Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Rachel Perry


Contact details

The Department for Health
1 West 4.2a
University of Bath
United Kingdom
+44 (0)1225 386696

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


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


Cardiovascular disease


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



Not Applicable

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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 GP’s 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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

The Department for Health
United Kingdom

Sponsor information


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
United Kingdom
+44 (0)1225 831800

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR Research for Patient Benefit Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2011 protocol in:
2015 results in:

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

05/12/2017: internal review.