Outcomes From a Hybrid Implementation-effectiveness Study of the Living Well During Pregnancy Tele-coaching Program for Women at High Risk of Excessive Gestational Weight Gain

BackgroundExcess gestational weight gain (GWG) is associated with short-term perinatal complications and longer term cardiometabolic risks for mothers and their babies. Dietitian counselling and weight gain monitoring for women at risk of high pregnancy weight gain is recommended by clinical practice guidelines. However, face-to-face appointments, during a time with high appointment burden, can introduce barriers to engaging with care. Telephone counselling may offer a solution. The Living Well during Pregnancy (LWdP) program is a dietitian-delivered telephone coaching program implemented within routine antenatal care for women at risk of excess GWG. This program evaluation used a hybrid implementation-effectiveness design guided by the RE-AIM framework reports on the primary outcomes (reach, adoption, implementation, maintenance) and secondary outcomes (effectiveness) of the LWdP intervention. MethodsThe LWdP program evaluation compared data from women participating in the LWdP program with a historical comparison group (pregnant women receiving dietetic counselling for GWG in the 12 months prior to the study). The primary outcomes were described for the LWdP program. Between group comparisons were used to determine effectiveness of achieving appropriate GWG and pre and post intervention comparisons of LWdP participants was used to determine changes to dietary intake and physical activity. ResultsThe LWdP intervention group (n=142) were compared with women in the historical comparison group (n=49). Women in the LWdP intervention group attended 3.4 (95% CI 2.9 – 3.8) appointments compared with 1.9 (95% CI, 1.6 – 2.2). GWG was similar between the two groups, including the proportion of women gaining weight above the Institute of Medicine recommendations (70% vs 73%, p=0.69). Within group comparison showed that total diet quality, intake of fruit and vegetables and weekly physical activity were all significantly improved from baseline to follow-up for the women in the LWdP, while consumption of discretionary food and time spent being sedentary decreased (all p<0.05). ConclusionThe LWdP program resulted in more women accessing care and positive improvements in diet quality, intuitive eating behaviours and physical activity. It was as effective as face-to-face appointments for GWG, though more research is required to identify how to engage women earlier in pregnancy and reduce appointment burden.

Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

Background There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods. Methods We originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators’ role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training. Conclusion The changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients. Trial registration ClinicalTrials.govNCT04206735. Registered on December 20, 2019;

Protocol for an Effectiveness-Implementation Hybrid Trial to Evaluate Scale up of an Evidence-Based Intervention Addressing Lifestyle Behaviours From the Start of Life: INFANT

IntroductionPromoting healthy eating and active play in early life is critical, however few interventions have been delivered or sustained at scale. The evaluation of interventions at scale is a crucial, yet under-researched aspect of modifying population-level health behaviours. INFANT is an evidence-based early childhood healthy lifestyle intervention that aims to improve parents’ knowledge and skills around promoting optimal energy balance-related behaviours that, in turn, influence children’s diet, activity and adiposity. It consists of: 1) Four group sessions delivered via first time parent groups across the first 12 months of life; 2) access to the My Baby Now app from birth to 18 months of age. This research aims to assess real-world implementation, effectiveness and cost-effectiveness of INFANT when delivered at scale across Victoria, Australia.Methods and AnalysisA hybrid type II implementation-effectiveness trial applying a mixed methods design will be conducted. INFANT will be implemented in collaboration with practice and policy partners including maternal and child health services, population health and Aboriginal health, targeting all local government areas (n=79) in Victoria, Australia. Evaluation is based on criteria from the ‘Outcomes for Implementation Research’ and ‘RE-AIM’ frameworks. Implementation outcomes will be assessed using descriptive quantitative surveys and qualitative interviews with those involved in implementation, and include intervention reach, organisational acceptability, adoption, appropriateness, cost, feasibility, penetration and sustainability. Process measures include organizational readiness, fidelity, and adaptation. Effectiveness outcomes will be assessed using a sample of INFANT participants and a non-randomized comparison group receiving usual care (1,500 infants in each group), recruited within the same communities. Eligible participants will be first time primary caregivers of an infant aged 0-3 months, owning a personal mobile phone and able to communicate in English. Effectiveness outcomes include infant lifestyle behaviours and BMIz at 12 and 18 months of age.ImpactThis is the first known study to evaluate the scale up of an evidence based early childhood obesity prevention intervention under real world conditions. This study has the potential to provide generalisable implementation, effectiveness and cost-effectiveness evidence to inform the future scale up of public health interventions both in Australia and internationally.Clinical Trial RegistrationAustralian and New Zealand Clinical Trial Registry https://www.anzctr.org.au/, identifier ACTRN12620000670976.

Implementasi Media Audio Visual untuk Meningkatkan Critical Thinking Siswa Menggunakan Strategi Point Counterpoint

This study aims to describe the implementation, effectiveness, constraints, and solutions for the implementation of audio-visual media using the point-counterpoint strategy in class XI TKJ A SMK Adi Sumarmo Colomadu in the 2020/2021 school year. This study used a mixed-methods approach with a sequential exploratory design. Samples were taken using purposive sampling with a total of 28 students. Qualitative data collection techniques were interviews, observations, documentation, while quantitative data were analyzed using the Paired Sample T-Test hypothesis test. Test the validity of the data using triangulation of sources and techniques. The validity test using Correlation Product Moment with a significant level of 5% obtained a price of 0.444 and reliability using KR 20 with a result of 0.653. The qualitative analysis uses flow model analysis, while the quantitative analysis uses descriptive statistics. The results of this study are the implementation of audio-visual media to improve students' critical thinking using a point-counterpoint strategy by providing material through WhatsApp Group in the form of video. The effectiveness of the implementation of audio-visual media using the point-counterpoint strategy can be seen from the average results of the pretest 54.5 and posttest 81.6, with a total of 20 questions greater than T table (15,144 > 1,700). In this study, there were obstacles such as time constraints related to the implementation of the research. An alternative solution to overcome these obstacles is that researchers arrive earlier than the research schedule and must manage time well.

The OptimalMe healthy lifestyle in preconception, pregnancy and postpartum (HiPPP) intervention: Trial protocol for a randomised controlled implementation effectiveness trial (Preprint)

BACKGROUND Reproductive aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognised as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation into real-world healthcare settings remains limited. OBJECTIVE OptimalMe is a randomised, hybrid implementation effectiveness study of an evidence based healthy lifestyle intervention. Which will evaluate intervention penetration and reach and the feasibility, acceptability, adoption and fidelity of the intervention implemented into, and in partnership with, private healthcare. Secondary outcomes include evaluation of individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management and health behaviours. METHODS The study design is a parallel, two arm, randomised trial at the level of the individual. Three hundred participants aged 18-44, who are not pregnant, but wish to conceive within the next 12 months at point of recruitment and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and ongoing text messages across preconception, pregnancy and postpartum. Implementation delivery will be tested comparing two remote delivery methods for health coaching including telephone or video conferencing. All methods are theoretically underpinned by the Consolidated Framework for Implementation Research (CFIR) and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance (RE-AIM) and the Penetration, Implementation, Participation, Effectiveness (PIPE) frameworks. RESULTS The Monash Health Human Research and Ethics Committee has approved the study (reference: RES-19-0000291A, approved: 16 August 2019) which has been registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12620001053910). The project is supported with funding from Medibank Private Ltd. Recruitment commenced in July 2020 with results expected to be published in 2022. CONCLUSIONS Our study design aligns with best practice implementation research, informed by evidence from across efficacy trials, integrated into systematic reviews, meta-analyses and guidelines. Results generated will inform translation of evidence from randomised controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy and postpartum. Learnings will target consumers, program facilitators, health professionals, services and policy makers to inform future scale-up to ultimately benefit the health of women across these life-phases.ults expected to be published in 2022. CLINICALTRIAL ACTRN12620001053910

Implementation of a community-based low-calorie dietary intervention for the induction of type-2 diabetes and pre-diabetes remission: a feasibility study utilising a type 2 hybrid design

Objectives The aims of this feasibility study were to (1) examine the implementation of a community-based health advocate (CHA) training programme to develop the clinical skills needed to support a diabetes remission protocol based on a low-calorie diet (LCD) and (2) investigate if participant weight loss can be achieved and diabetes remission induced under these conditions. Methods This tripartite study followed a type 2 implementation-effectiveness design. Three faith-based organisations (FBOs) were purposively selected as study sites. Implementation outcomes were guided by the Consolidated Framework for Implementation Research. During the pre-implementation phase, site ‘readiness’ to facilitate the intervention was determined from a site visit and an interview with the FBOs’ leadership. During the implementation phase, congregants could volunteer for the 10-week CHA training which included practical exercises in weight, glucose and blood pressure (BP) measurement, and a summative practical assessment. Acceptability and implementation effectiveness were assessed via survey. During the intervention phase, other congregants and community members with T2DM or pre-diabetes and overweight were invited to participate in the 12-week LCD. Anti-diabetic medication was discontinued on day 1 of the intervention. Clinical effectiveness was determined from the change in weight, fasting blood glucose (FBG) and BP which were monitored weekly at the FBO by the CHA. HbA1C was performed at weeks 1 and 12. Results The FBOs were found to be ready as determined by their adequate resources and engagement in health-related matters. Twenty-nine CHAs completed the training; all attained a passing grade at ≥1 clinical station, indicating implementation effectiveness. CHA feedback indicated that the programme structure was acceptable and provided sufficient access to intervention-related material. Thirty-one persons participated in the LCD (11 T2DM:20 pre-diabetes). Mean (95%CI) weight loss was 6.0 kg (3.7 to 8.2), 7.9 kg in males vs 5.7 kg in females; A1C (%) decreased from 6.6 to 6.1, with a greater reduction in those with T2DM when compared to pre-diabetes. FBG decreased from 6.4 to 6.0mmol/L. T2DM remission rates were 60% and 90% by A1C<6.5% and FBG<7mmol/L respectively. Pre-diabetes remission was 18% and 40% by A1C<5.7% and FBG<5.6 respectively. Conclusion Implementation of a community-based diabetes remission protocol is both feasible and clinically effective. Its sustainability is to be determined. Adaptability to other disorders or other settings should be investigated. Trial registration NCT03536377 registered on 24 May 2018.

Pandemi Covid-19: Eefektivitas Pembelajaran dalam Jaringan

This study aimed to analyze the implementation effectiveness of the learning from home (BDR) process during the Covid-19 pandemic in grade V of MI Muhammadiyah Botoputih Tembarak. This research used mix method. The data collection technique used was a questionnaire given to the students once a month. The subjects of this study were the students of grade V at MI Muhammadiyah Botoputih Tembarak. Based on the results of research conducted by filling out questionnaires, in general, the implementation of learning from home (BDR) in the sixth-grade students of MI Muhammadiyah Botoputih Tembarak run quite effectively with a percentage of 60-79%. The results of the BDR learning implementation questionnaire which had bad effectiveness with the criteria of 48% were in the evaluation process. It is suggested in learning from home (BDR), teachers are required to be able to design learning activities from planning to evaluating in a simpler, more creative and effective way