The 6:1 diet for the reduction of risk of breast cancer.
Research type
Research Study
Full title
Testing the feasibility of a 6:1 intermittent diet breast cancer risk reduction programme to promote healthy eating and prevent weight gain in women at increased risk of breast cancer.
IRAS ID
343256
Contact name
Michelle Harvie
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN14330469
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Weight gain in young women increases risk of breast cancer and other cancers and conditions. Weight gain occurs in young women attending high risk clinics and there is an unmet need for effective weight gain prevention interventions for these women. This 4 months feasibility study will test whether a novel intermittent 6:1 intermittent diet is acceptable and can promote healthy eating and limit weight gain with minimal harms in women at increased risk of breast cancer aged 18-40 who are a healthy weight. Findings will inform whether further research with the 6:1 diet is warranted
The study will invite 30 women at increased risk of breast cancer to join the programme for 4 months. The study will see if the programme is manageable and acceptable by looking at numbers who join the programme, and the numbers who stay in the programme and how well they many manage to follow the diet. We will also ask women their views of being in the programme and trying to follow the diet with a feedback questionnaire.
We will also look at whether the programme has any benefits for weight healthy eating, or being more active or if it has the potential to harms by increasing binge eating behaviour or impacting on sleep. Also how assess how easy the programme is to deliver and the amount of dietitian time it requires to deliver.
Good uptake (>15%), retention to the programme (>70%) and diet adherence (>50% of potential low calorie days) and minimal harms (<10% of subjects) will mean we will conduct further research of the benefits of this diet programme.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0321
Date of REC Opinion
15 Oct 2024
REC opinion
Favourable Opinion