A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial.

BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4-9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22.

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.

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.

BACKGROUND: The REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effectiveness of a community, group-based physical activity intervention for reducing, or reversing, the progression of functional limitations in older people who are at high risk of mobility-related disability. METHODS/DESIGN: A sample of 768 sedentary, community-dwelling, older people aged 65 years and over with functional limitations, but who are still ambulatory (scores between 4 and 9 out of 12 in the Short Physical Performance Battery test (SPPB)) will be randomised to receive either the REACT intervention, delivered over a period of 12 months by trained facilitators, or a minimal control intervention. The REACT study incorporates comprehensive process and economic evaluation and a nested sub-study which will test the hypothesis that the REACT intervention will slow the rate of brain atrophy and of decline in cognitive function assessed using magnetic resonance imaging (MRI). Outcome data will be collected at baseline, 6, 12 and 24 months for the main study, with MRI sub-study data collected at baseline, 6 and 12 months. The primary outcome analysis (SPPB score at 24 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: REACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence. REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN45627165 . Retrospectively registered on 13 June 2016. Trial sponsor: University of Bath. Protocol Version 1.5.

The effect a of community-based social marketing campaign on recruitment and retention of low-income groups into physical activity programmes - a controlled before-and-after study.

BACKGROUND: The beneficial effect of physical activity for the prevention of a range of chronic diseases is widely acknowledged. These conditions are most prevalent in low-income groups where physical activity levels are consistently lower. Social marketing is the government's recommended approach to promoting physical activity but evidence of its effectiveness is limited. The purpose of this study was to examine the effect of a social marketing campaign on the monthly recruitment, attendance and retention levels at a community-based physical activity programme in a low income area. METHODS: A six-month social marketing campaign was designed and delivered in a highly-deprived suburban neighbourhood. Analysis of variance was used to assess effects on recruitment and attendance. χ2 tests of independence were used to compare dropouts and adherers and effectiveness of recruitment mechanisms. Percentages were used to compare adherence rates at intervention, pre-existing sessions in the intervention area and control area sessions. RESULTS: Attendance data were collected weekly and presented and analysed monthly to provide a view of changing participation over the six month intervention period, as compared to attendance at pre-existing sessions in the intervention area and in a control area. Recruitment into intervention sessions was significantly greater than into pre-existing and control area sessions in Month 1 (18.13v1.04 p = .007, 18.13v.30 p=.005), Month 5 (3.45v.84 p=.007, 3.45v.30 p<.001) and Month 6 (5.60v.65 p<.001, 5.60v.25 p<.001). Attendance at intervention sessions was significantly greater in all six months than at pre-existing and control area sessions; Month 1 (38.83v7.17 p<.001, 38.83v4.67, p<.001), Month 2 (21.45v6.20 p<.001, 21.45v4.00, p<.001), Month 3 (9.57v6.15 p<.001, 9.57v3.77, p<.001), Month 4 (17.35v7.31 p<.001, 17.35v4.75, p<.001), Month 5 (20.33v8.81 p=.007, 20.33v4.54 p<.001) and Month 6 (28.72v8.28 p<.001, 28.72v.4.00 p<.001). Drop-out rates in the intervention area were similar to the control area (66.2%v69.9%), and considerably lower than in pre-existing sessions (83%). In months one and two, traditional marketing techniques (posters/outdoor banners/flyers) had the greatest influence on recruitment compared to word of mouth communication (84.5%v15.5%). In months five and six word of mouth influenced 57.5% of new recruits. CONCLUSIONS: Direct comparisons with other programmes were difficult due to a lack of standard definitions of recruitment and adherence and limited reporting of findings. However when compared to pre-existing sessions and sessions delivered in a control area, monthly attendance patterns indicated that a reasonably well funded social marketing campaign increased recruitment into exercise sessions, maintained good levels of attendance and reasonable levels of adherence. Good attendance levels support on-going campaign success by offering evidence of peer and social support for the activity and increasing opportunities for social interaction. They also increase the capacity and reach of the word of mouth communication channels, the most effective form of promotion. Further study into methods of improving exercise adherence is required.

Families' and health professionals' perceptions of influences on diet, activity and obesity in a low-income community.

This qualitative study examined reported barriers to consuming a healthy diet and engaging in regular physical activity among low-income families with existing issues of overweight or obesity. Parents and health professionals reported that issues of access, availability and cost were perceived as major barriers to a healthy lifestyle along with familial shape, metabolism and safety. Many felt their diet and activity levels were already good. The study concluded that improving access, availability and income may increase activity but only in some groups. Issues of perceived helplessness (genetics/metabolism) and high optimistic bias may provide rationalisations that undermine behaviour change. Together these issues may mask the more complex, less easily articulated influences (cultural, social and family influences and practices, knowledge and skill levels, and emotional status) that lead to unhealthy behaviours.