Condition category
Not Applicable
Date applied
15/02/2017
Date assigned
21/07/2017
Last edited
19/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
It is estimated that 38% of breast cancer could be prevented by increasing physical activity, decreasing alcohol intake and losing weight. It is notable that weight gain in adult life is associated with a greater risk of the disease (e.g., an increase of 2-10 kg after age 50 is associated with a 30% increased risk). The aim of this study is to assess the impact of a lifestyle intervention (ActWELL) on body weight and physical activity in women attending NHS breast screening clinics.

Who can participate?
Women aged 50-70 who are overweight and attending routine breast screening in four Scottish breast screening service centres

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. Participants in the intervention group have two face-to-face visits with a lifestyle coach and a further nine phone calls over 12 months. They are given a diet and physical activity programme with the aim of weight management and change in physical activity. This is delivered in the community by Breast Cancer Now volunteer lifestyle coaches. Participants in the control group continue with usual care. After the study is completed they are offered a one-off session with a lifestyle coach if they wish. All participants attend measurement visits with a research nurse at the start of the study and at 12 months follow up and have one phone call at 3 months. This involves recording demographic details, physiological measures such as weight, waist circumference and blood pressure, one blood sample and health questions.

What are the possible benefits and risks of participating?
Possible benefits are weight loss and a healthier lifestyle which may lead to a reduced risk of obesity-related chronic (long-term) conditions which are a major cause of death in the UK. There are considered to be no risks of taking part.

Where is the study run from?
1. NHS Tayside (UK)
2. NHS Grampian (UK)
3. NHS Lothian (UK)
4. NHS Greater Glasgow and Clyde (UK)

When is the study starting and how long is it expected to run for?
January 2017 to December 2019

Who is funding the study?
Scottish Government (UK)

Who is the main contact?
Ms Stephanie Gallant
s.gallant@dundee.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Stephanie Gallant

ORCID ID

Contact details

University of Dundee
Division of Cancer Research
CPHNR
Mailbox 7
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383994
s.gallant@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol V1.1, 22/06/2017

Study information

Scientific title

A randomised control trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening

Acronym

ActWELL

Study hypothesis

In Scotland, the incidence of breast cancer is predicted to rise by 27% by 2030 and whilst there are measures to support reductions in morbidity and mortality, the breast cancer community is now turning to support weight management programmes in post-menopausal women. In Scotland, 72% of women aged 55 to 74 years have a BMI >25kg/m2. A recent feasibility study of a lifestyle intervention initiated in the NHS breast screening sites and delivered in the community reported significant findings in weight loss and increased activity after 12 weeks in intervention versus control groups.

The aim of this study is to assess the impact of a lifestyle intervention (ActWELL) on body weight and physical activity in women invited to NHS breast screening clinics.

Ethics approval

East of Scotland Research Ethics Committee, 28/06/2017, ref: 17/ES/0073

Study design

Four-centre 1:1 parallel-group randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Body weight and physical activity

Intervention

This study is a minimal contact, weight management and physical activity intervention initiated within the breast cancer screening setting.

Actwell is a randomised controlled trial of a lifestyle intervention and is 26 months in duration. Randomisation is via the online TRuST system provided by Tayside Clinical Trials Unit (TCTU):
1. Those in the intervention group will have 2 face to face visits with a lifestyle coach and a further 9 phone calls over 12 months. They will be given a diet and physical activity programme with the aim of weight management and change in physical activity. This will be delivered in the community by Breast Cancer Now volunteer Lifestyle Coaches.
2. The control group continue with usual care. After the study is completed they are offered a one of session with a lifestyle coach if they wish.

Participants will attend for baseline and 12 month follow-up measurement visits with a research nurse and have one phone call at 3 months. This will involve recording of demographic details, physiological measures e.g. weight, waist circumference, blood pressure, heart rate, one blood sample and health questions.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Physical activity, measured using Scottish Physical Activity Questionnaire (SPAQ) and ActivPAL activity monitors
2. Weight loss, measured by research nurses (locally provided and calibrated by clinical research centres)

All outcomes are measured at two measurement visits at baseline and 12 months. At 3 months there is a telephone call to assess self-reported weight, SPAQ and EQ5D along with three food questions.

Secondary outcome measures

1. HbA1C, non-fasting lipids and non-fasting insulin, measured using a blood test analysed at University of Glasgow
2. Sedentary behaviour and modes of physical activity, measured using SPAQ
3. Eating habits, measured using modified questionnaire from the Scottish Health Survey
4. Alcohol intake, measured using Audit C
5. Psycho-social variables, measured using Modified Illness Perception Questionnaire and various questions
6. Economic outcomes, measured using EQ5D- L and health resource usage questions
7. Blood pressure, measured using blood pressure monitor
All outcomes are measured at two measurement visits at baseline and 12 months. At 3 months there is a telephone call to assess self-reported weight, SPAQ and EQ5D along with three food questions.

Overall trial start date

01/01/2017

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Invited to attend, or attended, routine breast screening clinics (not recall clinics)
2. Measured BMI >25kg/m2
3. Women aged 50-70 years

Participant type

Healthy volunteer

Age group

Mixed

Gender

Female

Target number of participants

552

Participant exclusion criteria

1. Currently undergoing treatment for any malignant condition
2. Reported contra-indication to physical activity (e.g. recent surgery)
3. Reported contra-indication to weight management (e.g. currently following a recovery programme for weight gain)
4. Diagnosis of Type 1 diabetes
5. No telephone contact
6. Current use of insulin
7. Unable to consent
8. On a special or prescribed diet e.g. gluten free

Recruitment start date

01/07/2017

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Tayside
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Trial participating centre

NHS Grampian
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

NHS Lothian
Edinburgh
EH1 3EG
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
G12 0XH
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

Tayside Medical Science Centre
Ninewells Hospital & Medical School
Research & Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383877
f.nuritova@dundee.ac.uk

Sponsor type

University/education

Website

Organisation

NHS Tayside

Sponsor details

Tayside Medical Science Centre
Ninewells Hospital & Medical School
Research & Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383837
liz.coote@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Scottish Government

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
Access to collated participant data will be restricted to the CI and appropriate study staff. Data will be held on university secure servers.

Intention to publish date

31/12/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes