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

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e027793 ◽  
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.

scholarly journals Social support, social network and salt-reduction behaviours in children: a substudy of the School-EduSalt trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028126
Author(s):  
Yuan Ma ◽  
Xiangxian Feng ◽  
Jun Ma ◽  
Feng J He ◽  
Haijun Wang ◽  
...  
Keyword(s):  
Social Networks ◽  
Primary Schools ◽  
Salt Intake ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Northern China ◽  
Secondary Outcome ◽  
Intervention Programme ◽  
Salt Reduction ◽  
Randomised Controlled

ObjectivesHealthy behaviour changes, such as reducing salt intake, are important to prevent lifestyle-related diseases. Social environment is a major challenge to achieve such behaviours, but the explicit mechanisms remain largely unknown. We investigated whether social networks of children were associated with their behaviours to reduce salt intake.DesignAn ancillary study of a school-based cluster randomised controlled trial to reduce salt intake in children and their families (School-EduSalt), in which salt intake of children was significantly reduced by 25%.Setting14 primary schools in urban Changzhi, northern China.Participants603 children aged 10–12 years in the intervention arm.Primary and secondary outcome measuresWe developed a score assessing salt-reduction behaviours (SRB score) of children based on self-administered questionnaires. The SRB score was validated by the changes in salt intake measured by 24-hour urine collection in a random sample of 135 children. A 1-unit increase in SRB score was associated with a 0.31 g/day greater reduction in salt intake during the trial (95% CI 0.06 to 0.57, p=0.016).ResultsChildren from families with more family members not supporting salt reduction had significantly lower SRB scores (p<0.0001). Children from a class with a smaller size and from a class with more friendship connections, as well as children having more friends within the class all showed higher SRB scores (all p<0.05). Children whose school teachers attended the intervention programme more frequently also had higher SRB scores (p=0.043).ConclusionSocial networks were associated with the behaviours to reduce salt intake in children. Future salt-reduction programmes may benefit from strategies that actively engage families and teachers, and strategies that enhance interconnectivity among peers.Trial registration numberNCT01821144; post-results.

scholarly journals Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038744
Author(s):  
Wenwen Du ◽  
Jiguo Zhang ◽  
Yuan Li ◽  
Feng J He ◽  
Xue Zhou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Theory ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Intervention Group ◽  
Baseline Survey ◽  
Control Group ◽  
Salt Reduction ◽  
Randomised Controlled

IntroductionSalt intake in China is high, and most of it comes from that added by consumers. Nevertheless, recent years have seen a rapid increase in the frequency at which people eat out. The aim of this study is to evaluate the effectiveness of interventions designed for salt reduction in restaurants through a randomised controlled trial in China.Methods and analysisAs a randomised controlled trial with restaurants as study subjects, we recruited 192 restaurants from 12 counties of 6 provinces in China. After the baseline survey, restaurants were randomly assigned to intervention or control group. Using social cognitive theory, comprehensive intervention activities were designed to encourage salt reduction in all restaurant foods, and at the same time, to encourage consumers to choose lower salt options when eating out. The interventions will be conducted only in restaurants of the intervention group during the first year. The follow-up assessment will be conducted at the end of the trial. The primary outcome is the change in the average salt content of the five best-selling dishes of the restaurant, as measured by laboratory tests. Secondary outcomes include differences in the monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers.Ethics and disseminationThe study was reviewed and approved by the Review Board of the National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media.Trial registration numberChiCTR1800019694; Pre-results.

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

2019 ◽  
Author(s):  
Steven Mann ◽  
Alex Lucas ◽  
Matthew Wade ◽  
Jack Shakespeare ◽  
Emily Budzynski-Seymour ◽  
...  
Keyword(s):  
Teacher Training ◽  
Primary Schools ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Training Programme ◽  
Future Research ◽  
Control Group ◽  
Literacy Assessment ◽  
The Impact

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.

scholarly journals Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033842 ◽  
Author(s):  
Xiaochang Zhang ◽  
Xiao Hu ◽  
Jixiang Ma ◽  
Puhong Zhang ◽  
Yuan Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Cluster Randomised ◽  
The Difference ◽  
Randomised Controlled

IntroductionSalt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.Methods and analysisA cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.Trial registration numberChiCTR1800016804.

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

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).

scholarly journals Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

2020 ◽  
Vol 23 (6) ◽  
pp. 1117-1126
Author(s):  
Anne Himberg-Sundet ◽  
Anne Lene Kristiansen ◽  
Lene Frost Andersen ◽  
Mona Bjelland ◽  
Nanna Lien
Keyword(s):  
Randomised Controlled Trial ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Public And Private ◽  
Cluster Randomised ◽  
Block Randomisation ◽  
Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

Effects of the Rango Cards game intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices of high school students: a cluster randomised controlled trial

2020 ◽  
Vol 23 (13) ◽  
pp. 2424-2433 ◽  
Author(s):  
Carolina Martins dos Santos Chagas ◽  
Giselle Rhai-Sa Melo ◽  
Raquel Braz Assunção Botelho ◽  
Natacha Toral
Keyword(s):  
High School Students ◽  
Healthy Eating ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Nutritional Knowledge ◽  
School Students ◽  
Eating Practices

AbstractObjective:The study aimed to assess the impact of a game-based nutritional intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.Design:This cluster randomised controlled trial included both male and female high school students from private schools in the Federal District, Brazil. Four schools were randomly selected for each group. Investigated variables were age, sex, monthly family income, maternal education level, dietary perceptions and practices, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.Setting:Intervention group participants were instructed to play Rango Cards, a digital game developed for the study, on their own, for a period of 7–17 d, while the control group was not provided with any game or material during the study.Participants:The study included 319 adolescents (mean age = 15·8 (sd 0·7) years).Results:Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants. The intervention group showed increased knowledge of the effects of fruit and vegetable consumption as well as improved self-efficacy in the adoption of healthy eating practices such as reducing Na intake and preparing healthy meals.Conclusions:The design of Rango Cards is potentially capable of effecting positive changes. Therefore, the digital game promotes autonomy and self-care among adolescents with regard to healthy eating.

scholarly journals Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial

2016 ◽  
Vol 20 (70) ◽  
pp. 1-122 ◽  
Author(s):  
Stefan Priebe ◽  
Stephen A Bremner ◽  
Christoph Lauber ◽  
Catherine Henderson ◽  
Tom Burns
Keyword(s):  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Subjective Quality Of Life ◽  
Semistructured Interviews ◽  
Randomised Controlled

BackgroundPoor adherence to long-term antipsychotic injectable (LAI) medication in patients with psychotic disorders is associated with a range of negative outcomes. No psychosocial intervention has been found to be consistently effective in improving adherence.ObjectivesTo test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives.DesignA cluster randomised controlled trial with economic and nested qualitative evaluation. The intervention period lasted for 12 months with 24 months’ follow-up. The unit of randomisation was mental health teams in the community.SettingCommunity teams in secondary mental health care.ParticipantsPatients with a diagnosis of schizophrenia, schizoaffective psychosis or bipolar illness, receiving ≤ 75% of their prescribed LAI medication. In total, 73 teams with 141 patients (interventionn = 78 and controln = 63) were included.InterventionsParticipants in the intervention group received £15 for each LAI medication. Patients in the control group received treatment as usual.Main outcome measuresPrimary outcome: adherence to LAI medication (the percentage of received out of those prescribed). Secondary outcomes: percentage of patients with at least 95% adherence; clinical global improvement; subjective quality of life; satisfaction with medication; hospitalisation; adverse events; and costs. Qualitative evaluation: semistructured interviews with patients in the intervention group and their clinicians.ResultsPrimary outcome: outcome data were available for 131 patients. Baseline adherence was 69% in the intervention group and 67% in the control group. During the intervention period, adherence was significantly higher in the intervention group than in the control group (85% vs. 71%) [adjusted mean difference 11.5%, 95% confidence interval (CI) 3.9% to 19.0%;p = 0.003]. Secondary outcome: patients in the intervention group showed statistically significant improvement in adherence of at least 95% (adjusted odds ratio 8.21, 95% CI 2.00 to 33.67;p = 0.003) and subjective quality of life (difference in means 0.71, 95% CI 0.26 to 1.15;p = 0.002). Follow-ups: after incentives stopped, adherence did not differ significantly between groups, neither during the first 6 months (adjusted difference in means –7.4%, 95% CI –17.0% to 2.1%;p = 0.175) nor during the period from month 7 to month 24 (difference in means –5.7%, 95% CI –13.1% to 1.7%;p = 0.130). Cost-effectiveness: the average costs of the financial incentives was £303. Overall costs per patient were somewhat higher in the intervention group, but the difference was not significant. Semistructured interviews: the majority of patients and clinicians reported positive experiences with the incentives beyond their monetary value. These included improvement in the therapeutic relationship. The majority of both patients and clinicians perceived no negative impact after the intervention was stopped after 1 year.ConclusionsFinancial incentives are effective in improving adherence to LAI medication. Health-care costs (including costs of the financial incentive) are unlikely to be increased substantially by this intervention. Once the incentives stop, the advantage is not maintained. The experiences of both patients and clinicians are largely, but not exclusively, positive. Whether or not financial incentives are effective for patients with more favourable background, those on oral mediation or for shorter or longer time periods remains unknown.Trial registrationCurrent Controlled Trials ISRCTN77769281.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 70. See the NIHR Journals Library website for further project information.

A Smartphone App in Promoting Mental Wellbeing and Awareness of Anxiety Disorders for Adolescents: A Pilot Cluster Randomised Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yuying Sun ◽  
Man Ping Wang ◽  
Sai Yin Ho ◽  
Christian S. Chan ◽  
Patrick K.W. Man ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Anxiety Disorders ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Mental Wellbeing ◽  
Smartphone App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

BACKGROUND Mental health problems in adolescents are prevalent while population-based interventions for improving mental wellbeing of adolescents are limited. OBJECTIVE To design a smartphone app and evaluate its effect on promoting mental wellbeing of adolescents and awareness of anxiety disorders. METHODS A pilot cluster randomised controlled trial was conducted with 2 secondary schools (390 students, mean age 13.1 years) randomised to the intervention and control groups. A smartphone app was designed for one month’s use to promote mental wellbeing through “Sharing, Mind and Enjoyment (SME)” related interactions between students and their parents (e.g., express gratitude to family in words or actions), with assistance of App designers in releasing SME tasks daily. The waitlist control group was offered the app after completing all assessments. The primary outcomes were SME behaviours measured at 3-month after baseline. Secondary outcomes included subjective happiness, wellbeing, personal health and happiness, family health, happiness and harmony, self-perceived knowledge and understanding of anxiety disorders. Two focus groups of students and three individual in-depth interviews of service providers were conducted. RESULTS In the intervention students, 11.2% used the app together with parents and 45.4% used it without involving parents. The intervention group did not show significant difference in the change of SME behaviours at 1-month or 3-month compared with the control group. The intervention group showed greater increase in the awareness of anxiety disorders at follow-ups than the control group (Cohen’s d=0.52 at 1-month and 0.43 at 3-month, both P<0.001). Post-hoc analysis showed significantly greater increase in SME-related behaviours in the adherent subgroup than the control group at 3-month (d=0.46, P=0.04). The interviews found favourable changes in app users, but motivation of using the app was low in general. Both students and community partners suggested primary school students would be more receptive users. CONCLUSIONS The app did not show effectiveness in increasing SME behaviours of students but was effective in increasing awareness of anxiety disorders. Further improvements and tests among younger children and their parents are warranted. CLINICALTRIAL ClinicalTrials.gov NCT03361475

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