Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children: a pilot randomised controlled trial

Abstract

BackgroundFew evidence-based physical activity interventions for pre-school children are available. This two-armed pilot cluster randomised controlled trial aimed to evaluate the feasibility of conducting a full-scale trial and of delivering an outdoor physical activity intervention for pre-school children.MethodsSchool was the unit of randomisation, and follow-up occurred at 10 and 52 weeks. Trial feasibility was assessed by recruitment, retention and completion rates of primary (daily moderate-to-vigorous physical activity (MVPA)) and secondary (anthropometric, quality of life, self-efficacy) outcomes. Potential effectiveness was assessed for the primary outcome using a linear regression model comparing MVPA between trial arms adjusting for clustering by school. Feasibility of delivering the intervention was assessed by intervention fidelity and attendance. Semi-structured interviews with parents, intervention facilitators, and head teachers explored acceptability and capability to deliver the intervention as well as acceptability of the study design.ResultsRecruitment rates were 37 % of schools (n = 10 schools) and 48 % of pre-school children (n = 164 children). Retention of children to the trial at 52 weeks was 83.5 %. Thirty-nine percent of children had valid primary outcome accelerometer data at baseline and 52 weeks. Response rates for secondary outcome measures ranged from 52 to 88 % at 10 weeks and 59 to 80 % at 52 weeks. The mean difference in daily MVPA between trial arms at 52 weeks was 0.4, 95 % CI 16.3 to 17.0; p = 0.96. Fidelity of intervention implementation was 81 %. Intervention attendance was higher (82 %) during the summer initiation phase compared to autumn/spring initiation (50 %). Parents, facilitators and head teachers found the intervention acceptable and beneficial.ConclusionsRecruitment and retention rates suggest a trial in this outdoor setting with this population was feasible but is weather sensitive. However, strategies to increase accelerometer wear-time would need to be implemented for reliable primary outcome data to be obtained. There was high implementation fidelity by facilitators, and the intervention was seen as acceptable and deliverable. However, attendance was low and preliminary data showed no evidence of intervention effectiveness. A revised intervention, building on the successful elements of this pilot alongside adapting implementation strategies to improve attendance, should therefore be considered.Trial registrationTrial registry name and number: Current Controlled Trials, ISRCTN54165860. Date of registration: 4 September 2012.

Objectively-measured sedentary time and physical activity in a bi-ethnic sample of young children: variation by socio-demographic, temporal and perinatal factors

“…Data were pooled from three projects that are related to the Born in Bradford birth cohort study [14] and research programme (www.borninbradford.nhs.uk). Two projects were observational studies [15,16] and another was a multiple time-point school-based pilot cluster randomised control trial (RCT) that targeted preschool children [17]. Each study included objective measurement of free-living physical activity in young children living in Bradford, which is one of most deprived and ethnically diverse cities in the UK [18].…”

“…Data were collected between June 2011 and November 2015. Because intervention attendance was low and there was no evidence for trial effectiveness, all data from both the control and intervention groups of the RCT were used [17]; this allowed each trial participant to contribute up to four repeated measurements of physical activity (collected at baseline, 10, 30 and 52 weeks of follow-up). The study sample used for this investigation was heavily deprived because the RCT recruited schools from the poorest locations in Bradford.…”

“…This could be due to a combination of cultural and environmental differences. It has been suggested that South Asian parents prefer to keep children indoors given inclement weather or winter colds [17,41]. Additionally, the South Asian families who took part in this study lived in the most deprived areas.…”

About Errors in Meta-Analyses of Cardiovascular Effects of Omega-3 PUFA Part 1. Pharmacological and Clinical Aspects of Validity in the Era of Post-Genomic Research, Artificial Intelligence and Big Data Analysis

“…Иоаннидиса: «Доказательность чрезвычайно уязвима к обоснованным упрекам в том, что отражает не объективную реальность, а просто устоявшееся мнение» [1,2]. Действительно, когда главнейшие выводы доказательных кохрейновских иссле- дований звучат как «физкультура полезна для дошкольников, но зависит от погоды» (trial in this outdoor setting with this population was feasible but is weather sensitive) [21], «более низкое потребление жира ведет к малому, но статистически значимому снижению массы тела» (lower total fat intake leads to small but statistically significant and clinically meaningful, sustained reductions in body weight in adults) [22], «регулярные упражнения улучшают гликемический контроль у пациентов с сахарным диабетом 2-го типа» [23], «сжимаемые бутылки с соской удобнее при использовании у грудных детей (с расщелиной неба)» (squeezable bottles appear easier to use than rigid feeding bottles for babies born with clefts of the lip and/or palate) [24], «нельзя исключить клинически важные эффекты от снижения потребления поваренной соли на сердечно-сосудистую патологию» (there is still insufficient power to exclude clinically important effects of reduced dietary salt on mortality or CVD morbidity) [ Из таких омега-3 ПНЖК, как декозагексаеновая и эйкозапентаеновая, образуются важнейшие регуляторы воспаления -эйкозаноиды и докозаноиды, в том числе нейропротектины, резолвины и маресины [42]. Эйкозаноиды и докозаноиды, синтезируемые из соответствующих кислот в каскаде арахидоновой кислоты, имеют ключевое значение для физиологического окончания воспаленияразрешения воспаления (resolution of inflammation).…”

Assessing the acceptability of an adapted preschool obesity prevention programme: ToyBox‐Scotland

“…This is despite the fact that the importance of assessing feasibility and acceptability within a rigorous process of development and evaluation of a complex intervention is recommended by the UK's Medical Research Council (Moore et al, ). Additionally, although more recent studies have assessed components of feasibility and acceptability (Griffin et al, ; Langford et al, ), such studies rarely use multiple data collection methods to achieve data triangulation, instead opting to exclusively use questionnaires or interviews/focus groups (Barber et al, ; Pinket et al, ).…”