Twelve-month effectiveness of telephone and SMS support to mothers with children aged 2 years in reducing children's BMI: a randomized controlled trial.

BACKGROUND/OBJECTIVES: Few quality intervention studies have assessed whether a combined telephone and short message service (SMS) intervention to mothers is effective in reducing BMI and obesity risk behaviors of children at 3 years of age. This study aimed to assess effectiveness of telephone and SMS support in reducing children's body mass index (BMI) and obesity risk behaviors. SUBJECTS/METHODS: A randomized controlled trial (RCT) with 662 women of 2-year-old children (with the proportion of overweight and obesity being similar to the general population) was conducted in Sydney, Australia, March 2019-October 2020. The mothers in the intervention group received three telephone support sessions plus SMS messages and mailed-intervention-booklets over a 12 months period i.e., 24-26, 28-30, and 32-34 months of the child's age. Mothers in the control group received usual care and two mailed booklets on information not related to the intervention. The primary outcome was child's BMI at 3 years of age. Secondary outcomes were children's dietary and activity behaviors. All outcome measures were based on mothers' self-report using standardized tools due to COVID-19 pandemic restrictions. RESULTS: 537 (81%) mothers completed the post-intervention assessment at 3 years with only 470 (71%) children having weight and height measures. Multiple imputation analysis showed no statistically significant difference in mean BMI between the groups. Children in the intervention group were more likely not to eat in front of the TV [AOR 1.79 (95% CI 1.17-2.73), P = 0.008], more likely to meet the dietary recommendations [AOR 1.73 (95% CI 0.99-3.02), P = 0.054] and meet the activity recommendations [AOR 1.72 (95% CI 1.11-2.67), P = 0.015] than those in the control group respectively. Among those with an annual household income (

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial.

INTRODUCTION: The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial. METHODS AND ANALYSIS: Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes. ETHICS AND DISSEMINATION: This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12619000065190.

Demographic Predictors of Mothers' Willingness to Vaccinate Young Children Against COVID-19, Get Tested and Isolate: A Cross-Sectional Survey Before and During the Greater Sydney Lockdown 2021, Australia.

Background and Objectives: Having a COVID-19 vaccination, getting tested, and self-isolating if symptomatic are some of the most important mitigation strategies for preventing the spread of COVID-19. This study aimed to investigate whether demographic factors are associated with mothers' willingness to vaccinate their 4-year-old children against COVID-19 if a suitable vaccine becomes available or to get tested and self-isolate if they themselves have COVID-19 symptoms and whether the willingness could be influenced by the Greater Sydney lockdown 2021. Methods: A cross-sectional telephone survey was conducted between 24th February and 26th October 2021. Questions from the NSW Adult Population Health Survey and from previously published studies were used to assess family demographics, mothers' willingness to vaccinate their young children, and willingness to get tested and self-isolate if symptomatic. The survey involved 604 mothers of children aged 4 years who participated in an existing trial in Sydney, Australia. Results: Mothers were more willing to vaccinate their children when the child's father had a tertiary education or higher, with an adjusted odds ratio (AOR) of 2.60 (95% CI 1.67-4.04). Mothers who were older than 30 years or who completed the survey during the lockdown were more willing to get tested if symptomatic, with AOR 2.50 (95% CI 1.17-5.36) and AOR 3.36 (95% CI 1.41-8.02), respectively. Mothers who were married or had de-facto partners were more willing to self-isolate if symptomatic [AOR 17.15 (95% CI 3.56-82.65)]. Conclusion: Fathers' educational level, mothers' age, and marital status were associated with mothers' willingness to vaccinate their young children if a suitable vaccine were available, to get tested, and self-isolate if symptomatic respectively. The promotion of mitigation strategies for tackling the COVID-19 pandemic needs to take into account specific family demographics.

Face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: protocol of a multicentre, randomised controlled trial-the REFORM trial.

INTRODUCTION: Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively. METHODS AND ANALYSIS: The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions. TRIAL REGISTRATION NUMBER: CPMP/ICH-135/95. PROTOCOL VERSION: The most recent version of the protocol is V.1.2 dated November 2019.