An exploratory cluster randomized controlled trial to assess the impact of training for teachers upon children’s motor competency outcomes

Purpose: Primary school Physical Education (PE) teachers often do not possess the knowledge to sufficiently develop motor competency. This study presents an exploratory cluster randomised controlled trial that examined a teacher training programme, specifically motor competency PE delivery, in primary schools. Methods: Participants were children (n=136) aged 5-7 years, from eight primary schools (nine classes) located in Buckinghamshire, England. Measures were adapted from the Canadian ‘Physical Literacy Assessment for Youth’ methodology, including locomotion, throwing, kicking, and balancing. Pre-post measures were collected six months apart during the same academic year. A wait-list control group received no intervention. Results: Motor competency improved for both groups, yet analysis showed that the changes were not significantly different between groups. However, there was a tendency for greater effect and interval estimates [95% confidence intervals] in the intervention group across most variables. Conclusion: Teacher training may at best produce a small improvement in children’s motor competency. However, future research should test this with larger more powerful research designs.

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An Application-based programme to reinforce and maintain lower salt intake (AppSalt) in schoolchildren and their families in China

BMJ Open ◽

10.1136/bmjopen-2018-027793 ◽

2019 ◽

Vol 9 (7) ◽

pp. e027793 ◽

Cited By ~ 9

Author(s):

Feng J He ◽

Puhong Zhang ◽

Rong Luo ◽

Yuan Li ◽

Fengge Chen ◽

...

Keyword(s):

Rural Areas ◽

Primary Schools ◽

Salt Intake ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Education Programme ◽

Health Science ◽

Control Group ◽

Salt Reduction

IntroductionSalt intake is very high in China, with ≈80% being added by the consumers. It is difficult to reduce salt in such settings. Our previous study (School-based Education programme to reduce Salt(School-EduSalt)) demonstrated that educating schoolchildren, who then instructed their families to reduce the amount of salt used at home, is effective in lowering salt intake in both children and adults. Our team also developed an app called ‘KnowSalt’, which could help individuals to estimate their salt intake and the major sources of salt in the diet. Building on School-EduSalt and KnowSalt, we propose to develop a new app (AppSalt) focusing on salt reduction through education, target setting, monitoring, evaluation, decision support and management to achieve a progressive lower salt intake for long term. To evaluate the effectiveness of the AppSalt programme, we will carry out a cluster randomised controlled trial.Methods and analysisWe will recruit 54 primary schools from urban and rural areas of three provinces in China. A total of 594 children aged 8–9 years and 1188 adult family members will be randomly selected for evaluation. After baseline assessment, schools will be randomly allocated to either the intervention or control group. Children in the intervention group will be taught, with support of AppSalt, about salt reduction and assigned homework to get the whole family involved in the activities to reduce salt consumption. The duration of the intervention is two school terms (ie, 1 year). The primary outcome is the difference between the intervention and control group in the change of salt intake as measured by 24-hour urinary sodium.Ethics and disseminationThe study has been approved by Queen Mary Research Ethics Committee and Peking University Health Science Centre IRB. Results will be disseminated through presentations, publications and social media.Trial registration numberChiCTR1800017553.

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

Otolaryngology ◽

10.1177/0194599821994742 ◽

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.

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

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.

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Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽

10.1161/circ.125.suppl_10.ap186 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jaime Céspedes ◽

German Briceño ◽

Michael Farkouh ◽

Rajesh Vedanthan ◽

Martha Leal ◽

...

Keyword(s):

Educational Intervention ◽

Cardiovascular Health ◽

Controlled Trial ◽

Intervention Group ◽

Educational Programs ◽

Control Group ◽

Active Lifestyle ◽

And Control ◽

The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

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Effectiveness of balance training programme in reducing the frequency of falling in established osteoporotic women: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215516628616 ◽

2016 ◽

Vol 31 (2) ◽

pp. 217-224 ◽

Cited By ~ 7

Author(s):

Ibolya Mikó ◽

Imre Szerb ◽

Anna Szerb ◽

Gyula Poor

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Balance Training ◽

Training Programme ◽

Exercise Programme ◽

Berg Balance Scale ◽

Control Group ◽

Timed Up And Go ◽

Randomized Controlled

Objective: To investigate the effect of a 12-month sensomotor balance exercise programme on postural control and the frequency of falling in women with established osteoporosis. Design: Randomized controlled trial where the intervention group was assigned the 12-month Balance Training Programme and the control group did not undertake any intervention beyond regular osteoporosis treatment. Subjects: A total of 100 osteoporotic women – at least with one osteoporotic fracture – aged 65 years old and above. Main measures: Balance was assessed in static and dynamic posture both with performance-based measures of balance, such as the Berg Balance Scale and the Timed Up and Go Test, and with a stabilometric computerized platform. Interventions: Patients in the intervention group completed the 12-month sensomotor Balance Training Programme in an outpatient setting, guided by physical therapists, three times a week, for 30 minutes. Results: The Berg Balance Scale and the Timed Up and Go Test showed a statistically significant improvement of balance in the intervention group ( p = 0.001 and p = 0.005, respectively). Balance tests using the stabilometer also showed a statistically significant improvement in static and dynamic postural balance for osteoporotic women after the completion of the Balance Training Programme. As a consequence, the one-year exercise programme significantly decreased the number of falls in the exercise group compared with the control group. Conclusion: The Balance Training Programme significantly improved the balance parameters and reduced the number of falls in postmenopausal women who have already had at least one fracture in the past.

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The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

International Journal of Telemedicine and Applications ◽

10.1155/2011/909248 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Nicolaas P. Pronk ◽

A. Lauren Crain ◽

Jeffrey J. VanWormer ◽

Brian C. Martinson ◽

Jackie L. Boucher ◽

...

Keyword(s):

Body Weight ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Study Groups ◽

Outcome Variable ◽

Control Group ◽

Immediate Feedback ◽

The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

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

10.20944/preprints202103.0097.v1 ◽

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.

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Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09995-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Severin Haug ◽

Raquel Paz Castro ◽

Andreas Wenger ◽

Michael P. Schaub

Keyword(s):

Randomised Controlled Trial ◽

Cigarette Smoking ◽

Internet Use ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Addiction Prevention ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

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The Impact of Traditional Medicine-Based Lifestyle and Diet on Infertility Treatment in Women Undergoing Assisted Reproduction: A Randomized Controlled Trial

Complementary Medicine Research ◽

10.1159/000505016 ◽

2020 ◽

Vol 27 (4) ◽

pp. 230-241

Author(s):

Zeinab Alibeigi ◽

Effat Jafari-Dehkordi ◽

Soleiman Kheiri ◽

Maryam Nemati ◽

Gholamreza Mohammadi-Farsani ◽

...

Keyword(s):

Traditional Medicine ◽

Controlled Trial ◽

Intervention Group ◽

Infertility Treatment ◽

Control Group ◽

Lifestyle Modifications ◽

Mature Ovum ◽

The Impact ◽

Diet And Lifestyle

The problem of infertility is growing rapidly in the world. Traditional medicine with thousands of years of history has claimed that it can treat some kinds of infertility using nutritional and lifestyle modifications and interventions. The purpose of this study was to evaluate the effect of a traditional medicine-oriented diet and lifestyle on infertility treatment. Based on a clinical trial study, 180 infertile women who were 20–40 years old and candidates for in vitro fertilization (IVF) were randomly assigned to 2 groups: an intervention group and a control group. The intervention group used diet and lifestyle recommendations based on Iranian traditional medicine for at least 3 months. The number of ova, mature ovum number, embryo number, embryo quality, and fertilization rate were significantly higher in the intervention group than in the control group (for all items; p < 0.05). Overall pregnancy rate was significantly higher in the intervention group (35.2 vs. 12.4%; odds ratio [OR], 3.8; 95% CI, 1.8–8.3). The intervention group had a higher rate of getting spontaneous pregnancy than the control group (20.9 vs. 2.2%; OR, 11.5; 95% CI, 2.6–50.9). Chemical pregnancy was significantly higher in the intervention group (64 vs. 27.5%; OR, 4.7; 95% CI, 1.9–11.6). Diet and lifestyle modifications based on traditional medicine can contribute greatly to the infertility treatment. Thus, many infertility cases can be treated without the need to use advanced methods. In case of using assisted reproductive techniques, traditional medicine can enhance the efficiency of these methods.

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A Nutrition Education Intervention Using NOVA Is More Effective Than MyPlate Alone: A Proof-of-Concept Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122965 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2965

Author(s):

Aydin Nazmi ◽

Marilyn Tseng ◽

Derrick Robinson ◽

Dawn Neill ◽

John Walker

Keyword(s):

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Education Intervention ◽

Proof Of Concept ◽

Food Groups ◽

Randomized Controlled ◽

The Impact ◽

Level Of Processing

The ability to classify foods based on level of processing, not only conventional MyPlate food groups, might be a useful tool for consumers faced with a wide array of highly processed food products of varying nutritional value. The objective of this study was to assess the impact of a proof-of-concept nutrition education intervention on nutrition knowledge, assessed by correct classification of foods according to MyPlate food groups, MyPlate ‘limit’ status (for fat, sugar, sodium), and level of processing (NOVA categories). We utilized a randomized, controlled design to examine the impact of a MyPlate vs. combined MyPlate + NOVA intervention vs. control group. Intervention groups received educational flyers via email and participants were assessed using electronic baseline and follow-up surveys. The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and ‘limit’ status. Moreover, the MyPlate + NOVA group far outperformed the other groups on classifying NOVA categories. Longer-term trials are needed, but our results suggest that NOVA principles may be more easily understood and applied than those of MyPlate. Education strategies focusing on level of food processing may be effective in the context of the modern food environment.

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