Improving cardiovascular health in patients with an abdominal aortic aneurysm: development of the cardiovascular risk reduction in patients with aneurysms (CRISP) behaviour change intervention.

BACKGROUND: Abdominal aortic aneurysm (AAA) is an important cardiovascular health problem. Ultrasound screening is proven to reduce AAA mortality and programmes have been implemented in some healthcare systems. Those who are identified as having a small AAA in screening enter into a surveillance programme to monitor AAA size. Individuals in AAA surveillance are at elevated risk of cardiovascular events, which is not currently addressed sufficiently. We aimed to develop a simple intervention to reduce cardiovascular risk, which could be embedded in AAA surveillance pathways. METHODS: Intervention mapping methods were used to co-develop the intervention with individuals with AAA, families/carers, and healthcare staff. We identified "targets for change" by synthesising research evidence and international guidelines and consulting with patients, caregivers and health service providers. We conducted a series of workshops to identify barriers to and facilitators of change and used taxonomies of behaviour change theories and techniques to match intervention strategies to each target. Further stakeholder involvement work helped refine the intervention. RESULTS: The developed intervention focusses on assessment and individually tailored discussion of risk factors, exchanging information, building motivation and action planning, followed by review of progress and problem-solving. Workbooks covering physical activity, diet, stress management, alcohol, smoking, blood pressure and mental health are provided to support behaviour change. The intervention is facilitated by trained healthcare professionals during the patient's AAA screening appointment for the duration that they are in surveillance. DISCUSSION: The developed intervention will now be tested to assess whether it can be integrated with the current AAA screening programme. The developed intervention is a novel approach to reducing cardiovascular disease in the AAA population, it is also the first intervention which tries to do this in this population. TRIAL REGISTRATION: International Clinical Trial Registration: ISRCTN93993995.

Improving balance in community-dwelling elders using trained volunteers within faith-based institutions: a mixed methods feasibility study.

PURPOSE: To investigate the feasibility and acceptability of a volunteer-led balance programme for older adults. METHODS: A feasibility cluster RCT with focus groups were conducted in faith-based institutions. Eligibility criteria were: participants were ≥65 years, able to do five times sit -to-stand, had no falls in the previous six months and had good mental capacity. The intervention included supervised group exercises and exercise booklets for six months, education and a fall poster. Assessments included, TUG, MCTSiB, FTST, FES, mABC, OPQoL and DGLS at baseline, 6 weeks, and 6 months. Feasibility measures included numbers of volunteers, sessions, and volunteers" time commitment, views of participants about sustainability of program using qualitative focus groups and volunteers' ability to deliver programme. RESULTS: Three churches participated with 31 participants in each group. Participants had a mean age of 77.3 years, were 100% British, and 79% female. The sample size estimate for a future trial using TUG, was 79 per group. Focus groups showed perceived social and physical improvements in participants, need to extend the programme to the wider community, and increased confidence, participation and socialisation. CONCLUSION: The community-based balance training in faith-based institutions, was feasible and acceptable in one geographical area and requires evaluation in cohesive diverse communities.Implications for RehabilitationIf an institution or a community is united through faith, culture, national roots, or tradition, then these groups are ideal for such balance rehabilitation programmes, because of the familiarity of the location and people, cohesive culture or their ideology to help their communities.Participants and volunteers perceived improved participation, confidence and socialisation and were keen to continue programme.It is important to develop community-based falls prevention programmes that the National Health Service (NHS) can partially support using volunteers to reduce the burden of falls in the community and for the NHS.

"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.

The REtirement in ACTion exercise programme and its effects on elements of long term functionality in older adults.

Background: The prevention of mobility-related disability amongst adults is a global healthcare priority. Cost-effective community-based strategies to improve physical function and independence in older adults with mobility limitations are needed. This study investigated the effectiveness of the REtirement in ACTion (REACT) exercise intervention on individual markers of physical function at 6-and 12-months. Methods: The REACT multicentre randomised controlled trial assigned 777 older adults (female, 514; male 263) (mean age 77·6 [SD 6·8] years) with reduced lower limb physical functioning (Short Physical Performance Battery [SPPB] score 4-9) to receive brief healthy ageing advice or a 12-month, group-based, multimodal exercise programme delivered in local communities. Estimated differences in the three individual component scores of the SPPB (strength, balance, gait speed) and physical functional outcomes recorded at 6- and 12-months were assessed. Results: The intervention group demonstrated significant improvements in strength (OR = 1.88, 95% CI = 1.36-2.59, p < 0.001) and balance (OR = 1.96, 95% CI = 1.39-2.67, p < 0.001) at 12-months, but not in gait speed (OR = 1.32, 95% CI = 0.91-1.90, p = 0.139). In comparison to the control group, at six-and 12-months, the intervention group reported statistically significant improvements in Mobility Assessment Tool-Short Form (MAT-SF), physical component score from SF-36 questionnaire, and strength and endurance items of subjectively reported physical activity (PASE 10-item). Greater than 75% adherence (attending ≥48 of the 64 exercise sessions delivered in 12-months) was associated with superior functional outcomes. Conclusion: The REACT exercise programme provides local, regional and national service providers with an effective solution to increase muscle strength and balance in older adults at risk of mobility disability.

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.

Preventing type 2 diabetes: A research agenda for behavioural science.

AIMS: The aim of this narrative review was to identify important knowledge gaps in behavioural science relating to type 2 diabetes prevention, to inform future research in the field. METHODS: Seven researchers who have published behaviour science research applied to type 2 diabetes prevention independently identified several important gaps in knowledge. They met to discuss these and to generate recommendations to advance research in behavioural science of type 2 diabetes prevention. RESULTS: A total of 21 overlapping recommendations for a research agenda were identified. These covered issues within the following broad categories: (a) evidencing the impact of whole population approaches to type 2 diabetes prevention, (b) understanding the utility of disease-specific approaches to type 2 diabetes prevention such as Diabetes Prevention Programmes (DPPs) compared to generic weight loss programmes, (c) identifying how best to increase reach and engagement of DPPs, whilst avoiding exacerbating inequalities, (d) the need to understand mechanism of DPPs, (e) the need to understand how to increase maintenance of changes as part of or following DPPs, (f) the need to assess the feasibility and effectiveness of alternative approaches to the typical self-regulation approaches that are most commonly used, and (g) the need to address emotional aspects of DPPs, to promote effectiveness and avoid harms. CONCLUSIONS: There is a clear role for behavioural science in informing interventions to prevent people from developing type 2 diabetes, based on strong evidence of reach, effectiveness and cost-effectiveness. This review identifies key priorities for research needed to improve existing interventions.

Development of a Mobile Health Snacktivity App to Promote Physical Activity in Inactive Adults (SnackApp): Intervention Mapping and User Testing Study.

BACKGROUND: Despite the unequivocal evidence demonstrating the benefits of being physically active, many people do not meet the recommended guidelines of at least 150 minutes of moderate- to vigorous-intensity physical activity per week. This can be changed with the development and implementation of innovative interventions. The use of mobile health (mHealth) technologies has been suggested as a mechanism to offer people innovative health behavior change interventions. OBJECTIVE: This study aims to outline the systematic, theory-driven processes and user testing applied to the development of a smartphone-based physical activity app (SnackApp) to promote participation in a novel physical activity intervention called Snacktivity. The acceptability of the app was explored and reported. METHODS: Intervention mapping involves a 6-step process, the first 4 of which were presented in this study. These steps were used to develop the SnackApp for use within the Snacktivity intervention. The first step involved a needs assessment, which included composing an expert planning group, patient and public involvement group, and gathering the views of the public on Snacktivity and the public perception of the use of wearable technology to support Snacktivity. This first step aimed to determine the overall purpose of the Snacktivity intervention. Steps 2 to 4 involved determining the intervention objectives, the behavior change theory and techniques on which the intervention is based, and the development of the intervention resources (ie, SnackApp). After the completion of steps 1 to 3 of the intervention mapping process, the SnackApp was developed and linked to a commercial physical activity tracker (Fitbit Versa Lite) for the automated capture of physical activity. SnackApp includes provisions for goal setting, activity planning, and social support. Stage 4 involved users (inactive adults, N=15) testing the SnackApp for 28 days. App engagement (mobile app use analytics) was analyzed to determine app use and to inform the further development of SnackApp. RESULTS: Over the study period (step 4), participants engaged with SnackApp an average of 77 (SD 80) times. On average, participants used the SnackApp for 12.6 (SD 47) minutes per week, with most of the time spent on the SnackApp dashboard and engaging, on average, 14 (SD 12.1) times, lasting 7 to 8 minutes per week. Overall, male participants used the SnackApp more than female participants did. The app rating score was 3.5 (SD 0.6) out of 5, suggesting that SnackApp was rated as fair to good. CONCLUSIONS: This study outlines and reports data regarding the development of an innovative mHealth app using a systematic, theory-driven framework. This approach can guide the development of future mHealth programs. User testing of the SnackApp suggested that physically inactive adults will engage with the SnackApp, indicating its applicability of use in the Snacktivity physical activity intervention.

Motivational support intervention to reduce smoking and increase physical activity in smokers not ready to quit: the TARS RCT.

Background: Physical activity can support smoking cessation for smokers wanting to quit, but there have been no studies on supporting smokers wanting only to reduce. More broadly, the effect of motivational support for such smokers is unclear. Objectives: The objectives were to determine if motivational support to increase physical activity and reduce smoking for smokers not wanting to immediately quit helps reduce smoking and increase abstinence and physical activity, and to determine if this intervention is cost-effective. Design: This was a multicentred, two-arm, parallel-group, randomised (1 : 1) controlled superiority trial with accompanying trial-based and model-based economic evaluations, and a process evaluation. Setting and participants: Participants from health and other community settings in four English cities received either the intervention (n = 457) or usual support (n = 458). Intervention: The intervention consisted of up to eight face-to-face or telephone behavioural support sessions to reduce smoking and increase physical activity. Main outcome measures: The main outcome measures were carbon monoxide-verified 6- and 12-month floating prolonged abstinence (primary outcome), self-reported number of cigarettes smoked per day, number of quit attempts and carbon monoxide-verified abstinence at 3 and 9 months. Furthermore, self-reported (3 and 9 months) and accelerometer-recorded (3 months) physical activity data were gathered. Process items, intervention costs and cost-effectiveness were also assessed. Results: The average age of the sample was 49.8 years, and participants were predominantly from areas with socioeconomic deprivation and were moderately heavy smokers. The intervention was delivered with good fidelity. Few participants achieved carbon monoxide-verified 6-month prolonged abstinence [nine (2.0%) in the intervention group and four (0.9%) in the control group; adjusted odds ratio 2.30 (95% confidence interval 0.70 to 7.56)] or 12-month prolonged abstinence [six (1.3%) in the intervention group and one (0.2%) in the control group; adjusted odds ratio 6.33 (95% confidence interval 0.76 to 53.10)]. At 3 months, the intervention participants smoked fewer cigarettes than the control participants (21.1 vs. 26.8 per day). Intervention participants were more likely to reduce cigarettes by ≥ 50% by 3 months [18.9% vs. 10.5%; adjusted odds ratio 1.98 (95% confidence interval 1.35 to 2.90] and 9 months [14.4% vs. 10.0%; adjusted odds ratio 1.52 (95% confidence interval 1.01 to 2.29)], and reported more moderate-to-vigorous physical activity at 3 months [adjusted weekly mean difference of 81.61 minutes (95% confidence interval 28.75 to 134.47 minutes)], but not at 9 months. Increased physical activity did not mediate intervention effects on smoking. The intervention positively influenced most smoking and physical activity beliefs, with some intervention effects mediating changes in smoking and physical activity outcomes. The average intervention cost was estimated to be £239.18 per person, with an overall additional cost of £173.50 (95% confidence interval -£353.82 to £513.77) when considering intervention and health-care costs. The 1.1% absolute between-group difference in carbon monoxide-verified 6-month prolonged abstinence provided a small gain in lifetime quality-adjusted life-years (0.006), and a minimal saving in lifetime health-care costs (net saving £236). Conclusions: There was no evidence that behavioural support for smoking reduction and increased physical activity led to meaningful increases in prolonged abstinence among smokers with no immediate plans to quit smoking. The intervention is not cost-effective. Limitations: Prolonged abstinence rates were much lower than expected, meaning that the trial was underpowered to provide confidence that the intervention doubled prolonged abstinence. Future work: Further research should explore the effects of the present intervention to support smokers who want to reduce prior to quitting, and/or extend the support available for prolonged reduction and abstinence. Trial registration: This trial is registered as ISRCTN47776579. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 4. See the NIHR Journals Library website for further project information.

NHS pharmacological and behavioural support helps smokers wanting to quit, and physical activity may also help. It is unclear if behavioural support for those not ready to quit may lead to more quit attempts and abstinence from smoking. A total of 915 smokers who wanted to reduce their smoking, but who had not yet quit, were recruited and randomised to receive an intervention or brief support as usual (brief advice to quit), in Plymouth, London, Oxford and Nottingham. The intervention involved up to eight sessions (by telephone or in person) of motivational support to reduce smoking and increase physical activity (and more sessions to support a quit attempt). Participants self-reported smoking and physical activity information at the start of the trial and after 3 and 9 months. Self-reported quitters confirmed their abstinence with a biochemical test of expired air or saliva. Our main interest was in whether or not the groups differed in the proportion who remained abstinent for at least 6 months. Overall, only 1­2% remained abstinent for 6 months. Although it appeared that a greater proportion did so after receiving the intervention, because few participants were abstinent, the results are not conclusive. However, the intervention had beneficial effects on less rigorous outcomes, including a reduction in the self-reported number of cigarettes smoked, and a greater proportion of intervention than control participants with self-reported and biochemically verified abstinence at 3 months. The intervention also helped participants to reduce, by at least half, the number of cigarettes they smoked at 3 and 9 months, and to report more physical activity, but only at 3 months. Despite reasonable intervention engagement and some short-term changes in smoking and physical activity, the trial does not provide evidence that this intervention would help smokers to quit for at least 6 months nor would it be cost-effective, with an average cost of £239 per smoker.

Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS).

AIMS: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. DESIGN: A multi-centred pragmatic two-arm parallel randomised controlled trial. SETTING: Primary care and the community across four United Kingdom sites. PARTICIPANTS: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. INTERVENTIONS: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. MEASUREMENTS: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. FINDINGS: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. CONCLUSIONS: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.

Intervention fidelity assessment: A sub-study of the Norfolk Diabetes Prevention Study (NDPS).

BACKGROUND: Previous research has shown that lifestyle modification can delay or prevent the onset of type 2 diabetes in high-risk individuals. The Norfolk Diabetes Prevention Study (NDPS) was a parallel, three-arm, randomized controlled trial with up to 46 months follow-up that tested a group-delivered, theory-based lifestyle intervention to reduce the incidence of type 2 diabetes in high-risk groups. The current study aimed to evaluate if the NDPS intervention was delivered to an acceptable standard and if any part(s) of the delivery required improvement. METHODS: A sub-sample of 30, 25 for inter-rater reliability and audio-recordings of the NDPS intervention education sessions were assessed independently by two reviewers (CT, TW) using a 12-item checklist. Each item was scored on a 0-5 scale, with a score of 3 being defined as 'adequate delivery'. Inter-rater reliability was assessed. Analysis of covariance (ANCOVA) was used to assess changes in intervention fidelity as the facilitators gained experience. RESULTS: Inter-rater agreement was acceptable (86%). A mean score of 3.47 (SD = .38) was achieved across all items of the fidelity checklist and across all intervention facilitators (n = 6). There was an apparent trend for intervention fidelity scores to decrease with experience; however, this trend was non-significant (p > .05) across all domains in this small sample. CONCLUSION: The NDPS was delivered to an acceptable standard by all Diabetes Prevention Facilitators. Further research is needed to better understand how the intervention's delivery characteristics can be optimized and how they might vary over time.

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).

Delivery fidelity of the REACT (REtirement in ACTion) physical activity and behaviour maintenance intervention for community dwelling older people with mobility limitations.

BACKGROUND: Fidelity assessment of behaviour change interventions is vital to understanding trial outcomes. This study assesses the delivery fidelity of behaviour change techniques used in the Retirement in ACTion (REACT) randomised controlled trial. REACT is a community-based physical activity (PA) and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years) at high risk of mobility-related disability in the UK. METHODS: The delivery fidelity of intervention behaviour change techniques and delivery processes were assessed using multi-observer coding of purposively sampled in-vivo audio recordings (n = 25) of health behaviour maintenance sessions over 12-months. Delivery fidelity was scored using a modified Dreyfus scale (scores 0-5) to assess competence and completeness of delivery for each technique and delivery process. "Competent delivery" was defined as a score of 3 points or more for each item. Examples of competent intervention delivery were identified to inform recommendations for future programme delivery and training. RESULTS: The mean intervention fidelity score was 2.5 (SD 0.45) with delivery fidelity varying between techniques/processes and intervention groups. Person-centred delivery, Facilitating Enjoyment and Promoting Autonomy were delivered competently (scoring 3.0 or more). There was scope for improvement (score 2.0-2.9) in Monitoring Progress (Acknowledging and Reviewing), Self-Monitoring, Monitoring Progress (Eliciting Benefits of Physical Activity), Goal Setting and Action Planning, Modelling, Supporting Self-Efficacy for Physical Activity and Supporting Relatedness. Managing Setbacks and Problem Solving was delivered with low fidelity. Numerous examples of both good and sub-optimal practice were identified. CONCLUSIONS: This study highlights successes and improvements needed to enhance delivery fidelity in future implementation of the behavioural maintenance programme of the REACT intervention. Future training of REACT session leaders and assessment of delivery fidelity needs to focus on the delivery of Goal setting and Action Planning, Modelling, Supporting Relatedness, Supporting Self-Efficacy for Physical Activity, and Managing Setbacks/ Problem Solving.

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.

Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial.

BACKGROUND: Mobility limitations in older populations have a substantial impact on health outcomes, quality of life, and social care costs. The Retirement in Action (REACT) randomised controlled trial assessed a 12-month community-based group physical activity and behaviour maintenance intervention to help prevent decline in physical functioning in older adults at increased risk of mobility limitation. We aimed to do an economic evaluation of the REACT trial to investigate whether the intervention is cost-effective. METHODS: In this health economic evaluation, we did cost-effectiveness and cost-utility analyses of the REACT programme versus standard care on the basis of resource use, primary outcome, and health-related quality-of-life data measured in the REACT trial. We also developed a decision analytic Markov model that forecasts the mobility of recipients beyond the 24-month follow-up of the trial and translated this into future costs and potential benefit to health-related quality of life using the National Health Service and Personal Social Services perspective. Participants completed questionnaire booklets at baseline, and at 6, 12, and 24 months after randomisation, which included a resource use questionnaire and the EQ-5D-5L and 36-item short-form survey (SF-36) health-related quality-of-life instruments. The cost of delivering the intervention was estimated by identifying key resources, such as REACT session leader time, time of an individual to coordinate the programme, and venue hire. EQ-5D-5L and SF-36 responses were converted to preference-based utility values, which were used to estimate quality-adjusted life-years (QALYs) over the 24-month trial follow-up using the area-under-the-curve method. We used generalised linear models to examine the effect of the REACT programme on costs and QALYs and adjust for baseline covariates. Costs and QALYs beyond 12 months were discounted at 3·5% per year. This is a pre-planned analysis of the REACT trial; the trial itself is registered with ISRCTN (ISRCTN45627165). FINDINGS: The 12-month REACT programme was estimated to cost £622 per recipient to deliver. The most substantial cost components are the REACT session leader time (£309 per participant), venue hire (£109), and the REACT coordinator time (£80). The base-case analysis of the trial-based economic evaluation showed that reductions in health and social care usage due to the REACT programme could offset the REACT delivery costs (£3943 in the intervention group vs £4043 in the control group; difference: -£103 [95% CI -£695 to £489]) with a health benefit of 0·04 QALYs (0·009-0·071; 1·354 QALYs in the intervention group vs 1·314 QALYs in the control group) within the 24-month timeframe of the trial. INTERPRETATION: The REACT programme could be considered a cost-effective approach for improving the health-related quality of life of older adults at risk of mobility limitations. FUNDING: National Institute for Health Research Public Health Research Programme.

Effect of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: the REACT (Retirement in Action) randomised controlled trial.

BACKGROUND: Mobility limitations in old age can greatly reduce quality of life, generate substantial health and social care costs, and increase mortality. Through the Retirement in Action (REACT) trial, we aimed to establish whether a community-based active ageing intervention could prevent decline in lower limb physical functioning in older adults already at increased risk of mobility limitation. METHODS: In this pragmatic, multicentre, two-arm, single-blind, parallel-group, randomised, controlled trial, we recruited older adults (aged 65 years or older and who are not in full-time employment) with reduced lower limb physical functioning (Short Physical Performance Battery [SPPB] score 4-9) from 35 primary care practices across three sites (Bristol and Bath; Birmingham; and Devon) in England. Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal physical activity (64 1-h exercise sessions) and behavioural maintenance (21 45-min sessions) programme delivered by charity and community or leisure centre staff in local communities. Randomisation was stratified by site and adopted a minimisation approach to balance groups by age, sex, and SPPB score, using a centralised, online, randomisation algorithm. Researchers involved in data collection and analysis were masked but participants were not because of the nature of the intervention. The primary outcome was change in SPPB score at 24 months, analysed by intention to treat. This trial is registered with ISRCTN, ISRCTN45627165. FINDINGS: Between June 20, 2016, and Oct 30, 2017, 777 participants (mean age 77·6 [SD 6·8] years; 66% female; mean SPPB score 7·37 [1·56]) were randomly assigned to the intervention (n=410) and control (n=367) groups. Primary outcome data at 24 months were provided by 628 (81%) participants (294 in the control group and 334 in the intervention group). At the 24-month follow-up, the SPPB score (adjusted for baseline SPPB score, age, sex, study site, and exercise group) was significantly greater in the intervention group (mean 8·08 [SD 2·87]) than in the control group (mean 7·59 [2·61]), with an adjusted mean difference of 0·49 (95% CI 0·06-0·92; p=0·014), which is just below our predefined clinically meaningful difference of 0·50. One adverse event was related to the intervention; the most common unrelated adverse events were heart conditions, strokes, and falls. INTERPRETATION: For older adults at risk of mobility limitations, the REACT intervention showed that a 12-month physical activity and behavioural maintenance programme could help prevent decline in physical function over a 24-month period. FUNDING: National Institute for Health Research Public Health Research Programme (13/164/51).

Quantity and specificity of action-plans as predictors of weight loss: analysis of data from the Norfolk Diabetes Prevention Study (NDPS).

OBJECTIVE: Investigate associations between quantity, content and specificity of action-plans and weight loss in a diabetes prevention study. DESIGN: Prospective cohort study nested within a randomised controlled trial. Participants completed action-planning worksheets during intervention sessions. MAIN OUTCOME MEASURES: Action-plans were coded in terms of: number of plans set, their content, and specificity. Multivariate regression analyses assessed associations with weight loss at four-months. RESULTS: 890 planning-worksheets from 106 participants were analysed. Participants wrote a mean of 2.12 (SD = 1.20) action-plans per worksheet, using a mean of 2.20 (SD = 0.68) specificity components per action-plan. Quantity of action-plans per worksheet decreased over time (r = -0.137, p < 0.001) and increased quantity was associated with reduced specificity [r = -.215, p < 0.001]. Walking (34.9% of action-plans) and reducing high fat/sugar snacks (26.1%) were the most commonly planned lifestyle actions. In multivariate modelling, increased quantity of action-plans was associated with greater weight loss (R2 = 0.135, Unstandardised Beta = 0.144, p = 0.002). Specificity was not significantly associated with weight-loss (p = 0.096). CONCLUSION: Producing more action-plans was associated with greater weight loss. Further research should directly compare more versus less specific action-plans and explore ways to sustain engagement in action-planning. Our findings imply that participants should freely set numerous action-plans, rather than being encouraged to focus on specificity.Supplemental data for this article is available online at https://doi.org/10.1080/08870446.2022.2055026 .

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial.

BACKGROUND: There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. METHODS: A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. DISCUSSION: This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ANZCTR ) Registration date: 10/12/2018.

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.

A systematic review of provider-and system-level factors influencing the delivery of cardiac rehabilitation for heart failure.

BACKGROUND: There is a longstanding research-to-practice gap in the delivery of cardiac rehabilitation for patients with heart failure. Despite adequate evidence confirming that comprehensive cardiac rehabilitation can improve quality of life and decrease morbidity and mortality in heart failure patients, only a fraction of eligible patients receives it. Many studies and reviews have identified patient-level barriers that might contribute to this disparity, yet little is known about provider- and system-level influences. METHODS: A systematic review using narrative synthesis. The aims of the systematic review were to a) determine provider- and system-level barriers and enablers that affect the delivery of cardiac rehabilitation for heart failure and b) juxtapose identified barriers with possible solutions reported in the literature. A comprehensive search strategy was applied to the MEDLINE, Embase, PsycINFO, CINAHL Plus, EThoS and ProQuest databases. Articles were included if they were empirical, peer-reviewed, conducted in any setting, using any study design and describing factors influencing the delivery of cardiac rehabilitation for heart failure patients. Data were synthesised using inductive thematic analysis and a triangulation protocol to identify convergence/contradiction between different data sources. RESULTS: Seven eligible studies were identified. Thematic analysis identified nine overarching categories of barriers and enablers which were classified into 24 and 26 themes respectively. The most prevalent categories were 'the organisation of healthcare system', 'the organisation of cardiac rehabilitation programmes', 'healthcare professional' factors and 'guidelines'. The most frequent themes included 'lack of resources: time, staff, facilities and equipment' and 'professional's knowledge, awareness and attitude'. CONCLUSIONS: Our systematic review identified a wide range of provider- and system-level barriers impacting the delivery of cardiac rehabilitation for heart failure, along with a range of potential solutions. This information may be useful for healthcare professionals to deliver, plan or commission cardiac rehabilitation services, as well as future research.

A novel method for assessing design fidelity in web-based behavioral interventions.

OBJECTIVE: Delivery is one of the most common ways of assessing fidelity in behavioral interventions. However, there is a lack of research reporting on how well an intervention protocol reflects its proposed theoretical principles (design fidelity). This study presents a systematic method for assessing design fidelity and applies it to the eMotion web-based intervention targeting physical activity and depression. METHOD: The eMotion intervention comprises of 13 web-based modules, designed according to an underlying intervention map. An independent rater with expertise in behavior change coded the presence or absence of behavior change techniques (BCTs) in the content of eMotion. Results of coding were compared to the intervention designers' a priori specification for interrater reliability. RESULTS: After discussion, the independent rater and the intervention designer had a high agreement for the presence of BCTs relating to behavioral activation (AC1 = 0.91) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). There was also high agreement for the presence of BCTs targeting physical activity (AC1 = 0.88) with "demonstration of behavior" and "monitoring of emotional consequences" having the lowest agreement (AC1 < 0.4). The eMotion description was then amended to align the interrater agreement. CONCLUSIONS: This study presents a novel method for assessing design fidelity. Developers of behavioral (and other multicomponent) interventions are encouraged to develop and refine this method and assess design fidelity in future interventions to ensure BCTs are operationalized as intended. (PsycInfo Database Record (c) 2021 APA, all rights reserved).