scholarly journals Can Garfield make children eat healthier?: A cluster-randomized controlled trial to examine the effect of a serious health game on children’s eating behavior. (Preprint)

2019 ◽  
Author(s):  
Frans Folkvord ◽  
Gosse Hage ◽  
Alexandra Theben
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intake ◽  
Eating Behavior ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Dietary Guidelines ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns and innovative methods need to be developed and tested in order effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games. OBJECTIVE The main aim of this study was to examine the effect of a serious health computer game on young children’s eating behavior and attitudes towards healthy and unhealthy foods. METHODS A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks. RESULTS The results showed that playing a serious health game did not have an effect on the attitude towards fruits or energy-dense snacks and on the intake of fruits or less energy-dense snacks, compared to the control group. Additional Bayesian analyses supported these findings. CONCLUSIONS Serious health games are increasingly considered as a potential effective intervention technique when it comes to behavioral change. The results of the current study stress the importance to tailor serious health games in order to be effective, because no effect was found on attitude or eating behavior.

scholarly journals The Effect of a Serious Health Game on Children’s Eating Behavior: Cluster-Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Frans Folkvord ◽  
Gosse Haga ◽  
Alexandra Theben
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intake ◽  
Eating Behavior ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Computer Game ◽  
Dietary Guidelines ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Currently, children’s dietary intake patterns do not meet prescribed dietary guidelines. Consequently, childhood obesity is one of the most serious health concerns. Therefore, innovative methods need to be developed and tested in order to effectively improve the dietary intake of children. Teaching children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games. OBJECTIVE The main aim of this study was to examine the effect of a serious health computer game on young children’s eating behavior and attitudes toward healthy and unhealthy foods. METHODS A cluster-randomized controlled trial with a between-group design was conducted (n=157; 8-12 years), wherein children played a game that promoted a healthy lifestyle or attended regular classes and did not play a game (control). The game was designed in collaboration with researchers and pilot-tested among a group of children repeatedly before conducting the experiment. After 1 week of playing, attitudes toward food snacks and actual intake (children could eat <i>ad libitum</i> from fruits or energy-dense snacks) was assessed. RESULTS The results showed that playing a serious health game did not have an effect on attitude toward fruits or energy-dense snacks or on the intake of fruits or less energy-dense snacks. Additional Bayesian analyses supported these findings. CONCLUSIONS Serious health games are increasingly considered to be a potential effective intervention when it comes to behavior change. The results of the current study stress the importance of tailoring serious health games in order to be effective, because no effect was found on attitude or eating behavior. CLINICALTRIAL ClinicalTrials.gov NCT05025995; https://tinyurl.com/mdd7wrjd

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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 The Impact of a Childcare Food Service Intervention on Child Dietary Intake in Care: An Exploratory Cluster Randomized Controlled Trial

2019 ◽  
Vol 33 (7) ◽  
pp. 991-1001 ◽  
Author(s):  
Sze Lin Yoong ◽  
Alice Grady ◽  
Kirsty Seward ◽  
Meghan Finch ◽  
John Wiggers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intake ◽  
Diet Quality ◽  
Controlled Trial ◽  
Food Service ◽  
Cluster Randomized Controlled Trial ◽  
Audit And Feedback ◽  
Randomized Controlled ◽  
Service Intervention ◽  
Cluster Randomized

Purpose: To assess the efficacy of a food service implementation intervention designed to increase provision of foods consistent with nutrition guidelines on child consumption of fruit, vegetables, breads/cereals, meat/alternatives, dairy, and diet quality in care. Design: Exploratory cluster randomized controlled trial. Setting: Twenty-five childcare centers in New South Wales, Australia. Sample: Three hundred ninety-five children aged 2 to 5 years. Intervention: Centers were randomized to the intervention or control group. Intervention development was guided by the Theoretical Domains Framework and included securing executive support, provision of group training, resources, audit and feedback, and one-on-one support. The intervention was delivered across six months and the study was conducted between March and December 2016. Measures: Child diet was assessed by educators using a validated questionnaire modified for completion in childcare center. Analysis: Data were analyzed in SAS using generalized linear mixed models adjusted for clustering. Results: Children in the intervention group consumed significantly higher number of serves of vegetables (0.4 serves; P < .001), wholegrain cereals (0.7 serves; P = .02), and meat/alternatives (0.5 serves; P < .001), and had higher diet quality scores (10.3; P < .001). Conclusions: A food service intervention targeting the provision of food significantly improved child dietary intake in care. Such findings are relevant to health promotion practitioners responsible for supporting improvements in child diet.

scholarly journals The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

2019 ◽  
Author(s):  
Esther Steenaart ◽  
Rik Crutzen ◽  
Math JJM Candel ◽  
Nanne K de Vries
Keyword(s):  
Randomized Controlled Trial ◽  
Organ Donation ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Post Test ◽  
Cluster Randomized ◽  
And Control ◽  
Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

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