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 |
| Protocol serial number | 9846 |
| Sponsor | Bath and North East Somerset Primary Care Trust (UK) |
| Funder | NIHR Research for Patient Benefit Programme (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Recruitment rate measured at baseline |
| Key secondary outcome measure(s) |
1. All measures proposed for the main trial (e.g. weight) will be taken and variance explored at 0, 4, and 12 months |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Department for Health
Bath
BA2 7AY
United Kingdom
BA2 7AY
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 | 16/01/2015 | Yes | No | |
| Protocol article | protocol | 01/05/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2017: internal review.
