Designing, delivering, and evaluating novel interventions to support dietary change for weight management

Background: Recent empirical research and theoretical models acknowledge that impulsive processes, can often undermine peoples’ attempts to lose weight despite currently available and effective support (Chapter 2). Aim: To develop, deliver, and evaluate an impulse management intervention to support weight loss in adults. Methods: A systematic review was conducted to identify available impulse management techniques for influencing eating behaviour (Chapter 3). Intervention Mapping was used to develop the intervention (Chapter 4) which drew on various sources including the findings from the systematic review, stakeholder consultations, existing guidance, and qualitative interviews. A two-arm randomised controlled feasibility trial (Chapter 5), with nested mixed-methods process evaluation and two cycles of intervention delivery and data collection (Chapter 6), was conducted. This assessed the feasibility and acceptability of, and informed refinements to, both the intervention and trial procedures in preparation for a full-scale effectiveness evaluation. Weight was measured as the proposed primary outcome for a full-scale trial at baseline, one-month, and three-months of follow-up, app usage data were collected at both follow-up time points, and semi-structured interviews were conducted at one-month with a subsample of intervention group participants only. Results: The systematic review critically appraised and synthesised evidence on 17 identified techniques which were categorised as Impulse-focused or Reflective techniques. Promising changes in eating behaviour and craving were found for the techniques of visuospatial loading, physical activity, and implementation intentions. Intervention Mapping resulted in development of a novel smartphone app-based intervention (ImpulsePal) aimed to reduce unhealthy snacking, overeating, and alcoholic and sugary drink consumption using impulse management techniques identified in the systematic review. Eighty-eight adults with a Body Mass Index of ≥25kg/m2 and wishing to lose weight, were recruited and randomised in a 2:1 ratio to use ImpulsePal (n=58) or to a waiting list control (n=30) group. Data were available for 74 participants (84%) at one-month and 67 (76%) at three months. Exploratory analyses suggest that the ImpulsePal group (n=43) lost 1.03kg (95% CI 0.33 to 1.74) more than controls (n=26) at one-month, and 1.01kg (95% CI -0.45 to 2.47) more at three months. Participants reported high satisfaction with the intervention and trial procedures. The process evaluation suggests that ImpulsePal and the impulse management techniques are feasible to deliver and acceptable to users. Interviews with twenty-two participants suggest that they 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 resist temptations. Conclusions: This work has developed a novel, theory- and evidence-informed, person-centred app which showed potential to improve impulse management, promote healthier eating, and support weight loss. ImpulsePal is acceptable to overweight and obese adults who want to lose weight and is now ready for evaluation in a full-scale trial. The thesis discusses theoretical, methodological, and practical implications for the future development, evaluation, and implementation of digital behaviour change interventions.UEM

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

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

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

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

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

Does device matter? Impacts of food-specific inhibition training on food choice, liking and approach bias when delivered by smartphone or computer.

Food-specific inhibition training (FSIT) requires users to inhibit responses to energy-dense (ED) food stimuli within a reaction time game. FSIT reduces choice and liking of ED foods. Research with the public shows larger effects when FSIT is delivered by computer versus smartphone. This pre-registered study is the first to compare computer-FSIT versus smartphone-FSIT in a controlled setting. Three-hundred-and-thirty-one adults were randomised to computer-FSIT, smartphone-FSIT or non-food control training (computer-delivered). In session 1, participants completed baseline measures of impulsive food choice, food approach bias (approach/avoid implicit association test), and food liking ratings, before completing eight minutes of FSIT/control training. In session 2, participants repeated the same training task, followed by the same measures of food choice, approach bias and liking. We hypothesised that FSIT groups would show healthier food choices, lower ED food liking, and reduced ED food approach bias at post-training compared to control. We expected no statistically significant differences between the two FSIT groups. Post-exclusions, data for 259 participants was analysed. Contrary to predictions, there was no evidence of significant group differences on any of the outcome measures. Baseline measures suggest participants already showed high approach to healthy foods, which may explain these null results

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

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

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

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707