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1.
Cochrane Database Syst Rev ; 5: CD015328, 2024 05 20.
Article in English | MEDLINE | ID: mdl-38763517

ABSTRACT

BACKGROUND: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. AUTHORS' CONCLUSIONS: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.


Subject(s)
Body Mass Index , Exercise , Pediatric Obesity , Child , Child, Preschool , Female , Humans , Male , Bias , Diet, Healthy , Energy Intake , Pediatric Obesity/prevention & control , Randomized Controlled Trials as Topic , Sedentary Behavior , Sleep
2.
Cochrane Database Syst Rev ; 5: CD015330, 2024 05 20.
Article in English | MEDLINE | ID: mdl-38763518

ABSTRACT

BACKGROUND: Prevention of obesity in adolescents is an international public health priority. The prevalence of overweight and obesity is over 25% in North and South America, Australia, most of Europe, and the Gulf region. Interventions that aim to prevent obesity involve strategies that promote healthy diets or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective, and numerous new studies have been published over the last five years since the previous version of this Cochrane Review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in adolescents by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in adolescents (mean age 12 years and above but less than 19 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were BMI, zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 74 studies (83,407 participants); 54 studies (46,358 participants) were included in meta-analyses. Sixty studies were based in high-income countries. The main setting for intervention delivery was schools (57 studies), followed by home (nine studies), the community (five studies) and a primary care setting (three studies). Fifty-one interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over 28 months. Sixty-two studies declared non-industry funding; five were funded in part by industry. Dietary interventions versus control The evidence is very uncertain about the effects of dietary interventions on body mass index (BMI) at short-term follow-up (mean difference (MD) -0.18, 95% confidence interval (CI) -0.41 to 0.06; 3 studies, 605 participants), medium-term follow-up (MD -0.65, 95% CI -1.18 to -0.11; 3 studies, 900 participants), and standardised BMI (zBMI) at long-term follow-up (MD -0.14, 95% CI -0.38 to 0.10; 2 studies, 1089 participants); all very low-certainty evidence. Compared with control, dietary interventions may have little to no effect on BMI at long-term follow-up (MD -0.30, 95% CI -1.67 to 1.07; 1 study, 44 participants); zBMI at short-term (MD -0.06, 95% CI -0.12 to 0.01; 5 studies, 3154 participants); and zBMI at medium-term (MD 0.02, 95% CI -0.17 to 0.21; 1 study, 112 participants) follow-up; all low-certainty evidence. Dietary interventions may have little to no effect on serious adverse events (two studies, 377 participants; low-certainty evidence). Activity interventions versus control Compared with control, activity interventions do not reduce BMI at short-term follow-up (MD -0.64, 95% CI -1.86 to 0.58; 6 studies, 1780 participants; low-certainty evidence) and probably do not reduce zBMI at medium- (MD 0, 95% CI -0.04 to 0.05; 6 studies, 5335 participants) or long-term (MD -0.05, 95% CI -0.12 to 0.02; 1 study, 985 participants) follow-up; both moderate-certainty evidence. Activity interventions do not reduce zBMI at short-term follow-up (MD 0.02, 95% CI -0.01 to 0.05; 7 studies, 4718 participants; high-certainty evidence), but may reduce BMI slightly at medium-term (MD -0.32, 95% CI -0.53 to -0.11; 3 studies, 2143 participants) and long-term (MD -0.28, 95% CI -0.51 to -0.05; 1 study, 985 participants) follow-up; both low-certainty evidence. Seven studies (5428 participants; low-certainty evidence) reported data on serious adverse events: two reported injuries relating to the exercise component of the intervention and five reported no effect of intervention on reported serious adverse events. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, do not reduce BMI at short-term follow-up (MD 0.03, 95% CI -0.07 to 0.13; 11 studies, 3429 participants; high-certainty evidence), and probably do not reduce BMI at medium-term (MD 0.01, 95% CI -0.09 to 0.11; 8 studies, 5612 participants; moderate-certainty evidence) or long-term (MD 0.06, 95% CI -0.04 to 0.16; 6 studies, 8736 participants; moderate-certainty evidence) follow-up. They may have little to no effect on zBMI in the short term, but the evidence is very uncertain (MD -0.09, 95% CI -0.2 to 0.02; 3 studies, 515 participants; very low-certainty evidence), and they may not reduce zBMI at medium-term (MD -0.05, 95% CI -0.1 to 0.01; 6 studies, 3511 participants; low-certainty evidence) or long-term (MD -0.02, 95% CI -0.05 to 0.01; 7 studies, 8430 participants; low-certainty evidence) follow-up. Four studies (2394 participants) reported data on serious adverse events (very low-certainty evidence): one reported an increase in weight concern in a few adolescents and three reported no effect. AUTHORS' CONCLUSIONS: The evidence demonstrates that dietary interventions may have little to no effect on obesity in adolescents. There is low-certainty evidence that activity interventions may have a small beneficial effect on BMI at medium- and long-term follow-up. Diet plus activity interventions may result in little to no difference. Importantly, this updated review also suggests that interventions to prevent obesity in this age group may result in little to no difference in serious adverse effects. Limitations of the evidence include inconsistent results across studies, lack of methodological rigour in some studies and small sample sizes. Further research is justified to investigate the effects of diet and activity interventions to prevent childhood obesity in community settings, and in young people with disabilities, since very few ongoing studies are likely to address these. Further randomised trials to address the remaining uncertainty about the effects of diet, activity interventions, or both, to prevent childhood obesity in schools (ideally with zBMI as the measured outcome) would need to have larger samples.


Subject(s)
Body Mass Index , Exercise , Pediatric Obesity , Randomized Controlled Trials as Topic , Humans , Adolescent , Child , Pediatric Obesity/prevention & control , Female , Energy Intake , Male , Sedentary Behavior , Bias , Diet, Healthy , Research Support as Topic , Sleep
3.
Public Health Res (Southampt) ; : 1-35, 2024 Mar 27.
Article in English | MEDLINE | ID: mdl-38549448

ABSTRACT

Background and objectives: The COVID-19 lockdowns impacted physical activity for all, but especially parents, because they had to balance home, work and leisure activities. Motivation for exercise is consistently shown to be associated with physical activity levels. Self-determination theory provides a framework through which the motivation for exercise and its social-contextual antecedents can be explored. The purpose of this study is to explore the role of motivation in determining physical activity in parents and carers of English primary school children before, during and after the COVID-19 lockdowns. Design, setting and participants: This study uses a mixed-methods design combining quantitative data and individual interviews. Participants were all parents/carers of children in year 6 (aged 10-11 years) at English primary schools in the United Kingdom. Methods: Quantitative data were collected on three occasions: between March 2017 and May 2018 (Wave 0, N = 1296), between May and December 2021 (Wave 1, N = 393) and between January and July 2022 (wave 2, N = 436). Motivation for exercise was assessed using the Behavioural Regulations in Exercise Questionnaire-2 and moderate-to-vigorous physical activity was estimated via waist-worn accelerometers. Data were analysed via regression models. Interviews with a subsample of parents (N = 43) were conducted on two occasions: between September and December 2021 and between February and July 2022. Interviews covered the impact of the pandemic on children and parents' physical activity and changes over time. This study focuses on discussions around the parents' own physical activity behaviour and their motivation. The framework method was used for analysis. Results: In separate linear regression models, intrinsic and identified regulation were associated with higher moderate-to-vigorous physical activity in waves 0 and 2. Amotivation was associated with lower moderate-to-vigorous physical activity in waves 0 and 2. In fully adjusted multivariable regression models, identified regulation was associated with a 4.9-minute increase in moderate-to-vigorous physical activity and introjected regulation was associated with a 2.3-minute decrease in moderate-to-vigorous physical activity at wave 0. Associations with moderate-to-vigorous physical activity were different in wave 2, with introjected regulation changing direction and a negative association with amotivation, although confidence intervals were wide due to smaller sample sizes. In the interviews, parents spoke of the effects that the COVID-19 lockdowns had on their motivation to be physically active in four theoretically driven themes: (1) motivation for physical activity, (2) perceived autonomy for physical activity, (3) perceived competence for physical activity and (4) perceived relatedness for physical activity. Limitations: The smaller sample sizes for waves 1 and 2 may have limited the ability to identify associations between behavioural regulations and moderate-to-vigorous physical activity post pandemic. Across all waves, parents were predominantly active, females, white and from higher socioeconomic areas and therefore may not reflect broader experiences. Conclusions and future work: Autonomous motivation, especially enjoyment and the importance for mental and physical well-being, was a key driver in keeping parents active during lockdowns and remains important for physical activity post lockdown, with introjected regulation potentially playing an increased role. Parents' interviews highlighted that while for some the lockdowns promoted autonomous motivation for exercise, others had enduring negative influences on their autonomy, competence and relatedness, which could be detrimental to their well-being. Strategies that focus on offering a range of novel activities for parents and that bring parent groups together may be effective. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847.


The COVID-19 pandemic affected parents' ability to be active. Motivation is important for taking part in physical activity. We wanted to know how motivation for exercise had changed since before the pandemic and how it might still impact parents' physical activity. We asked groups of parents of children in year 6 (aged 10­11 years) to complete a questionnaire and wear a device that measures physical activity. One group did this before the pandemic and two groups did this after the lockdowns. We also spoke to parents two times after schools reopened. We asked about their physical activity, what they felt helped or stopped them being active and how this changed during the pandemic. Motivation plays a part in how much physical activity parents do. Enjoying activities, being active because it is part of your identity and being active due to health make parents more active. Some parents felt they were more active in the first lockdown, as they had more time, freedom and a choice of new and exciting activities, while others felt the lockdowns led to them being less active. This was due to a loss of connection with other people and feeling less confident in their physical activity. This means that it is important that parents are well-supported in their physical activity post pandemic efforts to help parents be active should focus on creating opportunities for parents to try new activities opportunities for parents to be active together might lead to more physical activity, improved connections with others and better well-being.

4.
Public Health Res (Southampt) ; : 1-37, 2024 Feb 07.
Article in English | MEDLINE | ID: mdl-38345271

ABSTRACT

Background: The COVID-19 lockdowns and social distancing measures, including school closures, had a major impact on children's physical activity in England, with data showing an initial reduction in activity in the short-term post-lockdown phase of the pandemic followed by a recovery on average in the medium-term post-lockdown period. The school environment is an important context for child physical activity. The purpose of this study is to understand the changes that took place to school physical activity environments once schools reopened after lockdowns. This information will improve understanding of why changes to children's physical activity have occurred over the course of the pandemic and the implications for future promotion of physical activity in schools. Methods: Interviews with parents (n = 43), school staff (n = 18) and focus groups with 10- to 11-year-old children (participant n = 92) were conducted at two time points: between September-December 2021 and February-July 2022. Interview and focus group guides covered the impact of the pandemic on child physical activity and changes to this over time. The framework method was used for analysis. Results: Three themes and three subthemes were generated: (1) the return to school; (2) over-pressured staff and environment and (3) the uneven impact of the pandemic. Theme 3 consists of three subthemes: (a) retained pandemic policies, (b) impact on physical activity culture and (c) different children need different things. Limitations and future work: Conducting this research in schools during ongoing COVID-19 disruptions was a challenge and may have limited school and participant participation, particularly school staff. The parent interview sample is predominantly female, active and of higher socioeconomic status, so the experiences of male, less active and lower socioeconomic parents are limited. This study suggests that the impact of COVID-19 on child physical activity is uneven, affecting some children more than others. Future work is therefore needed to explore the details of this potential diverging experience. Conclusion: The COVID-19 pandemic, school closures and post-lockdown school policies have impacted upon primary school physical activity environments. The post-lockdown school environment is highly pressured, impacting the extent to which schools can support and encourage child physical activity. Future research is needed to further explore the impact of post-lockdown changes on physical activity environments in schools, particularly over the longer term, as schools continue to adapt post lockdowns. Strategies required to support school physical activity environments must be context specific and sensitive to these changes, pressures and needs. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847.


Schools are important spaces for children's physical activity. Children can be active in physical education lessons, break times, after-school clubs and travelling to school. School closures and other COVID-19 restrictions affected children's physical activity. We wanted to know how physical activity in primary schools might have changed since the pandemic. We spoke to school staff, pupils and parents two times after schools reopened. We asked about children's physical activity, and if or how this had changed over the course of the pandemic. We asked school staff about school policies around physical activity. When children went back to school, schools needed a 'recovery' approach. Children's academic, social and physical skills had been affected. For this time schools prioritised physical activity, but this was short-lived. Since then, schools have been highly pressured. They have had to 'catch up' on missed learning, staff are overloaded and some pupils are still affected by the lockdowns. Physical activity policies in schools have changed, but in many different ways. Some have kept social distancing policies; others feel their school culture has changed. Additionally, pupil ability and needs are more polarised. These factors have shaped, but are also shaped by, the high pressure in schools. Supporting changing child needs in highly pressured schools is hard for state primary schools. Changes to school physical activity policies need to be understood and evaluated. Strategies to ease pressure in schools are needed to support physical activity.

5.
PLoS One ; 19(1): e0297016, 2024.
Article in English | MEDLINE | ID: mdl-38215072

ABSTRACT

INTRODUCTION: Supporting adolescents with their health and wellbeing is an international public health priority. Schools are well placed to universally detect unmet health needs and support pupils. This study aimed to evaluate the effectiveness of a digital health and wellbeing screening tool, called the 'Digital Health Contact' (DHC) implemented in schools in the East Midlands of England. The DHC, delivered by Public Health Nurses (School Nurses) (PHN(SN)), aims to identify pupils with unmet health needs (via a 'red flag' system) and provide appropriate support. MATERIALS AND METHODS: Using data from 22 schools which took part in the DHC and 14 schools which did not take part, across three academic years (2018-2020), we conducted a controlled interrupted timeseries analysis with negative binomial regression to explore the effect of the DHC on the number of annual referrals to PHN(SN). Using DHC data from 164 pupils, we further conducted a Difference-in-Difference analysis to explore the impact of 'red flag' and referral via the DHC in Year 9 (age 13-14) on the number of red flags in Year 11 (age 15-16). RESULTS: Across all schools, the mean annual number of referrals increased over the three year follow-up period. In the adjusted model, the number of referrals was comparable between schools taking part in the DHC and non-participating schools (0.15 referrals [95% CI -0.21, 0.50]). Red flag score was not significantly different among Year 11 pupils, after being referred via the DHC in Year 9 (-0.36 red flags [95% CI -0.97, 0.24]). DISCUSSION: The DHC, and similar screening tools, have the potential to raise awareness of the health and wellbeing support in schools and provide an additional pathway of referral to this support for pupils with unmet health needs, without replacing the traditional pathway where pupils refer themselves or are referred by teachers.


Subject(s)
Digital Health , Humans , Adolescent , England
6.
Crisis ; 2023 Nov 17.
Article in English | MEDLINE | ID: mdl-37975217

ABSTRACT

Background: People who present to the emergency department with self-harm and co-occurring substance use problems often have difficulty accessing effective care. Aims: To develop a brief psychosocial intervention for this population, which would be suitable for testing in a future randomized controlled trial. Methods: A modified Delphi method was used. A 34-item, 3-round, online Delphi survey was informed by a literature review and stakeholder telephone discussions (n = 17). Two panels consisting of people with lived experience (PWLE: n = 15) and people with occupational experience (PWOE: n = 21) participated in the survey. The threshold for consensus was a pooled agreement rate across the two panels of 80% or more. Results: Expert consensus was achieved for 22 items. The new intervention consists of weekly follow-up phone calls for up to 1 month, delivered by Liaison Psychiatry practitioners, in which both self-harm and substance use problems are explored and addressed, and patients are supported in accessing community services. Limitations: Some stakeholder ideas regarding intervention components could not be included as survey options due to anticipated difficulties with implementation. Conclusions: The key elements of a brief psychosocial intervention for self-harm and co-occurring substance use problems have been agreed. Feasibility testing is currently underway.

7.
PLoS One ; 18(11): e0289344, 2023.
Article in English | MEDLINE | ID: mdl-38011119

ABSTRACT

Physical activity is important for children's health, but moderate to vigorous physical activity (MVPA) declines with age. COVID-19 lockdowns resulted in reduced MVPA and increased sedentary time among children. Characterising children's activity patterns may help identify groups who are most likely to be inactive post-lockdown. Data were combined from a pre-COVID-19 cohort study on children aged 5-6 years (Year1: n = 1299), 8-9 years (Year4: n = 1223) and 10-11 years (Year6: n = 1296) and cross-sectional post-lockdown data from a natural experiment on 10-11-year-olds in 2021 (Year6-W1: n = 393) and 2022 (Year6-W2: n = 436). The proportions of time spent in MVPA, light physical activity (LPA) and sedentary time on weekdays and weekends were derived from accelerometer data. Latent class analysis was used to identify activity profiles pre and post-lockdown, and estimate pre-COVID-19 transitions between Year4 and Year6. We identified six pre-COVID-19 activity profiles in Year6, including a new profile characterised by very low MVPA and high sedentary time (19% of children). There was substantial movement between profiles at Year4 and Year6, with 45% moving to a profile with lower MVPA. Likelihood ratio tests suggested differences in Year6 activity profiles pre and post-lockdown, with a new post-lockdown profile emerging characterised by higher LPA. The percentage of children in the least active profiles (where under 20% meet UK physical activity guidelines), rose post-lockdown, from 34% pre-COVID-19 to 50% in 2021 and 40% in 2022. We also saw gender and socioeconomic gaps widen, and increased separation between high and low physical activity levels. Children's physical activity has changed post-COVID-19, in terms of who is being active and how. The impact varies by activity profile, which is influenced by gender and socio-economic position. A greater understanding of these differences and targeting of low active groups is needed to increase both individual and population levels of physical activity.


Subject(s)
Accelerometry , COVID-19 , Humans , Child , Cohort Studies , Cross-Sectional Studies , COVID-19/epidemiology , Communicable Disease Control , Exercise
8.
Int J Behav Nutr Phys Act ; 20(1): 120, 2023 10 05.
Article in English | MEDLINE | ID: mdl-37798727

ABSTRACT

BACKGROUND: Children's physical activity in England is more dependent on active clubs after the COVID-19 pandemic. However, it is unclear how the COVID-19 pandemic and related cost-of-living crisis have impacted on active club participation, costs and provision. This mixed-methods natural experiment explored school-based and community-based active clubs after lockdowns, using a unique combination of data sources to highlight implications for policy and practice post-COVID-19. METHODS: Cross-sectional questionnaire data on school and community active clubs were collected from 10-11-year-old children pre-COVID-19 in 2017-18 (N = 1,296; 50 schools), in 2021 (N = 393; 23 schools), and 2022 (N = 463; 27 schools). Club participation and attendance frequency were modelled using logistic and Poisson mixed effects models, adjusted for child age, gender and household education. In 2021 and 2022, parents reported expenditure on community-based clubs and schools provided data on school-based club provision, with data summarised descriptively. Qualitative data were collected in 2021 and 2022, with one-to-one interviews with school staff (N = 18) and parents (N = 43), and twelve child focus groups (N = 92), and analysed using the framework method. RESULTS: School-based active club participation was higher in 2022 compared to pre-pandemic (50% /43%), while community-based club participation was lower (74%/80%). Children attended 0.3 fewer clubs per week. Those from lower education households were less likely to participate in both types of active clubs, and girls less likely to attend community clubs. In 2022, the median cost of community and school club sessions were £6.67 and £3.88 respectively, with 52% of school-based clubs free to parents. Schools offered an average of 3.4 active clubs per week for 10-11-year-olds in 2022, with 34% partly/wholly subsidised. Qualitative analysis highlighted the impact of the cost-of-living crisis and COVID-19 pandemic on family resources, encouraging a shift to more affordable and convenient school-based active clubs, which negatively impacted the community-based active club environment. However, many schools struggled to meet this increased demand. CONCLUSIONS: Findings emphasise the importance for policymakers to support schools to meet increased demand for clubs and community clubs to increase affordable and convenient physical activity opportunities. Targeted support is needed to prevent socioeconomic and gender inequalities.


Subject(s)
COVID-19 , Pandemics , Female , Humans , Child , Cross-Sectional Studies , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , England , Schools , Surveys and Questionnaires , Policy
9.
BMC Public Health ; 23(1): 1432, 2023 07 27.
Article in English | MEDLINE | ID: mdl-37495976

ABSTRACT

BACKGROUND: The COVID-19 pandemic significantly impacted children's physical activity. Recent evidence indicated children's accelerometer-measured physical activity levels have, on average, returned to near pre-pandemic levels in 2022, though sedentary behaviour remains higher. However, insufficient physical activity levels among children continues to be a critical public health issue in the UK, with only 41% meeting physical activity guidelines. This study aimed to provide in-depth analysis of how the pandemic has shaped children's physical activity patterns beyond the short-term periods following lockdowns and identify the new challenges to engaging children in physical activity. METHODS: One-to-one interviews with parents (n = 22), school staff (n = 9), and six focus groups with children aged 10-11 years (n = 45) were conducted between February and July 2022. Topics explored changes to children's physical activity and sedentary behaviour patterns, including screen-viewing, and factors influencing any changes. The framework method was used for analysis. RESULTS: Five themes were generated. Theme 1 described residual lockdown habits, including increased screen-viewing within the home, while activities outside the home continued to feel less spontaneous. Theme 2 highlighted an interrupted development of social, emotional, and physical skills among children compared to what would be expected pre-pandemic. This coincided with Theme 3 which reflected increased mental health challenges among families, creating complex barriers to children's physical activity. A new normal for child physical activity was evoked and explored in Theme 4, with greater dependence on structured and organised activities. However, Theme 5 highlighted that girls and children with lower socio-economic position may be especially at risk of decreased physical activity. CONCLUSIONS: There is a new normal for children's physical activity that is characterised by increased dependence on structured and organised physical activities, such as active clubs, and less on unstructured and spontaneous physical activities, such as physical play. While this may suit many children, girls and children from lower socio-economic households face barriers to participating in the new normal. It is important that affordable and equitable opportunities are provided to all children to prevent physical activity and health inequalities.


Subject(s)
COVID-19 , Pandemics , Female , Humans , Child , Pandemics/prevention & control , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Exercise/psychology , Parents/psychology , United Kingdom/epidemiology
10.
Int J Behav Nutr Phys Act ; 20(1): 42, 2023 04 27.
Article in English | MEDLINE | ID: mdl-37101270

ABSTRACT

BACKGROUND: The COVID-19 pandemic has resulted in marked impacts on children's physical activity, with large reductions in moderate-to-vigorous physical activity (MVPA) reported during lockdowns. Previous evidence showed children's activity levels were lower and sedentary time higher immediately post-COVID lockdown, while there was little change in parental physical activity. We need to know if these patterns persist. METHODS: Active-6 is a natural experiment using repeated cross-sectional data conducted in two waves. Accelerometer data were collected on 393 children aged 10-11 and their parents from 23 schools in Wave 1 (June 2021-December 2021), and 436 children and parents from 27 schools in Wave 2 (January 2022-July 2022). These were compared to a pre-COVID-19 comparator group (March 2017-May 2018) of 1,296 children and parents in the same schools. Mean minutes of accelerometer-measured MVPA and sedentary time were derived for week- and weekend-days and compared across waves via linear multilevel models. We also analysed the date of data collection as a time series, to explore temporal patterns via generalised additive mixed models. RESULTS: There was no difference in children's mean MVPA in Wave 2 (weekdays: -2.3 min; 95% CI: -5.9, 1.3 and weekends: 0.6 min; 95% CI: -3.5, 4.6) when compared to the pre-COVID-19 data. Sedentary time remained higher than pre-pandemic by 13.2 min (95% CI:5.3, 21.1) on weekdays. Differences compared to pre-COVID-19 changed over time, with children's MVPA decreasing over winter, coinciding with COVID-19 outbreaks, and only returning to pre-pandemic levels towards May/June 2022. Parents' sedentary time and weekday MVPA was similar to pre-COVID-19 levels, with MVPA higher than pre-pandemic by 7.7 min (95% CI: 1.4, 14.0) on weekends. CONCLUSION: After an initial drop, children's MVPA returned to pre-pandemic levels by July 2022, while sedentary time remained higher. Parents' MVPA remained higher, especially at weekends. The recovery in physical activity is precarious and potentially susceptible to future COVID-19 outbreaks or changes in provision, and so robust measures to protect against future disruptions are needed. Furthermore, many children are still inactive, with only 41% meeting UK physical activity guidelines, and so there is still a need to increase children's physical activity.


Subject(s)
COVID-19 , Sedentary Behavior , Humans , Child , Cross-Sectional Studies , Pandemics , Accelerometry , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Exercise , Parents
11.
Article in English | MEDLINE | ID: mdl-36982124

ABSTRACT

Food insecurity amongst households with children is a growing concern globally. The impacts in children include poor mental health and reduced educational attainment. Providing universal free school meals is one potential way of addressing these impacts. This paper reports findings on the impact of a universal free school meals pilot in two English secondary schools. We adopted a mixed-methods, quasi-experimental design. The intervention schools were one mainstream school (n = 414) and one school for students with special educational needs (n = 105). Two other schools were used as comparators (n = 619; n = 117). The data collection comprised a cross sectional student survey during the pilot (n = 404); qualitative interviews with students (n = 28), parents (n = 20) and school staff (n = 12); and student observations of lunchtimes (n = 57). Qualitative data were analysed using thematic analysis, and descriptive analyses and logistic regressions were conducted on the quantitative data. Self-reports of food insecurity were high at both intervention (26.6%) and comparator schools (25.8%). No effects of the intervention were seen in the quantitative findings on either hunger or food insecurity. Qualitative findings indicated that students, families and staff perceived positive impact on a range of outcomes including food insecurity, hunger, school performance, family stress and a reduction in stigma associated with means-tested free school meals. Our research provides promising evidence in support of universal free school meals in secondary schools as a strategy for addressing growing food insecurity. Future research should robustly test the impact of universal free school meals in a larger sample of secondary schools, using before and after measures as well as a comparator group.


Subject(s)
Food Services , Meals , Child , Humans , Cross-Sectional Studies , Schools , Lunch , Students
12.
BMC Public Health ; 23(1): 300, 2023 02 09.
Article in English | MEDLINE | ID: mdl-36759797

ABSTRACT

BACKGROUND: In the UK, one in five households with children experienced food insecurity in 2022, defined as a household-level economic and social condition of limited or uncertain access to adequate food. Free school meals are a public health intervention aimed at reducing food insecurity amongst children. The provision of universal free school meals (UFSM) to secondary school-aged children is a novel and untested intervention in the UK. This study is a process evaluation of a pilot of UFSM in two secondary schools in England. The aim was to understand the feasibility, acceptability, cost implications and lessons for the implementation of UFSM. METHODS: 20 parents, 28 students and 8 school staff from two intervention schools participated in online qualitative interviews, as well as 4 staff from non-intervention schools. The Framework Method of thematic analysis was applied. These data were supplemented with student-led observations of school meal times, and school lunch uptake-data and cost information provided by the local authority delivering the pilot. RESULTS: UFSM in secondary schools is a feasible and acceptable intervention, with coherent goals of increased access to a healthy meal, reduced food insecurity and better nutrition. All participants perceived these goals were met. Acceptability was further enhanced by the perception that UFSM were supporting a greater proportion of low-income families than the national, targeted Free School Meal scheme, as well as being easier to implement. Potential barriers to implementation include limited school kitchen and dining infrastructure, meal quality and choice, and increased queuing times. Participants' concerns that UFSM may benefit middle- and high- income families not in need were not as prevalent as the perception that UFSM was an effective way to support all families with secondary-aged children experiencing food insecurity. CONCLUSION: This small-scale pilot study suggests that UFSM in secondary schools is feasible and acceptable, but more evidence is required from larger studies on the impact on long-term health, psychosocial and educational outcomes. Future, larger studies should also include detailed economic evaluations so this approach can be compared with other possible interventions.


Subject(s)
Food Services , Meals , Child , Humans , Aged , London , Pilot Projects , Schools , Lunch
13.
BMC Public Health ; 23(1): 116, 2023 01 17.
Article in English | MEDLINE | ID: mdl-36650495

ABSTRACT

BACKGROUND: Restrictions during the COVID-19 pandemic have led to increased screen-viewing among children, especially during strict periods of lockdown. However, the extent to which screen-viewing patterns in UK school children have changed post lockdowns is unclear. The aim of this paper is to examine how screen-viewing changed in 10-11-year-old children over the 2020-21 COVID-19 pandemic, how this compares to before the pandemic, and the influences on screen-viewing behaviour. METHODS: This is a mixed methods study with 10-11-year-olds from 50 schools in the Greater Bristol area, UK. Cross-sectional questionnaire data on minutes of weekday and weekend television (TV) viewing and total leisure screen-viewing were collected pre-COVID-19 in 2017-18 (N = 1,296) and again post-lockdowns in 2021 (N = 393). Data were modelled using Poisson mixed models, adjusted for age, gender, household education and seasonality, with interactions by gender and household education. Qualitative data were drawn from six focus groups (47 children) and 21 one-to-one parent interviews that explored screen-viewing behaviour during the pandemic and analysed using the framework method. RESULTS: Total leisure screen-viewing was 11% (95% CI: 12%-18%) higher post-lockdown compared to pre-COVID-19 on weekdays, and 8% (95% CI: 6%-10%) on weekends, equating to around 12-15 min. TV-viewing (including streaming) was higher by 68% (95% CI: 63%-74%) on weekdays and 80% (95% CI: 75%-85%) on weekend days. Differences in both were higher for girls and children from households with lower educational attainment. Qualitative themes reflected an unavoidable increase in screen-based activities during lockdowns, the resulting habitualisation of screen-viewing post-lockdown, and the role of the parent in reducing post-2020/21 lockdown screen-viewing. CONCLUSIONS: Although screen-viewing was higher post-lockdown compared to pre-COVID-19, the high increases reported during lockdowns were not, on average, sustained post-lockdown. This may be attributed to a combination of short-term fluctuations during periods of strict restrictions, parental support in regulating post-lockdown behaviour and age-related, rather than COVID-19-specific, increases in screen-viewing. However, socio-economic differences in our sample suggest that not all families were able to break the COVID-19-related adoption of screen-viewing, and that some groups may need additional support in managing a healthy balance of screen-viewing and other activities following the lockdowns.


Subject(s)
COVID-19 , Computers , Female , Humans , Child , Cross-Sectional Studies , Pandemics/prevention & control , Sedentary Behavior , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Surveys and Questionnaires , United Kingdom/epidemiology , Television
14.
Pilot Feasibility Stud ; 8(1): 245, 2022 Dec 03.
Article in English | MEDLINE | ID: mdl-36463273

ABSTRACT

BACKGROUND: Dental caries in childhood is a burden on the daily lives of children and their families, and associated with poor oral health in adulthood. In England, dental caries is the most common reason for young children to be admitted to hospital. It is believed that most tooth extractions (due to decay) for children aged 10 years and under, could be avoided with improved prevention and early management. National public health policy recommendations in England include specific oral health initiatives to tackle tooth decay. One of these initiatives is delivered as part of the Healthy Child Programme and includes providing workforce training in oral health, integrating oral health advice into home visits, and the timely provision of fluoride toothpaste. This protocol seeks to assess the delivery of the First Dental Steps intervention and uncertainties related to the acceptability, recruitment, and retention of participants. METHODS: This study seeks to explore the feasibility and acceptability of the First Dental Steps intervention and research methods. First Dental Steps intervention will be delivered in local authority areas in South West England and includes oral health training for health visitors (or community nursery nurses) working with 0-5-year-olds and their families. Further, for vulnerable families, integrating oral health advice and the provision of an oral health pack (including a free flow cup, an age appropriate toothbrush, and 1450 ppm fluoride toothpaste) during a mandated check by a health visitor. In this study five local authority areas will receive the intervention. Interviews with parents receiving the intervention and health visitors delivering the intervention will be undertaken, along with a range of additional interviews with stakeholders from both intervention and comparison sites (four additional local authority areas). DISCUSSION: This protocol was written after the start of the COVID-19 pandemic, as a result, some of the original methods were adjusted specifically to account for disruptions caused by the pandemic. Results of this study will primarily provide evidence on the acceptability and feasibility of both the First Dental Steps intervention and the research methods from the perspective of both families and stakeholders.

15.
Int J Behav Nutr Phys Act ; 19(1): 114, 2022 09 05.
Article in English | MEDLINE | ID: mdl-36064548

ABSTRACT

BACKGROUND: Active-6 is exploring how the COVID-19 pandemic has impacted physical activity behaviour among Year 6 children (aged 10-11 years) and their parents in Southwest England. Initial findings from the Active-6 project have shown a 7-8 min decrease in moderate-to-vigorous physical activity and an increase in sedentary behaviour among children following the easing of restrictions in the UK in latter half of 2021. This finding suggests that the pandemic has had a persistent impact on child physical activity behaviour. This paper explored the possible mechanisms behind these changes. METHODS: Interviews with parents (n = 21), members of school staff (n = 9) and focus groups with children aged 10-11 years (n = 47) were conducted between August and December 2021 to discuss the impact of the pandemic on child physical activity behaviour. The framework method was used for analysis. RESULTS: Five themes spanning two key stages of the pandemic were described. Three themes related to the period of lockdowns and fluctuating restrictions (March 2020 - April 2021). These included: Theme 1) Lockdown: A short-lived adventure; Theme 2) Access to facilities during restrictions; and Theme 3) The importance of the parent. A further two themes were identified related to the period following the gradual easing of restrictions in April 2021. These included: Theme 4) An overwhelming return to normal; and Theme 5) Reopening fatigue. CONCLUSIONS: The analysis suggested that feelings of novelty experienced during the initial stages of lockdown waned as restrictions were prolonged, creating an increasingly challenging period for parents and their children. However, during periods of restrictions, the importance of parental encouragement and access to appropriate facilities in the local and home environment helped facilitate physical activity. Following the easing of COVID-19 restrictions, emotional overwhelm and physical fatigue among children, stemming from a sedentary and socially isolated life in lockdown and other restrictions, were key contributors to the decreased moderate to vigorous physical activity and increased sedentary behaviour that was observed in a related quantitative study.


Subject(s)
COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , Child , Communicable Disease Control , Exercise , Fatigue , Humans , Pandemics , United Kingdom/epidemiology
16.
Int J Behav Nutr Phys Act ; 19(1): 51, 2022 05 16.
Article in English | MEDLINE | ID: mdl-35570265

ABSTRACT

BACKGROUND: Restrictions due to the coronavirus disease 2019 (COVID-19) pandemic reduced physical activity provision for both children and their parents. Recent studies have reported decreases in physical activity levels during lockdown restrictions, but these were largely reliant on self-report methods, with data collected via unrepresentative self-report surveys. The post-pandemic impacts on children's activity levels remain unknown. A key question is how active children become once lockdown restrictions are lifted. METHODS: Active-6 is a repeated cross-sectional natural experiment. Accelerometer data from 1296 children aged 10-11 and their parents were collected in 50 schools in the Greater Bristol area, UK in March 2017-May 2018 (pre-COVID-19 comparator group), and compared to 393 children aged 10-11 and parents in 23 of the same schools, collected in May-December 2021. Mean minutes of accelerometer-measured moderate-to-vigorous physical activity (MVPA) were derived for weekdays and weekend and compared pre- and post-lockdown via linear multilevel models. RESULTS: After adjusting for seasonality, accelerometer wear time and child/parent demographics, children's mean weekday and weekend MVPA were 7.7 min (95% CI: 3.5 to 11.9) and 6.9 min (95% CI: 0.9 to 12.9) lower in 2021 than in 2018, respectively, while sedentary time was higher by 25.4 min (95% CI: 15.8 to 35.0) and 14.0 min (95% CI: 1.5 to 26.5). There was no evidence that differences varied by child gender or household education. There was no significant difference in parents' MVPA or sedentary time, either on weekdays or weekends. CONCLUSIONS: Children's MVPA was lower by 7-8 min/day in 2021 once restrictions were lifted than before the pandemic for all groups, on both weekdays and weekends. Previous research has shown that there is an undesirable age-related decline in children's physical activity. The 8-min difference reported here would be broadly comparable to the decline that would have previously been expected to occur over a three-year period. Parents' physical activity was similar to pre-pandemic levels. Our results suggest that despite easing of restrictions, children's activity levels have not returned to pre-pandemic levels. There is an urgent need to understand why these changes have occurred and how long they are maintained.


Subject(s)
COVID-19 , Sedentary Behavior , Accelerometry , COVID-19/epidemiology , COVID-19/prevention & control , Child , Communicable Disease Control , Cross-Sectional Studies , Exercise , Humans , Parents , United Kingdom/epidemiology
17.
Article in English | MEDLINE | ID: mdl-35409747

ABSTRACT

Despite high levels of need, many young people who experience health issues do not seek, access or receive support. Between May and November 2021, using semi-structured interviews, we explored the perspectives of 51 young people (aged 13-14) from two schools who had taken part in a novel online health and wellbeing screening programme, the Digital Health Contact (DHC). One school delivered the DHC during home-learning due to COVID-19 restrictions, whilst the other delivered it in school when restrictions were lifted. The DHC was seen as a useful approach for identifying health need and providing support, and had high levels of acceptability. Young people appreciated the online format of the DHC screening questionnaire and thought this facilitated more honest responses than a face-to-face approach might generate. Completion at home, compared to school-based completion, was perceived as more private and less time-pressured, which young people thought facilitated more honest and detailed responses. Young people's understanding of the screening process (including professional service involvement and confidentiality) influenced engagement and responses. Overall, our findings afford important insights around young people's perspectives of participating in screening programmes, and highlight key considerations for the development and delivery of health screening approaches in (and out of) school.


Subject(s)
COVID-19 , School Nursing , Adolescent , COVID-19/epidemiology , Creativity , Humans , Mass Screening , Schools
18.
NIHR Open Res ; 2: 1, 2022 Jan 18.
Article in English | MEDLINE | ID: mdl-35392303

ABSTRACT

This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact. This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews.

19.
BMC Public Health ; 22(1): 324, 2022 02 16.
Article in English | MEDLINE | ID: mdl-35168580

ABSTRACT

BACKGROUND: Supporting children and young people's (CYP) mental and physical health is a global policy priority but detecting need and facilitating access to health services and support is challenging. This paper explores professional stakeholders' perspectives of the acceptability, utility and effectiveness of a school-based online health and wellbeing screening tool, the Digital Health Contact (DHC). The DHC, delivered by Public Health School Nurses (PHSN), aims to identify, and put in place strategies to support, unmet health needs among CYP. METHODS: We employed a qualitative study design, using semi-structured interviews. Fourteen key stakeholders involved in the design and implementation of the DHC (commissioners, providers, PHSN and healthcare staff, school leaders) were purposively sampled. Data were analysed thematically. RESULTS: Our analysis generated two key themes: the perceived benefits of the DHC; and challenges in delivering the DHC. Stakeholders perceived the universal application of the DHC with linked follow-up intervention as an effective means of identifying and supporting CYP with unmet needs, and an efficient way to target limited service resources. There were barriers around enabling school engagement in the DHC, typically in terms of logistics, school infrastructure, and perspectives of fit with schools. These barriers were seen as being negated through developing effective working relationships between schools and PHSN. Effective relationships could highlight the potential benefits of participation. Overall, the DHC was seen as a valuable and effective use of resources, with a low burden on school staff. CONCLUSIONS: The DHC, as a universal school-based health and wellbeing screening tool with linked follow-up intervention, has great potential in identifying and supporting unmet health needs among CYP. The perspectives and experiences of those involved in delivering the DHC highlight important considerations which may enable effective implementation and delivery of school screening programmes across other areas.


Subject(s)
Mass Screening , Schools , Adolescent , Child , Delivery of Health Care , Humans , Qualitative Research
20.
N Engl J Med ; 385(10): 885-895, 2021 09 02.
Article in English | MEDLINE | ID: mdl-34469646

ABSTRACT

BACKGROUND: Immune thrombocytopenia is a rare autoimmune disorder with associated bleeding risk and fatigue. Recommended first-line treatment for immune thrombocytopenia is high-dose glucocorticoids, but side effects, variable responses, and high relapse rates are serious drawbacks. METHODS: In this multicenter, open-label, randomized, controlled trial conducted in the United Kingdom, we assigned adult patients with immune thrombocytopenia, in a 1:1 ratio, to first-line treatment with a glucocorticoid only (standard care) or combined glucocorticoid and mycophenolate mofetil. The primary efficacy outcome was treatment failure, defined as a platelet count of less than 30×109 per liter and initiation of a second-line treatment, assessed in a time-to-event analysis. Secondary outcomes were response rates, side effects, occurrence of bleeding, patient-reported quality-of-life measures, and serious adverse events. RESULTS: A total of 120 patients with immune thrombocytopenia underwent randomization (52.4% male; mean age, 54 years [range 17 to 87]; mean platelet level, 7×109 per liter) and were followed for up to 2 years after beginning trial treatment. The mycophenolate mofetil group had fewer treatment failures than the glucocorticoid-only group (22% [13 of 59 patients] vs. 44% [27 of 61 patients]; hazard ratio, 0.41; range, 0.21 to 0.80; P = 0.008) and greater response (91.5% of patients having platelet counts greater than 100×109 per liter vs. 63.9%; P<0.001). We found no evidence of a difference between the groups in the occurrence of bleeding, rescue treatments, or treatment side effects, including infection. However, patients in the mycophenolate mofetil group reported worse quality-of-life outcomes regarding physical function and fatigue than those in the glucocorticoid-only group. CONCLUSIONS: The addition of mycophenolate mofetil to a glucocorticoid for first-line treatment of immune thrombocytopenia resulted in greater response and a lower risk of refractory or relapsed immune thrombocytopenia, but with somewhat decreased quality of life. (Funded by the U.K. National Institute for Health Research; FLIGHT ClinicalTrials.gov number, NCT03156452; EudraCT number, 2017-001171-23.).


Subject(s)
Glucocorticoids/therapeutic use , Immunosuppressive Agents/therapeutic use , Mycophenolic Acid/therapeutic use , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Adolescent , Adult , Aged , Drug Therapy, Combination , Fatigue/chemically induced , Female , Glucocorticoids/adverse effects , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Immunosuppressive Agents/adverse effects , Male , Middle Aged , Mycophenolic Acid/adverse effects , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/complications , Quality of Life , Young Adult
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