<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/NCT02237144</url>
  </required_header>
  <id_info>
    <org_study_id>AEARCTR-0000247</org_study_id>
    <nct_id>NCT02237144</nct_id>
  </id_info>
  <brief_title>Transfer Modality Research Initiative - Bangladesh</brief_title>
  <acronym>TMRI</acronym>
  <official_title>Transfer Modality Research Initiative - Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Food Policy Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Nations World Food Programme (WFP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal Ministry of Economic Cooperation and Development (Germany)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Agency for Development and Cooperation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department for International Development, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Consortium of International Agricultural Research Centers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Food Policy Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is&#xD;
      assigned at the village level where treatments are: cash transfers (north and south); cash&#xD;
      transfers + nutrition behavior communication change (north only); food transfers (north and&#xD;
      south); food transfers + nutrition behavior communication change (south only); food-cash&#xD;
      split (north and south); and controls (north and south). Within treatment localities, women&#xD;
      living in very poor households are targeted to receive benefits for two years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">January 2015</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child anthropometry</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Height for age z scores Weight for height z scores Weight for age z scores Stunting Wasting Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child food intake</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Number of unique foods consumed in previous 24 hours Number of food groups consumed in previous 24 hours Consumption of specified food groups - animal source foods, dairy, Vitamin A rich foods etc Caloric consumption in previous 24 hours Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child health</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Did mother report child was ill in previous 2 weeks Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of food intake within the household</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Consumption of foods by all household members in previous 24 hours as recalled by mothers as measured by yes/no questions on foods, food groups and calories Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Household food security</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Food groups consumed by household in previous seven days Number of unique foods consumed in previous seven days Number of food groups consumed in previous seven days Number of food groups consumed in previous seven days weighted by nutritional value and frequency of consumption Value of food consumption in previous seven days Household caloric availability in previous seven days Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal nutrition knowledge</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Maternal knowledge of infant and young child feeding practices (IYCF) Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Levels assessed in 2013 and 2014 and as changes between 2012-2013, 2013-2014 and 2012-2014</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Household consumption</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Value of food consumption in previous seven days Value of monthly non-food consumption Value of monthly non-food consumption by specified sub-groups (clothing, medical expenses, education expenses, transport, consumables, semi-durables) Value of monthly household consumption (food and non-food) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household income</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Value of annual income derived from agriculture at endline (2014) Value of annual income derived from non-agricultural sources at endline (2014) Value of annual total income derived from all sources at endline (2014) Change in annual income (agriculture, non-agricultural, total) between 2012-2013, 2013-2014 and 2012-2014 Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asset accumulation</measure>
    <time_frame>Baseline. Up to 12 months. Up to 24 months.</time_frame>
    <description>Index (z score) of consumer durables Index (z score) of productive assets Index of quality of housing stock Productive land ownership (ha) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's empowerment</measure>
    <time_frame>Up to 12 months. Up to 24 months.</time_frame>
    <description>Index of women's decision making autonomy within the household Index of women's mobility outside the household Outcome measured as level in 2013, level in 2014 and change between 2013-2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information spillovers to non-beneficiaries</measure>
    <time_frame>Up to 24 months.</time_frame>
    <description>Knowledge of infant and young child feeding practices (IYCF) of mothers Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Non-beneficiaries are mothers living near intervention households (within approximately a 10 minute walk) in the following treatment arms: North: cash, cash + BCC, control. South: food, food + BCC, control. Levels assessed in 2014</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">5000</enrollment>
  <condition>Improving Pre-school Anthropometric Status</condition>
  <condition>Improving Household Food Security</condition>
  <condition>Improving Maternal Nutrition Knowledge</condition>
  <arm_group>
    <arm_group_label>Cash transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1500 taka ($18.75) per household distributed monthly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food and cash transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash transfer + BCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1500 taka ($18.75) per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food transfer + BCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cash transfer</intervention_name>
    <description>1500 taka ($18.75) per household distributed monthly</description>
    <arm_group_label>Cash transfer</arm_group_label>
    <arm_group_label>Cash transfer + BCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food transfer</intervention_name>
    <description>30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly</description>
    <arm_group_label>Food transfer</arm_group_label>
    <arm_group_label>Food transfer + BCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food and cash transfer</intervention_name>
    <description>15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly</description>
    <arm_group_label>Food and cash transfer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavior Communication Change (BCC)</intervention_name>
    <description>Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits</description>
    <arm_group_label>Cash transfer + BCC</arm_group_label>
    <arm_group_label>Food transfer + BCC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child age &lt; 60 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akhter Ahmed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Hoddinott, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shalini Roy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Food Policy Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Food Policy Research Institute</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02237144
org study id: AEARCTR-0000247
nct id: NCT02237144
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is
      assigned at the village level where treatments are: cash transfers (north and south); cash
      transfers + nutrition behavior communication change (north only); food transfers (north and
      south); food transfers + nutrition behavior communication change (south only); food-cash
      split (north and south); and controls (north and south). Within treatment localities, women
      living in very poor households are targeted to receive benefits for two years.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Child anthropometry
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Height for age z scores Weight for height z scores Weight for age z scores Stunting Wasting Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Child food intake
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Number of unique foods consumed in previous 24 hours Number of food groups consumed in previous 24 hours Consumption of specified food groups - animal source foods, dairy, Vitamin A rich foods etc Caloric consumption in previous 24 hours Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Child health
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Did mother report child was ill in previous 2 weeks Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Distribution of food intake within the household
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Consumption of foods by all household members in previous 24 hours as recalled by mothers as measured by yes/no questions on foods, food groups and calories Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Household food security
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Food groups consumed by household in previous seven days Number of unique foods consumed in previous seven days Number of food groups consumed in previous seven days Number of food groups consumed in previous seven days weighted by nutritional value and frequency of consumption Value of food consumption in previous seven days Household caloric availability in previous seven days Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Maternal nutrition knowledge
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Maternal knowledge of infant and young child feeding practices (IYCF) Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Levels assessed in 2013 and 2014 and as changes between 2012-2013, 2013-2014 and 2012-2014
measure: Household consumption
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Value of food consumption in previous seven days Value of monthly non-food consumption Value of monthly non-food consumption by specified sub-groups (clothing, medical expenses, education expenses, transport, consumables, semi-durables) Value of monthly household consumption (food and non-food) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Household income
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Value of annual income derived from agriculture at endline (2014) Value of annual income derived from non-agricultural sources at endline (2014) Value of annual total income derived from all sources at endline (2014) Change in annual income (agriculture, non-agricultural, total) between 2012-2013, 2013-2014 and 2012-2014 Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Asset accumulation
time frame: Baseline. Up to 12 months. Up to 24 months.
description: Index (z score) of consumer durables Index (z score) of productive assets Index of quality of housing stock Productive land ownership (ha) Outcomes specified in terms of levels one year after intervention started (2013), two years after intervention started and as changes: 2012-2013, 2013-2014 and 2012-2014
measure: Women's empowerment
time frame: Up to 12 months. Up to 24 months.
description: Index of women's decision making autonomy within the household Index of women's mobility outside the household Outcome measured as level in 2013, level in 2014 and change between 2013-2014
measure: Information spillovers to non-beneficiaries
time frame: Up to 24 months.
description: Knowledge of infant and young child feeding practices (IYCF) of mothers Knowledge, attitudes, practice of IYCF Scored as yes/no and as a total score on all questions Non-beneficiaries are mothers living near intervention households (within approximately a 10 minute walk) in the following treatment arms: North: cash, cash + BCC, control. South: food, food + BCC, control. Levels assessed in 2014
arm group label: Cash transfer
arm group type: Experimental
description: 1500 taka ($18.75) per household distributed monthly
arm group label: Food transfer
arm group type: Experimental
description: 30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
arm group label: Food and cash transfer
arm group type: Experimental
description: 15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly
arm group label: Cash transfer + BCC
arm group type: Experimental
description: 1500 taka ($18.75) per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
arm group label: Food transfer + BCC
arm group type: Experimental
description: 30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
intervention type: Other
intervention name: Cash transfer
description: 1500 taka ($18.75) per household distributed monthly
arm group label: Cash transfer
arm group label: Cash transfer + BCC
intervention type: Other
intervention name: Food transfer
description: 30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
arm group label: Food transfer
arm group label: Food transfer + BCC
intervention type: Other
intervention name: Food and cash transfer
description: 15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly
arm group label: Food and cash transfer
intervention type: Behavioral
intervention name: Behavior Communication Change (BCC)
description: Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
arm group label: Cash transfer + BCC
arm group label: Food transfer + BCC
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Akhter Ahmed, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: John Hoddinott, DPhil
role: Principal Investigator
affiliation: International Food Policy Research Institute
last name: Shalini Roy, PhD
role: Principal Investigator
affiliation: International Food Policy Research Institute
facility: 
country: Bangladesh
responsible party type: Sponsor