"It's what mothers do." A qualitative exploration of mothers' experiences of supporting their daughter to be physically active.

OBJECTIVE: Girls are more at risk than boys of the non-communicable diseases associated with insufficient levels of physical activity (PA), therefore it is important to explore the reasons why girls maintain or cease to be physically active. Maternal support plays an important role in girl's PA, yet the factors influencing mothers' support of their PA have received limited exploration. In response, the aim of this study was to explore, mothers' experiences of supporting their daughters to be physically active and their perceptions of the factors that might influence these experiences. METHOD: Semi-structured interviews were conducted with a purposive sample of mothers (n = 29) of girls (Mean age = 10.9 years; SD = 0.6). Reflexive Thematic Analysis was used to analyse the data, with themes mapped to the relevant domains of the Theoretical Domains Framework. RESULTS: Themes highlighted how mothers described providing PA support as an inherent part of their parental role and how their role was influenced by their own PA identity. Mothers recognised that the type and amount of support they provided was impacted by the community setting in which they lived. Mothers acknowledged how the role of others (e.g., partners, grandparents, peers) added a layer of complexity to supporting their daughters to be active. CONCLUSION: This study advances our understanding of maternal PA support behaviours recognising the complex interplay of individual, social and environmental factors. Additionally, the use of the Theoretical Domains Framework presents an in-depth behavioural diagnosis which can be used to inform future theory-based interventions to promote parent support of children's PA.

Six-Month Pilot Testing of a Digital Health Tool to Support Effective Self-Care in People With Heart Failure: Mixed Methods Study.

BACKGROUND: Digital tools may support people to self-manage their heart failure (HF). Having previously outlined the human-centered design development of a digital tool to support self-care of HF, the next step was to pilot the tool over a period of time to establish people's acceptance of it in practice. OBJECTIVE: This study aims to conduct an observational pilot study to examine the usability, adherence, and feasibility of a digital health tool for HF within the Irish health care system. METHODS: A total of 19 participants with HF were provided with a digital tool comprising a mobile app and the Fitbit Charge 4 and Aria Air smart scales for a period of 6 months. Changes to their self-care were assessed before and after the study with the 9-item European HF Self-care Behavior Scale (EHFScBS) and the Minnesota Living with HF Questionnaire (MLwHFQ) using a Wilcoxon signed rank test. After the study, 3 usability questionnaires were implemented and descriptively analyzed: the System Usability Scale (SUS), Wearable Technology Motivation Scale (WTMS), and Comfort Rating Scale (CRS). Participants also undertook a semistructured interview regarding their experiences with the digital tool. Interviews were analyzed deductively using the Theoretical Domains Framework. RESULTS: Participants wore their devices for an average of 86.2% of the days in the 6-month testing period ranging from 40.6% to 98%. Although improvements in the EHFScBS and MLwHFQ were seen, these changes were not significant (P=.10 and P=.70, respectively, where P>.03, after a Bonferroni correction). SUS results suggest that the usability of this system was not acceptable with a median score of 58.8 (IQR 55.0-60.0; range 45.0-67.5). Participants demonstrated a strong motivation to use the system according to the WTMS (median 6.0, IQR 5.0-7.0; range 1.0-7.0), whereas the Fitbit was considered very comfortable as demonstrated by the low CRS results (median 0.0, IQR 0.0-0.0; range 0.0-2.0). According to participant interviews, the digital tool supported self-management through increased knowledge, improved awareness, decision-making, and confidence in their own data, and improving their social support through a feeling of comfort in being watched. CONCLUSIONS: The digital health tool demonstrated high levels of adherence and acceptance among participants. Although the SUS results suggest low usability, this may be explained by participants uncertainty that they were using it fully, rather than it being unusable, especially given the experiences documented in their interviews. The digital tool targeted key self-management behaviors and feelings of social support. However, a number of changes to the tool, and the health service, are required before it can be implemented at scale. A full-scale feasibility trial conducted at a wider level is required to fully determine its potential effectiveness and wider implementation needs.

A qualitative study of perceived barriers and facilitators to interrupting sedentary behavior among adults living with obesity.

Introduction: Both obesity and sedentary behavior (SB) are associated with negative health consequences including cardiovascular disease, diabetes, certain cancers and all-cause mortality. To date, perceived barriers and facilitators to interrupting SB in adults living with obesity have not been identified. Objective: This study aimed to identify these perceived barriers and facilitators by conducting a behavioral analysis underpinned by the theoretical domains framework (TDF) and the Capability, Opportunity, Motivation-Behavior (COM-B) model to enhance knowledge and inform future intervention development. Methods: A purposive and snowball sample (N = 21) of adults living with obesity took part in semi-structured interviews, guided by the TDF, to investigate perceived barriers or facilitators to interrupt SB. Transcribed interviews were inductively coded using reflexive thematic analysis. Key themes and subthemes were generated by grouping similar and recurring codes. Finally, subthemes were mapped to the TDF and COM-B. Results: Five key themes were identified, which influence SB across all domains of living. These relate to (i) physical and mental wellbeing; (ii) motivational readiness; (iii) roles, responsibilities and support; (iv) weight bias and stigma; and (v) the environment. These themes were then deductively mapped to all 14 TDF domains and all six of the COM-B constructs. Conclusion: A complex interplay of individual, societal and policy factors contributes to the development and habituation of SB patterns in adults living with obesity. Factors identified in this study could assist in the development of interventions, strategies and policies designed to interrupt or reduce sedentary behavior in this population.

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

WHAT WAS THE RESEARCH ABOUT?: One of the best ways to prove that a new medicine really works is to use a scientific test called a 'placebo-controlled trial'. In this type of test, half of the participants are given a new pill and the other half are given a 'placebo', which is a dummy pill (usually a sugar pill) that is made to taste and look the same as the active pill, but has no active ingredients. The results are then compared. Just like medicines, new surgical procedures need to be tested to show that they are safe and benefit patients. Ideally, they would also be tested using the 'placebo-controlled trial' approach, but asking patients to have 'dummy' surgery is not the same as asking people to take a dummy pill. Placebo surgery raises lots of ethics questions and is controversial. As it is controversial, guidelines are needed to recommend when placebo surgery studies can be used (if at all) and what special considerations need to be taken into account. Our research team was commissioned to develop these guidelines. WHAT DID WE DO?: We summarised, to the best of our knowledge, all previous research that had used placebo surgery and reviewed all the ethics literature on this topic. We also looked at the latest scientific understanding of how placebos work. We then held a workshop to discuss and summarise the existing knowledge and to develop the new guidelines. This involved an international team of patients, surgeons, researchers, ethicists, psychologists, physiologists and funders. We published the guidelines [i.e. the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines] in an influential medical journal and also wrote several other publications. This report provides a slightly more detailed version of our findings and recommendations. WHO WILL THIS HELP?: The guidelines will help researchers and doctors know when, and how, to best design placebo surgery studies in the future.

A systematic review of the intervention characteristics, and behavior change theory and techniques used in mother-daughter interventions targeting physical activity.

Growing gender disparities in levels of physical inactivity put women and female youths at a greater risk of associated health problems. Mother-daughter interventions have been proposed as means to promote physical activity in this at-risk cohort. However, there is a lack of clarity as to if and why these types of interventions might be effective. This systematic review examined the intervention characteristics, and behavior change theory and techniques used in these interventions to promote physical activity for mothers and daughters. PubMed, EMBASE, PsycINfO, CINAHL and Cochrane Library (Wiley) databases were searched for English language studies from inception to 13th May 2020. Interventions of any design that targeted daughters and mothers' physical activity were included. Data was extracted using the Template for Intervention Description and Replication (TIDieR) checklist, and the Behavior Change Technique (BCT) Taxonomy v1. 4962 articles were screened and 11 unique studies met the inclusion criteria. The risk of bias in studies was generally high. Narrative summary highlighted that many studies used social cognitive theory as a theoretical foundation, were based in the community and less than three months in duration with multiple sessions per week. Thirty-seven behavior change techniques were identified across studies. Some techniques were deemed potentially effective including credible source, information on the health consequences of the behavior and the self-regulatory techniques of goal-setting, self-monitoring and problem-solving. Future research should consider the use of the TIDieR guidelines and BCT Taxonomy v1 to improve the quality of information for intervention development, implementation, and reporting phases.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Validation of the adult OMNI scale of perceived exertion for cycle ergometer exercise.

PURPOSE: Concurrent and construct validity of the OMNI-Cycle Scale of Perceived Exertion were examined using young adult women and men (18-32 yr). METHODS: Concurrent validity was established by correlating OMNI-Cycle Scale ratings of perceived exertion (RPE) with oxygen consumption (.VO2) and heart rate (HR) responses to a load-incremented cycle ergometer protocol. Construct validity was established by correlating RPE derived from the OMNI-Cycle Scale with RPE from the Borg (6-20) Scale. RPE, .VO2, and HR were measured during each exercise stage. RESULTS: The range of exercise responses across the incremental test for the female and male groups was .VO2 = 0.92-2.74 L.min-1, HR = 107.2-167.2 beats.min-1, and OMNI Scale RPE-Overall, RPE-Legs, and RPE-Chest 1.0-9.1. Correlation/regression analyses indicated that RPE-Overall, RPE-Legs, and RPE-Chest distributed as a positive linear function of both .VO2 and HR (r = 0.81 to 0.95; P < 0.01). Undifferentiated and differentiated RPE-OMNI Scale distributed as a positive linear function of RPE-Borg Scale (r = 0.92 to 0.97; P < 0.01). ANOVA indicated that OMNI-Cycle RPE-Legs was higher (P < 0.01) than RPE-Chest at each exercise stage for both genders. CONCLUSION: Concurrent and construct evidence supports use of the OMNI Scale by adult women and men to estimate RPE during cycle exercise.