion attending >=4 of the 7 sessions) measured at 8 months 3. Study completion rate measure at 12 months |
| Overall study start date | 16/03/2011 |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 100 |
| Key inclusion criteria | 1. Aged 40-74 2. BMI 30 or more (27.5 for S. Asians, if ethnicity is known) 3. A ten year cardiovascular risk score of 20% or more (calculated using either the Framingham or QRISK method) 4. IGT - Impaired glucose tolerance (2 hour glucose on IGT test of 7.8 to 11.0 mmol/l) 5. IFG - Impaired fasting plasma glucose (6.1 to 6.9mmol/l.) 6. Male and female participants If recruitment proves difficult using the above criteria, we will search practice databases for people with higher risk obesity, defined as having a Body Mass Index of 30 or more plus either hypertension, hypercholesterolemia, family history of diabetes or heart disease, history of gestational diabetes, or polycystic ovary syndrome. |
| Key exclusion criteria | 1. People with existing heart disease or type 2 diabetes 2. People who are currently pregnant 3. People currently using weight loss drugs (which will interfere with planned measures) 4. People not fluent in English 5. Anyone who, in their GPs opinion, has other conditions that would prevent engagement with the programme (including terminal illness, major mental health problems, communication difficulties requiring translation) |
| Date of first enrolment | 16/03/2011 |
| Date of final enrolment | 30/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Department for Health
Bath
BA2 7AY
United Kingdom
BA2 7AY
United Kingdom
Sponsor information
Bath and North East Somerset Primary Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Bath & North East Somerset NHS Trust Headquarters
St Martin's Hospital
Clara Cross Lane
Bath
BA2 5RP
England
United Kingdom
| Phone | +44 (0)1225 831800 |
|---|---|
| info@banes-pct.nhs.uk | |
| Website | http://www.banes.nhs.uk/ |
Funders
Funder type
Government
NIHR Research for Patient Benefit Programme (UK)
No information available
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 | 01/05/2012 | Yes | No | |
| Results article | results | 16/01/2015 | Yes | No |
Editorial Notes
05/12/2017: internal review.
