ISRCTN14330469进行中（未招募）Unknown
The 6:1 intermittent diet breast cancer prevention programme study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
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