scholarly journals Norms and Social Network–Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  
Keyword(s):  
Behavior Change ◽  
Low Income ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
Well Being ◽  
Baseline Survey ◽  
Behavior Change Intervention ◽  
Behavior Change Interventions ◽  
Cluster Randomized ◽  
The Impact

BACKGROUND Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. OBJECTIVE The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. METHODS Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. RESULTS We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. CONCLUSIONS Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. CLINICALTRIAL ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24407

scholarly journals Norms and Social Network–Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial

10.2196/24407 ◽  
2021 ◽  
Vol 10 (5) ◽  
pp. e24407
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  
Keyword(s):  
Behavior Change ◽  
Low Income ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
Well Being ◽  
Baseline Survey ◽  
Behavior Change Intervention ◽  
Behavior Change Interventions ◽  
Cluster Randomized ◽  
The Impact

Background Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. Objective The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. Methods Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. Results We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. Conclusions Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. Trial Registration ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 International Registered Report Identifier (IRRID) DERR1-10.2196/24407

scholarly journals Design and rationale of the Longitudinal Evaluation of Norms and Networks Study (LENNS): A cluster-randomized trial assessing the impact of a norms-centric intervention on exclusive toilet use and maintenance in peri urban communities of Tamil Nadu

2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G. Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  
Keyword(s):  
Behavior Change ◽  
Randomized Trial ◽  
Low Income ◽  
Tamil Nadu ◽  
Cluster Randomized Trial ◽  
List Type ◽  
Behavior Change Intervention ◽  
Ex Ante ◽  
Cluster Randomized ◽  
The Impact

AbstractIntroductionInconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norms-centric behavior change interventions to increase toilet use in low-income settings. This protocol details the rationale and design of an ex-ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norms-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.Methods and AnalysisFollowing two years of formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “Our wellbeing”). The multi-level intervention aims to shift collective beliefs by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to build, consistently use and maintain their toilets. This trial includes 76 wards in Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining serve as counterfactuals. During baseline and endline (conducted one year after the initiation of intervention) assessments, we collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, wellbeing outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We will also conduct a process evaluation to understand the extent to which the intervention was implemented, as designed.Ethics and DisseminationThe study protocol has been reviewed and approved by the ethics board at the University of Pennsylvania, USA and the Catalyst Foundation, India. Research findings will be disseminated through open access peer reviewed publications and presentations to stakeholders, government officials and conferences.Trial registrationNCT04269824.Strengths and limitations of this studyThis ex-ante, parallel cluster randomized trial assesses the impact of a norm-centric behavior change intervention strategy to improve sanitation practices. These behavior change techniques are novel to the sanitation sector but has been effective in changing a variety of behaviors, such as water use, drinking behavior, and energy consumption.The study outcomes include health, wellbeing outcomes, and a careful assessment of changes in social beliefs, expectations, and social determinants of collective sanitation behaviors.This study is being rolled out during the ongoing COVID-19 pandemic. This can potentially impact the effectiveness of this intervention package that uses community and network-based group activities. However, through a detailed process monitoring and evaluation we will be able to assess the impact on delivery, and subsequent behavior change in this unique setting.

scholarly journals The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jane Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Alexandra Czerniewska ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Infant Food ◽  
Food Hygiene ◽  
Randomized Controlled ◽  
Hygiene Intervention ◽  
Enteric Infections ◽  
Cluster Randomized ◽  
Start Trial ◽  
The Impact

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in low income urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targeted four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding, including when reheating or reserving; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The Safe Start trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children. Trial registration The trial was registered at clinicaltrial.gov on March 16th 2018 before enrolment of any participants (https://clinicaltrials.gov/ct2/show/NCT03468114).

scholarly journals A Peer-to-Peer Live-Streaming Intervention for Children During COVID-19 Homeschooling to Promote Physical Activity and Reduce Anxiety and Eye Strain: Cluster Randomized Controlled Trial

10.2196/24316 ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. e24316
Author(s):  
Yingfeng Zheng ◽  
Wei Wang ◽  
Yuxin Zhong ◽  
Fengchun Wu ◽  
Zhuoting Zhu ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Controlled Trial ◽  
Live Streaming ◽  
Square Root ◽  
Behavior Change Intervention ◽  
Randomized Controlled ◽  
Children’S Anxiety ◽  
Cluster Randomized

Background The COVID-19 pandemic has led to worldwide school closures, with millions of children confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions. Objective The objective of our study was to investigate whether a digital behavior change intervention aimed at promoting physical activity could reduce children’s anxiety and digital eye strain while undergoing prolonged homeschooling during the COVID-19 pandemic. Methods In this cluster randomized controlled trial, homeschooled grade 7 students at 12 middle schools in southern China were recruited through local schools and randomly assigned by the school to receive (1:1 allocation): (1) health education information promoting exercise and ocular relaxation, and access to a digital behavior change intervention, with live streaming and peer sharing of promoted activities (intervention), or (2) health education information only (control). The primary outcome was change in self-reported anxiety score. Secondary outcomes included change in self-reported eye strain and sleep quality. Results On March 16, 2020, 1009 children were evaluated, and 954 (94.5%) eligible children of consenting families were included in the intention-to-treat analysis. Children in the intervention (n=485, 6 schools) and control (n=469, 6 schools) groups were aged 13.5 (SD 0.5) years, and 52.3% (n=499) were male. The assigned interventions were completed by 896 children (intervention: n=467, 96.3%; control: n=429, 91.5%). The 2-week change in square-root–transformed self-reported anxiety scores was greater in the intervention (–0.23, 95% CI –0.27 to –0.20) vs control group (0.12, 95% CI 0.09-0.16; unadjusted difference –0.36, 95% CI –0.63 to –0.08; P=.02). There was a significant reduction in square-root–transformed eye strain in the intervention group (–0.08, 95% CI –0.10 to 0.06) compared to controls (0.07, 95% CI 0.05-0.09; difference –0.15, 95% CI –0.26 to –0.03; P=.02). Change in sleep quality was similar between the two groups. Conclusions This digital behavior change intervention reduced children’s anxiety and eye strain during COVID-19–associated online schooling. Trial Registration ClinicalTrials.gov NCT04309097; http://clinicaltrials.gov/ct2/show/NCT04309097

scholarly journals The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

2019 ◽  
Author(s):  
Jane Awiti Odhiambo Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Alexandra Czerniewska ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Infant Food ◽  
Food Hygiene ◽  
Randomized Controlled ◽  
Hygiene Intervention ◽  
Enteric Infections ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, especially in low-income urban settings. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targets four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria ( Enterococcus ) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the extension system can improve the health of young children.

scholarly journals Gauging the impact of behavior change interventions: A tutorial on the Numbers Needed to Treat

2017 ◽  
Author(s):  
Stefan L.K. Gruijters ◽  
Gjalt - Jorn Ygram Peters
Keyword(s):  
Behavior Change ◽  
Effect Size ◽  
Population Level ◽  
Applied Psychology ◽  
Behavior Change Intervention ◽  
Behavior Change Interventions ◽  
Effect Size Index ◽  
Numbers Needed To Treat ◽  
Explained Variance ◽  
The Impact

Effect size indices are valuable to research in applied psychology, but traditional measures (e.g. Cohen’s d or Pearson’s r) are limited by their ability to convey practical information about intervention effectiveness. Researchers rely on concepts such as ‘standardized mean difference’ or ‘explained variance’ to express effectiveness. Practitioners, policymakers, and lay-people prefer concepts such as frequencies. Partial solutions have been offered by rules-of-thumb (e.g. Cohen’s categories of ‘small’, ‘moderate’ and ‘large’), but such pigeon-holing is somewhat arbitrary and of little nuance. We review, and provide a tutorial on, the Numbers Needed for Treat (NNT) statistic—an effect size index that originated in the medical literature. NNT fills the communicative gap between research and practice, and is particularly suited to gauge the impact of a behavior change intervention on a population level. NNT is defined as the number of people who need to be exposed to an intervention to achieve the desired change in one more individual, relative to a control condition. NNT has informational advantages: 1) it communicates effect magnitude in a frequency-format (number of people) making the impact of an intervention on a population transparent, and 2) it considers the population behavior base-rate to estimate this number. We adapt and extend the NNT index to suit applied psychology endeavors, and argue that the measure can strengthen the translation of intervention research to practice. The statistical procedure to estimate the NNT is explained, illustrated with concrete examples, and supplemented by script and functions to calculate the index in the R - environment.

scholarly journals Reduced exposure to malaria vectors following indoor residual spraying of pirimiphos-methyl in a high-burden district of rural Mozambique with high ownership of long-lasting insecticidal nets: entomological surveillance results from a cluster-randomized trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Joseph M. Wagman ◽  
Kenyssony Varela ◽  
Rose Zulliger ◽  
Abuchahama Saifodine ◽  
Rodaly Muthoni ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Indoor Residual Spraying ◽  
Malaria Vectors ◽  
Light Traps ◽  
High Burden ◽  
Randomized Controlled ◽  
Pirimiphos Methyl ◽  
Cluster Randomized ◽  
The Impact ◽  
Long Lasting Insecticidal Nets

Abstract Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p < 0.001) in indoor light traps and by 74% (CI95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. < 0.001) and outdoors (68% reduction: CI95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.

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