Effects of the COVID-19 associated United Kingdom lockdown on physical activity in older adults at high risk of cardiovascular disease: a mixed methods perspective from the MedEx-UK multicenter trial.

Introduction: Physical inactivity and sedentary behaviour are linked to increased risk of cardiovascular disease, infections and dementia, as well as placing a significant economic burden on healthcare systems. The implementation of COVID-19 pandemic lockdown measures aimed at reducing virus transmission posed challenges to the opportunity to be physically active. This study investigates how the first UK COVID-19 lockdown affected objectively measured physical activity in older adults at higher risk of cardiovascular disease. Methods: We studied 48 individuals aged 55-74 years (81.3% female) with self-reported PA levels < 90 min/week and a QRISK2 score ≥ 10 (indicative of a ≥ 10% risk of a major cardiovascular event in the next 10 years) without mild cognitive impairment or dementia. Physical activity data was collected using objective wrist-based activity monitors and analysed across three time periods, usual activity (pre-pandemic), the precautionary phase when the UK began advising on limiting social contact and finally during the first UK lockdown period was collected (27 January 2020 and 07 June 2020). Data was analysed using linear mixed effects model was used to investigate PA levels over the measured 12-week period. Effects of BMI, age, deprivation score and baseline PA levels on PA across the three measurement periods were also examined. Focus-group and individual interviews were conducted, and data were thematically analysed. Results: Average daily step count (-34% lower, p < 0.001) and active energy expenditure (-26% lower, p < 0.001) were significantly lower during the precautionary period compared with the usual activity period. Physical activity remained low during the UK lockdown period. Participants with a lower BMI engaged in significantly more (+45% higher daily steps p < 0.001) physical activity and those over 70 years old were more physically active than those under 70 years across the 12-week period (+23% higher daily steps p < 0.007). The risk of COVID-19 infection and restrictions because of lockdown measures meant some individuals had to find alternative methods to staying physical active. Participants described a lack of access to facilities and concerns over health related to COVID-19 as barriers to engaging in physical activity during lockdown. For some, this resulted in a shift towards less structured activities such as gardening or going for a walk. Discussion: The data presented shows that lockdown measures during the COVID-19 pandemic significantly reduced physical activity among older individuals at risk of cardiovascular disease, particularly those with a higher body mass index. To support this population group in staying active during future lockdowns, a multifaceted strategy is needed, emphasizing psychosocial benefits and home-based physical activity. The MedEx-UK study was pre-registered with ClinicalTrials.gov (NCT03673722).

The association between psychosocial factors and mental health symptoms in cervical spine pain with or without radiculopathy on health outcomes: a systematic review.

BACKGROUND: Neck pain, with or without radiculopathy, can have significant negative effects on physical and mental wellbeing. Mental health symptoms are known to worsen prognosis across a range of musculoskeletal conditions. Understanding the association between mental health symptoms and health outcomes in this population has not been established. Our aim was to systematically review the association between psychosocial factors and/or mental health symptoms on health outcomes in adults with neck pain, with or without radiculopathy. METHODS: A systematic review of published and unpublished literature databases was completed. Studies reporting mental health symptoms and health outcomes in adults with neck pain with or without radiculopathy were included. Due to significant clinical heterogeneity, a narrative synthesis was completed. Each outcome was assessed using GRADE. RESULTS: Twenty-three studies were included (N = 21,968 participants). Sixteen studies assessed neck pain only (N = 17,604 participants); seven studies assessed neck pain with radiculopathy (N = 4,364 participants). Depressive symptoms were associated with poorer health outcomes in people with neck pain and neck pain with radiculopathy. These findings were from seven low-quality studies, and an additional six studies reported no association. Low-quality evidence reported that distress and anxiety symptoms were associated with poorer health outcomes in people with neck pain and radiculopathy and very low-quality evidence showed this in people with neck pain only. Stress and higher job strain were negatively associated with poorer health outcomes measured by the presence of pain in two studies of very low quality. CONCLUSIONS: Across a small number of highly heterogenous, low quality studies mental health symptoms are negatively associated with health outcomes in people with neck pain with radiculopathy and neck pain without radiculopathy. Clinicians should continue to utilise robust clinical reasoning when assessing the complex factors impacting a person's presentation with neck pain with or without radiculopathy. PROSPERO REGISTRATION NUMBER: CRD42020169497.

Recruitment and retention into longitudinal health research from an adolescent perspective: a qualitative study.

BACKGROUND: High quality longitudinal studies investigating changes in health behaviours over the transition into early adulthood are critical. However, recruiting and retaining adolescents is challenging. This study explored adolescents' perspectives of signing up to and continuing involvement in a hypothetical longitudinal health research study. METHODS: Forty-eight individuals (15-20y) participated in nine in-person focus groups about recruitment and retention in research. Participants were (a) school students in the last year of compulsory school (Year 11, 15-16y), (b) school/college students in Sixth Form (Year 13, 17-18y), (c) Further Education students studying after secondary education, but not higher education (16-18y) and (d) young adults not in education, employment, or training (18-20y) across England. Thematic analysis resulted in seven themes. RESULTS: Driving factors for sign-up included social connection e.g., joining with peer groups, personalised feedback, and incentives, primarily financial. Key barriers were lack of interest, the perception of commitment, and timing of recruitment. Young people preferred recruitment processes via social media with messages tailored to their motivations, monthly data collection of maximally 20-30 min, and hybrid data collection with some in-person contact with a consistent, non-judgemental researcher. The provision of autonomy, choice, and financial incentives were perceived to promote retention. CONCLUSIONS: Adolescent recruitment and retention strategies need to align with contemporary interests and motivations. Studies should involve adolescents early to develop a planned, systematic approach to participant sign-up and follow-up. Effective and ineffective recruitment and retention strategies should be reported as part of study findings. Future research should trial how perceived barriers to study engagement can be overcome.

Can public sector community health workers deliver a nurturing care intervention in South Africa? The Amagugu Asakhula feasibility study.

BACKGROUND: Nurturing care interventions have the potential to promote health and development in early childhood. Amagugu Asakhula was designed to promote developmentally important dietary and movement behaviours among children of preschool age (3-5 years) in South Africa. An initial formative study in Cape Town found the intervention to be feasible and acceptable when delivered by community health workers (CHWs) linked to a community-based organisation. This study evaluated the delivery of the Amagugu Asakhula intervention by CHWs linked to a public sector primary health care facility in Soweto, as this mode of delivery could have more potential for sustainability and scalability. METHODS: A qualitative design was utilised to assess feasibility, acceptability, adoption, appropriateness, implementation, fidelity and context. CHWs (n = 14) delivered the intervention to caregivers (n = 23) of preschool-age children in Soweto over 6 weeks. Following the completion of the intervention, focus group discussions were held with CHWs and caregivers. Further data were obtained through observations, study records and key informant interviews (n = 5). Data were analysed using deductive thematic analysis guided by a process evaluation framework. RESULTS: The delivery of the Amagugu Asakhula intervention through CHWs linked to a primary health care facility in Soweto was not found to be feasible due to contextual challenges such as late payment of salaries influencing CHW performance and willingness to deliver the intervention. CHWs expressed dissatisfaction with their general working conditions and were thus reluctant to take on new tasks. Despite barriers to successful delivery, the intervention was well received by both CHWs and caregivers and was considered a good fit with the CHWs' scope of work. CONCLUSIONS: Based on these findings, delivery of the Amagugu Asakhula intervention is not recommended through public sector CHWs in South Africa. This feasibility study informs the optimisation of implementation and supports further testing of the intervention's effectiveness when delivered by CHWs linked to community-based organisations. The present study further demonstrates how implementation challenges can be identified through qualitative feasibility studies and subsequently addressed prior to large-scale trials, avoiding the wasting of research and resources.

Reach, Recruitment, Dose, and Intervention Fidelity of the GoActive School-Based Physical Activity Intervention in the UK: A Mixed-Methods Process Evaluation.

School-based multi-component physical activity (PA) promotion is advocated; however, research has indicated that a multi-component approach may not always be effective at increasing adolescent PA. Evaluation of the GoActive 12-week multi-component school-based intervention showed no effect on adolescent PA. A mixed-methods process evaluation was embedded to facilitate greater understanding of the results, to elicit subgroup perceptions, and to provide insight into contextual factors influencing intervention implementation. This paper presents the reach, recruitment, dose, and fidelity of GoActive, and identifies challenges to implementation. The process evaluation employed questionnaires (1543 Year 9s), individual interviews (16 Year 9s; 7 facilitators; 9 contact teachers), focus groups (48 Year 9s; 58 mentors), alongside GoActive website analytics and researcher observations. GoActive sessions reached 39.4% of Year 9s. Intervention satisfaction was relatively high for mentors (87.3%) and facilitators (85.7%), but lower for Year 9s (59.5%) and teachers (50%). Intervention fidelity was mixed within and between schools. Mentorship was the most implemented component. Factors potentially contributing to low implementation included ambiguity of the roles subgroups played within intervention delivery, Year 9 engagement, institutional support, and further school-level constraints. Multiple challenges and varying contextual considerations hindered the implementation of GoActive in multiple school sites. Methods to overcome contextual challenges to implementation warrant in-depth consideration and innovative approaches.

Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial.

BACKGROUND: Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents. METHODS AND FINDINGS: Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample. CONCLUSIONS: In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale. TRIAL REGISTRATION: ISRCTN Registry ISRCTN31583496.

Adolescents' perspectives on a school-based physical activity intervention: A mixed method study.

Purpose: To examine adolescent experiences and perspectives of the GoActive intervention (ISRCTN31583496) using mixed methods process evaluation to determine satisfaction with intervention components and interpret adolescents' experiences of the intervention process in order to provide insights for future intervention design. Methods: Participants (n = 1542; 13.2 ±  0.4 years, mean ± SD) provided questionnaire data at baseline (shyness, activity level) and post-intervention (intervention acceptability, satisfaction with components). Between-group differences (boys vs. girls and shy/inactive vs. others) were tested with linear regression models, accounting for school clustering. Data from 16 individual interviews (shy/inactive) and 11 focus groups with 48 participants (mean = 4; range 2-7) were thematically coded. Qualitative and quantitative data were merged in an integrative mixed methods convergence matrix, which denoted convergence and dissonance across datasets. Results: Effect sizes for quantitative results were small and may not represent substantial between-group differences. Boys (vs. girls) preferred class-based sessions (ß = 0.2, 95% confidence interval (CI): 0.1-0.3); qualitative data suggested that this was because boys preferred competition, which was supported quantitatively (ß = 0.2, 95%CI: 0.1-0.3). Shy/inactive students did not enjoy the competition (ß = -0.3, 95%CI: -0.5 to -0.1). Boys enjoyed trying new activities more (ß = 0.1, 95%CI: 0.1-0.2); qualitative data indicated a desire to try new activities across all subgroups but identified barriers to choosing unfamiliar activities with self-imposed choice restriction leading to boredom. Qualitative data highlighted critique of mentorship; adolescents liked the idea, but older mentors did not meet expectations. Conclusion: We interpreted adolescent perspectives of intervention components and implementation to provide insights into future complex interventions aimed at increasing young people's physical activity in school-based settings. The intervention component mentorship was liked in principle, but implementation issues undesirably impacted satisfaction; competition was disliked by girls and shy/inactive students. The results highlight the importance of considering gender differences in preference of competition and extensive mentorship training.

Pathways to Increasing Adolescent Physical Activity and Wellbeing: A Mediation Analysis of Intervention Components Designed Using a Participatory Approach.

We assessed which intervention components were associated with change in moderate-to-vigorous physical activity (MVPA) and wellbeing through proposed psychosocial mediators. Eight schools (n = 1319; 13-14 years) ran GoActive, where older mentors and in-class-peer-leaders encouraged classes to conduct two new activities/week; students gained points and rewards for activity. We assessed exposures: participant-perceived engagement with components (post-intervention): older mentorship, peer leadership, class sessions, competition, rewards, points entered online; potential mediators (change from baseline): social support, self-efficacy, group cohesion, friendship quality, self-esteem; and outcomes (change from baseline): accelerometer-assessed MVPA (min/day), wellbeing (Warwick-Edinburgh). Mediation was assessed using linear regression models stratified by gender (adjusted for age, ethnicity, language, school, BMI z-score, baseline values), assessing associations between (1) exposures and mediators, (2) exposures and outcomes (without mediators) and (3) exposure and mediator with outcome using bootstrap resampling. No evidence was found to support the use of these components to increase physical activity. Among boys, higher perceived teacher and mentor support were associated with improved wellbeing via various mediators. Among girls, higher perceived mentor support and perception of competition and rewards were positively associated with wellbeing via self-efficacy, self-esteem and social support. If implemented well, mentorship could increase wellbeing among adolescents. Teacher support and class-based activity sessions may be important for boys' wellbeing, whereas rewards and competition warrant consideration among girls.

GoActive: a protocol for the mixed methods process evaluation of a school-based physical activity promotion programme for 13-14year old adolescents.

BACKGROUND: Process evaluations are critical for interpreting and understanding outcome trial results. By understanding how interventions function across different settings, process evaluations have the capacity to inform future dissemination of interventions. The complexity of Get others Active (GoActive), a 12-week, school-based physical activity intervention implemented in eight schools, highlights the need to investigate how implementation is achieved across a variety of school settings. This paper describes the mixed methods GoActive process evaluation protocol that is embedded within the outcome evaluation. In this detailed process evaluation protocol, we describe the flexible and pragmatic methods that will be used for capturing the process evaluation data. METHODS: A mixed methods design will be used for the process evaluation, including quantitative data collected in both the control and intervention arms of the GoActive trial, and qualitative data collected in the intervention arm. Data collection methods will include purposively sampled, semi-structured interviews and focus group interviews, direct observation, and participant questionnaires (completed by students, teachers, older adolescent mentors, and local authority-funded facilitators). Data will be analysed thematically within and across datasets. Overall synthesis of findings will address the process of GoActive implementation, and through which this process affects outcomes, with careful attention to the context of the school environment. DISCUSSION: This process evaluation will explore the experience of participating in GoActive from the perspectives of key groups, providing a greater understanding of the acceptability and process of implementation of the intervention across the eight intervention schools. This will allow for appraisal of the intervention's conceptual base, inform potential dissemination, and help optimise post-trial sustainability. The process evaluation will also assist in contextualising the trial effectiveness results with respect to how the intervention may or may not have worked and, if it was found to be effective, what might be required for it to be sustained in the 'real world'. Furthermore, it will offer suggestions for the development and implementation of future initiatives to promote physical activity within schools. TRIAL REGISTRATION: ISRCTN, ISRCTN31583496 . Registered on 18 February 2014.

A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13-14 years.

INTRODUCTION: Adolescent physical activity promotion is rarely effective, despite adolescence being critical for preventing physical activity decline. Low adolescent physical activity is likely to last into adulthood, increasing health risks. The Get Others Active (GoActive) intervention is evidence-based and was developed iteratively with adolescents and teachers. This intervention aims to increase physical activity through increased peer support, self-efficacy, group cohesion, self-esteem and friendship quality, and is implemented using a tiered-leadership system. We previously established feasibility in one school and conducted a pilot randomised controlled trial (RCT) in three schools. METHODS AND ANALYSIS: We will conduct a school-based cluster RCT (CRCT) in 16 secondary schools targeting all year 9 students (n=2400). In eight schools, GoActive will run for two terms: weekly facilitation support from a council-funded intervention facilitator will be offered in term 1, with more distant support in term 2. Tutor groups choose two weekly activities, encouraged by older adolescent mentors and weekly peer leaders. Students gain points for trying new activities; points are entered into a between-class competition. Outcomes will be assessed at baseline, interim (week 6), postintervention (week 14-16) and 10-month follow-up (main outcome). The primary outcome will be change from baseline in daily accelerometer-assessed moderate-to-vigorous physical activity. Secondary outcomes include accelerometer-assessed activity intensities on weekdays/weekends; self-reported physical activity and psychosocial outcomes; cost-effectiveness and cost-utility analyses; mixed-methods process evaluation integrating information from focus groups and participation logs/questionnaires. ETHICS AND DISSEMINATION: Ethical approval for the conduct of the study was gained from the University of Cambridge Psychology Research Ethics Committee. Given the lack of rigorously evaluated interventions, and the inclusion of objective measurement of physical activity, long-term follow-up and testing of causal pathways, the results of a CRCT of the effectiveness and cost-effectiveness of GoActive are expected to add substantially to the limited evidence on adolescent physical activity promotion. Workshops will be held with key stakeholders including students, parents, teachers, school governors and government representatives to discuss plans for wider dissemination of the intervention. TRIAL REGISTRATION NUMBER: ISRCTN31583496.