Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.

BACKGROUND: There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. OBJECTIVES: To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. DESIGN: A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). SETTING: Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. PARTICIPANTS: There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. INTERVENTION: e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. PRIMARY OUTCOME MEASURE: Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. SECONDARY OUTCOMES: Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. RESULTS: Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. LIMITATIONS: A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. FUTURE WORK: The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. CONCLUSIONS: Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15644451. 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. 24, No. 63. See the NIHR Journals Library website for further project information.

When health-care professionals refer patients with chronic conditions to an exercise referral scheme, the effects on long-term increases in physical activity are limited. We therefore developed the e-coachER support package to add to usual exercise referral schemes and to prompt the use of skills such as self-monitoring and goal-setting. This package was also intended to empower patients to increase their levels of physical activity long term. The seven-step programme was delivered online (via an interactive website). As part of the package, we mailed participants a guide for accessing the online programme, a pedometer and a fridge magnet with a notepad to record physical activity. We aimed to determine whether or not adding the e-coachER support to usual exercise referral schemes resulted in lasting changes in moderate and vigorous physical activity and whether or not it offers good value for money compared with exercise referral schemes alone. A total of 450 inactive individuals were recruited across Plymouth, Birmingham and Glasgow and were referred to an exercise referral scheme for the following participant-reported main reasons: weight loss (50%), low mood (19%), osteoarthritis (12%), type 2 diabetes (10%) and high blood pressure (8%). Half of the individuals were given access to the e-coachER support and the other half were not. All individuals were mailed a wrist-worn movement sensor (accelerometer) to wear for 1 week and a survey to assess other outcomes at the start of the study as well as at 4 and 12 months post randomisation. At the start of the study, the participants were inactive and most had multiple health conditions. The participants had an average body mass index of 33 kg/m² and an average age of 50 years. Most (83%) were white. Participants with access to e-coachER support were only slightly more active at 12 months than those who did not have access, but we cannot be confident in the findings because we had data from fewer participants than planned. The lack of a clear effect may have been as a result of around one-third of participants not accessing the website, but otherwise there was reasonable engagement. The provision of the e-coachER support package led to an additional cost of £439 per participant over a 12-month period.

Ecological momentary assessment of mood and physical activity in people with depression.

BACKGROUND: This study aimed to examine temporal associations between physical activity and subsequent mood in people with moderate to severe depression. METHODS: The study used ecological momentary assessment to associate mood, measured via text messaging twice daily for five days, using a 10-point Likert scale, with objectively measured physical activity (accelerometer data) in people with moderate-to-severe depression. Multilevel regression models were used to explore the relationship between physical activity undertaken at different intensities over the previous one and three hours, and subsequent affect score. A total of 388 paired data points were collected from 43 participants. RESULTS: There was no association between minutes of moderate-vigorous physical activity in the previous hour and subsequent affect score (which we had hypothesised). However, exploratory analyses found a significant relationship between affect and combined physical activity in the previous hour (ß1 coefficient = 0.023, p = 0.037). LIMITATIONS: Periods of moderate-vigorous activity were infrequent, reducing the statistical power for analysing associations with this intensity of activity. Only one dimension of mood was sampled. CONCLUSIONS: The data suggest that, in people with moderate-to-severe depression, time spent engaging in any intensity of physical activity was significantly associated with subsequent mood. Further research is needed to more clearly define the dynamics of the relationship between physical activity and low mood. This will aid identification of optimal prescription criteria for physical activity in people with depression.

Reprint of: Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention: JACC Health Promotion Series.

The primary objective of this study was to analyze the most up-to-date evidence regarding whether and how blood sugar regulation influences cardiovascular health promotion and disease prevention by carrying out an umbrella review. Three separate, systematic literature searches identified 2,343 papers in total. Overall, 44 studies were included for data extraction and analysis. The included systematic reviews and meta-analyses published between January 1, 2016, and December 31, 2017, were of good to very good quality (median Overview Quality Assessment Questionnaire score = 17). Identified evidence suggests that cardiovascular disease (CVD) prevention services should consider regulation of blood glucose as a key target for intervention. Furthermore, the recommendations for effective intervention and service development/training described here for prevention of CVD should be adopted into evidence-based practice guidelines. Multidisciplinary teams should be formed to deliver multicomponent interventions in community-based settings. There may be substantial opportunities for integrating CVD and diabetes prevention services.

Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention: JACC Health Promotion Series.

The primary objective of this study was to analyze the most up-to-date evidence regarding whether and how blood sugar regulation influences cardiovascular health promotion and disease prevention by carrying out an umbrella review. Three separate, systematic literature searches identified 2,343 papers in total. Overall, 44 studies were included for data extraction and analysis. The included systematic reviews and meta-analyses published between January 1, 2016, and December 31, 2017, were of good to very good quality (median Overview Quality Assessment Questionnaire score = 17). Identified evidence suggests that cardiovascular disease (CVD) prevention services should consider regulation of blood glucose as a key target for intervention. Furthermore, the recommendations for effective intervention and service development/training described here for prevention of CVD should be adopted into evidence-based practice guidelines. Multidisciplinary teams should be formed to deliver multicomponent interventions in community-based settings. There may be substantial opportunities for integrating CVD and diabetes prevention services.

Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial.

INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective. METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions. ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants. TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.

Intervention delivery fidelity assessment of a counseling-based intervention for promoting smoking reduction and increasing physical activity.

OBJECTIVE: The aims of this study were to (1) develop an approach to assess the delivery fidelity of a complex intervention to simultaneously increase physical activity and reduce smoking and (2) use this approach to assess the variation of fidelity across the delivery of different intervention components of the intervention. METHOD: Audio recorded and transcribed sessions (90 in total) involving 30 participants and 3 health trainers delivering a one-to-one intervention were purposively sampled across health trainer (HT) and stage of treatment. The Dreyfus system for skill acquisition informed a scoring system based on 12 intervention processes and applied by three experts in health behavior change. Scores ranged from 0 to 2 (poor quality), 3 to 4 (reasonable quality), and 5 to 6 (expert level quality). Scores were averaged across coders and presented in relation to fidelity of both HT and the intervention component. RESULTS: The methods were successfully applied with recommendations for future application. Average scores for each item by each coder differed by up to +0.7 to -0.9 points indicating reasonable agreement. Mean scores for the three HTs were 2.9, 2.2, and 2.4, across all 12 intervention processes. The delivery of all intervention components for physical activity was scored lower (<3) than their respective counterparts for smoking reduction (>3; p < .001). CONCLUSIONS: Novel methods for assessing delivery fidelity were successfully applied and areas for improvement identified. Delivery fidelity was deemed to be of reasonable quality but was higher for smoking related intervention components over physical activity ones. (PsycINFO Database Record

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.