Family History Lifestyle Study

• Research type

  Research Study

• Full 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

• IRAS ID

  230115

• Contact name

  Michelle Harvie

• Contact email

  michelle.harvie@manchester.ac.uk

• Sponsor organisation

  University Hospital of South Manchester NHS Foundation Trust

• Duration of Study in the UK

  1 years, 10 months, 0 days

• Research summary

  Summary of Research
  Being a healthy weight, taking regular physical activity and limiting alcohol intake can reduce risk of breast cancer by about 30 – 40% amongst women in the general population and amongst women at increased risk who attend family history clinics. We and others have shown that many high risk women who come for regular mammograms in family history clinics who are overweight and have unhealthy lifestyles will be increasing their risk of BC, other cancers, heart disease, stroke, diabetes and dementia. Unfortunately weight and lifestyle risk factors are not currently addressed in these clinics. Women receive general written advice which has a minimal effect on behaviour. This project aims to find the most effective type of programme to help women to lose weight to reduce their risk of breast cancer and other diseases.

  209 overweight/ obese women in 3 UK NHS family history clinics will be 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, six and twelve months.

  Summary of Results
  BACKGROUND: Overweight and obesity are common amongst women attending breast cancer Family History clinics Being overweight increases risk of breast cancer and other conditions including heart disease & stroke and type-2 diabetes. Family history clinics only provide written diet and exercise weight control advice with is likely to have minimal effects. We assessed how effective two remotely delivered weight loss programmes were compared with a group just receiving standard written advice.
  METHOD: 210 women with overweight or obesity attending three UK family history clinics were randomly allocated to either a breast cancer prevention programme framed to reduce risk of breast cancer (86 women), a multiple disease prevention programme framed to reduce risk of breast cancer, heart disease, stroke and diabetes ( 87 women) or to receive written advice (37 women). We assessed change in weight and health behaviours at the end of the 12 month study
  RESULTS: The breast cancer prevention programme group on average lost 6.3% of their weight, the multiple disease group lost 6.0% and the written advice group lost 3.3% of their weight. More women in the breast cancer prevention and the multiple disease programme lost significant amounts of weight (more than 10% of their weight) respectively 34% and 23% in these groups compared to 14% in the written advice group

  DISCUSSION: Both the breast cancer prevention and the multiple disease programme led to significant weight loss but there was no evidence that the multiple disease programme was better. We conclude that a multicentre study to test the breast cancer prevention programme across UK family history clinics is warranted.
  
  

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  17/NW/0440

• Date of REC Opinion

  21 Aug 2017

• REC opinion

  Further Information Favourable Opinion