BE-WEL trial (breast: evaluation of weight and exercise for lymphoedema) testing weight control and exercise programmes for women with breast cancer related lymphoedema: a feasibility trial.

PURPOSE: A combined body weight loss and upper body/arm exercise programme is a potential strategy for managing Breast cancer related lymphoedema (BCRL), but there is limited data on the best method for delivery or its potential efficacy. METHODS: Fifty-seven women with overweight/obesity and BCRL were randomised to a 12 week supervised (n = 12) or home-based combined weight loss and upper body/arm exercise programme (n = 16), a home-based upper-body arm exercise only programme (n = 17) or standard care (n = 12). Primary outcomes were uptake, retention and changes in weight and change in Relative Arm Volume Increase (RAVI) using analysis of covariance (ANCOVA). RESULTS: Sixteen percent of women invited joined the study and 49 completed the trial (85% retention). Reductions in weight occurred in the supervised and home-based weight control and exercise programmes; Mean (95% CI) change compared to standard care - 1.68 (- 4.36 to - 1.00), - 2.47(- 4.99 to - 0.04) Kg. Reductions in perometer assessed RAVI were seen in the supervised and home-based combined weight control and arm exercise groups and the weight stable home-based arm exercise only group: mean (95% CI) change compared to standard care - 2.4 (- 5.0 to + 0.4),- 1.8 (- 4.3 to + 0.7), - 2.5(- 4.9 to - 0.05)%. CONCLUSION: Women with BCRL and overweight and obesity engaged in diet and exercise weight loss programmes. Both weight loss/arm exercise programmes led to modest changes in weight and BCRL. Comparable reductions in BCRL were reported in the weight stable group undertaking arm exercise only. The independent and combined effects of weight loss and exercise on BCRL need further study. TRIAL REGISTRATION: ISRCTN86789850 https://doi.org/10.1186/ISRCTN86789850 , registered 2011.

Body composition changes during breast cancer preventive treatment with anastrozole: Findings from the IBIS-II trial.

Background: Uptake to anastrozole for breast cancer prevention is low, partly due to women's concerns about side effects including gains in weight and specifically gains in body fat. Previous evidence does not link anastrozole with gains in weight, but there is a lack of data on any effects on body composition i.e. changes in fat and fat free mass. Here we assess association of anastrozole with body composition changes in a prospective sub-study from the second international breast intervention trial (IBIS-II). Methods: Participants had DXA scans at baseline and for five years of anastrozole/placebo and beyond (between March 2004 and September 2017. Primary outcomes were changes in body weight, body fat and fat free mass at 9-18 months. A linear model was used to estimate the size of a differential effect in these outcomes by randomised treatment allocation adjusted for baseline value and time since last scan, age, 10-year breast cancer risk, smoking and HRT status. Results: 203 postmenopausal women were recruited (n = 95 anastrozole, n = 108 placebo), mean age 58 years (SD = 5.4), BMI 28.0 kg/m2 (SD = 5.5). There was no evidence of a strong association between anastrozole or placebo and endpoints at 9-18 months; effect size (95 %CI) for anastrozole minus placebo for body weight (per/kg) -0.11 (-1.29-1.08); body fat 0.11 (-0.75-0.96) and fat free mass -0.30 (-0.79-0.19). Conclusions: There is unlikely to be a clinically significant change to body composition with anastrozole for breast cancer prevention.

Correction: Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study.

[This corrects the article DOI: 10.2196/41246.].

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.

BACKGROUND: Overweight and obesity are common amongst women attending breast cancer Family History, Risk and Prevention Clinics (FHRPCs). Overweight increases risk of breast cancer (BC) and conditions including1 cardiovascular disease (CVD) and type-2 diabetes (T2D). Clinics provide written health behaviour advice with is likely to have minimal effects. We assessed efficacy of two remotely delivered weight loss programmes vs. written advice. METHOD: 210 women with overweight or obesity attending three UK FHRPCs were randomised to either a BC prevention programme (BCPP) framed to reduce risk of BC (n = 86), a multiple disease prevention programme (MDPP) framed to reduce risk of BC, CVD and T2D (n = 87), or written advice (n = 37). Change in weight and health behaviours were assessed at 12-months. RESULTS: Weight loss at 12 months was -6.3% (-8.2, -4.5) in BCPP, -6.0% (-7.9, -4.2) in MDPP and -3.3% (-6.2, -0.5) in the written group (p = 0.451 across groups). The percentage losing ≥10% weight in these groups were respectively 34%, 23% and 14% (p = 0.038 across groups). DISCUSSION: BCPP and MDPP programmes resulted in more women achieving ≥10% weight loss, but no evidence of additional benefits of MDPP. A multicentre RCT to test the BCPP across UK FHRPCs is warranted. Clinical Trial Registration ISRCTN16431108.

Obesity at age 20 and weight gain during adulthood increase risk of total and premature all-cause mortality: findings from women attending breast screening in Manchester.

BACKGROUND: Obesity in early adulthood is associated with lower breast cancer rates in later life. This could be interpreted as a positive reinforcement of excess weight amongst younger women however, the wider implications of higher weights are less well known. This study examined the association between both obesity in early adulthood and body mass index (BMI) change through adulthood, and all-cause mortality. METHODS: The Predicting Risk of Cancer At Screening (PROCAS) study recruited 57,902 women aged 46-73 years (median age 57.2, IQR 51.8-63.7 years) from the Greater Manchester National Health Service breast screening programme in North West England between 2009 and 2015. It was used to assess associations between BMI at 20 years and cohort entry with all-cause mortality ascertained via deaths recorded on the National Breast Screening System to June 2020. Hazard ratios were estimated using proportional hazards (Cox) regression adjusted for factors at entry to the cohort: age, deprivation, bilateral oophorectomy, hormone-replacement therapy, menopausal status, ethnicity, alcohol intake, physical activity, and BMI. RESULTS: The prevalence of overweight (25-30 kg/m2) and obesity (> 30 kg/m2) were 10.4% and 2.5% respectively at 20 years, increasing to 35.2% and 25.9% respectively at cohort entry. After a mean 8.7 years follow-up we observed that overweight (HR = 1.27, 95%CI = 1.10-1.47) and obesity (HR = 2.11, 95%CI = 1.67-2.66) at 20 years had a higher mortality rate compared with healthy weight. Women who were underweight/healthy weight at 20 years and gained weight to obesity at entry had a slightly increased mortality rate compared with women who were underweight/healthy weight at both time points (HR 1.16, 95%CI = 1.02-1.32). Women with overweight (HR = 1.36, 95%CI = 1.06-1.75) or obesity (HR = 1.90, 95%CI = 1.45-2.48) at both 20 years and entry had a higher mortality rate than women who were underweight/healthy weight at both points. CONCLUSIONS: Women who self-reported overweight and obesity at 20 years had a shorter life expectancy in this cohort of women attending breast cancer screening. Weight gain from 20 years was common in this group. Girls and women should be supported to maintain a healthy weight throughout the lifespan to help increase life expectancy. Trial registration number NCT04359420, retrospectively registered 24/04/2020.

Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study.

BACKGROUND: Breast cancer is the most common form of cancer in women, and around 20% of cases are associated with factors such as adult weight gain, overweight and obesity, and potentially modifiable health behaviors including high alcohol intake, smoking, lack of physical activity, and breastfeeding. Significant weight gain occurs between the ages of 18 and 35 years; hence, this age group could benefit from weight gain prevention interventions. Population studies have reported that women at increased risk of breast cancer account for a disproportionate amount of cases. Thus, there is a particular need to target weight gain prevention and other health behavior interventions for women at increased risk. A literature review identified no evidence-based apps that cover all relevant health behaviors. With patient and participant involvement from the target population, we have developed a new app to promote healthy behaviors among young women at increased risk of breast cancer. Alongside the app, a Facebook group provides peer support, and a virtual welcome event provides an overview of the project and the opportunity to meet the research team and other study participants. The aim of the intervention is to prevent weight gain via changes to eating habits and physical activity levels, and improve other health behaviors associated with breast cancer. The app includes goal setting and self-monitoring of health behaviors and provides education about breast cancer. OBJECTIVE: This study aims to assess the acceptability and usability of the app in young women at increased risk of breast cancer, and the feasibility of the study procedures for a future, larger efficacy study. METHODS: Young women (n=35, age 18-35 years) at increased risk of breast cancer (>17% lifetime risk) will be recruited via 2 recruitment procedures: mailed invite from the local breast cancer family history, risk and prevention clinic, and advertisements on social media and websites. Participants will have access to the app and the private Facebook group for 2 months. They will complete questionnaires regarding their health behaviors and breast cancer risk belief at the start and end of the study, complete app rating scales in the middle and at the end of the study, and be invited to give feedback on the app during the study period. Approximately 20 participants will have a semistructured interview at the end of the study regarding their views on the app and trial procedures. RESULTS: The trial is ongoing, and the publication of results is anticipated in 2023. CONCLUSIONS: The trial will provide evidence regarding the acceptability and usability of the newly developed app for young women at increased risk of breast cancer. Feedback obtained will be used to improve the app. The trial will also assess the feasibility of the study procedures and how these can be refined for a future efficacy study. TRIAL REGISTRATION: ClinicalTrials.gov NCT05460650; https://clinicaltrials.gov/ct2/show/NCT05460650. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/41246.

Magnitude and attributed reasons for adult weight gain amongst women at increased risk of breast cancer.

BACKGROUND: Excess weight (BMI ≥25.0 kg/m2) and weight gain during adult life increase the risk of postmenopausal breast cancer in women who are already at increased risk of the disease. Reasons for weight gain in this population can inform strategies for weight gain prevention. METHODS: Baseline data from six weight loss studies for women at increased risk of breast cancer (age 31-74 years) were collated. Self-reported patterns of adult weight gain and attributed reasons for weight gain before joining the weight loss study were reported for the whole population and secondary analyses reported the different reasons given by women with/without children, pre-/peri- or postmenopausal, and moderate/high risk of breast cancer. RESULTS: Five hundred and one women with a mean age of 47.6 (SD 8.4) years and median BMI of 29.9 (IQR 27.0-34.7) kg/m2 were included in the analyses. The median weight gain since young adulthood (18-20 years) was 20.5 (IQR 14.0-29.7) kg or 33.7 (23.4-50.2) % and median annual weight gain was 0.73 (IQR 0.51-1.08) kg. Four hundred and one women were included in analysis of weight gain reasons. The main five self-reported reasons for weight gain were children / childcare / pregnancy (stated by 55.9% of participants), followed by inactivity (41.9%), comfort or boredom eating (38.2%), portion size (32.4%), and stress (27.4%). Reasons appeared broadly similar between the different groups in the secondary analyses. CONCLUSIONS: We have highlighted common reasons for weight gain in women at increased risk of breast cancer. This will inform future interventions to support women to avoid weight gain in adulthood which would reduce the burden of breast cancer. TRIAL REGISTRATION: NIHR NRR N0226132725, ISRCTN52913838, ISRCTN77916487, ISRCTN91372184, ISRCTN10803394 and ISRCTN16431108.

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer.

BACKGROUND: Excess adiposity at diagnosis and weight gain during chemotherapy is associated with tumour recurrence and chemotherapy toxicity. We assessed the efficacy of intermittent energy restriction (IER) vs continuous energy restriction (CER) for weight control and toxicity reduction during chemotherapy. METHODS: One hundred and seventy-two women were randomised to follow IER or CER throughout adjuvant/neoadjuvant chemotherapy. Primary endpoints were weight and body fat change. Secondary endpoints included chemotherapy toxicity, cardiovascular risk markers, and correlative markers of metabolism, inflammation and oxidative stress. RESULTS: Primary analyses showed non-significant reductions in weight (-1.1 (-2.4 to +0.2) kg, p = 0.11) and body fat (-1.0 (-2.1 to +0.1) kg, p = 0.086) in IER compared with CER. Predefined secondary analyses adjusted for body water showed significantly greater reductions in weight (-1.4 (-2.5 to -0.2) kg, p = 0.024) and body fat (-1.1 (-2.1 to -0.2) kg, p = 0.046) in IER compared with CER. Incidence of grade 3/4 toxicities were comparable overall (IER 31.0 vs CER 36.5%, p = 0.45) with a trend to fewer grade 3/4 toxicities with IER (18%) vs CER (31%) during cycles 4-6 of primarily taxane therapy (p = 0.063). CONCLUSIONS: IER is feasible during chemotherapy. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials. CLINICAL TRIAL REGISTRATION: ISRCTN04156504.

Testing a breast cancer prevention and a multiple disease prevention weight loss programme amongst women within the UK NHS breast screening programme-a randomised feasibility study.

BACKGROUND: Excess weight and unhealthy behaviours (e.g. sedentariness, high alcohol) are common amongst women including those 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 randomised (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on 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]). Primary outcomes were uptake and retention and other feasibility outcomes which include intervention fidelity and prevalence of high CVD and T2D risk. Secondary outcomes included change in weight. RESULTS: The BCPP and MDPP had comparable rates of uptake: 45/508 (9%) vs. 81/848 (10%) and 12-month retention; 33/45 (73%) vs. 53/81 (65%). Both programmes had a high fidelity of delivery with receipt of mean (95% CI) 90 (88-98% of scheduled calls, 91 (86-95%) of scheduled e-mails and 89 (76-102) website entries per woman over the 12-month period. 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%. Both groups experienced good comparable weight loss: BCPP 26/45 (58%) and MDPP 46/81 (57%) with greater than 5% weight loss at 12 months using baseline observation carried forward imputation. CONCLUSIONS: Both programmes appeared feasible. The 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. A future definitive effectiveness trial of BCPP is supported by acceptable uptake and retention, and good weight loss. TRIAL REGISTRATION: ISRCTN91372184 , registered 28 September 2014.

Long-Term Evaluation of Women Referred to a Breast Cancer Family History Clinic (Manchester UK 1987-2020).

Clinics for women concerned about their family history of breast cancer are widely established. A Family History Clinic was set-up in Manchester, UK, in 1987 in a Breast Unit serving a population of 1.8 million. In this review, we report the outcome of risk assessment, screening and prevention strategies in the clinic and propose future approaches. Between 1987-2020, 14,311 women were referred, of whom 6.4% were from known gene families, 38.2% were at high risk (≥30% lifetime risk), 37.7% at moderate risk (17-29%), and 17.7% at an average/population risk who were discharged. A total of 4168 (29.1%) women were eligible for genetic testing and 736 carried pathogenic variants, predominantly in BRCA1 and BRCA2 but also other genes (5.1% of direct referrals). All women at high or moderate risk were offered annual mammographic screening between ages 30 and 40 years old: 646 cancers were detected in women at high and moderate risk (5.5%) with a detection rate of 5 per 1000 screens. Incident breast cancers were largely of good prognosis and resulted in a predicted survival advantage. All high/moderate-risk women were offered lifestyle prevention advice and 14-27% entered various lifestyle studies. From 1992-2003, women were offered entry into IBIS-I (tamoxifen) and IBIS-II (anastrozole) trials (12.5% of invitees joined). The NICE guidelines ratified the use of tamoxifen and raloxifene (2013) and subsequently anastrozole (2017) for prevention; 10.8% women took up the offer of such treatment between 2013-2020. Since 1994, 7164 eligible women at ≥25% lifetime risk of breast cancer were offered a discussion of risk-reducing breast surgery and 451 (6.2%) had surgery. New approaches in all aspects of the service are needed to build on these results.

Young adulthood body mass index, adult weight gain and breast cancer risk: the PROCAS Study (United Kingdom).

BACKGROUND: We tested the hypothesis that body mass index (BMI) aged 20 years modifies the association of adult weight gain and breast cancer risk. METHODS: We recruited women (aged 47-73 years) into the PROCAS (Predicting Risk Of Cancer At Screening; Manchester, UK: 2009-2013) Study. In 47,042 women, we determined BMI at baseline and (by recall) at age 20 years, and derived weight changes. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for new breast cancer using Cox models and explored relationships between BMI aged 20 years, subsequent weight changes and breast cancer risk. RESULTS: With median follow-up of 5.6 years, 1142 breast cancers (post-menopausal at entry: 829) occurred. Among post-menopausal women at entry, BMI aged 20 years was inversely associated [HR per SD: 0.87 (95% CI: 0.79-0.95)], while absolute weight gain was associated with breast cancer [HR per SD:1.23 (95% CI: 1.14-1.32)]. For post-menopausal women who had a recall BMI aged 20 years <23.4 kg/m2 (75th percentile), absolute weight gain was associated with breast cancer [HR per SD: 1.31 (95% CIs: 1.21-1.42)], but there were no associations for women with a recall BMI aged 20 years of >23.4 kg/m2 (Pinteraction values <0.05). CONCLUSIONS: Adult weight gain increased post-menopausal breast cancer risk only among women who were <23.4 kg/m2 aged 20 years.

Why young women gain weight: A narrative review of influencing factors and possible solutions.

Significant weight gain occurs in women during young adulthood, which increases risk of diseases such as diabetes, cardiovascular disease, and many cancers. This review aims to inform future individually targeted weight gain prevention programmes and summarizes possible targets: key life events, mediators that influence energy intake and physical activity levels, and moderators that could identify groups of women at greatest risk. Life events affecting weight include pregnancy and motherhood, smoking cessation, marriage and cohabiting, attending university, and possibly bereavement. Research has identified successful methods for preventing weight gain associated with pregnancy and motherhood, which could now be used in practice, but evidence is inconclusive for preventing weight gain around other life events. Weight gain is mediated by lack of knowledge and skills around food and nutrition, depression, anxiety, stress, satiety, neural responses, and possibly sleep patterns and premenstrual cravings. A paucity of research exists into altering these to limit weight gain. Moderators include socioeconomic status, genetics, personality traits, and eating styles. More research is required to identify at-risk females and engage them in weight gain prevention. There is a need to address evidence gaps highlighted and implement what is currently known to develop effective strategies to limit weight gain in young women.

How acceptable is a weight maintenance programme for healthy weight young women who are at increased risk of breast cancer?

Objective: To determine if a weight gain prevention intervention is acceptable to young women with a normal Body Mass Index and a moderately increased or high risk of breast cancer. Design: Qualitative semi-structured interview study involving 14 women aged 26-35 years who were registered with a Family History Clinic in Manchester, UK, due to family history of breast cancer. Participants' views were analysed thematically. Results: Four themes were produced: (1) perceptions of a healthy lifestyle: women's perceptions included health-related behaviours and subjective wellbeing; (2) construing a healthy weight: women rely on appearance, feelings and others opinions to construe weight instead of quantitative indicators; (3) configuring a useful programme: the idea of a programme that is remotely accessible; provides a point of contact; and promotes general wellbeing was appealing. Women believed information explaining the link between lifestyle and breast cancer would facilitate behaviour change; (4) the importance of will(power): women recognised that commitment to a programme is affected by time, money and readiness to change. Conclusion: A weight gain prevention intervention that focuses on wellbeing and behaviour change appears acceptable to many healthy weight women. Future research should examine whether women's expressed acceptability translates into actual acceptability of such a programme.

Breast cancer risk status influences uptake, retention and efficacy of a weight loss programme amongst breast cancer screening attendees: two randomised controlled feasibility trials.

BACKGROUND: Excess body weight and sub-optimal lifestyle are modifiable causes of breast cancer and other diseases. There is little evidence that behaviour change is possible within screening programmes and whether this is influenced by prior knowledge of disease risk. We determined whether breast cancer risk influences uptake, retention and efficacy of a weight control programme in the UK National Health Service Breast Screening Programme, and whether additional cardiovascular disease and type 2 diabetes risk information improves uptake and retention further. METHOD: Overweight/obese women in the UK National Health Service Breast Screening Programme identified at high, moderately increased, average and low-risk of breast cancer were randomised to receive individualised breast cancer risk information (breast cancer prevention programme), or individualised breast cancer, cardiovascular disease (QRISK2) and type 2 diabetes (QDiabetes, HbA1c) information (multiple disease prevention programme). Personalised breast cancer risk feedback was given before randomisation in Study-1, and after randomisation in Study-2. RESULTS: Recruitment was 9% (126/1356) in Study-1 and 7% (52/738) in Study-2. With respect to breast cancer risk, odds ratio of uptake for high/moderately increased vs low risk women was 1.99 (95% CI 1.24-3.17, P = 0.004) in Study-1 and 3.58 (95% CI 1.59-8.07, P = 0.002) in Study-2. Odds ratio of retention for high/moderately increased -risk vs. low risk women was 2.98 (95% CI 1.05-8.47, P = 0.041) in Study-1 and 3.88 (95% CI 1.07-14.04, P = 0.039) in Study-2. Weight loss of ≥5% at 12 months was achieved by 63% high/moderate vs. 43% low-risk women in Study-1 (P = 0.083) and 39% vs. 8% in Study-2 (P = 0.008). Uptake, retention and weight loss were equivalent in both the breast cancer prevention programme and the multiple disease prevention programme in both studies. CONCLUSIONS: Women who are informed that they are at increased breast cancer risk were significantly more likely to join and remain in the programmes and consequently lose more weight across both studies. High risk women are more likely engage in a lifetyle prevention programme and also have the greatest potential benefit fom risk reduction strategies. TRIAL REGISTRATION: ISRCTN91372184 Registered 28 September 2014.

The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.

BACKGROUND: Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women. METHODS: Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes. RESULTS: Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective. CONCLUSIONS: The programmes were equally effective for weight control, but the community programme had additional benefits. CLINICAL TRIAL REGISTRATION: ISRCTN68576140.

Lifestyle behaviours and health measures of women at increased risk of breast cancer taking chemoprevention.

Women at increased breast cancer (BC) risk are eligible for chemoprevention. Healthy lifestyles are potentially important for these women to improve efficacy and minimise side effects of chemoprevention and reduce the risk of BC and other lifestyle-related conditions. We investigated whether women taking chemoprevention adhere to healthy lifestyle recommendations, how their lifestyle risk factors and health measures compare to women in the general population, and whether these change whilst taking chemoprevention. Lifestyle risk factors and health measures in 136 premenopausal women taking tamoxifen for prevention of BC (Tam-Prev study) were compared to both national recommendations and an age-matched female population from the Health Survey for England 2012. The Tam-Prev population had high rates of overweight and obesity (59.2%) and low adherence to physical activity recommendations (30.6%) which were comparable to the general population (55.2 and 35.1%, respectively). Fewer Tam-Prev participants were current smokers (10.5 vs. 18.2%, P = 0.032), but more exceeded alcohol recommendations (45.0 vs. 18.7%, P < 0.001). Tam-Prev participants had suboptimal diets; proportions not meeting fibre, saturated fat and non-milk extrinsic sugar recommendations were 87.8, 64.9 and 21.4% respectively. Many Tam-Prev participants had markers of cardiovascular disease risk and the metabolic syndrome. Health behaviours did not change during the first year on tamoxifen. Women taking chemoprevention had a high prevalence of unhealthy lifestyle behaviours and health measures, similar to an age-matched English cohort. Improving these measures in women at increased BC risk could significantly decrease rates of BC and other noncommunicable diseases.

Recruitment to the "Breast-Activity and Healthy Eating After Diagnosis" (B-AHEAD) Randomized Controlled Trial.

Excess weight at breast cancer diagnosis and weight gain during treatment are linked to increased breast cancer specific and all-cause mortality. The Breast-Activity and Healthy Eating After Diagnosis (B-AHEAD) trial tested 2 weight loss diet and exercise programmes versus a control receiving standard written advice during adjuvant treatment. This article identifies differences in characteristics between patients recruited from the main trial site to those of the whole population from that site during the recruitment period and identifies barriers to recruitment. A total of 409 patients with operable breast cancer were recruited within 12 weeks of surgery. We compared demographic and treatment factors between women recruited from the main trial coordinating site (n = 300) to the whole breast cancer population in the center (n = 532). Uptake at the coordinating site was 42%, comparable to treatment trials in the unit (47%). Women recruited were younger (55.9 vs 61.2 years, P < .001), more likely to live in least deprived postcode areas (41.7% vs 31.6%, P = .004), and more likely to have screen-detected cancers (55.3% vs 48.7%, P = .026) than the whole breast cancer population. The good uptake highlights the interest in lifestyle change around the time of diagnosis, a challenging time in the patient pathway, and shows that recruitment at this time is feasible. Barriers to uptake among older women and women with a lower socioeconomic status should be understood and overcome in order to improve recruitment to future lifestyle intervention programs.

Intermittent energy restriction induces changes in breast gene expression and systemic metabolism.

BACKGROUND: Observational studies suggest weight loss and energy restriction reduce breast cancer risk. Intermittent energy restriction (IER) reduces weight to the same extent as, or more than equivalent continuous energy restriction (CER) but the effects of IER on normal breast tissue and systemic metabolism as indicators of breast cancer risk are unknown. METHODS: We assessed the effect of IER (two days of 65 % energy restriction per week) for one menstrual cycle on breast tissue gene expression using Affymetrix GeneChips, adipocyte size by morphometry, and systemic metabolism (insulin resistance, lipids, serum and urine metabolites, lymphocyte gene expression) in 23 overweight premenopausal women at high risk of breast cancer. Unsupervised and supervised analyses of matched pre and post IER biopsies in 20 subjects were performed, whilst liquid and gas chromatography mass spectrometry assessed corresponding changes in serum and urine metabolites in all subjects after the two restricted and five unrestricted days of the IER. RESULTS: Women lost 4.8 % (±2.0 %) of body weight and 8.0 % (±5.0 %) of total body fat. Insulin resistance (homeostatic model assessment (HOMA)) reduced by 29.8 % (±17.8 %) on the restricted days and by 11 % (±34 %) on the unrestricted days of the IER. Five hundred and twenty-seven metabolites significantly increased or decreased during the two restricted days of IER. Ninety-one percent of these returned to baseline after 5 days of normal eating. Eleven subjects (55 %) displayed reductions in energy restriction-associated metabolic gene pathways including lipid synthesis, gluconeogenesis and glycogen synthesis. Some of these women also had increases in genes associated with breast epithelial cell differentiation (secretoglobulins, milk proteins and mucins) and decreased collagen synthesis (TNMD, PCOLCE2, TIMP4). There was no appreciable effect of IER on breast gene expression in the other nine subjects. These groups did not differ in the degree of changes in weight, total body fat, fat cell size or serum or urine metabolomic markers. Corresponding gene changes were not seen in peripheral blood lymphocytes. CONCLUSION: The transcriptional response to IER is variable in breast tissue, which was not reflected in the systemic response, which occurred in all subjects. The mechanisms of breast responsiveness/non-responsiveness require further investigation. TRIAL REGISTRATION: ISRCTN77916487 31/07/2012.

Self-efficacy for temptations is a better predictor of weight loss than motivation and global self-efficacy: evidence from two prospective studies among overweight/obese women at high risk of breast cancer.

OBJECTIVES: Identifying predictors of weight loss could help to triage people who will benefit most from programs and identify those who require additional support. The present research was designed to address statistical, conceptual and operational difficulties associated with the role of self-efficacy in predicting weight loss. METHODS: In Study 1, 115 dieting overweight/obese women at high risk of breast cancer were weighed and completed questionnaires assessing motivation, global self-efficacy and self-efficacy for temptations. The main outcome measure was weight, measured 3-months post-baseline. Study 2 was identical (n=107), except changes in psychological variables were computed, and used to predict weight 6-months post-baseline. RESULTS: In Study 1, self-efficacy for temptations was a significant predictor of weight loss at 3-month follow-up. In Study 2, improved self-efficacy for temptations between baseline and four-weeks was predictive of lower weight at 6 months. CONCLUSION: The key finding was that self-efficacy for temptations, as opposed to motivation and global self-efficacy, was predictive of subsequent weight loss. PRACTICE IMPLICATIONS: The implication is that augmenting dieters' capability for dealing with temptations might boost the impact of weight loss programs.