Enhancing self-regulation skills in teenagers with severe asthma through a nurse-led intervention: a randomised controlled trial

2013 ◽  
Author(s):  
Philippa Madge
BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029425 ◽  
Author(s):  
Sarah Ellen Scott ◽  
Cristiana Duarte ◽  
Jorge Encantado ◽  
Elizabeth H Evans ◽  
Marja Harjumaa ◽  
...  

IntroductionObesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).Methods and analysisThe study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.Ethics and disseminationEthical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17–0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.Trial registration numberISRCTN88405328.


2019 ◽  
Vol 55 (3) ◽  
pp. 1901509 ◽  
Author(s):  
Vanessa M. McDonald ◽  
Vanessa L. Clark ◽  
Laura Cordova-Rivera ◽  
Peter A.B. Wark ◽  
Katherine J. Baines ◽  
...  

RationaleTreatable traits have been proposed as a new paradigm for airway disease management.ObjectivesTo characterise treatable traits in a severe asthma population and to determine the efficacy of targeting treatments to these treatable traits in severe asthma.MethodsParticipants (n=140) with severe asthma were recruited to a cross-sectional study and underwent a multidimensional assessment to characterise treatable traits. Eligible participants with severe asthma (n=55) participated in a 16-week parallel-group randomised controlled trial to determine the feasibility and efficacy of management targeted to predefined treatable traits, compared to usual care in a severe asthma clinic. The patient-reported outcome of health-related quality of life was the trial's primary end-point.Main resultsParticipants with severe asthma had a mean±sd of 10.44±3.03 traits per person, comprising 3.01±1.54 pulmonary and 4.85±1.86 extrapulmonary traits and 2.58±1.31 behavioural/risk factors. Individualised treatment that targeted the traits was feasible and led to significantly improved health-related quality of life (0.86 units, p<0.001) and asthma control (0.73, p=0.01).ConclusionsMultidimensional assessment enables detection of treatable traits and identifies a significant trait burden in severe asthma. Targeting these treatable traits using a personalised-medicine approach in severe asthma leads to improvements in health-related quality of life, asthma control and reduced primary care acute visits. Treatable traits may be an effective way to address the complexity of severe asthma.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031572 ◽  
Author(s):  
Kerstin Frie ◽  
Jamie Hartmann-Boyce ◽  
Susan A Jebb ◽  
Paul Aveyard

IntroductionPrevious trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss.Methods and analysesA parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m2will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks’ follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire.Ethics and disseminationThis trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences.Trial registration numberISRCTN14148239, prerecruitment.Protocol versionVersion 1.1, 7 December 2018.


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