scholarly journals Effect of nutrition counselling with a digital job aid on child dietary diversity: Analysis of secondary outcomes from a cluster randomised controlled trial in rural Bangladesh

2021 ◽  
Author(s):  
Sk Masum Billah ◽  
Tarana E. Ferdous ◽  
Patrick Kelly ◽  
Camille Raynes‐Greenow ◽  
Abu Bakkar Siddique ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Dietary Diversity ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Diversity Analysis ◽  
Rural Bangladesh ◽  
Nutrition Counselling ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

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.

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