Effects of drinking water, sanitation, handwashing, and nutritional interventions on immune status in young children: a cluster-randomized controlled trial in rural Bangladesh

While studies have speculated that immune function may play a role in how water, sanitation, hygiene, and nutritional (N+WSH) interventions may individually impact child growth and development, the combined effects of these interventions on immune system development are unknown. Here, we report on a trial in rural Bangladesh, where we cluster-randomized pregnant women into control and N+WSH arms. Among the birth cohort, we quantified plasma IL-1β, IL-6, TNF-α, IL-2, IL-12p70, IFN-γ, IL-4, IL-5, IL-13, IL-17A, IL-21, IL-10, and GM-CSF at ages 14 and 28 months. Cytokine ratios were included as prespecified outcomes to examine the net inflammatory environment. We assessed 704 children. After one year, TNF-α/IL-10, IL-12/IL-10, and IL-17A/IL-10 ratios were lower in the intervention group compared to the control group (mean difference: -0.12 to -0.19, p<0.05), indicating the intervention promoted IL-10 driven immunoregulation. Similar reductions in ratios of pro-inflammatory cytokines to IL-10 were sustained in the intervention group after two years. After one year, IL-12/IL-4, IL-12/IL-5, IFN-γ/IL-5, and IL-12/IL-13 ratios were lower in the intervention group (-0.18 to -0.27, p<0.05), suggesting a shift towards a Th2 cytokine response. These findings suggest that the N+WSH intervention enhanced the immunoprotective and immunoregulatory responses, and suppressed/counteracted the inflammatory/immunopathological response, of the immune triad.

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Apathy in Nursing Home Residents with Dementia: Results From A Cluster-Randomized Controlled Trial

European Psychiatry ◽

10.1016/j.eurpsy.2014.02.004 ◽

2015 ◽

Vol 30 (2) ◽

pp. 251-257 ◽

Cited By ~ 17

Author(s):

Y. Treusch ◽

T. Majic ◽

J. Page ◽

H. Gutzmann ◽

A. Heinz ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Cluster Randomized Trial ◽

Control Group ◽

Intervention Period ◽

Significant Group ◽

Dementia Patients ◽

Cluster Randomized ◽

One Year

AbstractPurpose:Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy.Subjects and methods:A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n = 117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months.Results:We found significant group differences with respect to apathy during the 10 month intervention period (F2,82 = 7.79, P < 0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P = 0.55).Conclusions:Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy.

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

Western Journal of Nursing Research ◽

10.1177/01939459211020757 ◽

2021 ◽

pp. 019394592110207

Author(s):

Min Wen ◽

Yaqin Liang ◽

Qianqian Shen ◽

Juping Yu ◽

Pingping He ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Health Education ◽

Controlled Trial ◽

Coping Styles ◽

Intervention Group ◽

Control Group ◽

Convenience Sample ◽

Cluster Randomized ◽

And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126633 ◽

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.

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Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial

Prevention Science ◽

10.1007/s11121-020-01145-z ◽

2020 ◽

Vol 21 (8) ◽

pp. 1028-1036

Author(s):

Takeo Fujiwara ◽

Aya Isumi ◽

Makiko Sampei ◽

Yusuke Miyazaki ◽

Fujiko Yamada ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Educational Video ◽

Health Checkup ◽

Infant Crying ◽

Randomized Controlled ◽

Cluster Randomized ◽

And Control

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

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Cluster Randomized Controlled Trial of Disability Education Module During Clinical Clerkship

Clinical Pediatrics ◽

10.1177/0009922819850475 ◽

2019 ◽

Vol 58 (13) ◽

pp. 1387-1393

Author(s):

Jonathan D. Santoro ◽

Emily E. Whitgob ◽

Lynne C. Huffman

Keyword(s):

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Family Control ◽

Time Interaction ◽

Functional Aspects ◽

Management Participation ◽

Cluster Randomized ◽

Disability Education

The effect of a randomized disability education program on medical student knowledge and attitudes concerning disability was performed. Intervention group received bedside teaching of physical examination/interview skills and case-based discussion. Twenty-three participants completed the study (control group n = 11; intervention group n = 12). Pre-clerkship, 39% of all participants reported no personal experience and 43% reported no professional experience with people with disabilities. Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant. Qualitative analysis of post-clerkship attitude responses demonstrated that intervention group gave more detailed answers. Intervention group used terms representing functional aspects of disability twice as frequently as control group. Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management. Participation in disability education resulted in changed attitude toward disability and better understanding of aspects of disability.

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Meridian Cuffing Exercises Improved Functional Fitness and Cardiopulmonary Functioning of Community Older Adults

Clinical Nursing Research ◽

10.1177/1054773818768021 ◽

2018 ◽

Vol 29 (1) ◽

pp. 37-47 ◽

Cited By ~ 1

Author(s):

Hsiao-Ting Tung ◽

Chi-Chieh Lai ◽

Kuei-Min Chen ◽

Han-Ya Tsai

Keyword(s):

Older Adults ◽

Community Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Fitness ◽

Randomized Controlled ◽

Cluster Randomized ◽

Study Intervention ◽

Single Blind

This study was aimed to test the effects of a meridian cuffing exercise, the Healthy Beat Acupunch (HBA) regimen, on the functional fitness and cardiopulmonary functioning of community older adults. A single-blind, cluster randomized controlled trial was conducted. We randomly allocated eight community care centers to the intervention or control group and recruited 228 participants who completed the study (intervention: four centers, n = 111; control: four centers, n = 117). The intervention group underwent a 40-min session of HBA regimen 3 times per week for 6 months. Functional fitness and cardiopulmonary functioning were assessed at baseline, 3 months, and 6 months of the intervention. The intervention group demonstrated significantly greater improvements in functional fitness and cardiopulmonary functioning than the control group between baseline and either 3 months or 6 months. We suggest that activities designed to promote health among community older adults include acupunch exercises.

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150 Falls in Malaysia: Magnitude, Risk, Disparities, and Solutions

Age and Ageing ◽

10.1093/ageing/afz164.150 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv34-iv39

Author(s):

Maw Pin Tan ◽

Sumaiyah Mat ◽

Deepa Alex ◽

Shahrul Bahyah Kamaruzzaman

Keyword(s):

Ethnic Differences ◽

Cultural Practices ◽

Longitudinal Research ◽

Controlled Trial ◽

Intervention Group ◽

Psychological Status ◽

Control Group ◽

Cross Sectional ◽

One Year ◽

Risk Factors For Falls

Abstract The Malaysian Elders Longitudinal Research (MELoR) study found 1 in 4 residents aged 65 years and over living in the Klang Valley of Malaysia fall at least once a year in their survey conducted between 2013 and 2015. Recent figures obtained from the First Older Persons’ National Health and Morbidity Survey conducted in 2018 revealed that 15% of Malaysians aged 60 years and over fall at least once a year. In a 10-year follow-up study involving 200 individuals who presented to the emergency department over a six-month period in 2002, 22% were no longer alive at one year, and 80% had died at 10 years. Older age, indoor falls, subsequent hospital admission and functional impairment predicted death at one year. Cross-sectional data from MELoR revealed ethnic differences in fall prevalence, with the ethnic Indians more likely to report falls in the past 12 months compared to the ethnic Malays. Independent risk factors for falls identified from MELoR were urinary incontinence, reduced grip strength, hearing impairment, comorbidities and reducing walking speed. The ethnic differences in falls in our population remain unexplained. Lifestyle and cultural practices may well be the underlying rationale, but genetic influences cannot currently be ruled out. The results of a randomized controlled trial on multifactorial interventions, the Malaysian Falls Assessment and Intervention Trial (MyFAIT), was published last year. Mo differences in falls outcomes with an individualized multifactorial intervention were observed, despite improvements in physical performance and psychological status in the intervention group compared to the control group. The research group has now secured two-year funding to evaluate post-fall behavior in our setting in the Life After Falls (LiAF) study. In addition, dissemination and upskilling efforts are underway through training workshops, formation of the Malaysian Falls Network (MyFalls) and collaborations with the private sector to increase awareness on falls and increase fall prevention efforts throughout the country.

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Reinforcing Adherence to Lipid-lowering Therapy after an Acute Coronary Syndrome: A Pragmatic Randomized Controlled Trial

10.21203/rs.3.rs-118012/v2 ◽

2020 ◽

Author(s):

Stefanos Zafeiropoulos ◽

Ioannis Farmakis ◽

Anastasios Kartas ◽

Alexandra Arvanitaki ◽

Konstantinos Arvanitakis ◽

...

Keyword(s):

Goal Attainment ◽

Controlled Trial ◽

Intervention Group ◽

Lipid Lowering ◽

Control Group ◽

Lipid Lowering Therapy ◽

Good Adherence ◽

Coronary Syndrome ◽

Randomized Controlled ◽

One Year

Abstract Aims: Achieving the low-density lipoprotein cholesterol (LDL-C) goal following an acute coronary syndrome (ACS) is a milestone often missed due to suboptimal adherence to secondary prevention treatments. Whether improved adherence could result in reduced LDL-C levels is unclear. We aimed to evaluate an educational-motivational intervention to increase long-term lipid-lowering therapy (LLT) adherence and LDL-C goal attainment rate among post-ACS patients.Methods: IDEAL-LDL was a parallel, two-arm, single-center, pragmatic, investigator-initiated randomized controlled trial. Hospitalized patients for ACS were randomized to a physician-led integrated intervention consisting of an educational session at baseline, followed by regular motivational interviewing phone sessions or usual care. Co-primary outcomes were the LLT adherence (measured by Proportion of Days Covered (PDC); good adherence defined as PDC>80%), and LDL-C goal (<70 mg/dl or 50% reduction from baseline) achievement rate at one year.Results: In total, 360 patients (mean age 62 years, 81% male) were randomized. Overall, good adherence was positively associated with LDL-C goal achievement rate at one year. Median PDC was higher in the intervention group than the control group [0.92 (IQR, 0.82–1.00) vs. 0.86 (0.62–0.98); p=0.03] while the intervention group had increased odds of good adherence (adjusted odds ratio: 1.76 (95% confidence interval 1.02 to 2.62; p=0.04). However, neither the rate of LDL-C goal achievement (49.6% in the intervention vs. 44.9% in the control group; p=0.49) nor clinical outcomes differed significantly between the two groups.Conclusion: Α multifaceted intervention improved LLT adherence in post-ACS patients without a significant difference in LDL-C goal attainment. (IDEAL-LDL, ClinicalTrials.gov: NCT02927808)

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/12950 ◽

2020 ◽

Vol 9 (2) ◽

pp. e12950

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

Background Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. Objective This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. Methods A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. Results The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as P<.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. Conclusions We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. Trial Registration Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&EncHid=&userName=Muhamad%20Hanafiah%20Juni International Registered Report Identifier (IRRID) PRR1-10.2196/12950

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