Debunking highly prevalent health misinformation using audio dramas delivered by WhatsApp: evidence from a randomised controlled trial in Sierra Leone

IntroductionInfectious disease misinformation is widespread and poses challenges to disease control. There is limited evidence on how to effectively counter health misinformation in a community setting, particularly in low-income regions, and unsettled scientific debate about whether misinformation should be directly discussed and debunked, or implicitly countered by providing scientifically correct information.MethodsThe Contagious Misinformation Trial developed and tested interventions designed to counter highly prevalent infectious disease misinformation in Sierra Leone, namely the beliefs that (1) mosquitoes cause typhoid and (2) typhoid co-occurs with malaria. The information intervention for group A (n=246) explicitly discussed misinformation and explained why it was incorrect and then provided the scientifically correct information. The intervention for group B (n=245) only focused on providing correct information, without directly discussing related misinformation. Both interventions were delivered via audio dramas on WhatsApp that incorporated local cultural understandings of typhoid. Participants were randomised 1:1:1 to the intervention groups or the control group (n=245), who received two episodes about breast feeding.ResultsAt baseline 51% believed that typhoid is caused by mosquitoes and 59% believed that typhoid and malaria always co-occur. The endline survey was completed by 91% of participants. Results from the intention-to-treat, per-protocol and as-treated analyses show that both interventions substantially reduced belief in misinformation compared with the control group. Estimates from these analyses, as well as an exploratory dose–response analysis, suggest that direct debunking may be more effective at countering misinformation. Both interventions improved people’s knowledge and self-reported behaviour around typhoid risk reduction, and yielded self-reported increases in an important preventive method, drinking treated water.ConclusionThese results from a field experiment in a community setting show that highly prevalent health misinformation can be countered, and that direct, detailed debunking may be most effective.Trial registration numberNCT04112680.

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Do Nutrition Education Approaches With Preschoolers and Their Caregivers Influence Retention of Biofortified Orange-Fleshed Sweetpotato on Farms?: Evidence From Homa Bay County, Kenya

Food and Nutrition Bulletin ◽

10.1177/03795721211025445 ◽

2021 ◽

pp. 037957212110254

Author(s):

Sylvester O. Ojwang ◽

David J. Otieno ◽

Julius J. Okello ◽

Penina Muoki ◽

Rose A. Nyikal

Keyword(s):

Nutrition Education ◽

Early Childhood Development ◽

Controlled Trial ◽

Text Messages ◽

Sub Saharan Africa ◽

Childhood Development ◽

Control Group ◽

Micronutrient Deficiencies ◽

Household Level ◽

Intention To Treat

Background: Biofortified staples have been promoted widely in sub-Saharan Africa to combat micronutrient deficiencies. Contemporary projects are increasingly using elementary schools to target households with these foods. Objective: This study assessed the effects of integrated nutrition education approaches, targeting preschoolers and their caregivers, on retention of orange-fleshed sweetpotato (OFSP) on farms in the second season after lapse of free vine dissemination initiatives. Methods: Rural farming households, with preschoolers and no prior engagement with OFSP, were targeted. A multistage sample of 431 preschooler–caregiver pairs was recruited for a cluster-randomized controlled trial. After issuing routine OFSP promotion activities, 15 village-level clusters of the pairs were randomized into 1 control group (3 villages) and 3 treatment arms (4 villages each) for the interventions. Baseline and follow-up household-level survey data were collected from the caregivers. The interventions included: (1) OFSP-branded exercise books, posters, and a poem to preschoolers only; (2) OFSP-oriented mobile phone-mediated text messages to caregivers only; and (3) both 1 and 2 provided to individual households concurrently. Interventions 1 and 2 were single-channeled, while 3 was multichanneled. We estimated the intention-to-treat (ITT) and treatment-on-the-treated (TOT) effects using a binary logit model and a special regressor method, respectively. Results: Only the multichanneled nutrition education approach had significant effects (ITT = 0.167, P = .001; TOT = .243, P = .007) on the caregivers’ likelihood to retain OFSP on their farms. Conclusions: The finding implies that multichanneled agriculture-nutrition education interventions through Early Childhood Development institutions can be effective in ensuring sustainable adoption of OFSP.

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

Infection Control and Hospital Epidemiology ◽

10.1086/661285 ◽

2011 ◽

Vol 32 (9) ◽

pp. 872-880 ◽

Cited By ~ 89

Author(s):

Stephanie A. Fritz ◽

Bernard C. Camins ◽

Kimberly A. Eisenstein ◽

Joseph M. Fritz ◽

Emma K. Epplin ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Soft Tissue ◽

Controlled Trial ◽

Control Group ◽

Open Label ◽

Intention To Treat ◽

Intranasal Mupirocin ◽

Mupirocin Ointment ◽

Hygiene Education ◽

To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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A Randomized Controlled Trial of Prenatal Pediatric Visits for Urban, Low-income Families

PEDIATRICS ◽

10.1542/peds.98.6.1069 ◽

1996 ◽

Vol 98 (6) ◽

pp. 1069-1075

Author(s):

Janet R. Serwint ◽

Modena E. H. Wilson ◽

Judith W. Vogelhut ◽

John T. Repke ◽

Henry M. Seidel

Keyword(s):

Health Care ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Care Utilization ◽

Control Group ◽

Health Maintenance ◽

Car Safety ◽

Low Income Families ◽

Safety Seat

Background. Prenatal pediatric visits have been recommended by the American Academy of Pediatrics to allow the pediatrician to counsel parents on infant care issues, establish a supportive relationship, and provide pediatric practice information to parents. We hypothesized that prenatal pediatric visits would have an impact on breastfeeding decisions, health care behaviors, health care utilization, and the doctor-patient relationship. Methods. We conducted a randomized controlled trial of prenatal pediatric visits for urban, low-income families to measure the impact on breastfeeding decisions, infant car safety seat use, circumcision, health maintenance, and emergency room visits and the pediatrician's perception that he/she would know the mother better. Pregnant women were recruited prenatally from the obstetrics clinic. Outcomes were measured by maternal interview prenatally and when the infant was 2 months old, in addition to review of the nursery record. Physicians were interviewed after the 2-month visit. Health care utilization was measured by chart review at 7 months. Results. A total of 156 pregnant women were enrolled and randomized, 81 to the intervention group and 75 to the control group. Of mothers who breastfed, 45% in the intervention group changed their mind in favor of breastfeeding after enrollment compared with 14% in the control group. Mothers in the intervention group compared with the control group were more likely to make fewer emergency room visits, 0.58 compared with 1.0. Pediatricians were more likely to think that they knew mothers in the intervention group well, 54% versus 29% in the control group, yet 67% of mothers in both groups agreed their pediatrician knew them well. There were no differences between groups in initiation or duration of breastfeeding at 30 or 60 days, infant car safety seat use, circumcision, or health maintenance visits. Conclusions. Prenatal pediatric visits have potential impact on a variety of health care outcomes. Among urban, low-income mothers, we found beneficial effects on breastfeeding decisions, a decrease in emergency department visits, and an initial impact on the doctor-patient relationship. We suggest urban practices actively promote prenatal pediatric visits.

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Title: Application of a physiotherapy protocol to women during the active phase of labour improves obstetric outcomes: a randomized clinical trial.

10.22541/au.161271575.57289965/v1 ◽

2021 ◽

Author(s):

LICIA SANTANA ◽

Rubneide Gallo ◽

Silvana Quintana ◽

Geraldo Duarte ◽

Cristine Homsi Ferreira ◽

...

Keyword(s):

Controlled Trial ◽

Perinatal Outcomes ◽

Active Phase ◽

Labour Pain ◽

Obstetric Outcomes ◽

Control Group ◽

Phase Duration ◽

Intention To Treat ◽

Reference Centre ◽

Care Protocol

Objective: To evaluate the effectiveness of a non-pharmacological childbirth care protocol in women in the active phase of labour in improving obstetric and perinatal outcomes. Design: Randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting: Reference Centre of Women’s Health of Ribeirão Preto–MATER, São Paulo, Brazil. Methods: Eighty low-risk primiparous women at the end of pregnancy and beginning of the active phase of labour were randomized to experimental group (EG) (n=40) or control group (CG) (n=40). Women in EG received four interventions: ambulation at 4 to 6 cm of cervical dilation; alternative maternal positions associated with TENS at 6 to 7 cm, and a warm shower bath at >7 cm. The CG received only routine obstetric. Main outcome measures: The length of the active phase of labour, the expulsive phase duration, and the prevalence of labour dystocia assessed by the partograph. Results: The parturients who received the sequential non-pharmacological protocol had a shorter length of the active phase of labour (CG=444 minutes; EG=373 minutes; p=0,02), presented rupture of membranes later in labour (CG=7cm; EG=8cm; p<0,01), requested pharmacological analgesia with more significant cervical dilatation (CG=5cm; EG=8cm; p<0,01) and had lower labour dystocia rates than the patients in the CG. Conclusion: The implementation of a sequential non-pharmacological protocol has the potential in decreased and delayed use of pharmacological analgesia, duration of the active phase of labour and dystocia rates. Keywords: length of labour, labour pain, dystocia, randomized controlled trial, non-pharmacological resources, pharmacological analgesia. Trial registration: NCT01601860 Link: https://clinicaltrials.gov/ct2/show/NCT01601860

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A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

Addiction Science & Clinical Practice ◽

10.1186/s13722-020-00209-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

K. Sorsdahl ◽

D. J. Stein ◽

S. Pasche ◽

Y. Jacobs ◽

R. Kader ◽

...

Keyword(s):

South Africa ◽

Controlled Trial ◽

Adverse Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Brief Treatment ◽

Middle Income ◽

Methamphetamine Use ◽

Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

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Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

10.21203/rs.3.rs-24814/v1 ◽

2020 ◽

Author(s):

Ameer Muhammad ◽

Yasir Shafiq ◽

M Imran Nisar ◽

Benazir Baloch ◽

Amna Tanweer Yazdani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Relative Length ◽

Trial Registration ◽

Control Group ◽

Lactating Women ◽

Randomized Controlled ◽

Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

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TREATMENT SWITCHING: STATISTICAL AND DECISION-MAKING CHALLENGES AND APPROACHES

International Journal of Technology Assessment in Health Care ◽

10.1017/s026646231600026x ◽

2016 ◽

Vol 32 (3) ◽

pp. 160-166 ◽

Cited By ~ 14

Author(s):

Nicholas R. Latimer ◽

Chris Henshall ◽

Uwe Siebert ◽

Helen Bell

Keyword(s):

Statistical Methods ◽

Failure Time ◽

Controlled Trial ◽

International Workshop ◽

Experimental Treatment ◽

Decision Makers ◽

Control Group ◽

Intention To Treat ◽

Treatment Switching ◽

New Treatment

Objectives: Treatment switching refers to the situation in a randomized controlled trial where patients switch from their randomly assigned treatment onto an alternative. Often, switching is from the control group onto the experimental treatment. In this instance, a standard intention-to-treat analysis does not identify the true comparative effectiveness of the treatments under investigation. We aim to describe statistical methods for adjusting for treatment switching in a comprehensible way for nonstatisticians, and to summarize views on these methods expressed by stakeholders at the 2014 Adelaide International Workshop on Treatment Switching in Clinical Trials.Methods: We describe three statistical methods used to adjust for treatment switching: marginal structural models, two-stage adjustment, and rank preserving structural failure time models. We draw upon discussion heard at the Adelaide International Workshop to explore the views of stakeholders on the acceptability of these methods.Results: Stakeholders noted that adjustment methods are based on assumptions, the validity of which may often be questionable. There was disagreement on the acceptability of adjustment methods, but consensus that when these are used, they should be justified rigorously. The utility of adjustment methods depends upon the decision being made and the processes used by the decision-maker.Conclusions: Treatment switching makes estimating the true comparative effect of a new treatment challenging. However, many decision-makers have reservations with adjustment methods. These, and how they affect the utility of adjustment methods, require further exploration. Further technical work is required to develop adjustment methods to meet real world needs, to enhance their acceptability to decision-makers.

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Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

Clinical Rehabilitation ◽

10.1177/0269215519879212 ◽

2019 ◽

Vol 34 (1) ◽

pp. 111-119 ◽

Cited By ~ 1

Author(s):

Elena Donoso-Úbeda ◽

Javier Meroño-Gallut ◽

José Antonio López-Pina ◽

Rubén Cuesta-Barriuso

Keyword(s):

Manual Therapy ◽

Joint Pain ◽

Controlled Trial ◽

Control Group ◽

Load Bearing ◽

Intention To Treat ◽

Joint Health ◽

Experimental Group ◽

Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

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