<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299218</url>
  </required_header>
  <id_info>
    <org_study_id>CBT Study Rahim Yar Khan</org_study_id>
    <nct_id>NCT03299218</nct_id>
  </id_info>
  <brief_title>Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Benazir Income Support Programme (BISP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Health, Government of Punjab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Food Programme (WFP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition is a public health problem, with long-lasting physiological consequences and&#xD;
      increased risk of morbidity and mortality. It can be recognized as one of the key obstacles&#xD;
      in national development, due to its influence on individual productivity, school performance&#xD;
      and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates&#xD;
      increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of&#xD;
      nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some&#xD;
      of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need&#xD;
      for addressing its causes through various nutrition interventions, in order to ensure a&#xD;
      bright future for the coming generations.&#xD;
&#xD;
      Although, malnutrition is a major problem across Pakistan, its burden and implications in the&#xD;
      remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim&#xD;
      Yar Khan are high, with 47% of children being underweight. These numbers also highlight the&#xD;
      presence of long-term undernutrition in the district, as evidenced by 45% of the children&#xD;
      being stunted in 2014.&#xD;
&#xD;
      Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food&#xD;
      Program (WFP) Pakistan is proposing an intervention program comprised of cash-based&#xD;
      transfers, specialized nutritious foods and behaviours change communication to prevent&#xD;
      stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered&#xD;
      through the existing health system and Benazir Income Support Programme (BISP). It is&#xD;
      anticipated that the intervention will reduce the widespread macro and micro nutrient&#xD;
      malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence&#xD;
      of adequate evidence to persuade policymakers for further scaling up, it is essential that an&#xD;
      impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health,&#xD;
      Aga Khan University (AKU) using robust methodologies on a representative sample size in the&#xD;
      district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process&#xD;
      and outcome indicators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition is a public health problem, with long-lasting physiological consequences and&#xD;
      increased risk of morbidity and mortality. It can be recognized as one of the key obstacles&#xD;
      in national development, due to its influence on individual productivity, school performance&#xD;
      and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates&#xD;
      increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of&#xD;
      nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some&#xD;
      of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need&#xD;
      for addressing its causes through various nutrition interventions, in order to ensure a&#xD;
      bright future for the coming generations.&#xD;
&#xD;
      The second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up&#xD;
      Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the&#xD;
      management and prevention of under-nutrition, such as breastfeeding counselling or&#xD;
      micronutrient supplementation, but evidence gaps still remain, particularly concerning&#xD;
      indirect interventions. The World Health Organization highlighted in 2010 the need to&#xD;
      consider prevention strategies when implementing programs aiming at reducing stunting rates.&#xD;
      There is also evidence showing that preventive programs, such as supplementation, can be more&#xD;
      effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash&#xD;
      transfer experiences show that this type of intervention has the potential to prevent&#xD;
      undernutrition. However, most of the cash transfer programs implemented and scientifically&#xD;
      evaluated do not have a clear nutritional objective, which leads to inconclusive evidence&#xD;
      regarding their nutritional benefits.&#xD;
&#xD;
      Although, malnutrition is a major problem across Pakistan, its burden and implications in the&#xD;
      remote districts of Punjab are especially evident. The levels of undernutrition in district&#xD;
      Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight&#xD;
      the presence of long-term undernutrition in the district, as evidenced by 45% of the children&#xD;
      being stunted in 2014.&#xD;
&#xD;
      Given the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food&#xD;
      Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based&#xD;
      transfers, specialized nutritious foods and behavior change communication to prevent stunting&#xD;
      in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the&#xD;
      existing health system and the social protection programme, Benazir Income Support Programme&#xD;
      (BISP). It is anticipated that the intervention will reduce the widespread macro and micro&#xD;
      nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the&#xD;
      presence of adequate evidence to persuade policymakers for further scaling up, it is&#xD;
      essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan&#xD;
      University (AKU) using robust methodologies on a representative sample size in the district&#xD;
      of Rahim Yar Khan. This document will describe the methods and strategies that AKU will&#xD;
      employ to assess the effectiveness of the interventions on process and outcome indicators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Control Group&#xD;
Cash-based transfers only by BISP&#xD;
Cash-based transfers and Social &amp; behaviour change communication (SBCC)&#xD;
Cash-based transfer and SNF&#xD;
Cash-based transfers, SNF and SBCC</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in stunting</measure>
    <time_frame>18 months</time_frame>
    <description>10% reduction in stunting in children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SBCC package on the basis of formative research</measure>
    <time_frame>3 months</time_frame>
    <description>SBCC package will be developed on the basis of formative research</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost-effectiveness of intervention packages for prevention of stunting in children</measure>
    <time_frame>18 months</time_frame>
    <description>Cost effectiveness analysis will run through the full three years of the program cost</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight gain in kilograms</measure>
    <time_frame>18 months</time_frame>
    <description>Child weight in kilograms will be measured on monthly basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length gain in centimeters</measure>
    <time_frame>18 months</time_frame>
    <description>Child length in centimeters will be measured on monthly basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the intervention on micronutrient deficiencies</measure>
    <time_frame>At 24 months of age</time_frame>
    <description>Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in IYCF practices</measure>
    <time_frame>18 months</time_frame>
    <description>Improvement in IYCF practices will be measured from monthly follow-up data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved nutrition, hygiene and health related knowledge and practices</measure>
    <time_frame>18 months</time_frame>
    <description>Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of households with moderate or severe hunger (food insecurity)</measure>
    <time_frame>18 months</time_frame>
    <description>Food insecurity will be measured from baseline and endline data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of health services and interventions</measure>
    <time_frame>18 months</time_frame>
    <description>Uptake of health services and interventions will be measured from baseline and endline data</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">2179</enrollment>
  <condition>Stunting</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receiving current Government of Punjab health services</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash-based transfers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cash-based transfers only by BISP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash with SBCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cash-based transfers and Social &amp; behaviour change communication (SBCC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash with SNF (Wawamum)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cash-based transfers and SNF (Wawamum)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash,SNF (Wawamum) &amp; SBCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cash-based transfers, SNF (Wawamum) and SBCC</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SNF (Wawamum)</intervention_name>
    <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.</description>
    <arm_group_label>Cash with SNF (Wawamum)</arm_group_label>
    <arm_group_label>Cash,SNF (Wawamum) &amp; SBCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social and behaviour change communication (SBCC)</intervention_name>
    <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.</description>
    <arm_group_label>Cash with SBCC</arm_group_label>
    <arm_group_label>Cash,SNF (Wawamum) &amp; SBCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cash</intervention_name>
    <description>Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.</description>
    <arm_group_label>Cash with SBCC</arm_group_label>
    <arm_group_label>Cash with SNF (Wawamum)</arm_group_label>
    <arm_group_label>Cash,SNF (Wawamum) &amp; SBCC</arm_group_label>
    <arm_group_label>Cash-based transfers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00&#xD;
             according to the BISP approach for control group;&#xD;
&#xD;
          2. Living in the catchment area of LHW;&#xD;
&#xD;
          3. Have at least one child of 6-7 months old at the time of inclusion, and;&#xD;
&#xD;
          4. Willing and able to provide written informed consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non BISP households&#xD;
&#xD;
          2. Planning to migrate form the study area in next 18 months&#xD;
&#xD;
          3. Unable to provide written informed consent&#xD;
&#xD;
          4. Children with severe malnutrition and/or chronic illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sajid B Soofi, FCPS, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tehsil Rahim Yar Khan</name>
      <address>
        <city>Rahim Yar Khan</city>
        <state>Punjab</state>
        <zip>64200</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>March 18, 2020</last_update_submitted>
  <last_update_submitted_qc>March 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Sajid Bashir Soofi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Specialized Nutritious Food (SNF)</keyword>
  <keyword>Social and Behaviour change communication (SBCC)</keyword>
  <keyword>Cash-based transfers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299218
org study id: CBT Study Rahim Yar Khan
nct id: NCT03299218
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention 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
primary purpose: Prevention
masking: None (Open Label)
measure: Reduction in stunting
time frame: 18 months
description: 10% reduction in stunting in children
measure: SBCC package on the basis of formative research
time frame: 3 months
description: SBCC package will be developed on the basis of formative research
measure: Cost-effectiveness of intervention packages for prevention of stunting in children
time frame: 18 months
description: Cost effectiveness analysis will run through the full three years of the program cost
measure: Weight gain in kilograms
time frame: 18 months
description: Child weight in kilograms will be measured on monthly basis
measure: Length gain in centimeters
time frame: 18 months
description: Child length in centimeters will be measured on monthly basis
measure: Impact of the intervention on micronutrient deficiencies
time frame: At 24 months of age
description: Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis
measure: Improvement in IYCF practices
time frame: 18 months
description: Improvement in IYCF practices will be measured from monthly follow-up data
measure: Improved nutrition, hygiene and health related knowledge and practices
time frame: 18 months
description: Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data
measure: Proportion of households with moderate or severe hunger (food insecurity)
time frame: 18 months
description: Food insecurity will be measured from baseline and endline data
measure: Uptake of health services and interventions
time frame: 18 months
description: Uptake of health services and interventions will be measured from baseline and endline data
arm group label: Control
arm group type: No Intervention
description: Receiving current Government of Punjab health services
arm group label: Cash-based transfers
arm group type: Experimental
description: Cash-based transfers only by BISP
arm group label: Cash with SBCC
arm group type: Experimental
description: Cash-based transfers and Social & behaviour change communication (SBCC)
arm group label: Cash with SNF (Wawamum)
arm group type: Experimental
description: Cash-based transfers and SNF (Wawamum)
arm group label: Cash,SNF (Wawamum) & SBCC
arm group type: Experimental
description: Cash-based transfers, SNF (Wawamum) and SBCC
intervention type: Dietary Supplement
intervention name: SNF (Wawamum)
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.
arm group label: Cash with SNF (Wawamum)
arm group label: Cash,SNF (Wawamum) & SBCC
intervention type: Behavioral
intervention name: Social and behaviour change communication (SBCC)
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.
arm group label: Cash with SBCC
arm group label: Cash,SNF (Wawamum) & SBCC
intervention type: Other
intervention name: Cash
description: Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
arm group label: Cash with SBCC
arm group label: Cash with SNF (Wawamum)
arm group label: Cash,SNF (Wawamum) & SBCC
arm group label: Cash-based transfers
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Sajid B Soofi, FCPS, MBBS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Sajid Bashir Soofi
investigator title: Associate Professor
mesh term: Growth Disorders
sharing ipd: No