Family History Lifestyle Study

ISRCTN	ISRCTN16431108
DOI	https://doi.org/10.1186/ISRCTN16431108
Protocol serial number	35447
Sponsor	University Hospital of South Manchester NHS Foundation Trust
Funder	Prevent Breast Cancer Limited

Submission date: 20/11/2017
Registration date: 30/11/2017
Last edited: 07/03/2024

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-healthy-eating-exercise-women-increased-risk-breast-cancer-the-family-history-lifestyle-study

Contact information

Dr Michelle Harvie
Public

Family History Clinic - Research Dietitians
Prevent Breast Cancer Research Centre
Nightingale Centre
Wythenshawe Hospital
Manchester
M23 9LT
United Kingdom

ORCID ID	0000-0001-9761-3089

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Prevention, Education or Self-Management, Dietary, Psychological & Behavioural, Complex Intervention, Physical
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN16431108_PIS_V2.1_30Aug17.pdf
Scientific title	Randomised comparison of two remotely delivered diet and physical activity weight loss programmes vs written diet and physical activity advice amongst overweight women attending a Family History Clinic at increased risk of breast cancer: a phase 3 efficacy study
Study objectives	This study is an individually randomised trial to test the efficacy for weight loss over 12 months of two different remotely delivered diet and physical activity weight loss programmes compared to only receiving written diet and physical activity information amongst 209 overweight/obese women in UK Family History Clinics.
Ethics approval(s)	North West - Preston Research Ethics Committee, 21/08/2017, ref: 17.NW.0440
Health condition(s) or problem(s) studied	Breast cancer
Intervention	209 overweight/obese women in 3 UK NHS family history clinics are randomly assigned to one of 2 different 12 month weight loss/lifestyle programmes or a group receiving written advice: 1. A written advice group (n=35): Women receive their personal breast cancer risk and are given written diet and physical advice for weight loss. 2. A breast cancer prevention programme (n=87): Women receive their personal breast cancer and a 6 month health care professional supported telephone, web based and e-mail programme followed by 6 months of web support. 3. A multiple disease prevention programme(n=87): Women receive their personal risks of breast cancer , heart disease stroke , from an NHS health check followed by a 6 month health care professional supported telephone, web based and e-mail programme followed by 6 months of web support. All participants have their weight and diet and physical activity behaviours assessed at baseline, 6 and 12 months.
Intervention type	Other
Primary outcome measure(s)	Percentage weight loss is measured using Tanita 180 bioelectrical impedance scales at baseline, 6 months and 12 months
Key secondary outcome measure(s)	1. Health behaviours is measured using the questionnaire “Mediterranean diet score” “IPAQ” and “Alcohol and Smoking” at baseline, 3 months, 6 months and 12 months and an optional physical activity monitor an baseline and 12 months 2. Change in body composition is measured using Tanita 180 bioelectrical impedance scales at baseline, 6 months and 12 months 3. Blood pressure is measured using a blood pressure monitor at baseline, 6 months and 12 months 4. Diet behaviour is measured using the questionnaire “Mediterranean diet score” at baseline, 3 months, 6 months and 12 months 5. Physical Activity is measured using the questionnaire “IPAQ” at baseline, 3 months, 6 months and 12 months and an optional physical activity monitor an baseline and 12 months 6. Quality of life is measured using the questionnaire “EQ-5D-5L”, ICE-CAP-A” and “health Resource Use” at baseline, 6 months and 12 months 7. Disease Risk perception is measured using the questionnaire “Study beliefs and Behaviours” at baseline, 6 months and 12 months 8. The impact of the three interventions on Health status and well-being is measured using the questionnaire “EQ-5D-5L” and ICE-CAP-A”” at baseline, 6 months and 12 months 9. Use of healthcare resources is measured using the questionnaire “health Resource Use” at baseline, 6 months and 12 months 10. The fidelity of the delivery of the Breast Cancer Prevention Programme and Multiple Disease Prevention Programme programmes is measured using the study phone call and email CRF 11. Behaviour change is measured using the questionnaire “Study beliefs and Behaviours” at baseline, 6 months and 12 months 12. Mammographic density is measured using automated volumetric and area based density analysis and visual assessment by a consultant radiologist at baseline and 12 months 13. The views of women using the programmes is measured using qualitative thematic analysis of a semi structured interview after 12 months
Completion date	01/05/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	209
Total final enrolment	210
Key inclusion criteria	1. Receiving annual or 18 monthly mammograms in the FHC (aged > 30 years) ), or as part of a mammographic surveillance programme for increased familial risk of BC 2. Have previously received information on their risk of developing BC within the FHC 2. Overweight / obese (BMI ≥ 25 kg/m2) 3. Access to the internet and telephone 4. Ability to understand English and complete trial paperwork as successful participation requires engagement with weekly tailored e-mails and an interactive patient forum 5. Participants must be willing to follow a diet and physical activity plan with the aim of losing weight 6. Agree that results of any NHS Health Checks conducted in the study can be communicated back to their GP. This is a requirement of NHS Health Checks to allow patients with undiagnosed CVD or T2DM or high risks of these diseases to receive appropriate follow up tests and medical management. 7. Assessed as safe to undertake a home based moderate intensity physical activity programme according to the physical activity readiness questionnaire (PAR-Q) +/- clearance from GP where appropriate 8. Women taking chemoprevention for BC, e.g. tamoxifen, raloxifine or aromatase inhibitors are eligible to join the trial
Key exclusion criteria	1. Only one woman per family is able to join the study to avoid contamination between the groups 2. Previous diagnosis of cancer with the exception of previous non-melanoma skin cancer or cervical intra-epithelial neoplasia 3. Previous diagnosis of cardiovascular disease i.e. stroke, transient ischaemic attack (TIA), angina, heart attack, heart failure or ventricular or aortic aneurysm 4. Currently prescribed statins for raised cholesterol 5. Current diagnosis of T2DM 6. Current physical co-morbidity or hypertension which makes the patients unsuitable for a home based moderate physical activity programme as assessed with a positive PAR-Q score and opinion of the patients general practitioner for example; unstable angina, resting systolic BP > 160 resting diastolic BP > 100 mmHg with or without medication, a significant drop in blood pressure during physical activity, uncontrolled tachycardia> 100 bpm at rest, uncontrolled arrhythmia 7. Previous diagnosis of borderline personality disorder, bipolar psychotic disorder, or self-harm. 8. Currently prescribed antipsychotics i.e. Aripiprazole, Clozapine, Olanzapine, Quetiapine, Risperidone as these can cause excessive weight gain 9. Current alcohol or drug dependency 10. People requiring highly specialist medical diets which cannot be adjusted to fit with a weight loss diet i.e. phenylketonuria, maple syrup urine disease, glycogen storage diseases, and urea cycle disorders advanced kidney disease, advanced liver disease 11. Currently pregnant, breast feeding or planning pregnancy in the next 12 months 12. Patients who are currently on treatment with Orlistat for weight loss or who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy 13. Current diagnosis of kidney disease 14. Patients with a diagnosis of an eating disorder (e.g. binge eating or bulimia) 15. Currently successfully following a diet and/or physical activity plan and have lost more than 2 lb (1 kg) of weight in the last 2 weeks 16. Currently or previously on the PROCAS (Predicting Risk of Breast Cancer at Screening) Study
Date of first enrolment	29/11/2017
Date of final enrolment	31/03/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Wythenshawe Hospital

Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Tameside General Hospital

Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Southampton General Hospital

Tremona Road
Hampshire
Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	All datasets used and analysed during the current study and the trial protocol are available from the corresponding author (Dr Michelle Harvie, michelle.harvie@manchester.ac.uk) on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/02/2023	27/02/2023	Yes	No
Participant information sheet	version V2.1	30/08/2017	30/11/2017	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			07/03/2024	No	Yes
Protocol file	version 2.0	14/01/2018	18/08/2022	No	No

Additional files

ISRCTN16431108_PIS_V2.1_30Aug17.pdf: Uploaded 30/11/2017
34451_protocol_V2.0_14Jan18.pdf: Protocol file

Editorial Notes

07/03/2024: A link to plain English results was added.
27/02/2023: Publication reference added.
04/01/2023: The intention to publish date was changed from 01/01/2023 to 01/03/2023.
18/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
03/08/2022: The IPD sharing statement has been added.
02/08/2022: The intention to publish date has been changed from 01/08/2022 to 01/01/2023.
22/04/2022: The following changes have been made:
1. The intention to publish date has been changed from 01/04/2022 to 01/08/2022.
2. The total final enrolment number has been changed from 209 to 210.
11/10/2021: The intention to publish date was changed from 01/10/2021 to 01/04/2022.
14/04/2021: The intention to publish date has been changed from 01/10/2020 to 01/10/2021.
09/06/2020: The intention to publish date was changed from 01/08/2020 to 01/10/2020.
05/04/2019: The following changes were made to the trial record:
1. The final enrolment number was added.
2. The intention to publish date was changed from 01/05/2021 to 01/08/2020.
29/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast" to "Breast cancer" following a request from the NIHR.
05/03/2019: Cancer Research UK lay summary link added to plain English summary field.
28/02/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 31/01/2019 to 31/03/2019.
2. The overall trial end date has been changed from 01/03/2020 to 01/05/2020.
3. The intention to publish date has been changed from 01/03/2021 to 01/05/2021.
29/01/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 30/11/2018 to 31/01/2019
2. The overall trial end date has been changed from 01/11/2019 to 01/03/2020
3. The intention to publish date has been changed from 01/11/2020to 01/03/2021
03/08/2018: The recruitment end date was changed from 30/06/2018 to 30/11/2018.
30/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.