A Web-Based Risk Reframing Intervention to Influence Early Childhood Educators’ Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Mariana Brussoni ◽  
Christina S Han ◽  
John Jacob ◽  
Fritha Munday ◽  
Megan Zeni ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Early Childhood ◽  
Behavior Change ◽  
Controlled Trial ◽  
Early Childhood Educators ◽  
Outdoor Play ◽  
Control Group ◽  
Web Based ◽  
Children's Play ◽  
Randomized Controlled

BACKGROUND Outdoor play supports children’s physical, social, emotional and intellectual development, yet opportunities for outdoor play are declining in many societies. Early learning and childcare centers (ELCCs) can offer young children critical opportunities for quality outdoor play. There are multiple actual and perceived barriers to outdoor play in ELCCs, ranging from safety fears and lack of familiarity with supporting play outdoors to challenges around diverse perspectives on outdoor play among colleagues, administrators, licensing officers and parents. Building on OutsidePlay.ca, our previous web-based intervention to change parents’ attitudes and behaviors toward risky play, we sought to develop a web-based intervention for Canadian ELCC stakeholders. OBJECTIVE Our study objective was to develop and evaluate a web-based intervention that influences early childhood educators’ (ECEs) and ELCC administrators’ perceptions and practices in support of children’s outdoor play in ELCCs. METHODS Our study was guided by the intervention mapping process. We first completed a needs assessment through focus groups of ELCC educators, administrators and licensing officers. We identified key issues, needs and challenges, opportunities to influence behavior change, and intervention outcomes and objectives. This enabled us to develop design objectives and identify features of the OutsidePlay.ca web-based intervention that are central to addressing ECEs and ELCC administrators’ issues, needs and challenges. We used social cognitive theory and behavior change techniques to select methods, applications and technology to deliver the intervention. A mock-up of the intervention was created and revised based on ELCC stakeholders feedback and recommendations. We will use a two-parallel-group randomized controlled trial (RCT) design to evaluate the efficacy of the intervention. We will recruit 324 ECEs and ELCC administrators to randomize into the intervention or the control group. The control group is reading the Position Statement on Active Outdoor Play. RESULTS The primary outcome is increased tolerance of risk in children’s play, as measured by the Teacher Tolerance of Risk in Play Scale. The secondary outcome is self-reported attainment of a self-developed behavior change goal. We will test the hypothesis that there will be a difference between the experimental and control groups with respect to tolerance of risk in children’s play using mixed-effects models. Differences in goal attainment will be tested using logistic regression. CONCLUSIONS The OutsidePlay.ca web-based intervention guides users through a personalized journey that is split into three chapters. An effective intervention that addresses the barriers to outdoor play in ELCC settings has the potential to improve children’s access to outdoor play and support high quality early childhood education. CLINICALTRIAL ClinicalTrials.gov PRS – NCT04624932

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Guided web-based treatment program for reducing cannabis use: a randomized controlled trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kristina Sinadinovic ◽  
Magnus Johansson ◽  
Ann-Sofie Johansson ◽  
Thomas Lundqvist ◽  
Philip Lindner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Program ◽  
Controlled Trial ◽  
Cannabis Use ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled ◽  
Intervention Adherence ◽  
Group Effects

Abstract Background The aim of this study was to investigate the effects of a web-based treatment program with therapist guidance for adults and adolescents with regular cannabis use from the general population. Methods A double blinded randomized controlled trial with a parallel group design was conducted (intervention group n = 151, wait-list control group n = 152). Follow-up 12 weeks from treatment commencement of a 13-module intervention. The primary outcome was frequency of cannabis use. Time by group interaction effects were modeled using generalized estimated equations and the instrumental variable approach was used to estimate the effect of intervention adherence. Results At follow-up, the intention to treat (ITT) analyses did not show any significant time by group effects. A significant association between intervention adherence and scores on the cannabis abuse screening test (CAST) was found. Secondary analysis excluding participants who had received other professional help revealed time by group effects for secondary outcomes gram cannabis consumed past week, number of dependency criteria and CAST score. Due to methodological limitations, these latter results should be interpreted with caution. Conclusions In this study we did not find a web-based treatment program with therapist guidance to be more effective than a waiting-list in reducing frequency of cannabis use. Trial registration The trial was pre-registered at ClinicalTrials.gov (NCT02408640) April 3, 2015

scholarly journals Evaluation of a Web-based tailored intervention (TAVIE en santé) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol

2021 ◽  
Author(s):  
José Côté ◽  
Sylvie Cossette ◽  
Pilar Ramirez-Garcia ◽  
Alexandra De Pokomandy ◽  
Catherine Worthington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
People Living With Hiv ◽  
Tailored Intervention ◽  
Convenience Sample ◽  
Web Based ◽  
Randomized Controlled ◽  
Health Promoting ◽  
Living With Hiv

Background Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours. Methods/Design An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis. Discussion This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors.

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

scholarly journals Surviving and Thriving With Cancer Using a Web-Based Health Behavior Change Intervention: Randomized Controlled Trial

2014 ◽  
Vol 16 (2) ◽  
pp. e54 ◽  
Author(s):  
Erin O'Carroll Bantum ◽  
Cheryl L Albright ◽  
Kami K White ◽  
Jeffrey L Berenberg ◽  
Gabriela Layi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Behavior ◽  
Behavior Change ◽  
Controlled Trial ◽  
Health Behavior Change ◽  
Web Based ◽  
Behavior Change Intervention ◽  
Randomized Controlled

scholarly journals Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

2018 ◽  
Vol 7 (4) ◽  
pp. e87 ◽  
Author(s):  
Anna L Macready ◽  
Rosalind Fallaize ◽  
Laurie T Butler ◽  
Judi A Ellis ◽  
Sharron Kuznesof ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Study Protocol ◽  
Intervention Study ◽  
Controlled Trial ◽  
Personalized Nutrition ◽  
Behavior Change Techniques ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial

10.2196/15001 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e15001
Author(s):  
Sarah MacLean ◽  
Daniel J Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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