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Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan

Primary Purpose

Stunting

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SNF (Wawamum)
Social and behaviour change communication (SBCC)
Cash
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stunting focused on measuring Specialized Nutritious Food (SNF), Social and Behaviour change communication (SBCC), Cash-based transfers

Eligibility Criteria

6 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tehsil Rahim Yar Khan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Cash-based transfers

Cash with SBCC

Cash with SNF (Wawamum)

Cash,SNF (Wawamum) & SBCC

Arm Description

Receiving current Government of Punjab health services

Cash-based transfers only by BISP

Cash-based transfers and Social & behaviour change communication (SBCC)

Cash-based transfers and SNF (Wawamum)

Cash-based transfers, SNF (Wawamum) and SBCC

Outcomes

Primary Outcome Measures

Reduction in stunting
10% reduction in stunting in children
SBCC package on the basis of formative research
SBCC package will be developed on the basis of formative research
Cost-effectiveness of intervention packages for prevention of stunting in children
Cost effectiveness analysis will run through the full three years of the program cost

Secondary Outcome Measures

Weight gain in kilograms
Child weight in kilograms will be measured on monthly basis
Length gain in centimeters
Child length in centimeters will be measured on monthly basis
Impact of the intervention on micronutrient deficiencies
Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis
Improvement in IYCF practices
Improvement in IYCF practices will be measured from monthly follow-up data
Improved nutrition, hygiene and health related knowledge and practices
Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data
Proportion of households with moderate or severe hunger (food insecurity)
Food insecurity will be measured from baseline and endline data
Uptake of health services and interventions
Uptake of health services and interventions will be measured from baseline and endline data

Full Information

First Posted
August 12, 2017
Last Updated
March 18, 2020
Sponsor
Aga Khan University
Collaborators
Benazir Income Support Programme (BISP), Department of Health, Government of Punjab, World Food Programme (WFP)
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1. Study Identification

Unique Protocol Identification Number
NCT03299218
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Benazir Income Support Programme (BISP), Department of Health, Government of Punjab, World Food Programme (WFP)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting
Keywords
Specialized Nutritious Food (SNF), Social and Behaviour change communication (SBCC), Cash-based transfers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Control Group Cash-based transfers only by BISP Cash-based transfers and Social & behaviour change communication (SBCC) Cash-based transfer and SNF Cash-based transfers, SNF and SBCC
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Receiving current Government of Punjab health services
Arm Title
Cash-based transfers
Arm Type
Experimental
Arm Description
Cash-based transfers only by BISP
Arm Title
Cash with SBCC
Arm Type
Experimental
Arm Description
Cash-based transfers and Social & behaviour change communication (SBCC)
Arm Title
Cash with SNF (Wawamum)
Arm Type
Experimental
Arm Description
Cash-based transfers and SNF (Wawamum)
Arm Title
Cash,SNF (Wawamum) & SBCC
Arm Type
Experimental
Arm Description
Cash-based transfers, SNF (Wawamum) and SBCC
Intervention Type
Dietary Supplement
Intervention Name(s)
SNF (Wawamum)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social and behaviour change communication (SBCC)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cash
Intervention Description
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
Primary Outcome Measure Information:
Title
Reduction in stunting
Description
10% reduction in stunting in children
Time Frame
18 months
Title
SBCC package on the basis of formative research
Description
SBCC package will be developed on the basis of formative research
Time Frame
3 months
Title
Cost-effectiveness of intervention packages for prevention of stunting in children
Description
Cost effectiveness analysis will run through the full three years of the program cost
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Weight gain in kilograms
Description
Child weight in kilograms will be measured on monthly basis
Time Frame
18 months
Title
Length gain in centimeters
Description
Child length in centimeters will be measured on monthly basis
Time Frame
18 months
Title
Impact of the intervention on micronutrient deficiencies
Description
Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis
Time Frame
At 24 months of age
Title
Improvement in IYCF practices
Description
Improvement in IYCF practices will be measured from monthly follow-up data
Time Frame
18 months
Title
Improved nutrition, hygiene and health related knowledge and practices
Description
Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data
Time Frame
18 months
Title
Proportion of households with moderate or severe hunger (food insecurity)
Description
Food insecurity will be measured from baseline and endline data
Time Frame
18 months
Title
Uptake of health services and interventions
Description
Uptake of health services and interventions will be measured from baseline and endline data
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajid B Soofi, FCPS, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehsil Rahim Yar Khan
City
Rahim Yar Khan
State/Province
Punjab
ZIP/Postal Code
64200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34612491
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.
Results Reference
derived
PubMed Identifier
32831183
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.
Results Reference
derived

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Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan

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