Testing a Breast Cancer Prevention and a Multiple Disease Prevention Weight Loss Programme Among Women Within The UK NHS Breast Screening Programme - A Randomised Feasibility Study

Abstract

Excess weight and unhealthy behaviours (sedentariness, high alcohol and suboptimal diet) are common among women attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/ behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP). Methods Women aged 47-73 years with overweight or obesity (n=1356) in the NHS Breast Screening Programme (NHSBSP) were randomized (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on individual level of breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Uptake, retention, change in weight, and potential harms (anxiety and self-rated health) were assessed, along with the numbers in the MDPP with previously unknown CVD and T2D risk.ResultsThe BCPP and MDPP had comparable rates of uptake; 45/508 (9%) vs. 81/848 (10%) 12-month retention; 33/45 (73%) vs. 53/81 (65%) and numbers (%) losing ≥5% body weight at 12 months; 26/45 (58%) vs. 46/81 (57%) with baseline observation carried forward imputation. Both groups experienced reductions in state anxiety score; BCPP (n=37) -0.7 (-4.6 to 3.2), MDPP (n=60) -3.5 (-6.7 to -0.4) and an increase in the EQ-5D-5L score; BCPP (n=40) 4.1 (0.6 to 7.6), MDPP (n=60) 7.3 (3.6 to 11.1). The MDPP identified 15% of women with a previously unknown 10 year CVD QRISK2 of ≥10% and 56% with 10-year Qdiabetes risk of ≥10%.ConclusionsThe MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. The results suggest a definitive effectiveness trial of the BCPP intervention is warranted, with acceptable uptake and retention, and a clear weight loss signal.Trial Registration ISRCTN91372184, https://doi.org/10.1186/ISRCTN91372184, registered 28 September 2014.

Randomised controlled trial of breast cancer and multiple disease prevention weight loss programmes vs written advice amongst women attending a breast cancer family history clinic

“…There was no difference in retention or weight loss success between the MDPP and BCPP groups which is consistent with our findings in women in the general population attending breast screening [18]. Prior to this trial it was unclear whether additional personalised CVD and T2D risk to women in the FHRPC would enhance or decrease weight loss success due to a greater response efficacy for CVD and T2D compared to the risk of BC [13,14] or CVD/T2D risk information being less personally relevant to women at increased risk of BC [15].…”

“…Retention at 12 months was just below 60%. This aligns with previous weight loss intervention studies amongst women attending breast screening [18] and women in the general population [40].…”

“…Future multi-centres studies should include more robust support, training and incentives for the participating centres [64]. The retention rate was 55%, which whilst comparable to rates previously reported for 12 month weight loss interventions in other settings [18,40], makes the trial underpowered and is below an 80% retention so raises concerns about attrition bias and the validity of the trial [65]. Comparable study outcomes between multiple imputation and the conservative baseline observation carried forward analyses however increase confidence in the study findings.…”

“…Breast Cancer risk was communicated by a clinician in their recruiting FHRPC during a phone or face to face consultation along with verbal advice on how risk could be reduced through weight loss of 5-10% and health behaviour change. All groups received identical comprehensive written information to follow either a weight reducing intermittent (5:2) or daily energy restricted Mediterranean diet including portion guides and recipes as described previously [18]. They also received a detailed booklet which outlined the benefits of physical activity and a home based programme designed to meet physical activity recommendations (150 min of moderate intensity cardiovascular and 40 min of resistance exercise/week) [19,20].…”

“…Secondary outcomes. Body fat and fat free mass (bioelectrical impedance), waist and hip circumference were assessed using standardised methods as described previously [18]. Health behaviours were assessed using validated questionnaires; diet quality (12-point Mediterranean diet score) [29], physical activity (IPAQ short form) [30], alcohol (7-day recall [31] AUDIT alcohol use disorders test) [32] smoking behaviour (never/exsmoker or current smoker, number of cigarettes/day).…”