Evidence for exercise-based interventions across 45 different long-term conditions: an overview of systematic reviews.

Background: Almost half of the global population face significant challenges from long-term conditions (LTCs) resulting in substantive health and socioeconomic burden. Exercise is a potentially key intervention in effective LTC management. Methods: In this overview of systematic reviews (SRs), we searched six electronic databases from January 2000 to October 2023 for SRs assessing health outcomes (mortality, hospitalisation, exercise capacity, disability, frailty, health-related quality of life (HRQoL), and physical activity) related to exercise-based interventions in adults (aged >18 years) diagnosed with one of 45 LTCs. Methodological quality was assessed using AMSTAR-2. International Prospective Resister of Systematic Reviews (PROSPERO) ID: CRD42022319214. Findings: Forty-two SRs plus three supplementary RCTs were included, providing 990 RCTs in 936,825 people across 39 LTCs. No evidence was identified for six LTCs. Predominant outcome domains were HRQoL (82% of SRs/RCTs) and exercise capacity (66%); whereas disability, mortality, physical activity, and hospitalisation were less frequently reported (≤25%). Evidence supporting exercise-based interventions was identified in 25 LTCs, was unclear for 13 LTCs, and for one LTC suggested no effect. No SRs considered multimorbidity in the delivery of exercise. Methodological quality varied: critically-low (33%), low (26%), moderate (26%), and high (12%). Interpretation: Exercise-based interventions improve HRQoL and exercise capacity across numerous LTCs. Key evidence gaps included limited mortality and hospitalisation data and consideration of multimorbidity impact on exercise-based interventions. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).

Understanding the causes of missingness in primary care: a realist review.

BACKGROUND: Although missed appointments in healthcare have been an area of concern for policy, practice and research, the primary focus has been on reducing single 'situational' missed appointments to the benefit of services. Little attention has been paid to the causes and consequences of more 'enduring' multiple missed appointments in primary care and the role this has in producing health inequalities. METHODS: We conducted a realist review of the literature on multiple missed appointments to identify the causes of 'missingness.' We searched multiple databases, carried out iterative citation-tracking on key papers on the topic of missed appointments and identified papers through searches of grey literature. We synthesised evidence from 197 papers, drawing on the theoretical frameworks of candidacy and fundamental causation. RESULTS: Missingness is caused by an overlapping set of complex factors, including patients not identifying a need for an appointment or feeling it is 'for them'; appointments as sites of poor communication, power imbalance and relational threat; patients being exposed to competing demands, priorities and urgencies; issues of travel and mobility; and an absence of choice or flexibility in when, where and with whom appointments take place. CONCLUSIONS: Interventions to address missingness at policy and practice levels should be theoretically informed, tailored to patients experiencing missingness and their identified needs and barriers; be cognisant of causal domains at multiple levels and address as many as practical; and be designed to increase safety for those seeking care.

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

BACKGROUND: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. METHODS: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. FINDINGS: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. INTERPRETATION: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. FUNDING: Versus Arthritis.

Pilot study of a ketogenic diet in bipolar disorder.

BACKGROUND: Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date. AIMS: To assess the recruitment and feasibility of a ketogenic diet intervention in bipolar disorder. METHOD: Euthymic individuals with bipolar disorder were recruited to a 6-8 week trial of a modified ketogenic diet, and a range of clinical, economic and functional outcome measures were assessed. Study registration number: ISRCTN61613198. RESULTS: Of 27 recruited participants, 26 commenced and 20 completed the modified ketogenic diet for 6-8 weeks. The outcomes data-set was 95% complete for daily ketone measures, 95% complete for daily glucose measures and 95% complete for daily ecological momentary assessment of symptoms during the intervention period. Mean daily blood ketone readings were 1.3 mmol/L (s.d. = 0.77, median = 1.1) during the intervention period, and 91% of all readings indicated ketosis, suggesting a high degree of adherence to the diet. Over 91% of daily blood glucose readings were within normal range, with 9% indicating mild hypoglycaemia. Eleven minor adverse events were recorded, including fatigue, constipation, drowsiness and hunger. One serious adverse event was reported (euglycemic ketoacidosis in a participant taking SGLT2-inhibitor medication). CONCLUSIONS: The recruitment and retention of euthymic individuals with bipolar disorder to a 6-8 week ketogenic diet intervention was feasible, with high completion rates for outcome measures. The majority of participants reached and maintained ketosis, and adverse events were generally mild and modifiable. A future randomised controlled trial is now warranted.

Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

BACKGROUND: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, health behaviour change, and risk management components. Social support and social network interventions have potential to improve outcomes of these programmes, but whether and how these interventions work is poorly understood.  OBJECTIVES: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. The comparator was usual care with no element of social support (i.e. secondary prevention alone or with cardiac rehabilitation).  SEARCH METHODS: We undertook a systematic search of the following databases on 9 August 2022: CENTRAL, MEDLINE, Embase, and the Web of Science. We also searched ClinicalTrials.gov and the WHO ICTRP. We reviewed the reference lists of relevant systematic reviews and included primary studies, and we contacted experts to identify additional studies.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of social network or social support interventions for people with heart disease. We included studies regardless of their duration of follow-up, and included those reported as full text, published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened all identified titles. We retrieved full-text study reports and publications marked 'included', and two review authors independently screened these, and conducted data extraction. Two authors independently assessed risk of bias, and assessed the certainty of the evidence using GRADE. Primary outcomes were all-cause mortality, cardiovascular-related mortality, all-cause hospital admission, cardiovascular-related hospital admission, and health-related quality of life (HRQoL) measured at > 12 months follow-up.  MAIN RESULTS: We included 54 RCTs (126 publications) reporting data for a total of 11,445 people with heart disease. The median follow-up was seven months and median sample size was 96 participants. Of included study participants, 6414 (56%) were male, and the mean age ranged from 48.6 to 76.3 years. Studies included heart failure (41%), mixed cardiac disease (31%), post-myocardial infarction (13%), post-revascularisation (7%), CHD (7%), and cardiac X syndrome (1%) patients. The median intervention duration was 12 weeks. We identified notable diversity in social network and social support interventions, across what was delivered, how, and by whom.  We assessed risk of bias (RoB) in primary outcomes at > 12 months follow-up as either 'low' (2/15 studies), 'some concerns' (11/15), or 'high' (2/15). 'Some concerns' or 'high' RoB resulted from insufficient detail on blinding of outcome assessors, data missingness, and absence of pre-agreed statistical analysis plans. In particular, HRQoL outcomes were at high RoB. Using the GRADE method, we assessed the certainty of evidence as low or very low across outcomes. Social network or social support interventions had no clear effect on all-cause mortality (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.49 to 1.13, I2 = 40%) or cardiovascular-related mortality (RR 0.85, 95% CI 0.66 to 1.10, I2 = 0%) at > 12 months follow-up. The evidence suggests that social network or social support interventions for heart disease may result in little to no difference in all-cause hospital admission (RR 1.03, 95% CI 0.86 to 1.22, I2 = 0%), or cardiovascular-related hospital admission (RR 0.92, 95% CI 0.77 to 1.10, I2 = 16%), with a low level of certainty. The evidence was very uncertain regarding the impact of social network interventions on HRQoL at > 12 months follow-up (SF-36 physical component score: mean difference (MD) 31.53, 95% CI -28.65 to 91.71, I2 = 100%, 2 trials/comparisons, 166 participants; mental component score MD 30.62, 95% CI -33.88 to 95.13, I2 = 100%, 2 trials/comparisons, 166 participants).  Regarding secondary outcomes, there may be a decrease in both systolic and diastolic blood pressure with social network or social support interventions. There was no evidence of impact found on psychological well-being, smoking, cholesterol, myocardial infarction, revascularisation, return to work/education, social isolation or connectedness, patient satisfaction, or adverse events.  Results of meta-regression did not suggest that the intervention effect was related to risk of bias, intervention type, duration, setting, and delivery mode, population type, study location, participant age, or percentage of male participants.  AUTHORS' CONCLUSIONS: We found no strong evidence for the effectiveness of such interventions, although modest effects were identified in relation to blood pressure. While the data presented in this review are indicative of potential for positive effects, the review also highlights the lack of sufficient evidence to conclusively support such interventions for people with heart disease. Further high-quality, well-reported RCTs are required to fully explore the potential of social support interventions in this context. Future reporting of social network and social support interventions for people with heart disease needs to be significantly clearer, and more effectively theorised, in order to ascertain causal pathways and effect on outcomes.

Adolescents' interactive electronic device use, sleep and mental health: a systematic review of prospective studies.

Optimal sleep, both in terms of duration and quality, is important for adolescent health. However, young people's sleeping habits have worsened over recent years. Access to and use of interactive electronic devices (e.g., smartphones, tablets, portable gaming devices) and social media have become deep-rooted elements of adolescents' lives and are associated with poor sleep. Additionally, there is evidence of increases in poor mental health and well-being disorders in adolescents; further linked to poor sleep. This review aimed to summarise the longitudinal and experimental evidence of the impact of device use on adolescents' sleep and subsequent mental health. Nine electronic bibliographical databases were searched for this narrative systematic review in October 2022. Of 5779 identified unique records, 28 studies were selected for inclusion. A total of 26 studies examined the direct link between device use and sleep outcomes, and four reported the indirect link between device use and mental health, with sleep as a mediator. The methodological quality of the studies was generally poor. Results demonstrated that adverse implications of device use (i.e., overuse, problematic use, telepressure, and cyber-victimisation) impacted sleep quality and duration; however, relationships with other types of device use were unclear. A small but consistent body of evidence showed sleep mediates the relationship between device use and mental health and well-being in adolescents. Increasing our understanding of the complexities of device use, sleep, and mental health in adolescents are important contributions to the development of future interventions and guidelines to prevent or increase resilience to cyber-bullying and ensure adequate sleep.

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH.

BACKGROUND: The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. METHODS: Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. RESULTS: Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. CONCLUSIONS: STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. TRIAL REGISTRATION: ISRCTN97369178.

Environmental and practice factors associated with children's device-measured physical activity and sedentary time in early childhood education and care centres: a systematic review.

BACKGROUND: Early childhood education and care (ECEC) settings offer a potentially cost-effective and sustainable solution for ensuring children have opportunities to meet physical activity (PA) and sedentary time (ST) guidelines. This paper systematically reviewed the association between childcare environment and practice and children's PA and ST. METHODS: Three electronic databases were searched, and citation tracking of eligible studies performed between June-July 2020 (updated March 2022). Studies were eligible when (i) participants attended ECEC settings, (ii) they reported the association between use of outdoor space, including factors of time, availability, play, size and equipment, and children's device-measured PA and ST, and (iii) where applicable, they compared the exposure to use of indoor space. Risk of bias was assessed using the Critical Appraisal Skills Program (CASP) tools. A synthesis was performed using effect direct plots and charts to visualise effect sizes. RESULTS: Of 1617 reports screened, 29 studies met the inclusion criteria. Studies provided data on outdoor versus indoor time (n = 9; 960 children), outdoor versus indoor play (n = 3; 1104 children), outdoor play space (n = 19; 9596 children), outdoor space use external to ECEC (n = 2; 1148 children), and portable (n = 7; 2408 children) and fixed (n = 7; 2451 children) outdoor equipment. Time spent outdoors versus indoors was associated with increased moderate-to-vigorous PA (MVPA), light PA (LPA) and total PA, while the association with ST was inconclusive. The mean (standard deviation) levels of outdoor MVPA (4.0 ± 3.2 to 18.6 ± 5.6 min/h) and LPA (9.9 ± 2.6 to 30.8 ± 11.8 min/h) were low, and ST high (30.0 ± 6.5 to 46.1 ± 4.3 min/h). MVPA levels doubled when children played outdoors versus indoors. Outdoor play space, and outdoor portable equipment, were associated with increased MVPA. A dose-response relationship for outdoor play area size was observed, demonstrating increased MVPA with areas ≥505m2 (5436 ft2), but no further increases when areas were > 900m2 (9688 ft2). No studies reported on injuries in outdoor settings. CONCLUSIONS: ECEC policies and practices should promote not only outdoor time but also the availability of resources such as portable play equipment and sufficient size of outdoor play areas that enable children to be physically active for sustained periods while outdoors. SYSTEMATIC REVIEW REGISTRATION: International prospective register of systematic reviews (PROSPERO) Registration Number: CRD42020189886.

Parents' perceptions of children's emotional well-being during spring 2020 COVID-19 restrictions: A qualitative study with parents of young children in England.

BACKGROUND: During COVID-19 restrictions in England in spring 2020, early years settings for young children were closed to all but a small percentage of families, social contact was limited and play areas in parks were closed. Concerns were raised about the impact of these restrictions on young children's emotional well-being. The aim of this study was to explore parents' perceptions of young children's emotional well-being during these COVID-19 restrictions. METHODS: We interviewed 20 parents of children 3-4 years due to begin school in England in September 2020. Interviews were conducted via telephone (n = 18) and video call (n = 2), audio-recorded and transcribed verbatim. Interviews focused on childcare arrangements, children's behaviour and transition to school. A sample of transcripts were coded line by line to create a coding framework, which was subsequently applied to the remaining transcripts. Coded data were then analysed using a nurture lens to develop themes and further understanding. RESULTS: Participants were predominantly mothers (n = 16), White British (n = 10) and educated to degree level (n = 13), with half the sample living in the highest deprivation quintile in England (n = 10). Five were single parents. Three themes developed from nurturing principles were identified: creating age-appropriate explanations, understanding children's behaviour and concerns about school transition. Parents reported that their children's emotional well-being was impacted and described attempts to support their young children while looking ahead to their transition to primary school. CONCLUSIONS: This study is one of the first to examine in-depth perceptions of COVID-19 restrictions on young children's emotional well-being. The longer term impacts are not yet understood. Although young children may be unable to understand in detail what the virus is, they undoubtedly experience the disruption it brings to their lives. The well-being of families and children needs to be nurtured as they recover from the effects of the pandemic to allow them to thrive.

SAFETEL: a pilot randomised controlled trial to assess the feasibility and acceptability of a safety planning and telephone follow-up intervention to reduce suicidal behaviour.

BACKGROUND: A previous suicide attempt is an important predictor of future suicide. However, there are no evidence-based interventions administered in UK general hospital contexts to reduce suicidal behaviour in patients admitted following a suicide attempt. Consequently, the objective of this pilot randomised controlled trial was to explore whether a safety planning and telephone follow-up intervention (SAFETEL) was feasible and acceptable for individuals treated in hospital following a suicide attempt. METHODS: In this three-phase study with an embedded process evaluation, a safety planning intervention was tailored to the UK context (Phase I), piloted (Phase II, n = 32), and tested in a feasibility randomised controlled trial (Phase III). In Phase III, participants were allocated to either the intervention (n = 80) or control group (n = 40) using telephone randomisation with a 2:1 ratio. The acceptability and feasibility of the trial and intervention procedures were evaluated using both qualitative (interviews and focus groups) and quantitative data. The number of hospital representations of suicidal behaviour was also collected 6 months after study recruitment based on electronic patient records. RESULTS: Findings indicated that SAFETEL was both acceptable and feasible. Hospital staff reported the intervention fitted and complemented existing services, and patients reported that they favoured the simplicity and person-centred approach of the safety planning intervention. CONCLUSIONS: All progression criteria were met supporting further evaluation of the intervention in a full-scale clinical effectiveness trial. TRIAL REGISTRATION: ISRCT, ISRCTN62181241 , 5/5/2017.

Loneliness and personal well-being in young people: Moderating effects of individual, interpersonal, and community factors.

INTRODUCTION: Loneliness is prevalent among young people. But, there is little work exploring the association between loneliness with well-being among this age group. Framed by social-ecological theory, we examined demographic, interpersonal, and community factors associated with personal wellbeing and, critically, identified malleable moderators of the relationship between loneliness and well-being that could be targeted in intervention efforts. METHODS: We used cross-sectional, secondary data from 965 young people (aged 16-24) from the Community Life Survey in England. Loneliness was measured using a single-item direct measure; personal wellbeing was measured through a composite measure containing items assessing happiness, life satisfaction, and a sense that life is worthwhile (α = 0.88). Regression techniques were used to assess associations between individual, interpersonal, and community factors and well-being, and to identify moderators of the relationship between loneliness and well-being. RESULTS: Loneliness was negatively associated with well-being. Chatting with neighbors and having people to provide help moderated the relationship between loneliness and well-being. Full-time students and those with good physical health had higher well-being while being a carer was predictive of lower well-being. All community variables were strongly associated with increased well-being. Of all interpersonal variables investigated, only having people to count on was associated with increased well-being. CONCLUSIONS: Our results demonstrate that supportive relationships and close community ties are important for reducing the negative impact of loneliness on youth well-being. Interventions to improve well-being could benefit from targeting these aspects of young people's social and community lives, while acknowledging individual vulnerabilities, such as poor physical health.

A qualitative exploration of weight management during COVID-19.

COVID-19 has been associated with worse outcomes in people living with obesity and has altered how people can engage with weight management. However, the impact of risk perceptions and changes to daily life on weight loss has not been explored. This study aimed to examine how COVID-19 and perception of risk interacted with weight loss attempts in adults participating in a behavioural weight management programme. Forty-eight participants completed a semi-structured interview exploring the impact of COVID-19 on their weight management experience. Interviews were completed via telephone and analysed using a thematic approach. Reaction to perceived risk varied, but most participants reported the knowledge of increased risk promoted anxiety and avoidance behaviours. Despite this, many reported it as a motivating factor for weight loss. Restrictions both helped (e.g., reduced temptation) and hindered their weight loss (e.g., less support). However, there was consensus that the changes to everyday life meant participants had more time to engage with and take control of their weight loss. To the authors' knowledge, this is the first study to explore the impact of COVID-19 on participation in a weight management programme started during the pandemic in the United Kingdom. Restrictions had varying impacts on participant's weight loss. How risk is perceived and reported to participants is an important factor influencing engagement with weight management. The framing of health information needs to be considered carefully to encourage engagement with weight management to mitigate risk. Additionally, the impact of restrictions and personal well-being are key considerations for weight management programmes.

Feasibility study of peer-led and school-based social network Intervention (STASH) to promote adolescent sexual health.

BACKGROUND: Effective sex education is the key to good sexual health. Peer-led approaches can augment teacher-delivered sex education, but many fail to capitalise on mechanisms of social influence. We assessed the feasibility of a novel intervention (STASH) in which students (aged 14-16) nominated as influential by their peers were recruited and trained as Peer Supporters (PS). Over a 5-10-week period, they spread positive sexual health messages to friends in their year group, both in-person and via social media, and were supported to do so via weekly trainer-facilitated meetings. The aims of the study were to assess the feasibility of STASH (acceptability, fidelity and reach), to test and refine the programme theory and to establish whether the study met pre-set progression criteria for continuation to larger-scale evaluation. METHODS: The overall design was a non-randomised feasibility study of the STASH intervention in 6 schools in Scotland. Baseline (n=680) and follow-up questionnaires (approx. 6 months later; n=603) were administered to the intervention year group. The control group (students in year above) completed the follow-up questionnaire only (n=696), 1 year before the intervention group. The PS (n=88) completed a brief web survey about their experience of the role; researchers interviewed participants in key roles (PS (n=20); PS friends (n=22); teachers (n=8); trainers (n=3)) and observed 20 intervention activities. Activity evaluation forms and project monitoring data also contributed information. We performed descriptive quantitative analysis and thematic qualitative analysis. RESULTS: The PS role was acceptable; on average across schools >50% of students nominated as influential by their friends, signed up and were trained (n=104). This equated to 13% of the year group. Trained PS rarely dropped out (97% completion rate) and 85% said they liked the role. Fidelity was good (all bar one trainer-led activity carried out; PS were active). The intervention had good reach; PS were reasonably well connected and perceived as 'a good mix' and 58% of students reported exposure to STASH. Hypothesised pre-conditions, contextual influences and mechanisms of change for the intervention were largely confirmed. All bar one of the progression criteria was met. CONCLUSION: The weight of evidence supports continuation to full-scale evaluation. TRIAL REGISTRATION: Current controlled trials ISRCTN97369178.

Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation.

INTRODUCTION: Mothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications. METHODS: The International Weight Management in Pregnancy Collaborative Network database is a living repository of IPD from randomised trials on diet and physical activity in pregnancy identified through a systematic literature search. We shall update our existing search on MEDLINE, Embase, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment Database without language restriction to identify relevant trials until March 2021. Primary researchers will be invited to join the Network and share their IPD. Trials including women with GDM at baseline will be excluded. We shall perform a one and two stage random-effect meta-analysis for each intervention type (all interventions, diet-based, physical activity-based and mixed approach) to obtain summary intervention effects on GDM with 95% CIs and summary treatment-covariate interactions. Heterogeneity will be summarised using I2 and tau2 statistics with 95% prediction intervals. Publication and availability bias will be assessed by examining small study effects. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool, and the Grading of Recommendations, Assessment, Development and Evaluations approach will be used to grade the evidence in the results. A model-based economic analysis will be carried out to assess the cost-effectiveness of interventions to prevent GDM and its complications compared with usual care. ETHICS AND DISSEMINATION: Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42020212884). Results will be submitted for publication in peer-reviewed journals.

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum.

OBJECTIVE: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. METHODS: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. INTERVENTIONS: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. RESULTS: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was -0.02 (95% CI -0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. CONCLUSIONS: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25260464.

Definition and Characteristics of Behavioral Medicine, and Main Tasks and Goals of the International Society of Behavioral Medicine-an International Delphi Study.

BACKGROUND: In the past decades, behavioral medicine has attained global recognition. Due to its global reach, a critical need has emerged to consider whether the original definition of behavioral medicine is still valid, comprehensive, and inclusive, and to reconsider the main tasks and goals of the International Society of Behavioral Medicine (ISBM), as the umbrella organization in the field. The purpose of the present study was to (i) update the definition and scope of behavioral medicine and its defining characteristics; and (ii) develop a proposal on ISBM's main tasks and goals. METHOD: Our study used the Delphi method. A core group prepared a discussion paper. An international Delphi panel rated questions and provided comments. The panel intended to reach an a priori defined level of consensus (i.e., 70%). RESULTS: The international panel reached consensus on an updated definition and scope of behavioral medicine as a field of research and practice that builds on collaboration among multiple disciplines. These disciplines are concerned with development and application of behavioral and biomedical evidence across the disease continuum in clinical and public health domains. Consensus was reached on a proposal for ISBM's main tasks and goals focused on supporting communication and collaboration across disciplines and participating organizations; stimulating research, education, and practice; and supporting individuals and organizations in the field. CONCLUSION: The consensus on definition and scope of behavioral medicine and ISBM's tasks and goals provides a foundational step toward achieving these goals.

Effectiveness of social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. As a secondary output of this review, and to assist in conceptualising future research focused on social network and social support interventions, we aim to develop a logic model theorising the relationship between social networks or social support and heart disease outcomes. We will draw on existing models of social support for health (e.g. Berkman 2000), as well as established approaches to theorising and implementing behaviour change (e.g. Michie 2011).

Accelerometry-assessed sleep duration and timing in late childhood and adolescence in Scottish schoolchildren: A feasibility study.

Children and adolescents commonly suffer from sleep and circadian rhythm disturbances, which may contribute to poorer mental health and wellbeing during this critical developmental phase. Many studies however rely on self-reported sleep measures. This study assessed whether accelerometry data collection was feasible within the school setting as a method for investigating the extent of sleep and circadian disruption, and associations with subjective wellbeing, in Scotland. Fourteen days of wrist-worn accelerometry data were collected from 69 pupils, aged 10-14 years. Objective measures of sleep timing, sleep duration and circadian rest-activity patterns were derived. Questionnaires assessed subjective sleep timing, depressive symptoms, and experiences of wearing the accelerometer. Pupils slept on average less than 8 hours per night, failing to meet standard age-specific recommendations. Sleep timing was later and duration longer on weekends compared to weekdays (B = 0.87, 95% confidence interval (CI) 0.70, 1.04; B = 0.49, 95% CI 0.29, 0.69), indicating social jetlag. Lower daytime activity was correlated with higher depressive symptoms (r = -0.84, p = 0.008). Compared to primary school pupils, secondary pupils had shorter sleep window duration and lower circadian relative amplitude. Over half of participants reported some discomfort/inconvenience wearing the accelerometer. These data highlight that inadequate sleep is prevalent in this sample of schoolchildren. Future, larger scale investigations will examine in more detail the associations between sleep, circadian function and physical activity with mental health and wellbeing.

Barriers and facilitators of successful weight loss during participation in behavioural weight management programmes: a protocol for a systematic review.

BACKGROUND: Behavioural weight management programmes are effective in assisting people with overweight or obesity to lose excess body weight. Yet, many still struggle to attain their weight loss goals in such programmes. Little is understood about the factors which impact success in these programmes. Synthesising this data will allow for theory to be developed on how to improve success in such programmes. The main aim of this review will be to extract and synthesise the barriers and facilitators of successful weight loss during participation of behavioural weight loss programmes in adults living with overweight and obesity. METHODS: A systematic search of MEDLINE, Embase, PsycINFO, The Cochrane Library and CINAHL will be performed from inception onwards. Studies will also be sought by contacting experts in the field, reference and website searching. Studies will be eligible if the participants are adults living with obesity (population) undertaking or recently completed behavioural weight loss programmes (intervention) with the primary focus of weight loss (outcome). The primary outcomes will be amount of weight lost and information on barriers and/or facilitators to success. The secondary outcomes will be reasons or factors related to attrition and adherence and behaviour change techniques used in programmes. Two reviewers will screen citations and full-text data. Reviewer 1 will screen all, and reviewer 2 will screen a random 50% of articles. Data extraction will be completed by reviewer 1, and 10% will be checked by the research team. Potential conflicts will be resolved through discussion. Data will be synthesised and described narratively to show the characteristics of each study, levels of success and barriers and facilitators during programme participation. A thematic approach will be taken, and themes will be coded against the levels of the socioecological model. Quantitative data will be extracted and categorised according to these themes and presented alongside the qualitative data. DISCUSSION: Our findings can be used to inform how weight loss programmes can be improved to facilitate success in those at risk of failure. Results will be published in a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: ( PROSPERO CRD42019148158 ).