The feasibility and acceptability of an app-based intervention with brief behavioural support (APPROACH) to promote brisk walking in people diagnosed with breast, prostate and colorectal cancer in the UK.

INTRODUCTION: Increased moderate to vigorous physical activity (MVPA) can improve clinical and psychosocial outcomes for people living with and beyond cancer (LWBC). This study aimed to assess the feasibility and acceptability of trial procedures in a pilot randomised controlled trial (RCT) of a theory-driven app-based intervention with behavioural support focused on promoting brisk walking (a form of MVPA) in people LWBC (APPROACH). METHODS: Participants diagnosed with breast, prostate or colorectal cancer were recruited from a single UK hospital site. Assessments at baseline and 3 months included online questionnaires, device-measured brisk walking (activPAL accelerometer) and self-reported weight and height. Participants were randomised to intervention or control (care as usual). The intervention comprised a non-cancer-specific app to promote brisk walking (National Health Service 'Active 10') augmented with print information about habit formation, a walking planner and two behavioural support telephone calls. Feasibility and acceptability of trial procedures were explored. Initial estimates for physical activity informed a power calculation for a phase III RCT. A preliminary health economics analysis was conducted. RESULTS: Of those medically eligible, 369/577 (64%) were willing to answer further eligibility questions and 90/148 (61%) of those eligible were enrolled. Feasibility outcomes, including retention (97%), assessment completion rates (>86%) and app download rates in the intervention group (96%), suggest that the trial procedures are acceptable and that the intervention is feasible. The phase III RCT will require 472 participants to be randomised. As expected, the preliminary health economic analyses indicate a high level of uncertainty around the cost-effectiveness of the intervention. CONCLUSIONS: This pilot study demonstrates that a large trial of the brisk walking intervention with behavioural support is both feasible and acceptable to people LWBC. The results support progression onto a confirmatory phase III trial to determine the efficacy and cost-effectiveness of the intervention.

Development of the Top Tips Habit-Based Weight Loss App and Preliminary Indications of Its Usage, Effectiveness, and Acceptability: Mixed-Methods Pilot Study.

BACKGROUND: The Ten Top Tips (10TT) is an intervention based on the habit formation theory that promotes a set of weight management behaviors alongside advice about repetition in a consistent context. Overall, 3 studies have demonstrated that the 10TT can support individuals to lose weight when delivered in a leaflet format. Delivery of 10TT via new technology such as a mobile app could potentially improve its effectiveness and make it more convenient, appealing, and wide reaching. OBJECTIVE: This study aimed to provide preliminary indications of the usage, effectiveness, and acceptability of an Android app of the 10TT intervention (Top Tips only app) and a second version including self-regulatory strategies for dealing with tempting foods (Top Tips plus app). METHODS: The 3-month pilot randomized adults with overweight or obesity to (1) Top Tips only app, (2) Top Tips plus app, or (3) waiting list condition. Automated data from app users were collected. Validated questionnaires assessed self-regulatory skills, weight loss (kg), and behaviors at baseline and 3 months. Users' feedback on their experience using the app was assessed using open questions. RESULTS: A total of 81 participants took part in the pilot; 28 participants were randomized to the Top Tips only app, 27 to the Top Tips plus app, and 26 to the waiting list condition. On average, participants viewed a mean of 43.4 (SD 66.9) screens during a mean of 24.5 (SD 44.07) log-ins and used the app for 124.2 (SD 240.2) min over the 3-month period. Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (meanself-regulation 0.15, SD 0.42; meanweight -1.9, SD 3.9; and meanbehaviors 0.29, SD 0.29) and waiting list condition (meanself-regulation -0.02, SD 0.29; meanweight -0.01, SD 0.51; and meanbehaviors 0.08, SD 0.38). Participants who reported the largest improvements, on average, viewed pages 2 to 3 times more, had 2 to 3 times more log-ins, logged their weight 2 to 3 times more, and achieved the tips more than those who reported smaller changes in these outcomes. According to users' feedback, engagement with the app could be increased by making the app more interactive and allowing more tailoring. CONCLUSIONS: This study suggests that the Top Tips app could potentially be a useful intervention for promoting eating self-regulatory skills, weight loss, and weight management behaviors among adults with overweight or obesity. Future research should develop the app further based on user feedback and test it in larger sample sizes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN10470937; http://www.isrctn.com/ISRCTN10470937 (Archived by Webcite at http://www.webcitation.org/76j6rQibI).

Acceptability of receiving lifestyle advice at cervical, breast and bowel cancer screening.

Cancer screening could be an opportunity to deliver cancer prevention advice, but it is not known how such information would be received. We explored willingness to receive lifestyle advice in the context of the English National Health Service cervical, breast, and bowel (FS; flexible sigmoidoscopy) screening programmes. A population-based survey was conducted in 2016 to collect nationally representative data on willingness to receive lifestyle advice across cervical (n = 768), breast (n = 420) and FS (n = 308) screening programmes. Additional items assessed the impact of lifestyle advice on screening attendance, preference for receiving advice in the event of an abnormal screening result, and timing of advice. Most respondents were willing to receive lifestyle advice around the time of cancer screening (cervical 78.9%, breast 79.4%, FS 81.8%), and if their results were abnormal (cervical 86.3%, breast 83.0%, FS 85.1%). A small proportion indicated it may discourage future attendance (cervical 4.9%, breast 7.0%, FS 8.8%). Most preferred information to be delivered at the screening appointment (cervical 69.8%, breast 72.6%, FS 70.7%). There were no associations between sociodemographic characteristics and willingness to receive lifestyle advice at breast screening. For those intending to attend cervical screening, non-White ethnicity and higher education were associated with increased willingness to receive lifestyle advice. Women were more likely to be willing to receive advice at FS screening than men. Providing lifestyle advice at cancer screening is likely to be acceptable to the general population. The optimal approach for delivery needs careful consideration to minimise potential negative effects on screening attendance.

Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial.

OBJECTIVE: Ten Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service. DESIGN: An economic evaluation was conducted alongside an individually randomised controlled trial. SETTING: 14 general practitioner practices in England. PARTICIPANTS: All patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention. OUTCOMES MEASURES: Health service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation. RESULTS: Over a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of -£36 (95% CI -£512 to £441) and a mean QALY difference of 0.001 (95% CI -0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI -£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold. CONCLUSIONS: Costs and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations. TRIAL REGISTRATION NUMBER: ISRCTN16347068; Post-results.

The role of self-regulatory skills and automaticity on the effectiveness of a brief weight loss habit-based intervention: secondary analysis of the 10 top tips randomised trial.

BACKGROUND: Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. METHODS: 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. RESULTS: Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (ß = .52, 95% Bias Corrected CI .17; .91). CONCLUSIONS: As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. TRIAL REGISTRATION: This study was prospectively registered with the International Standard Randomised Controlled Trials ( ISRCTN16347068 ) on 26 September 2011.

Applied Interventions in the Prevention and Treatment of Obesity Through the Research of Professor Jane Wardle.

PURPOSE OF REVIEW: Obesity presents a challenge for practitioners, policy makers, researchers and for those with obesity themselves. This review focuses on psychological approaches to its management and prevention in children and adults. RECENT FINDINGS: Through exploring the work of the late Professor Jane Wardle, we look at the earliest behavioural treatment approaches and how psychological theory has been used to develop more contemporary approaches, for example incorporating genetic feedback and habit formation theory into interventions. We also explore how Jane has challenged thinking about the causal pathways of obesity in relation to eating behaviour. Beyond academic work, Jane was an advocate of developing interventions which had real-world applications. Therefore, we discuss how she not only developed new interventions but also made these widely available and the charity that she established.

Assessment of processes of change for weight management in a UK sample.

OBJECTIVE: The present study aimed to validate the English version of the Processes of Change questionnaire in weight management (P-Weight). METHODS: Participants were 1,087 UK adults, including people enrolled in a behavioural weight management programme, university students and an opportunistic sample. The mean age of the sample was 34.80 (SD = 13.56) years, and 83% were women. BMI ranged from 18.51 to 55.36 (mean = 25.92, SD = 6.26) kg/m(2). Participants completed both the stages and processes questionnaires in weight management (S-Weight and P-Weight), and subscales from the EDI-2 and EAT-40. A refined version of the P-Weight consisting of 32 items was obtained based on the item analysis. RESULTS: The internal structure of the scale fitted a four-factor model, and statistically significant correlations with external measures supported the convergent validity of the scale. CONCLUSION: The adequate psychometric properties of the P-Weight English version suggest that it could be a useful tool to tailor weight management interventions.

Public beliefs about the causes of obesity and attitudes towards policy initiatives in Great Britain.

OBJECTIVE: To assess attributions for overweight and the level of support for policy initiatives in Great Britain. DESIGN: Cross-sectional. Respondents indicated their agreement (5-point scales: strongly disagree to strongly agree) to three potential causes of overweight (environment, genes, willpower) and five policies (free weight-loss treatment, taxing unhealthy foods, healthy lifestyle campaigns, food labelling, advertising restrictions). SETTING: Data were collected as part of a computer-assisted, face-to-face Omnibus survey of adults (aged >15 years) from across Great Britain in April 2012 carried out by a market research company. SUBJECTS: A population-representative sample of British adults (n 1986). RESULTS: More people attributed overweight to the food environment (61 %) and lack of willpower (57 %) than to genes (45 %). Policy support was highest for healthy lifestyle campaigns (71 %) and food labelling (66 %), and lowest for taxing unhealthy foods (32 %). Food environment attributions were associated with higher support for all policies (P < 0·001). Genetic attributions were associated with higher support for free weight-loss treatments and healthy lifestyle campaigns (P < 0·001), but not other policies. Attributions to lack of willpower were not associated differentially with support for any policies (P > 0·01). CONCLUSIONS: Belief that overweight is caused by the food environment or genes ­ both seen as outside individual control ­ was associated with greater support for government policies to prevent and treat obesity. Improving awareness of the multiple causes of obesity could facilitate acceptance of policy action to reduce obesity prevalence.

Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.

BACKGROUND: National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with learning disabilities has been demonstrated. The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities. In order to provide healthcare for all, and ensure equality of treatment for people with learning disabilities, services must be developed specifically with this population in mind. The aim of this project is to pilot the evaluation of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities (Shape Up-LD). METHODS/DESIGN: An individually randomised, controlled pilot trial in 60 overweight and obese (body mass index ≥ 25) adults (age ≥ 18) with mild-moderate learning disabilities and their carers will be carried out, comparing "Shape Up-LD" with usual care. The manualised Shape Up-LD intervention will involve 12 weekly sessions, which include healthy eating messages, advice on physical activity and use of behaviour change techniques to help people manage their weight. Assessments of participants will be conducted at baseline, 12 weeks and 6 months. Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks. Feasibility outcomes will include recruitment rates, loss to follow-up, compliance rates, completion rates, collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight. DISCUSSION: The findings from this study will inform our preparation for a definitive randomised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population. Weight loss through Shape Up-LD could lead to improvements in health and quality of life. Costs to the National Health Service might be reduced through decreased overall service use because of improved health. The programme would also ensure a more equitable service for overweight service users with learning disabilities and fill the current gap in weight management services for this population. TRIAL REGISTRATION: International Standard Randomised Controlled Trial No ISRCTN39605930.

Study protocol for the 10 Top Tips (10TT) trial: randomised controlled trial of habit-based advice for weight control in general practice.

BACKGROUND: Primary care is the first port of call for advice about weight control. There is hence a need for simple, effective interventions that can be delivered without specialist skills. We have developed such an intervention; the 10 Top Tips (10TT). This intervention was effective with respect to weight loss in a volunteer population, but has yet to be tested in primary care. The aim of this trial is therefore to test the effectiveness of the 10TT intervention in primary care, incorporating clinical outcomes and health economic analyses. METHODS/DESIGN: The trial is a two-arm, individually-randomised, controlled trial in obese (BMI ≥ 30) adults (n = 520) in primary care, comparing weight loss in patients receiving the 10TT intervention with weight loss in a control group of patients receiving usual care. The intervention is based on habit formation theory, using written materials to take people through a set of simple weight control behaviours with strategies to make them habitual; an approach that could make it more successful than others in establishing long-term behaviour change. Patients will be recruited from 14 General Practices across England. Randomisation will be through telephoning a central randomisation service using a computer-generated list of random numbers. Patients are followed up at 3, 6, 12, 18 and 24 months. The primary outcome is weight loss at 3 months, with assessment by a health professional who is blind to group allocation. Other follow-ups will be un-blinded. We will examine whether weight loss is maintained up to 24 months. We will also assess changes in the automaticity of the 10TT target behaviours and improvement in clinical markers for potential co-morbidities. Finally, we will undertake a full economic evaluation to establish cost-effectiveness in the NHS context. DISCUSSION: If proven to be effective when delivered through primary care, 10TT could make a highly cost-effective contribution to improvements in population health. TRIAL REGISTRATION: ISRCTN16347068.

Cancer fatalism: deterring early presentation and increasing social inequalities?

BACKGROUND: Fatalistic beliefs about cancer have been implicated in low uptake of screening and delay in presentation particularly in low socioeconomic status (SES) groups, but no studies have systematically evaluated interrelationships between SES, fatalism, and early detection behaviors. We explored whether (i) fatalism is associated with negative attitudes toward early detection, (ii) lower SES groups are more fatalistic, and (iii) SES differences in fatalism partly explain SES differences in attitudes toward early detection. METHODS: In a population-representative sample of adults in Britain using computer-based interviews in the home setting, respondents (N = 2,018) answered two questions to index fatalism (expectations of cancer survival and cure) and two items on early detection attitudes (the perceived value of early detection and fear of symptom reporting). SES was indexed with a social grade classification. RESULTS: Fatalism was associated with being less positive about early detection (ß = -0.40, P < 0.001) and more fearful about seeking help for a suspicious symptom (ß = 0.24, P < 0.001). Lower SES groups were more fatalistic (ß = -0.21, P < 0.001). Path analyses suggest that SES differences in fatalism might explain SES differences in attitudes about early detection. CONCLUSIONS: In this population sample, SES differences in fatalism partly explained SES differences in the perceived value of early detection and fear of symptom presentation. IMPACT: Fatalistic beliefs about cancer should be targeted to promote early presentation of cancer and this may be particularly important for lower SES groups.