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)

Abstract

BACKGROUND In Pakistan, the prevalence of stunting in children under five years has remained above global critical levels over the two decades, with the current 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 specialized nutritious food (SNF), cash transfers (CBTs) and social and behavior change communication (SBCC) on reducing stunting in children 6-23 months. METHODS A five-arm cluster randomized controlled trial will be conducted in district Rahim Yar Khan, Punjab, Pakistan. The intervention packages will be: 1) Cash only; 2) Cash with SNF; 3) Cash with SBCC; and 4) Cash with SBCC and SNF. The control arm will receive routine standard-of-care. We will enroll children at 6 months of age and follow 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 at 24 months of age. 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 All recruitment and follow-up data are complete. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from BISP, with or without additional SNF and/or SBCC to prevent childhood stunting. CONCLUSIONS The findings of this trial will provide robust evidence as to which intervention package(s) can have significant effect on linear growth of children and to design effective intervention package(s) to prevent stunting in children at 24 months of age. CLINICALTRIAL ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218

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

“…We thank all the mothers, children, and their families who participated in this trial; the leaders and district- level staff of the BISP; all the LHWs, LHSs, and leaders of IRMNCH&NP who supported and facilitated field operations; and the World Food Programme for facilitating project implementation and transportation of food supplements during the entire duration of the study. We acknowledge that the results of this trial were previously published in an online report ( 34 ).…”

“…Around 13% of the population has access to improved sources of drinking water (piped water), 75.6% have access to improved sanitation, and 90.6% have access to electricity. Only 7.8% of households own agricultural land and 56% own livestock ( 33 , 34 ). Informed consent was obtained from all parents or caregivers prior to the recruitment in the study, data collection, and anthropometric measurements.…”

“…The primary study outcome was to reduce the prevalence of stunting among children at the age of 24 mo. Secondary outcomes included reduction in the prevalence of wasting and underweight among children at 24 mo of age ( 34 ).…”

“…A sample size of 400 children per arm was estimated based on 45% baseline stunting prevalence in district Rahim Yar Khan to detect a 20% difference (power of 0.80, α of 0.05, and intracluster correlation of 0.0008) in the prevalence of stunting among children at the age of 24 mo ( 34 , 36 ). The prevalence of stunting is assumed to be in the range of ±5%.…”

“…The multivariable analysis, performed by adjusting the effect of baseline covariates, was found to differ across arms. Mean anthropometric measurements and z scores were reported at 6, 12, 18, and 24 mo and compared using linear regression ( 34 ).…”