A pragmatic effectiveness-implementation study comparing trial evidence with routinely collected outcome data for patients receiving the REACH-HF home-based cardiac rehabilitation programme.

BACKGROUND: Cardiac rehabilitation for heart failure continues to be greatly underused worldwide despite being a Class I recommendation in international clinical guidelines and uptake is low in women and patients with mental health comorbidities. METHODS: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme was implemented in four UK National Health Service early adopter sites ('Beacon Sites') between June 2019 and June 2020. Implementation and patient-reported outcome data were collected across sites as part of the National Audit of Cardiac Rehabilitation. The change in key outcomes before and after the supervised period of REACH-HF intervention across the Beacon Sites was assessed and compared to those of the intervention arm of the REACH-HF multicentre trial. RESULTS: Compared to the REACH-HF multicentre trial, patients treated at the Beacon Site were more likely to be female (33.8% vs 22.9%), older (75.6 vs 70.1), had a more severe classification of heart failure (26.5% vs 17.7%), had poorer baseline health-related quality of life (MLHFQ score 36.1 vs 31.4), were more depressed (HADS score 6.4 vs 4.1) and anxious (HADS score 7.2 vs 4.7), and had lower exercise capacity (ISWT distance 190 m vs 274.7 m). There appeared to be a substantial heterogeneity in the implementation process across the four Beacon Sites as evidenced by the variation in levels of patient recruitment, operationalisation of the REACH-HF intervention and patient outcomes. Overall lower improvements in patient-reported outcomes at the Beacon Sites compared to the trial may reflect differences in the population studied (having higher morbidity at baseline) as well as the marked challenges in intervention delivery during the COVID-19 pandemic. CONCLUSION: The results of this study illustrate the challenges in consistently implementing an intervention (shown to be clinically effective and cost-effective in a multicentre trial) into real-world practice, especially in the midst of a global pandemic. Further research is needed to establish the real-world effectiveness of the REACH-HF intervention in different populations.

The Exeter Activity Unlimited statement on physical activity and exercise for cystic fibrosis: methodology and results of an international, multidisciplinary, evidence-driven expert consensus.

BACKGROUND: The roles of physical activity (PA) and exercise within the management of cystic fibrosis (CF) are recognised by their inclusion in numerous standards of care and treatment guidelines. However, information is brief, and both PA and exercise as multi-faceted behaviours require extensive stakeholder input when developing and promoting such guidelines. METHOD: On 30th June and 1st July 2021, 39 stakeholders from 11 countries, including researchers, healthcare professionals and patients participated in a virtual conference to agree an evidence-based and informed expert consensus about PA and exercise for people with CF. This consensus presents the agreement across six themes: (i) patient and system centred outcomes, (ii) health benefits, iii) measurement, (iv) prescription, (v) clinical considerations, and (vi) future directions. The consensus was achieved by a stepwise process, involving: (i) written evidence-based synopses; (ii) peer critique of synopses; (iii) oral presentation to consensus group and peer challenge of revised synopses; and (iv) anonymous voting on final proposed synopses for adoption to the consensus statement. RESULTS: The final consensus document includes 24 statements which surpassed the consensus threshold (>80% agreement) out of 30 proposed statements. CONCLUSION: This consensus can be used to support health promotion by relevant stakeholders for people with CF.

A review and content analysis of engagement, functionality, aesthetics, information quality, and change techniques in the most popular commercial apps for weight management.

BACKGROUND: There are thousands of apps promoting dietary improvement, increased physical activity (PA) and weight management. Despite a growing number of reviews in this area, popular apps have not been comprehensively analysed in terms of features related to engagement, functionality, aesthetics, information quality, and content, including the types of change techniques employed. METHODS: The databases containing information about all Health and Fitness apps on GP and iTunes (7,954 and 25,491 apps) were downloaded in April 2015. Database filters were applied to select the most popular apps available in both stores. Two researchers screened the descriptions selecting only weight management apps. Features, app quality and content were independently assessed using the Mobile App Rating Scale (MARS) and previously-defined categories of techniques relevant to behaviour change. Inter-coder reliabilities were calculated, and correlations between features explored. RESULTS: Of the 23 popular apps included in the review 16 were free (70%), 15 (65%) addressed weight control, diet and PA combined; 19 (83%) allowed behavioural tracking. On 5-point MARS scales, apps were of average quality (Md = 3.2, IQR = 1.4); "functionality" (Md = 4.0, IQR = 1.1) was the highest and "information quality" (Md = 2.0, IQR = 1.1) was the lowest domain. On average, 10 techniques were identified per app (range: 1-17) and of the 34 categories applied, goal setting and self-monitoring techniques were most frequently identified. App quality was positively correlated with number of techniques included (rho = .58, p < .01) and number of "technical" features (rho = .48, p < .05), which was also associated with the number of techniques included (rho = .61, p < .01). Apps that provided tracking used significantly more techniques than those that did not. Apps with automated tracking scored significantly higher in engagement, aesthetics, and overall MARS scores. Those that used change techniques previously associated with effectiveness (i.e., goal setting, self-monitoring and feedback) also had better "information quality". CONCLUSIONS: Popular apps assessed have overall moderate quality and include behavioural tracking features and a range of change techniques associated with behaviour change. These apps may influence behaviour, although more attention to information quality and evidence-based content are warranted to improve their quality.

"It helps me to stay on the right path, rather than give in": Mixed-method process evaluation of the ImpulsePal app-based intervention for weight management.

Background: Empirical research indicates that impulsive processes that operate below conscious monitoring can undermine peoples' attempts to change behaviour patterns, especially those that have become habitual. This may, therefore, be a serious challenge for those trying to lose weight. A novel smartphone app-based intervention (ImpulsePal) offers practical strategies to manage impulsive urges to facilitate reductions in the consumption of energy-dense processed food and overeating. Aim: This process evaluation of ImpulsePal aimed to explore what was delivered/received and used, mechanisms of action, and potential contextual factors impacting intervention engagement and outcomes. Methods: A mixed-methods process evaluation, with composite analysis of the quantitative (app usage statistics) and qualitative data (semi-structured interviews), was conducted alongside a feasibility randomised controlled trial with individuals with a body mass index of at least 25 kg/m2 who wanted to lose weight. Results: Of 58 participants receiving ImpulsePal, 56 had successfully shared app usage statistics, and 36 (62%) were interviewed. Although usage statistics indicated reductions in the use of some features, interviews indicated that participants were still using app-recommended strategies without requiring them to open ImpulsPal. Overall, interviews highlighted that participants valued having access to in-the-moment support, felt more aware of their own eating behaviour and influences on it, and felt an increased ability to avoid and reconceptualise, in-the-moment temptations. Conclusion: This process evaluation offers support for a logic model suggesting that impulse management, using ImpulsePal, can promote healthier eating among those motivated to lose weight. It also highlights the necessity of using multimodal methods to explore the delivery and use of digital interventions.

Addressing the psychology of weight loss and maintenance: A feasibility study of the Skills for weight loss and Maintenance weight management programme.

OBJECTIVES: Building on prior theory, we aimed to evaluate the feasibility and acceptability of integrating novel, weight loss maintenance strategies into existing weight management programmes. We also piloted recruitment and data collection procedures for future research. DESIGN: Two phases of action research nested within a single-arm feasibility study. The intervention was refined between phases using feedback from intervention fidelity analysis and qualitative exploration of patient and provider experiences. Changes in outcomes were assessed up to 18 months post-baseline. METHODS: One hundred adults with a mean body mass index of 37 kg/m2 were offered the Skills for weight loss and Maintenance (SkiM) intervention. This included existing weight management programme content and additional weight loss maintenance techniques delivered fortnightly for 6 months in local community centres to groups of 11-15 people. RESULTS: Of the 100 participants, 65%, 58% and 56% provided data at 7, 12 and 18 months. Across both phases, the mean initial weight loss was 4.2 kg (95% CI: 2.4-5.9) and 3.1 kg at 18 months (95% CI: .8-5.5). In Phase 2, we observed better weight loss maintenance (.5 kg [13.2%] regain from 7 to 18 months, vs. 1.7 kg [36.2%] in Phase 1). Variation in outcomes, high early dropout rates and qualitative feedback indicated that, although delivery of the intervention and trial procedures was feasible and acceptable, there was scope to refine the intervention to engage a wider range of participants. Intervention fidelity was acceptable, particularly in Phase 2. CONCLUSIONS: The SkiM intervention seems promising, but more research is needed to improve recruitment and retention prior to further evaluation.

Barriers and facilitators to implementation of a home-based cardiac rehabilitation programme for patients with heart failure in the NHS: a mixed-methods study.

OBJECTIVES: This study aimed to identify barriers to, and facilitators of, implementation of the Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme within existing cardiac rehabilitation services, and develop and refine the REACH-HF Service Delivery Guide (an implementation guide cocreated with healthcare professionals). REACH-HF is an effective and cost-effective 12-week home-based cardiac rehabilitation programme for patients with heart failure. SETTING/PARTICIPANTS: In 2019, four early adopter 'Beacon Sites' were set up to deliver REACH-HF to 200 patients. In 2020, 5 online REACH-HF training events were attended by 85 healthcare professionals from 45 National Health Service (NHS) teams across the UK and Ireland. DESIGN: Our mixed-methods study used in-depth semi-structured interviews and an online survey. Interviews were conducted with staff trained specifically for the Beacon Site project, identified by opportunity and snowball sampling. The online survey was later offered to subsequent NHS staff who took part in the online REACH-HF training. Normalisation Process Theory was used as a theoretical framework to guide data collection/analysis. RESULTS: Seventeen healthcare professionals working at the Beacon Sites were interviewed and 17 survey responses were received (20% response rate). The identified barriers and enablers included, among many, a lack of resources/commissioning, having interest in heart failure and working closely with the clinical heart failure team. Different implementation contexts (urban/rural), timing (during the COVID-19 pandemic) and factors outside the healthcare team/system (quality of the REACH-HF training) were observed to negatively or positively impact the implementation process. CONCLUSIONS: The findings are highly relevant to healthcare professionals involved in planning, delivering and commissioning of cardiac rehabilitation for patients with heart failure. The study's main output, a refined version of the REACH-HF Service Delivery Guide, can guide the implementation process (eg, designing new care pathways) and provide practical solutions to overcoming common implementation barriers (eg, through early identification of implementation champions).

White Paper: Open Digital Health - accelerating transparent and scalable health promotion and treatment.

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).

ImpulsePal: The systematic development of a smartphone app to manage food temptations using intervention mapping.

BACKGROUND: Impulsive processes driving eating behaviour can often undermine peoples' attempts to change their behaviour, lose weight and maintain weight loss. AIM: To develop an impulse management intervention to support weight loss in adults. METHODS: Intervention Mapping (IM) was used to systematically develop the "ImpulsePal" intervention. The development involved: (1) a needs assessment including a qualitative study, Patient and Public advisory group and expert group consultations, and a systematic review of impulse management techniques; (2) specification of performance objectives, determinants, and change objectives; (3) selection of intervention strategies (mapping of change techniques to the determinants of change); (4) creation of programme materials; (5) specification of adoption and implementation plans; (6) devising an evaluation plan. RESULTS: Application of the IM Protocol resulted in a smartphone app that could support reductions in unhealthy (energy dense) food consumption, overeating, and alcoholic and sugary drink consumption. ImpulsePal includes inhibition training, mindfulness techniques, implementation intentions (if-then planning), visuospatial loading, use of physical activity for craving management, and context-specific reminders. An "Emergency Button" was also included to provide access to in-the-moment support when temptation is strong. CONCLUSIONS: ImpulsePal is a novel, theory- and evidence-informed, person-centred app that aims to support impulse management for healthier eating. Intervention Mapping facilitated the incorporation of app components that are practical operationalisations of change techniques targeting our specific change objectives and their associated theoretical determinants. Using IM enabled transparency and provided a clear framework for evaluation, and enhances replicability and the potential of the intervention to accomplish the desired outcome of facilitating weight loss through dietary change.

Getting evidence into clinical practice: protocol for evaluation of the implementation of a home-based cardiac rehabilitation programme for patients with heart failure.

INTRODUCTION: Cardiac rehabilitation (CR) improves health-related quality of life and reduces hospital admissions. However, patients with heart failure (HF) often fail to attend centre-based CR programmes. Novel ways of delivering healthcare, such as home-based CR programmes, may improve uptake of CR. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a new, effective and cost-effective home-based CR programme for people with HF. The aim of this prospective mixed-method implementation evaluation study is to assess the implementation of the REACH-HF CR programme in the UK National Health Service (NHS). The specific objectives are to (1) explore NHS staff perceptions of the barriers and facilitators to the implementation of REACH-HF, (2) assess the quality of delivery of the programme in real-life clinical settings, (3) consider the nature of any adaptation(s) made and how they might impact on intervention effectiveness and (4) compare real-world patient outcomes to those seen in a prior clinical trial. METHODS AND ANALYSIS: REACH-HF will be rolled out in four NHS CR centres across the UK. Three healthcare professionals from each site will be trained to deliver the 12-week programme. In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme. Consultations for 48 patients (12 per site) will be audio recorded and scored using an intervention fidelity checklist. Outcomes routinely recorded in the National Audit of Cardiac Rehabilitation will be analysed and compared with outcomes from a recent randomised controlled trial: the Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test). Qualitative research findings will be mapped onto the Normalisation Process Theory framework and presented in the form of a narrative synthesis. Results of the study will inform national roll-out of REACH-HF. ETHICS AND DISSEMINATION: The study (IRAS 261723) has received ethics approval from the South Central (Hampshire B) Research Ethics Committee (19/SC/0304). Written informed consent will be obtained from all health professionals and patients participating in the study. The research team will ensure that the study is conducted in accordance with the Declaration of Helsinki, the Data Protection Act 2018, General Data Protection Regulations and in accordance with the Research Governance Framework for Health and Social Care (2005). Findings will be published in scientific peer-reviewed journals and presented at local, national and international meetings to publicise and explain the research methods and findings to key audiences to facilitate the further uptake of the REACH-HF intervention. TRIAL REGISTRATION: ISRCTN86234930.

Feasibility Randomized Controlled Trial of ImpulsePal: Smartphone App-Based Weight Management Intervention to Reduce Impulsive Eating in Overweight Adults.

BACKGROUND: ImpulsePal is a theory-driven (dual-process), evidence-informed, and person-centered smartphone app intervention designed to help people manage impulsive processes that prompt unhealthy eating to facilitate dietary change and weight loss. OBJECTIVE: The aims of this study were to (1) assess the feasibility of trial procedures for evaluation of the ImpulsePal intervention, (2) estimate standard deviations of outcomes, and (3) assess usability of, and satisfaction with, ImpulsePal. METHODS: We conducted an individually randomized parallel two-arm nonblinded feasibility trial. The eligibility criteria included being aged ≥16 years, having a body mass index of ≥25 kg/m2, and having access to an Android-based device. Weight was measured (as the proposed primary outcome for a full-scale trial) at baseline, 1 month, and 3 months of follow-up. Participants were randomized in a 2:1 allocation ratio to the ImpulsePal intervention or a waiting list control group. A nested action-research study allowed for data-driven refinement of the intervention across 2 cycles of feedback. RESULTS: We screened 179 participants for eligibility, and 58 were randomized to the intervention group and 30 to the control group. Data were available for 74 (84%, 74/88) participants at 1 month and 67 (76%, 67/88) participants at 3 months. The intervention group (n=43) lost 1.03 kg (95% CI 0.33 to 1.74) more than controls (n=26) at 1 month and 1.01 kg (95% CI -0.45 to 2.47) more than controls (n=43 and n=24, respectively) at 3 months. Feedback suggested changes to intervention design were required to (1) improve receipt and understanding of instructions and (2) facilitate further engagement with the app and its strategies. CONCLUSIONS: The evaluation methods and delivery of the ImpulsePal app intervention are feasible, and the trial procedures, measures, and intervention are acceptable and satisfactory to the participants. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 14886370; http://www.isrctn.com/ISRCTN14886370 (Archived by WebCite at http://www.webcitation.org/76WcEpZ51).

Informing the development of online weight management interventions: a qualitative investigation of primary care patient perceptions.

BACKGROUND: The internet is a potentially promising medium for delivering weight loss interventions. The current study sought to explore factors that might influence primary care patients' initial uptake and continued use (up to four-weeks) of such programmes to help inform the development of novel, or refinement of existing, weight management interventions. METHODS: Semi-structured interviews were conducted with 20 patients purposively sampled based on age, gender and BMI from a single rural general practice. The interviews were conducted 4 weeks after recruitment at the general practice and focused on experiences with using one of three freely available weight loss websites. Thematic Analysis was used to analyse the data. RESULTS: Findings suggested that patients were initially motivated to engage with internet-based weight loss programmes by their accessibility and novelty. However, continued use was influenced by substantial facilitators and barriers, such as time and effort involved, reaction to prompts/reminders, and usefulness of information. Facilitation by face-to-face consultations with the GP was reported to be helpful in supporting change. CONCLUSIONS: Although primary care patients may not be ready yet to solely depend on online interventions for weight loss, their willingness to use them shows potential for use alongside face-to-face weight management advice or intervention. Recommendations to minimise barriers to engagement are provided.

Techniques for modifying impulsive processes associated with unhealthy eating: A systematic review.

OBJECTIVE: This systematic review aimed to (a) identify and categorize techniques used to modify or manage impulsive processes associated with unhealthy eating behavior, (b) describe the mechanisms targeted by such techniques, and (c) summarize available evidence on the effectiveness of these techniques. METHOD: Searches of 5 bibliographic databases identified studies, published in English since 1993, that evaluated at least 1 technique to modify impulsive processes affecting eating in adults. Data were systematically extracted on study characteristics, population, study quality, intervention techniques, proposed mechanisms of action, and outcomes. Effectiveness evidence was systematically collated and described without meta-analysis. RESULTS: Ninety-two studies evaluated 17 distinct impulse management techniques. They were categorized according to whether they aimed to (a) modify the strength of impulses or (b) engage the reflective system or other resources in identifying, suppressing, or otherwise managing impulses. Although higher quality evidence is needed to draw definitive conclusions, promising changes in unhealthy food consumption and food cravings were observed for visuospatial loading, physical activity, and if-then planning, typically for up to 1-day follow-up. CONCLUSIONS: A wide range of techniques have been evaluated and some show promise for use in weight management interventions. However, larger-scale, more methodologically robust, community-based studies with longer follow-up times are needed to establish whether such techniques can have a long-term impact on eating patterns. (PsycINFO Database Record