scholarly journals Feasibility of a Web-Based Implementation Intervention to Improve Child Dietary Intake in Early Childhood Education and Care: Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Courtney Barnes ◽  
Sze Lin Yoong ◽  
Nicole Nathan ◽  
Luke Wolfenden ◽  
Taya Wedesweiler ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Intervention Group ◽  
Web Based ◽  
Randomized Controlled ◽  
Eating Practices ◽  
The Impact ◽  
The Web ◽  
Policies And Practices

BACKGROUND Internationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children’s healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices. OBJECTIVE The broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group. METHODS A 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care. RESULTS Of the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11). CONCLUSIONS This study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s40814-020-00707-w

scholarly journals Feasibility of a Web-Based Implementation Intervention to Improve Child Dietary Intake in Early Childhood Education and Care: Pilot Randomized Controlled Trial

10.2196/25902 ◽  
2021 ◽  
Vol 23 (12) ◽  
pp. e25902
Author(s):  
Courtney Barnes ◽  
Sze Lin Yoong ◽  
Nicole Nathan ◽  
Luke Wolfenden ◽  
Taya Wedesweiler ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Intervention Group ◽  
Web Based ◽  
Randomized Controlled ◽  
Eating Practices ◽  
The Impact ◽  
The Web ◽  
Policies And Practices

Background Internationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children’s healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices. Objective The broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group. Methods A 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care. Results Of the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11). Conclusions This study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099 International Registered Report Identifier (IRRID) RR2-10.1186/s40814-020-00707-w

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)

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Physicians’ Choice in Using Internet and Fax for Patient Recruitment and Follow-up in a Randomized Controlled Trial

2004 ◽  
Vol 43 (03) ◽  
pp. 268-272 ◽  
Author(s):  
S. Morita ◽  
T. Fukui ◽  
J. Sakamoto ◽  
M. Rahman
Keyword(s):  
Randomized Controlled Trial ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Data Entry ◽  
Regression Analyses ◽  
Multivariate Logistic Regression ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

Summary Objective: To examine the physicians’ preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. Methods: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians’ choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. Results: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. Conclusions: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

scholarly journals Evaluation of the Computer-Based Intervention Program Stayingfit Brazil to Promote Healthy Eating Habits: The Results from a School Cluster-Randomized Controlled Trial

2019 ◽  
Vol 16 (10) ◽  
pp. 1674
Author(s):  
Karine Brito Beck da Silva ◽  
Naiá Ortelan ◽  
Sheila Giardini Murta ◽  
Isabel Sartori ◽  
Ricardo David Couto ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized ◽  
And Control

Interventions via the Internet are promising regarding the promotion of healthy habits among youth. The objective of this study was to evaluate the effect of an adapted version of StayingFit to promote healthy eating habits and the measurement adequacy of anthropometric markers among adolescents. A web school-based 12-month cluster-randomized controlled trial examining 7th to 9th grade students was conducted in twelve schools in Salvador, Bahia, Brazil. The schools’ students were randomly distributed into the intervention and control groups. The intervention group participated in StayingFit, an online program designed to encourage and guide healthy eating habits and control body weight. Data on food consumption, anthropometry, physical activity level, and sedentary behavior were collected from all of the students at the beginning of and after the 12-month study. Demographic and socioeconomic data were collected at baseline. The baseline data indicated high rates of overweight (14.4% overweight and 8.5% obese), insufficiently active (87.6%), and sedentary (63.7%). Furthermore, few adolescents regularly consumed fruits (18.8%) and vegetables/legumes (16.4%). Generalized estimating equations (GEEs) were used to evaluate the effect of the intervention. At the end of the follow-up period, students in the intervention group had a 43% increased chance of regularly consuming beans (OR = 1.43, 95% CIs = 1.10–1.86) and a 35% decreased chance of regularly consuming soft drinks (OR = 0.65, 95% CIs = 0.50–0.84). No differences were found between the groups studied with regard to the anthropometric parameters. Despite these modest results, the implementation of a web intervention can be beneficial and help promote positive changes in adolescent eating habits.

scholarly journals Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Claudia Gregoriano ◽  
Thomas Dieterle ◽  
Anna-Lisa Breitenstein ◽  
Selina Dürr ◽  
Amanda Baum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ambulatory Setting ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Copd Patients ◽  
The Impact ◽  
Inhaled Medication

Abstract Background Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. Methods This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. Results Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. Conclusion Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. Trial registration ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

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