- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299218
Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Rahim Yar Khan, Punjab, Pakistan, 64200
- Tehsil Rahim Yar Khan
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;
- Living in the catchment area of LHW;
- Have at least one child of 6-7 months old at the time of inclusion, and;
- Willing and able to provide written informed consent for the study.
Exclusion Criteria:
- Non BISP households
- Planning to migrate form the study area in next 18 months
- Unable to provide written informed consent
- Children with severe malnutrition and/or chronic illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Receiving current Government of Punjab health services
|
|
Experimental: Cash-based transfers
Cash-based transfers only by BISP
|
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
|
Experimental: Cash with SBCC
Cash-based transfers and Social & behaviour change communication (SBCC)
|
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
SBCC messages will be delivered by LHWs in their monthly routine household visits.
Male and female group sessions will be arranged on quarterly basis with the help of health committees.
|
Experimental: Cash with SNF (Wawamum)
Cash-based transfers and SNF (Wawamum)
|
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs.
Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.
|
Experimental: Cash,SNF (Wawamum) & SBCC
Cash-based transfers, SNF (Wawamum) and SBCC
|
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
SBCC messages will be delivered by LHWs in their monthly routine household visits.
Male and female group sessions will be arranged on quarterly basis with the help of health committees.
A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs.
Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in stunting
Time Frame: 18 months
|
10% reduction in stunting in children
|
18 months
|
SBCC package on the basis of formative research
Time Frame: 3 months
|
SBCC package will be developed on the basis of formative research
|
3 months
|
Cost-effectiveness of intervention packages for prevention of stunting in children
Time Frame: 18 months
|
Cost effectiveness analysis will run through the full three years of the program cost
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight gain in kilograms
Time Frame: 18 months
|
Child weight in kilograms will be measured on monthly basis
|
18 months
|
Length gain in centimeters
Time Frame: 18 months
|
Child length in centimeters will be measured on monthly basis
|
18 months
|
Impact of the intervention on micronutrient deficiencies
Time Frame: At 24 months of age
|
Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis
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At 24 months of age
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Improvement in IYCF practices
Time Frame: 18 months
|
Improvement in IYCF practices will be measured from monthly follow-up data
|
18 months
|
Improved nutrition, hygiene and health related knowledge and practices
Time Frame: 18 months
|
Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data
|
18 months
|
Proportion of households with moderate or severe hunger (food insecurity)
Time Frame: 18 months
|
Food insecurity will be measured from baseline and endline data
|
18 months
|
Uptake of health services and interventions
Time Frame: 18 months
|
Uptake of health services and interventions will be measured from baseline and endline data
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sajid B Soofi, FCPS, MBBS, Aga Khan University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT Study Rahim Yar Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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