scholarly journals Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Gul Nawaz Khan ◽  
Sumra Kureishy ◽  
Shabina Ariff ◽  
Muhammad Atif Habib ◽  
Asra Abeer Usmani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Rural Areas ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Change Communication ◽  
Cluster Randomized ◽  
And Behavior

BACKGROUND In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. OBJECTIVE The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. METHODS A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. RESULTS The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. CONCLUSIONS The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. CLINICALTRIAL ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19001

scholarly journals Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial

10.2196/19001 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e19001
Author(s):  
Gul Nawaz Khan ◽  
Sumra Kureishy ◽  
Shabina Ariff ◽  
Muhammad Atif Habib ◽  
Asra Abeer Usmani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Rural Areas ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Change Communication ◽  
Cluster Randomized ◽  
And Behavior

Background In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. Objective The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. Methods A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. Results The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. Conclusions The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. Trial Registration ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 International Registered Report Identifier (IRRID) DERR1-10.2196/19001

scholarly journals Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial

2021 ◽  
Author(s):  
Sajid Bashir Soofi ◽  
Shabina Ariff ◽  
Gul Nawaz Khan ◽  
Atif Habib ◽  
Sumra Kureishy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Behavior Change Communication ◽  
Randomized Controlled ◽  
Change Communication ◽  
Nutrient Supplement ◽  
Significant Difference ◽  
Cluster Randomized

Abstract Background In Pakistan, the prevalence of stunting among children under-five years has remained above WHO critical thresholds (≥30%) over the last two decades. Objective We hypothesized that an unconditional cash transfer (UCT) combined with lipid-based nutrient supplement (LNS) and/or social and behavior change communication (SBCC) will prevent stunting among children 6-23 months of age. Design This was a four-arm, community-based cluster randomized controlled trial conducted in the district of Rahim Yar Khan, Pakistan. A total of 1729 children (UCT n = 434); (UCT+SBCC n = 433); (UCT+LNS n = 430) and (UCT+LNS+SBCC n = 432) were enrolled at 6 months of age and measured monthly for 18 months until the age of 24 months. Results At 24 months of age, children who received UCT+LNS (rate ratio [RR], 0.85 [95% CI 0.74, 0.97]; P = 0.015); and UCT+LNS+SBCC (RR, 0.86 [95% CI 0.77, 0.96]; P = 0.007) had significantly lower risk of being stunted as compared to the UCT arm. No significant difference was noted among children who received UCT+SBCC (RR, 1.03 [95% CI 0.91, 1.16]; P = 0.675) in the risk of being stunted as compared to the UCT arm. The pooled prevalence of stunting among children 6-23 months was 41.7%, 44.8%, 38.5% and 39.3% in UCT, UCT+SBCC, UCT+LNS and UCT+LNS+SBCC, respectively. In pairwise comparisons, a significant impact on stunting among children in UCT+LNS (P = 0.029) and UCT+LNS+SBCC (P = <0.001) was noted as compared to UCT arm. Conclusions UCT combined with LNS and UCT+LNS+SBCC were effective in reducing the prevalence of stunting among children aged 6-23 months in marginalized populations. UCT+SBCC was not effective in reducing the child stunting prevalence. Clinical trial registration number: ClinicalTrials.gov NCT03299218

scholarly journals Effectiveness of Social Protection Program to Prevent Stunting Among Children 6–24 Months in Rural Pakistan; A Cluster Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 284-284
Author(s):  
Sajid Soofi ◽  
Gul Nawaz
Keyword(s):  
Randomized Controlled Trial ◽  
Social Protection ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Cash Transfer ◽  
Control Group ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Change Communication ◽  
Cluster Randomized

Abstract Objectives A 5-arm cluster randomized controlled trial to examine the effectiveness of specialized nutritious foods (SNF), unconditional cash transfers (UCTs) delivered to the regular BISP beneficiaries and social and behavioral change communication (SBCC) to prevent stunting among children 6–23 months. Methods The 5 study arms were (1) control group, which received routine government health services; (2) Unconditioned Cash Transfer (UCTs); (3) UCTs and Specialized Behaviour Change Communication (SBCC); (4) UCTs and SNF; and (5) UCTs, SNF and SBCC. BISP beneficiary households with children 6–23 months were eligible to participate in the study. Children at 6 months of age were enrolled and followed on a monthly basis up to 24 months of age. A total of 2179 children were randomized into the 4 interventions and control arms to detect a 20% reduction in the prevalence of stunting at 24 months of age. Results At 24 months of age, children who received UCTs with SNF (stunting RR = 0.80, 95% CI: 0.67–0.94, P = 0.007) and UCTs with SBCC and SNF (stunting RR = 0.77, 95% CI: 0.66–0.90, P = 0.001) had a significant reduction in the risk of being stunted as compared to the control arm. Furthermore, when compared with the control arm at 24 months of age (49.3%, 95% CI: 44.77–54.28), a 15% reduction in the prevalence of stunting was found in both the UCTs with SNF arm (41.73%, 95% CI: 37.22–46.74, P = 0.007) and the UCTs with SBCC and SNF arm (41.83%, 95% CI: 37.21–46.93, P = 0.001). Conclusions The study found a significant reduction in the prevalence of stunting, wasting, and underweight in children who received UCTs, SBCC and SNF between 6–23 months of age. Funding Sources World Food Programme and the German Government's Economic Cooperation and Development Section.

scholarly journals Implementation and Evaluation of a Digitally Enabled Precision Public Health Intervention to Reduce Inappropriate Gabapentinoid Prescription: Cluster Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Andre Q Andrade ◽  
Jean-Pierre Calabretto ◽  
Nicole L Pratt ◽  
Lisa M Kalisch-Ellett ◽  
Gizat M Kassie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
General Practitioners ◽  
Controlled Trial ◽  
Mode Of Delivery ◽  
Audit And Feedback ◽  
Professional Behavior ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Digital Delivery

BACKGROUND Digital technologies can enable rapid targeted delivery of audit and feedback interventions at scale. Few studies have evaluated how mode of delivery affects clinical professional behavior change and none have assessed the feasibility of such an initiative at a national scale. OBJECTIVE The aim of this study was to develop and evaluate the effect of audit and feedback by digital versus postal (letter) mode of delivery on primary care physician behavior. METHODS This study was developed as part of the Veterans’ Medicines Advice and Therapeutics Education Services (MATES) program, an intervention funded by the Australian Government Department of Veterans’ Affairs that provides targeted education and patient-specific audit with feedback to Australian general practitioners, as well as educational material to veterans and other health professionals. We performed a cluster randomized controlled trial of a multifaceted intervention to reduce inappropriate gabapentinoid prescription, comparing digital and postal mode of delivery. All veteran patients targeted also received an educational intervention (postal delivery). Efficacy was measured using a linear mixed-effects model as the average number of gabapentinoid prescriptions standardized by defined daily dose (individual level), and number of veterans visiting a psychologist in the 6 and 12 months following the intervention. RESULTS The trial involved 2552 general practitioners in Australia and took place in March 2020. Both intervention groups had a significant reduction in total gabapentinoid prescription by the end of the study period (digital: mean reduction of 11.2%, <i>P</i>=.004; postal: mean reduction of 11.2%, <i>P</i>=.001). We found no difference between digital and postal mode of delivery in reduction of gabapentinoid prescriptions at 12 months (digital: –0.058, postal: –0.058, <i>P</i>=.98). Digital delivery increased initiations to psychologists at 12 months (digital: 3.8%, postal: 2.0%, <i>P</i>=.02). CONCLUSIONS Our digitally delivered professional behavior change intervention was feasible, had comparable effectiveness to the postal intervention with regard to changes in medicine use, and had increased effectiveness with regard to referrals to a psychologist. Given the logistical benefits of digital delivery in nationwide programs, the results encourage exploration of this mode in future interventions.

scholarly journals Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H. Dow ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania. Methods We will conduct a type I hybrid implementation–effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic). Discussion This trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond. Trial registration ClinicalTrials.gov NCT04201353. Registered on December 17, 2019

scholarly journals Assessing the Effectiveness of an App-Based Unintentional Injury Intervention for Caregivers of Rural Chinese Preschoolers: Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Author(s):  
Jieyi He ◽  
Wanhui Wang ◽  
Peishan Ning ◽  
Peixia Cheng ◽  
Jie Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Injury Prevention ◽  
Rural Areas ◽  
Controlled Trial ◽  
Unintentional Injury ◽  
Cluster Randomized Controlled Trial ◽  
Parenting Education ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Abstract BackgroundCompared to urban children, children living in rural areas of most countries, including China, are at higher risk of suffering unintentional injuries. Most proven injury prevention interventions, however, are rarely implemented in rural China due to lack of resources. Mobile health interventions are low-cost and easy-to-implement, facilitating implementing injury prevention in resource-limited areas (e.g., rural areas). This study is designed to examine the effectiveness of an app-based intervention for unintentional injury prevention among rural preschoolers in China. MethodsA single-blind, 18-month, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in 2 rural areas of China (Yang County, Shaanxi Province, and Shicheng County, Jiangxi Province). In total, at least 3508 rural caregivers of preschoolers aged 3-6 years old who own a smartphone will be recruited from 24 preschools. Clusters will be randomized at the preschool level and allocated to the control group (receiving routine school-based education plus app-based parenting education excluding unintentional injury prevention) or the intervention group (receiving routine school-based education plus app-based parenting education including unintentional injury prevention). External support strategies will be adopted by local partners to minimize user fatigue, non-compliance, and attrition. Data collection will be conducted at baseline and then every 3 months during the 18-month follow-up time period. Intention-to-treat (ITT) data analysis will be implemented. Missing values will be imputed by using the Expectation Maximization algorithm (EM). Generalized estimation equations (GEE) will test the overall effectiveness of the app-based intervention. A per-protocol (PP) sensitivity analysis will be conducted to test the robustness of results. Subgroup analyses will follow the strategies for primary analyses.ResultsThe primary outcome measure is the incidence rate of unintentional injury among preschoolers during the study period. Secondary outcome measures comprise longitudinal changes in caregiver’s attitudes, caregiver-reported supervision behaviors, and caregiver-assessed home environment safety surrounding child unintentional injury prevention in the last week using a standardized audit instrument.ConclusionThe app-based intervention is expected to be feasible and effective over the 18-month intervention period. If the app is demonstrated effective as hypothesized, we will initiate processes to generalize and popularize it broadly to rural child caregivers across China. Trial registrationChiCTR2000037606, registered on August 29, 2020.

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