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

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.

Download Full-text

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).

Download Full-text

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

Public Health Nutrition ◽

10.1017/s1368980019003963 ◽

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.

Download Full-text

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

10.2196/preprints.22684 ◽

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

Download Full-text

Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

10.1101/2021.08.16.21261782 ◽

2021 ◽

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G Monsieurs ◽

Jarl Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Predictive Values ◽

Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

Download Full-text

Post-harvest interventions decrease aflatoxin and fumonisin contamination in maize and subsequent dietary exposure in Tanzanian infants: a cluster randomised-controlled trial

World Mycotoxin Journal ◽

10.3920/wmj2017.2234 ◽

2018 ◽

Vol 11 (3) ◽

pp. 447-458 ◽

Cited By ~ 9

Author(s):

A. Kamala ◽

M. Kimanya ◽

B. De Meulenaer ◽

P. Kolsteren ◽

L. Jacxsens ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Dietary Exposure ◽

Cluster Randomised Controlled Trial ◽

Mitigation Strategies ◽

Control Group ◽

Post Harvest ◽

Cluster Randomised ◽

Randomised Controlled

A cluster randomised controlled trial was performed in three agro-ecological zones of Tanzania to evaluate the effectiveness of locally available post-harvest mitigation strategies in preventing and reducing aflatoxin and fumonisin contamination in maize. A total of 300 children, each from one household, were randomly selected from 30 villages (intervention: n=15). The mitigation strategies focused on hand sorting (prior to storage and use), drying maize on mat/raised platforms, proper sun drying, application of storage insecticides and de-hulling before milling. Maize sample was collected from each household at harvest (baseline) and six months after harvest. Maize intake by each child, estimated using the 24 h dietary recall technique and its body weight measured using standard procedures were taken at six months after harvest. Aflatoxins and fumonisins in the maize samples were determined using HPLC. Follow-up (six month after harvest) data were available for 261 of the 300 households (intervention: n=136). Mean concentration of aflatoxins, or fumonisins was significantly (P<0.05) lower in the intervention than in the control group: intervention effects: μg/kg (95% confidence interval (CI)) -4.9 (-7.3,-2.5), and -405, (-647,-162), respectively. The difference corresponds to 83 and 70% for aflatoxins, and fumonisins, respectively. At the end of the intervention, aflatoxin and fumonisin estimated mean intakes were lower in the intervention than in the control group by 78 and 65%, respectively. Six months after harvest, prevalence of underweight in the intervention group was 6.7% lower (P=0.014) than in the control group. Mean weight-for-age Z-score difference between the groups was 0.57 (95% CI; 0.16,-0.98; P=0.007). Post-harvest practices are effective in preventing and reducing aflatoxin and fumonisin contamination in maize and subsequent dietary exposure to infants. The interventions may be applied in these and other communities with similar environmental conditions or agricultural practices that favour production of aflatoxin and fumonisins in food crops. The trial was registered at ClinicalTrials.gov identifier: NCT02438774.

Download Full-text

Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised controlled trial

10.21203/rs.2.17081/v1 ◽

2019 ◽

Author(s):

Tuva Moseng ◽

Hanne Dagfinrud ◽

Leti van Bodegom-Vos ◽

Krysia Dziedzic ◽

Kåre Birger Hagen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Care Model ◽

Structured Model ◽

Cluster Randomised ◽

Randomised Controlled ◽

And Control

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

Download Full-text

Is there an app for that? A cluster randomised controlled trial of a mobile app–based mental health intervention

Health Informatics Journal ◽

10.1177/1460458219884195 ◽

2019 ◽

Vol 26 (3) ◽

pp. 1538-1559 ◽

Cited By ~ 3

Author(s):

Rachel Kenny ◽

Amanda Fitzgerald ◽

Ricardo Segurado ◽

Barbara Dooley

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Mobile App ◽

Control Group ◽

Cluster Randomised ◽

Randomised Controlled

Demand for the use of mobile apps in mental health interventions has grown in recent years, particularly among adolescents who experience elevated levels of distress. However, there is a scarcity of evidence for the effectiveness of these tools within this population. The aim of this study was to test the effectiveness of CopeSmart, a mental health mobile app, using a multicentre cluster randomised controlled trial design. Participants were 15–18-years-olds (N = 560) recruited from 10 schools randomly assigned to an intervention or control condition. Intervention participants used the app over a 4-week period. Multi-level modelling analyses revealed no significant changes in the intervention group from pre-test to post-test, when compared to the control group, in terms of emotional distress, well-being, emotional self-awareness or coping strategies. Findings suggest that a 4-week app-based intervention may not be enough to elicit intra-personal changes in mental health outcomes in a general adolescent population.

Download Full-text

Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

Download Full-text

Training to enhance psychiatrist communication with patients with psychosis (TEMPO): cluster randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.115.179499 ◽

2016 ◽

Vol 209 (6) ◽

pp. 517-524 ◽

Cited By ~ 32

Author(s):

Rose McCabe ◽

Paula John ◽

Jemima Dooley ◽

Patrick Healey ◽

Annie Cushing ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Therapeutic Relationship ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Medium Effect ◽

Secondary Outcome ◽

Shared Understanding ◽

Cluster Randomised ◽

Self Repair ◽

Randomised Controlled

BackgroundA better therapeutic relationship predicts better outcomes. However, there is no trial-based evidence on how to improve therapeutic relationships in psychosis.AimsTo test the effectiveness of communication training for psychiatrists on improving shared understanding and the therapeutic relationship (trial registration: ISRCTN94846422).MethodIn a cluster randomised controlled trial in the UK, 21 psychiatrists were randomised. Ninety-seven (51% of those approached) out-patients with schizophrenia/schizoaffective disorder were recruited, and 64 (66% of the sample recruited at baseline) were followed up after 5 months. The intervention group received four group and one individualised session. The primary outcome, rated blind, was psychiatrist effort in establishing shared understanding (self-repair). Secondary outcome was the therapeutic relationship.ResultsPsychiatrists receiving the intervention used 44% more self-repair than the control group (adjusted difference in means 6.4, 95% CI 1.46–11.33, P<0.011, a large effect) adjusting for baseline self-repair. Psychiatrists rated the therapeutic relationship more positively (adjusted difference in means 0.20, 95% CI 0.03–0.37, P = 0.022, a medium effect), as did patients (adjusted difference in means 0.21, 95% CI 0.01–0.41, P = 0.043, a medium effect).ConclusionsShared understanding can be successfully targeted in training and improves relationships in treating psychosis.

Download Full-text