Prevention of breast cancer in women at increased risk Cancer
Conditions
Interventions
The 6:1 diet programme includes an intermittent 6:1 diet which involves one 1000 kcal day per week (to include ~70 g of protein and ~100g carbohydrate) and 6 days per week of healthy eating with a Med
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Born female and not undergone gender reassignment aged 18-40 years. 2. Moderate or high risk of BC (>17% lifetime risk or >10 year risk of BC of >3% at 40) 3. BMI > or=20 and < or = 25 Kg/m² 4. Able to communicate (written and spoken) in English or other languages 5. Able to attend two face-to-face appointments at MFT at baseline and 4 months 6. Not pregnant or planning to become pregnant: Where appropriate potential participants will have a negative urine pregnancy test at screening and agreement to maintain contraception or abstinence for the trial.
Exclusion criteria
Exclusion criteria: 1. Previous breast cancer or bilateral preventative mastectomy 2. Currently trying to gain weight 3. Previously had weight loss surgery or taking weight loss medication 4. Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis. 5. Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm 6. Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT) 7. Current or previous diagnosis of an eating disorder 8. Participants with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES) 9. Participants with severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire 10. Participants with severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire. 11. Confirmed pregnant via a pregnancy test, planning pregnancy in the next 4 months, or currently breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the 6:1 intervention assessed through: 1.1. Uptake: The percentage of patients who are sent the patient information sheet who consent to participate and the percentage of eligible patients who consent to participate. 1.2. Retention to the study: the percentage of patients consented who complete the 4-month review 1.3. Adherence to the low-calorie days will be self-reported as the percentage completion of the potential low-calorie days between randomisation and the 4-month review. 1.4. Patient acceptability of the intervention will be assessed using a validated intervention evaluation questionnaire at the end of the study (Sekhon et al 2022). 2. Preliminary evaluation of any benefits of the diet 2.1. Changes in body weight and body composition (body fat and lean body mass assessed with bioelectrical impedance, waist and hip circumferences) between baseline and 4 months 2.2. Changes in diet quality (Mediterranean diet score) and alcohol intake (7-day recall) and energy and macronutrient intake from 7-day food record (Myfood24 app or 7-day paper food diary) between baseline and 2 and 4 months. 2.3. Changes in physical activity (International Physical Activity Questionnaire IPAQ short form) between baseline and 2 and 4 months and change in activity assessed with an Actigraph between baseline and 4 months i.e. time spent in sleep, sedentary, light, moderate and vigorous activity, total wear time and step count. 3. Preliminary evaluation of any possible harms 3.1. Changes in binge eating between baseline 2 and 4 months assessed with a binge eating questionnaire (Bruce et al J Am Diet Assoc 1996) 3.2. Change in sleep between baseline 2 and 4 months assessed using the Pittsburgh sleep quality index) 3.3. Tthe number of potentially diet-related adverse events including fatigue, constipation, dizziness, headache, irritability (agitation), bad breath indigestion in the month before starting the diet and monthly throughout the intervention at each | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary intake and physical activity during low calorie and the other days of the week measured from 7 day food diaries at 2 and 4 months and actigraph measurements at 4 months 2. Adherence to the 6:1 intermittent diet across the 4 weeks of the menstrual cycle measured using self -report diet adherence and menstrual cycle diaries across each week of the 4-month intervention | — |
Countries
England, United Kingdom
Contacts
Public ContactMichelle Harvie
Outcome results
None listed