Contact information
Type
Scientific
Primary contact
Ms Rachel Perry
ORCID ID
Contact details
The Department for Health
1 West 4.2a
University of Bath
Bath
BA2 7AY
United Kingdom
+44 (0)1225 386696
R.Perry@bath.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9846
Study information
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
Acronym
Waste the Waist
Study hypothesis
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
Not provided at time of registration
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
16/03/2011
Overall trial end date
30/08/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 100
Participant 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)
Recruitment start date
16/03/2011
Recruitment end date
30/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Department for Health
Bath
BA2 7AY
United Kingdom
Sponsor information
Organisation
Bath and North East Somerset Primary Care Trust (UK)
Sponsor details
Bath & North East Somerset NHS Trust Headquarters
St Martin's Hospital
Clara Cross Lane
Bath
BA2 5RP
United Kingdom
+44 (0)1225 831800
info@banes-pct.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22107451
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25592201
Publication citations
-
Protocol
Gillison F, Greaves C, Stathi A, Ramsay R, Bennett P, Taylor G, Francis M, Chandler R, 'Waste the Waist': the development of an intervention to promote changes in diet and physical activity for people with high cardiovascular risk., Br J Health Psychol, 2012, 17, 2, 327-345, doi: 10.1111/j.2044-8287.2011.02040.x.
-
Results
Greaves C, Gillison F, Stathi A, Bennett P, Reddy P, Dunbar J, Perry R, Messom D, Chandler R, Francis M, Davis M, Green C, Evans P, Taylor G, Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk, Int J Behav Nutr Phys Act, 2015, 12, 1, 1, doi: 10.1186/s12966-014-0159-z.