Testing the feasibility of a 6:1 intermittent diet breast cancer prevention programme to promote healthy eating and prevent weight gain in women at increased risk of breast cancer

Not Applicable

• Conditions: Prevention of breast cancer in women at increased risk; Cancer

• Registration Number: ISRCTN14330469
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Last Update Posted: 13 May 2024
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 30

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

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 breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified