LivingWELL: assessing the impact of a lifestyle intervention in people attending family history clinics with an increased risk of colorectal or breast cancer.

LivingWELL A feasibility study to assess the impact of a lifestyle intervention in people attending family history clinics with an increased risk of colorectal or breast cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13123470

Enrollment

120

Registered

2015-04-02

Start date

2015-08-01

Completion date

Unknown

Last updated

2018-10-22

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

Conditions

Patients attending genetic screening for colorectal and/or breast cancer risk Cancer Patients attending genetic screening for colorectal and/or breast cancer risk

Interventions

The LivingWELL intervention programme aims to help participants increase physical activity, modify diet, and set individual weight management goals (weight loss) in the short term towards 5% body weig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a family history of colorectal or breast cancer and measured BMI>25kg/m2. 2. Age of 18 years and older

Exclusion criteria

Exclusion criteria: 1. Participants with severe cognitive impairment, or conditions where physical activity is contra-indicated 2. Unable to consent

Design outcomes

Primary

Measure	Time frame
The study will be reported in accord with CONSORT guidelines. Basic statistical analysis of indicative findings will be undertaken including descriptive statistics to enable characterisation of the cohort, chi squared tests for comparisons of proportions and paired t tests for comparisons of means. Linear regression analyses (adjusted for baseline values) will also be performed, with group allocation as a fixed effect. It is however important to note that these are indicative findings only. Interviews with participants will be audio-recorded with participant consent, transcribed verbatim and analysed using the constant comparison methods. They will explore patient views on recruitment methods and timing, assessment procedures, programme content, interest in a 12 month intervention period, body weight goals, delivery, duration, intensity and exit strategy. In addition, participants will be asked to discuss factors influencing adherence including personal beliefs, motivation, family members, social and NHS staff support. The following will be reported: 1. Feasibility measures: message delivery, programme implementation, fidelity to protocol, achieved measurements, recruitment, response, early retention and reported adherence. 2. Acceptability measures of recruitment, implementation and exit strategy. 3. Indicative outcomes. Reporting on results (recruitment, retention and acceptability) will also be analysed and presented by BC and CRC risk groups.	—

Measure

Time frame

The study will be reported in accord with CONSORT guidelines. Basic statistical analysis of indicative findings will be undertaken including descriptive statistics to enable characterisation of the cohort, chi squared tests for comparisons of proportions and paired t tests for comparisons of means. Linear regression analyses (adjusted for baseline values) will also be performed, with group allocation as a fixed effect. It is however important to note that these are indicative findings only. Interviews with participants will be audio-recorded with participant consent, transcribed verbatim and analysed using the constant comparison methods. They will explore patient views on recruitment methods and timing, assessment procedures, programme content, interest in a 12 month intervention period, body weight goals, delivery, duration, intensity and exit strategy. In addition, participants will be asked to discuss factors influencing adherence including personal beliefs, motivation, family members, social and NHS staff support. The following will be reported: 1. Feasibility measures: message delivery, programme implementation, fidelity to protocol, achieved measurements, recruitment, response, early retention and reported adherence. 2. Acceptability measures of recruitment, implementation and exit strategy. 3. Indicative outcomes. Reporting on results (recruitment, retention and acceptability) will also be analysed and presented by BC and CRC risk groups.

—

Countries

United Kingdom

Contacts

Public ContactStephen Caswell

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026