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

ISRCTN	ISRCTN11057518
DOI	https://doi.org/10.1186/ISRCTN11057518
Protocol serial number	Protocol V1.1, 22/06/2017
Sponsors	University of Dundee, NHS Tayside
Funder	Scottish Government

Submission date: 15/02/2017
Registration date: 21/07/2017
Last edited: 05/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Stephanie Gallant
Public

University of Dundee
Division of Cancer Research
CPHNR
Mailbox 7, Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 383994
Email	s.gallant@dundee.ac.uk

Study information

Primary study design	Interventional
Study design	Four-centre 1:1 parallel-group randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening
Study acronym	ActWELL
Study objectives	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 >25 kg/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(s)	East of Scotland Research Ethics Committee, 28/06/2017, ref: 17/ES/0073
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Lower age limit	50 Years
Upper age limit	70 Years
Sex	Female
Target sample size at registration	552
Total final enrolment	560
Key inclusion criteria	1. Invited to attend, or attended, routine breast screening clinics (not recall clinics) 2. Measured BMI >25 kg/m2 3. Women aged 50-70 years
Key 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
Date of first enrolment	05/09/2017
Date of final enrolment	14/08/2018

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centres

NHS Tayside

Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

NHS Grampian

Aberdeen
AB25 2ZN
United Kingdom

NHS Lothian

Edinburgh
EH1 3EG
United Kingdom

NHS Greater Glasgow and Clyde

G12 0XH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	feasibility and optimisation results	05/06/2020	08/06/2020	Yes	No
Results article		06/03/2021	18/06/2021	Yes	No
Protocol article	protocol	08/11/2018		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Letter	05/06/2021	05/08/2024	Yes	No
Other publications	SWAT 76 evaluation	08/02/2021	05/08/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/08/2024: Publication references added.
07/06/2023: Internal review.
18/06/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
08/06/2020: Publication reference added.
02/06/2020: The recruitment start date was changed from 01/07/2017 to 05/09/2017.
12/11/2018: Publication reference added.
11/10/2018: The recruitment end date was changed from 31/08/2018 to 14/08/2018.