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.

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.

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 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.

Systematic review of the effect of training interventions on the skills of health professionals in promoting health behaviour, with meta-analysis of subsequent effects on patient health behaviours.

BACKGROUND: We aimed to identify, synthesise and evaluate randomised control trial evidence on the effects of healthcare professional training on the delivery quality of health behaviour change interventions and, subsequently, on patient health behaviours. METHODS: Systematic review with narrative synthesis of effects on delivery quality and meta-analysis of health behaviour outcomes. We searched: Medline, EMBASE, PsychInfo, AMED, CINAHL Plus and the Cochrane Central Register of Control Trials up to March 2019. Studies were included if they were in English and included intervention delivery quality as an outcome. The systematic review was registered on PROSPERO (registration: CRD42019124502). RESULTS: Twelve-studies were identified as suitable for inclusion. All studies were judged as being high risk of bias with respect to training quality outcomes. However with respect to behavioural outcomes, only two of the six studies included in the meta-analysis had a high risk and four had some concerns. Educational elements (e.g. presentations) were used in all studies and nine included additional practical learning tasks. In eight studies reporting delivery quality, 54% of healthcare professional communication outcomes and 55% of content delivery outcomes improved in the intervention arm compared to controls. Training that included both educational and practical elements tended to be more effective. Meta-analysis of patient health behavioural outcomes in six-studies found significant improvements (Standardised mean difference (SMD): 0.20, 95% confidence interval: 0.11 to 0.28, P < 0.0001, I2 = 0%). No significant difference was found between short (≤6-months) and long-term (> 6-months) outcomes (SMD: 0.25 vs 0.15; P = 0.31). CONCLUSIONS: Delivery quality of health behaviour change interventions appears to improve following training and consequently to improve health behaviours. Future studies should develop more concise /integrated measures of delivery quality and develop optimal methods of training delivery.

A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study.

BACKGROUND: Osteoarthritis is a prevalent condition in older adults that causes many patients to require a hip or knee replacement. Reducing patients' sedentariness prior to surgery may improve physical function and post-operative outcomes. METHODS: We conducted a pragmatic randomised-controlled feasibility study with 2:1 allocation into intervention or usual care groups. The intervention, based on Self-Determination Theory, involved techniques to reduce sedentary behaviour, including motivational interviewing, setting of behavioural goals, and more. The primary outcome was feasibility, assessed using mixed methods. We included exploratory measures to inform a future definitive trial, such as ActivPal3 accelerometry to measure movement, the Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers. Assessments were at baseline, 1-week pre-surgery, and 6-week post-surgery. RESULTS: We recruited 35 participants aged ≥ 60 years approximately 8 weeks before hip or knee arthroplasty. Participant uptake rate was 14.2%, and retention rate 85.7%. Participants were very satisfied with the study which was found to be feasible with some modifications. Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d-1. CONCLUSION: In this older surgical population, it is feasible to use behavioural techniques to displace sedentary time to activity and to conduct a trial spanning the period of surgical intervention. This may improve physical function and surgical outcomes. The INTEREST intervention is now ready for evaluation in a full-scale randomised-controlled trial. REGISTRATION: This trial was registered on Clinicaltrials.gov on 13/11/2018. ID: NCT03740412.

The community-based prevention of diabetes (ComPoD) study: a randomised, waiting list controlled trial of a voluntary sector-led diabetes prevention programme.

OBJECTIVE: This two-site randomised trial compared the effectiveness of a voluntary sector-led, community-based diabetes prevention programme to a waiting-list control group at 6 months, and included an observational follow-up of the intervention arm to 12 months. METHODS: Adults aged 18-75 years at increased risk of developing type 2 diabetes due to elevated blood glucose and being overweight were recruited from primary care practices at two UK sites, with data collected in participants' homes or community venues. Participants were randomised using an online central allocation service. The intervention, comprising the prototype "Living Well, Taking Control" (LWTC) programme, involved four weekly two-hour group sessions held in local community venues to promote changes in diet and physical activity, plus planned follow-up contacts at two, three, six, nine and 12 months alongside 5 hours of additional activities/classes. Waiting list controls received usual care for 6 months before accessing the programme. The primary outcome was weight loss at 6 months. Secondary outcomes included glycated haemoglobin (HbA1c), blood pressure, physical activity, diet, health status and well-being. Only researchers conducting analyses were blinded. RESULTS: The target sample of 314 participants (157 each arm) was largely representative of local populations, including 44% men, 26% from ethnic minorities and 33% living in deprived areas. Primary outcome data were available for 285 (91%) participants (141 intervention, 144 control). Between baseline and 6 months, intervention participants on average lost more weight than controls (- 1.7 kg, 95% CI - 2.59 to - 0.85). Higher attendance was associated with greater weight loss (- 3.0 kg, 95% CI - 4.5 to - 1.5). The prototype LWTC programme more than doubled the proportion of participants losing > 5% of their body weight (21% intervention vs. 8% control, OR 2.83, 95% CI 1.36 to 5.90) and improved self-reported dietary behaviour and health status. There were no impacts on HbA1c, blood pressure, physical activity and well-being at 6 months and, amongst intervention participants, few further changes from six to 12-months (e.g. average weight re-gain 0.36 kg, 95% CI - 0.20 to 0.91). There were no serious adverse events but four exercise-related injuries were reported in the intervention arm. CONCLUSIONS: This voluntary sector-led diabetes prevention programme reached a broad spectrum of the population and had modest effects on weight-related outcomes, but limited impacts on other diabetes risk factors. TRIAL REGISTRATION: Trial registration number: ISRCTN70221670, 5 September 2014 Funder (National Institute for Health Research School for Public Health Research) project reference number: SPHR-EXE-PES-COM.

Web-Based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression (The eMotion Study): Pilot Randomized Controlled Trial.

BACKGROUND: Physical activity is a potentially effective treatment for depression and depressive relapse. However, promoting physical activity in people with depression is challenging. Interventions informed by theory and evidence are therefore needed to support people with depression to become more physically active. eMotion is a Web-based intervention combining behavioral activation and physical activity promotion for people in the community with symptoms of depression. OBJECTIVE: The objectives were to assess the feasibility and acceptability of delivering eMotion to people in the community with symptoms of depression and to explore outcomes. METHODS: Participants with elevated depressive symptoms were recruited from the community through various methods (eg, social media) and randomized to eMotion or a waiting list control group for 8 weeks. eMotion is an administratively supported weekly modular program that helps people use key behavior change techniques (eg, graded tasks, action planning, and self-monitoring) to re-engage in routine, pleasurable, and necessary activities, with a focus on physical activities. Feasibility data were collected that included the following: recruitment and trial retention rates; fidelity of intervention delivery, receipt, and enactment; and acceptability of the intervention and data collection procedures. Data were collected for the primary (depression) and secondary outcomes (eg, anxiety, physical activity, fidelity, and client satisfaction) at baseline and 2 months postrandomization using self-reported Web-based questionnaires and accelerometers. Delivery fidelity (logins, modules accessed, time spent) was tracked using Web usage statistics. Exploratory analyses were conducted on the primary and secondary outcomes. RESULTS: Of the 183 people who contacted the research team, 62 were recruited and randomized. The mean baseline score was 14.6 (SD 3.2) on the 8-item Patient Health Questionnaire depression scale (PHQ-8). Of those randomized, 52 participants provided accelerometer-recorded physical activity data at baseline that showed a median of 35.8 (interquartile range [IQR] 0.0-98.6) minutes of moderate-to-vigorous physical activity (MVPA) recorded in at least 10-minute bouts per week, with only 13% (7/52) people achieving guideline levels (150 minutes of MVPA per week). In total, 81% (50/62) of participants provided follow-up data for the primary outcome (PHQ-8), but only 39% (24/62) provided follow-up accelerometer data. Within the intervention group, the median number of logins, modules accessed, and total minutes spent on eMotion was 3 (IQR 2.0-8.0), 3 (IQR 2.0-5.0), and 41.3 (IQR 18.9-90.4), respectively. Acceptability was mixed. Exploratory data analysis showed that PHQ-8 levels were lower for the intervention group than for the control group at 2 months postrandomization (adjusted mean difference -3.6, 95% CI -6.1 to -1.1). CONCLUSIONS: It was feasible to deliver eMotion in UK communities to inactive populations. eMotion has the potential to be effective and is ready for testing in a full-scale trial. Further work is needed to improve engagement with both the intervention and data collection procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT03084055; https://clinicaltrials.gov/ct2/show/NCT03084055 (Archived by WebCite at http://www.webcitation.org/6zoyM8UXa).

Assessment of fidelity in individual level behaviour change interventions promoting physical activity among adults: a systematic review.

BACKGROUND: Behaviour change interventions that promote physical activity have major implications for health and well-being. Measuring intervention fidelity is crucial in determining the extent to which an intervention is delivered as intended, therefore increasing scientific confidence about effectiveness. However, we lack a clear overview of how well intervention fidelity is typically assessed in physical activity trials. METHODS: A systematic literature search was conducted to identify peer - reviewed physical activity promotion trials that explicitly measured intervention fidelity. Methods used to assess intervention fidelity were categorised, narratively synthesised and critiqued using assessment criteria from NIH Behaviour Change Consortium (BCC) Treatment Fidelity Framework (design, training, delivery, receipt and enactment). RESULTS: Twenty eight articles reporting of twenty one studies used a wide variety of approaches to measure intervention fidelity. Delivery was the most common domain of intervention fidelity measured. Approaches used to measure fidelity across all domains varied from researcher coding of observational data (using checklists or scales) to participant self-report measures. There was considerable heterogeneity of methodological approaches to data collection with respect to instruments used, attention to psychometric properties, rater-selection, observational method and sampling strategies. CONCLUSIONS: In the field of physical activity interventions, fidelity measurement is highly heterogeneous both conceptually and methodologically. Clearer articulation of the core domains of intervention fidelity, along with appropriate measurement approaches for each domain are needed to improve the methodological quality of fidelity assessment in physical activity interventions. Recommendations are provided on how this situation can be improved.

An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

INTRODUCTION: Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. METHODS: Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. RESULTS: Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. CONCLUSIONS: A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity.

A checklist to improve reporting of group-based behaviour-change interventions.

BACKGROUND: Published descriptions of group-based behaviour-change interventions (GB-BCIs) often omit design and delivery features specific to the group setting. This impedes the ability to compare behaviour-change interventions, synthesise evidence on their effectiveness and replicate effective interventions. The aim of this study was to develop a checklist of elements that should be described to ensure adequate reporting of GB-BCIs. METHODS: A range of characteristics needed to replicate GB-BCIs were extracted from the literature and precisely defined. An abbreviated checklist and a coder manual were developed, pilot tested and refined. The final checklist and coder manual were used to identify the presence or absence of specified reporting elements in 30 published descriptions of GB-BCIs by two independent coders. Reliability of coding was assessed. RESULTS: The checklist comprises 26 essential reporting elements, covering intervention design, intervention content, participant characteristics, and facilitator characteristics. Inter-rater reliability for identification of reporting elements was high (95% agreement, Mean AC1 = 0.89). CONCLUSION: The checklist is a practical tool that can be used, alongside other reporting guidelines, to ensure comprehensive description and to assess reporting quality of GB-BCIs. It can also be helpful for designing group-based health interventions.

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.

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.

Processes of change in an asthma self-care intervention.

In this article, we present a qualitative exploration of the psychological and communication processes that occur within an intervention to improve self-care for people with asthma. In the context of a primary-care-based trial of the intervention, we collected data at three time points for 21 patients, comprising 2 audiotaped consultations (nurse and patient together) and individual semistructured interviews 3 months after the second consultation. Using framework analysis, we identified both psychological processes (illness understanding, affective response to asthma, and reasoned motivation) and patient-provider interactions (active patient involvement and individual tailoring). We use these findings to extend and refine the pre-existing theoretical model of behavior change underpinning the intervention, in particular with relation to patient-provider interaction processes. We conclude that it is important for developers and providers of asthma self-care interventions to attend to the style of delivery as well as the behavior change techniques involved.

"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.

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.

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.

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.

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.