ActWELL - working together to support active living and well-being in the health-promoting health service

ISRCTN ISRCTN56223933
DOI https://doi.org/10.1186/ISRCTN56223933
Secondary identifying numbers 13811
Submission date
19/03/2014
Registration date
07/04/2014
Last edited
19/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Breast cancer is diagnosed in over 4,500 women in Scotland each year and this number is rising (13.7% increase between 2001 and 2011). We know that around 40% of post-menopausal breast cancers could be prevented by following dietary (including alcohol consumption), weight management and physical activity guidelines for cancer prevention. There is some evidence that women attending breast cancer screening are interested in receiving lifestyle advice although neither this or the response to this approach has been formally assessed. This study aims to assess the response of women to lifestyle advice as part of breast cancer screening.

Who can participate?
Women attending NHS breast screening clinics who have a BMI greater than 20kg/m2 and no contraindication to physical activity or weight loss.

What does the study involve?
At the start of the study and after 3 months, height, weight and waist circumference will be recorded, sitting blood pressure measured, a 24 hour dietary recall and questionnaires on health behaviours, diet (including alcohol consumption) and physical activity will be completed. Based on the initial measures, women will be randomly allocated to one of two groups: ActWELL group (advice) or usual care (booklet only). The advice will be delivered via a one hour counselling session (face to face) with a lifestyle coach and fortnightly telephone consultations for 3 months. It will focus on body weight, diet and physical activity. The face to face session will be interactive and include a 10 minute walk and talk session, self-identification of BMI from standard coloured charts and measurement of one standard unit of alcohol using a wine coloured liquid. Behavioural techniques will be used including goal setting, action plans, implementation intentions, coping planning and self-monitoring.

What are the possible benefits and risks of participating?
Possible benefits include weight loss, a healthier lifestyle, fewer risks of all obesity related chronic diseases which are major causes of death in the UK. No risks are foreseen from participation.

Where is the study run from?
University of Dundee (UK)

When is the study starting and how long is it expected to run for?
The study started on 1st Dec 2012, recruitment started on 7th June 2013 and ended on 28th February 2013 and a final report will be available on April 30th 2014.

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Prof Annie Anderson
a.s.anderson@dundee.ac.uk

Contact information

Prof Annie Anderson
Scientific

Centre for Research into Cancer Prevention and Screening
Cancer Division
Medical Research Institute
Level 7
Ninewells Medical School
Dundee
DD1 9SY
United Kingdom

Phone +44 (0) 1382 383299
Email a.s.anderson@dundee.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleActWELL - working together to support ACTive living and WELLbeing in the health-promoting health service - a feasibility trial to reduce breast cancer risk factors
Study acronymActWELL
Study objectivesIt is feasible to deliver a minimal contact behaviour change intervention (ActWELL) initiated within the breast cancer screening setting and achieve significant improvement in lifestyle behaviours over a 3-month period.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13811
Ethics approval(s)East of Scotland Research Ethics Service, 09/10/2012, REC ref: 12/ES/0087.
Health condition(s) or problem(s) studiedBreast cancer/cancer screening/cancer prevention
InterventionParticipants were randomised (1:1) to either the ActWELL intervention or usual care (booklet only).

The ActWELL intervention consisted of a 1-hour counselling session (face to face) with a lifestyle coach and fortnightly follow-up telephone consultations for 3 months with access to written/online support materials. The face-to-face session was designed to be interactive and included a 10-minute walk and talk session, self-identification of Body Mass Index from standard coloured charts and measurement of one standard unit of alcohol using a wine-coloured liquid. Behavioural techniques were used including goal setting, action plans, implementation intentions, coping planning and self-monitoring.
Intervention typeOther
Primary outcome measure1. Feasibility outcomes - programme implementation, fidelity to protocol, achieved measurements, recruitment, response, early retention and reported adherence. Acceptability measures of recruitment, implementation and exit strategy (i.e., signposting to further support)
2. Indicative findings - primary outcome was weight change, measured at baseline and follow up (after 3 months)
Secondary outcome measures1. Indicative findings measured at baseline and follow up (after 3 months):
1.1. Changes in waist circumference
1.2. Changes in blood pressure
1.3. Changes in physical activity (International Physical Activity Questionnaire Short form)
1.4. Changes in diet and alcohol habits (dietary instrument for nutrition education, 24 h diet recall, 7-day alcohol record)
Overall study start date01/04/2013
Completion date30/04/2014

Eligibility

Participant type(s)Patient
Age groupOther
SexFemale
Target number of participants80
Key inclusion criteriaParticipation in the NHS breast cancer screening programme (age range 50 – 75 years)
Key exclusion criteria1. Breast cancer diagnosis
2. BMI < 20 kg/m2
3. Any known contra-indicators to physical activity or weight management
Date of first enrolment01/04/2013
Date of final enrolment30/04/2014

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Centre for Research into Cancer Prevention and Screening
Dundee
DD1 9SY
United Kingdom

Sponsor information

Tayside Medical Science Centre (UK)
Hospital/treatment centre

c/o Vera Nuritova
TASC R&D Office
Ninewells Hospital and Medical School
Residency Block Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom

Phone +44 (0) 1382 383877
Email f.nuritova@dundee.ac.uk
Website http://www.tahsc.org/
ROR logo "ROR" https://ror.org/000ywep40

Funders

Funder type

Government

Chief Scientist Office (UK) (CHZ/4/745)
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/12/2014 Yes No