An mHealth intervention in early childhood education and care services to reduce the packing of discretionary foods in children’s lunchboxes: a cluster randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
Nicole Pearson ◽  
Meghan Finch ◽  
Rachel Sutherland ◽  
Melanie Kingsland ◽  
Luke Wolfenden ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Saturated Fat ◽  
Cluster Randomised Controlled Trial ◽  
Childhood Education ◽  
Mhealth Intervention ◽  
Cluster Randomised ◽  
Education And Care ◽  
Secondary Outcomes ◽  
Randomised Controlled

BACKGROUND Interventions in early childhood education and care (ECEC) services have the potential to improve child diet at the population level. OBJECTIVE This study aims to test the efficacy of an mHealth intervention in ECEC services to reduce parent packing of foods high in saturated fat, sugar and/or sodium (discretionary foods) in children’s (3-6 years) lunchboxes. METHODS A cluster randomised controlled trial was undertaken with 355 parent/child dyads recruited by phone and in person from 17 ECEC services (8 intervention and 9 control services) . Parents in the intervention group received a 10-week fully automated program, targeting common barriers to packing healthy lunchboxes delivered via an existing service communication app. The program included weekly push notifications, within-app messages, and links to further resources including weblinks and videos. The control group did not receive any intervention. The primary outcomes were kilojoules from discretionary foods and associated nutrients (saturated fat, free sugars and sodium) packed in children’s lunchboxes. Secondary outcomes included consumption of kilojoules from discretionary foods and related nutrients, and packing and consumption of serves of discretionary foods and core food groups. Photography and weights of foods in children’s lunchboxes were undertaken by trained researchers pre and post the trial to assess primary and secondary outcomes. Outcome assessors were blind to service allocation. A process evaluation assessed feasibility, acceptability and use of the app among parents via an online survey. RESULTS Data on packed lunchbox contents were collected for 355/400 (89%) consenting children at baseline and 337/400 (84%) at follow up. There was no significant difference between groups in kilojoules from discretionary foods packed (49.22 kJ, CI=-183.87, 282.31, P= .68), nor for any of the other primary or secondary outcomes. The additional analysis including only data from children of parents who owned the app also failed to detect any change in primary or secondary outcomes. Approximately 63% of parents downloaded the app, and mean viewing rate of weekly within-app messages was 23%. Parents reported that they liked the SWAP IT program (83%), and found the program useful (80%). Estimated viewing rates of within-app messages ranged from 11% to 39% per week. CONCLUSIONS Parents found it acceptable to receive lunchbox information via an existing ECEC communication app, however the intervention did not decrease the amount of energy or associated nutrients from discretionary foods packed in children’s lunchboxes. Low app downloads and program message views indicate a need for further investigation of factors influencing parent engagement with such mHealth interventions. CLINICALTRIAL The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618000133235).

scholarly journals A Cluster Randomised Controlled Trial of an Intervention to Increase Physical Activity of Preschool-Aged Children Attending Early Childhood Education and Care: Study Protocol for the ‘Everybody Energise’ Trial

2019 ◽  
Vol 16 (21) ◽  
pp. 4275
Author(s):  
Tessa Delaney ◽  
Jacklyn K. Jackson ◽  
Jannah Jones ◽  
Alix Hall ◽  
Ashleigh Dives ◽  
...  
Keyword(s):  
Physical Activity ◽  
Early Childhood ◽  
Early Childhood Education ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Childhood Education ◽  
Cluster Randomised ◽  
Education And Care ◽  
Randomised Controlled

The use of ‘Energisers,’ short bouts of moderate-to-vigorous physical activity (MVPA), have been shown to significantly increase children’s physical activity within the school setting but not within Early Childhood Education and Care (ECEC) centres. The aim of this study is to assess the efficacy of an intervention involving the provision of educator-led daily Energisers to increase the time children spend in MVPA while attending ECEC. Fourteen ECEC centres in the Hunter region of New South Wales, Australia, will be randomised to either an intervention or control group. The intervention group will be supported by the research team to implement three brief (5-min) educator-led Energisers each day for children aged three to six years between the hours of 9:00 a.m. to 3.00 p.m. Control ECEC centres will continue to provide ‘normal practice’ to children. The primary trial outcome is child minutes of MVPA whilst in ECEC, assessed objectively via accelerometery over three days. Outcome assessment will occur at baseline and 6 months post-baseline. Linear mixed models under an intention-to-treat framework will be used to compare differences between groups in MVPA at follow-up. This will be the first cluster randomised controlled trial to test the efficacy of Energisers in isolation on increasing the time children spend in MVPA.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

Healthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial

2020 ◽  
Vol 26 (6) ◽  
pp. 581-587
Author(s):  
Rebecca Ivers ◽  
Julieann Coombes ◽  
Catherine Sherrington ◽  
Tamara Mackean ◽  
Anne Tiedemann ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Fall Prevention ◽  
Aboriginal People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Fall Prevention Programme

IntroductionOlder Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people.MethodsWe will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated.ConclusionThis is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services.Trial registration numberACTRN12619000349145.

scholarly journals Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017740 ◽  
Author(s):  
Christiane Muth ◽  
Lorenz Uhlmann ◽  
Walter E Haefeli ◽  
Justine Rochon ◽  
Marjan van den Akker ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration numberISRCTN99526053. NCT01171339; Results.

scholarly journals Time-efficient intervention to improve older adolescents’ cardiorespiratory fitness: findings from the ‘Burn 2 Learn’ cluster randomised controlled trial

2020 ◽  
pp. bjsports-2020-103277
Author(s):  
David R Lubans ◽  
Jordan J Smith ◽  
Narelle Eather ◽  
Angus A Leahy ◽  
Philip J Morgan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cardiorespiratory Fitness ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Muscular Fitness ◽  
End Point ◽  
Cluster Randomised ◽  
Older Adolescents ◽  
Secondary Outcomes ◽  
Randomised Controlled

BackgroundCardiorespiratory fitness (CRF) is an important marker of current and future health status. The primary aim of our study was to evaluate the impact of a time-efficient school-based intervention on older adolescents’ CRF.MethodsTwo-arm cluster randomised controlled trial conducted in two cohorts (February 2018 to February 2019 and February 2019 to February 2020) in New South Wales, Australia. Participants (N=670, 44.6% women, 16.0±0.43 years) from 20 secondary schools: 10 schools (337 participants) were randomised to the Burn 2 Learn (B2L) intervention and 10 schools (333 participants) to the control. Teachers in schools allocated to the B2L intervention were provided with training, resources, and support to facilitate the delivery of high-intensity interval training (HIIT) activity breaks during curriculum time. Teachers and students in the control group continued their usual practice. The primary outcome was CRF (20 m multi-stage fitness test). Secondary outcomes were muscular fitness, physical activity, hair cortisol concentrations, mental health and cognitive function. Outcomes were assessed at baseline, 6 months (primary end-point) and 12 months. Effects were estimated using mixed models accounting for clustering.ResultsWe observed a group-by-time effect for CRF (difference=4.1 laps, 95% CI 1.8 to 6.4) at the primary end-point (6 months), but not at 12 months. At 6 months, group-by-time effects were found for muscular fitness, steps during school hours and cortisol.ConclusionsImplementing HIIT during curricular time improved adolescents’ CRF and several secondary outcomes. Our findings suggest B2L is unlikely to be an effective approach unless teachers embed sessions within the school day.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618000293268).

scholarly journals COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus—protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e046436
Author(s):  
David A Richards ◽  
Holly VR Sugg ◽  
Emma Cockcroft ◽  
Joanne Cooper ◽  
Susanne Cruickshank ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Nursing Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Care Quality ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Care Protocol ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionPatient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse–patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.Methods and analysiswe aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.Ethics and disseminationResearch governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.Trial registration numberISRCTN13177364; Pre-results.

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