Condition category
Cancer
Date applied
20/11/2017
Date assigned
30/11/2017
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Dr Michelle Harvie

ORCID ID

http://orcid.org/0000-0001-9761-3089

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35447

Study information

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

Acronym

Study hypothesis

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

North West - Preston Research Ethics Committee, 21/08/2017, ref: 17.NW.0440

Study design

Randomised; Interventional; Design type: Prevention, Education or Self-Management, Dietary, Psychological & Behavioural, Complex Intervention, Physical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast

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

Phase

Drug names

Primary outcome measure

Percentage weight loss is measured using Tanita 180 bioelectrical impedance scales at baseline, 6 months and 12 months

Secondary outcome measures

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

Overall trial start date

01/05/2017

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 209; UK Sample Size: 209

Participant 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

Recruitment start date

29/11/2017

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road Hampshire
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust

Sponsor details

Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Prevent Breast Cancer Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The data from the trial will be owned by the sponsor. Trial results will be written as a final report for the funding body and disseminated at national/international scientific conferences and peer reviewed scientific papers and a number of web sites which for example may include Prevent Breast Cancer, the Manchester Breast Centre, Manchester Biomedical Research Centre Cancer Prevention and Early Detection, University of Manchester Women’s Cancer. Outputs from the trial will be written up jointly by the Chief Investigator and all co-applicants.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/11/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2018: Internal review 14/05/2018: Internal review. 16/01/2018: Internal review. 07/12/2017: Internal review. 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.