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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11057518

Enrollment

552

Registered

2017-07-21

Start date

2017-09-05

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body weight and physical activity Not Applicable

Interventions

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 int

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Scotland, United Kingdom

Contacts

Public ContactStephanie Gallant

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026