Condition category
Circulatory System
Date applied
14/02/2012
Date assigned
14/02/2012
Last edited
19/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

http://www.banes.nhs.uk/

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

  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