Clinical trial NCT03299218: Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan
Official title: Effectiveness of a Programme Comprised of SNF, Cash-based Transfers and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Punjab, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Keywords: Specialized Nutritious Food (SNF)
Social and Behaviour change communication (SBCC)
Cash-based transfers
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Benazir Income Support Programme (BISP)
name: Department of Health, Government of Punjab
name: World Food Programme (WFP)
First posted: 2017-10-03
Enrollment: 2179
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1. Control Group
2. Cash-based transfers only by BISP
3. Cash-based transfers and Social \& behaviour change communication (SBCC)
4. Cash-based transfer and SNF
5. Cash-based transfers, SNF and SBCC
Primary purpose: PREVENTION

Brief summary: Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.

Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.

Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.

Detailed description: Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.

The second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the management and prevention of under-nutrition, such as breastfeeding counselling or micronutrient supplementation, but evidence gaps still remain, particularly concerning indirect interventions. The World Health Organization highlighted in 2010 the need to consider prevention strategies when implementing programs aiming at reducing stunting rates. There is also evidence showing that preventive programs, such as supplementation, can be more effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash transfer experiences show that this type of intervention has the potential to prevent undernutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to inconclusive evidence regarding their nutritional benefits.

Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are especially evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.

Given the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based transfers, specialized nutritious foods and behavior change communication to prevent stunting in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the existing health system and the social protection programme, Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan. This document will describe the methods and strategies that AKU will employ to assess the effectiveness of the interventions on process and outcome indicators.

Eligibility criteria: Inclusion Criteria:

1. BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;
2. Living in the catchment area of LHW;
3. Have at least one child of 6-7 months old at the time of inclusion, and;
4. Willing and able to provide written informed consent for the study.

Exclusion Criteria:

1. Non BISP households
2. Planning to migrate form the study area in next 18 months
3. Unable to provide written informed consent
4. Children with severe malnutrition and/or chronic illness

Primary outcomes:
measure: Reduction in stunting
timeFrame: 18 months
measure: SBCC package on the basis of formative research
timeFrame: 3 months
measure: Cost-effectiveness of intervention packages for prevention of stunting in children
timeFrame: 18 months
Secondary outcomes:
measure: Weight gain in kilograms
timeFrame: 18 months
measure: Length gain in centimeters
timeFrame: 18 months
measure: Impact of the intervention on micronutrient deficiencies
timeFrame: At 24 months of age
measure: Improvement in IYCF practices
timeFrame: 18 months
measure: Improved nutrition, hygiene and health related knowledge and practices
timeFrame: 18 months
measure: Proportion of households with moderate or severe hunger (food insecurity)
timeFrame: 18 months
measure: Uptake of health services and interventions
timeFrame: 18 months
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Tehsil Rahim Yar Khan
state: Punjab
Study officials:
affiliation: Aga Khan University
name: Sajid B Soofi, FCPS, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soofi SB, Ariff S, Khan GN, Habib A, Kureishy S, Ihtesham Y, Hussain M, Rizvi A, Sajid M, Akbar N, Garzon C, de Pee S, Bhutta ZA. 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. Am J Clin Nutr. 2022 Feb 9;115(2):492-502. doi: 10.1093/ajcn/nqab341.
citation: Khan GN, Kureishy S, Ariff S, Habib MA, Usmani AA, Mubarik A, Hussain M, Akbar N, Rodriguez de Castro P, Garzon AC, de Pee S, Soofi SB. 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. JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.