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

Not Applicable

Completed

• Conditions: Body weight and physical activity; Not Applicable

• Registration Number: ISRCTN11057518
• Lead Sponsor: niversity of Dundee

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30413516 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32503606/ feasibility and optimisation results (added 08/06/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33676538/ (added 18/06/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34090495/ Letter (added 05/08/2024) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33968362/ SWAT 76 evaluation (added 05/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-21
• Study Completion: 2019-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 560

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
1. HbA1C, non-fasting lipids and non-fasting insulin, measured using a blood test analysed at University of Glasgow<br>2. Sedentary behaviour and modes of physical activity, measured using SPAQ<br>3. Eating habits, measured using modified questionnaire from the Scottish Health Survey<br>4. Alcohol intake, measured using Audit C<br>5. Psycho-social variables, measured using Modified Illness Perception Questionnaire and various questions <br>6. Economic outcomes, measured using EQ5D- L and health resource usage questions<br>7. Blood pressure, measured using blood pressure monitor<br>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.