<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/NCT03752762</url>
  </required_header>
  <id_info>
    <org_study_id>Inter-AmericanDB Mexico</org_study_id>
    <nct_id>NCT03752762</nct_id>
  </id_info>
  <brief_title>SPOON: Sustained Program for Improving Nutrition - Mexico</brief_title>
  <official_title>Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Tepic, Mexico</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inter-American Development Bank</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Infantil de Mexico Federico Gomez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The PepsiCo Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inter-American Development Bank</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>
      The primary goal of this study is to assess the impact of an innovative strategy to prevent&#xD;
      undernutrition and obesity in early childhood in children 0-24 months in Mexico. This study&#xD;
      is designed to evaluate the impact of promoting adequate infant an young child feeding&#xD;
      practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the&#xD;
      nutritional status of infants and young children. The study will be conducted in peri-urban&#xD;
      areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México&#xD;
      Federico Gómez and the Nayarit Secretariat of Health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged&#xD;
      0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to&#xD;
      improve infant and young children feeding practices, including exclusive breastfeeding, and&#xD;
      promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based&#xD;
      nutrient supplements) through a novel behavior change strategy.&#xD;
&#xD;
      The study will recruit children between 0 and 6 months of age as well as pregnant women in&#xD;
      the third trimester. Mothers or caregivers of eligible children will be invited to&#xD;
      participate and a consent form obtain. Participation will start at 0-6 months and the&#xD;
      intervention will last until children are up to 24 months. Participants will be randomly&#xD;
      assigned at the household level to one of two groups: a control group and a treatment group.&#xD;
      Participants in the control group will receive the standard services provided by their local&#xD;
      health clinics according to the national protocol. Participants in Treatment Group 1 will&#xD;
      receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy&#xD;
      designed using ethnographic and marketing methods to promote adequate infant and young child&#xD;
      feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or&#xD;
      caregivers through individual home-visits and group sessions.&#xD;
&#xD;
      A sample size of 600 children per group has been calculated to detect a minimum effect size&#xD;
      of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has&#xD;
      been included in the sample size calculation.&#xD;
&#xD;
      Main outcomes include infant and young child feeding practices, height, weight, hemoglobin,&#xD;
      prevalence of anemia, prevalence of stunting, prevalence of obesity, and weight gain rate. A&#xD;
      baseline and final survey will be conducted to collect data for these variables, as well as&#xD;
      sociodemographic information. Impact estimation will be done comparing the average results&#xD;
      and the distribution of indicators between the treatment and control group. Differences of&#xD;
      simple means and regression models including co-variables of the child's age and sex, and&#xD;
      characteristics of the primary caregiver and household will be estimated. In addition to&#xD;
      potential changes in indicator averages, changes in the distribution of variables will be&#xD;
      explored under the hypothesis that the intervention might not only improve average value for&#xD;
      a given indicator, but compress the distribution over a range of values closer to an optimal&#xD;
      range. Changes to distributions will be checked by applying the Kolmogorov-Smirnov test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding cancelled&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 9 months</measure>
    <time_frame>Measured at 9 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices 15 months</measure>
    <time_frame>Measured 15 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 21 months</measure>
    <time_frame>Measured at 21 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant and young child feeding practices at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 9 months</measure>
    <time_frame>Measured at 9 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 15 months</measure>
    <time_frame>Measured at 15 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 21 months</measure>
    <time_frame>Measured at 21 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 6 months</measure>
    <time_frame>Constructed from weight measurements at 6 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 9 months</measure>
    <time_frame>Constructed from weight measurements at 9 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 12 months</measure>
    <time_frame>Constructed from weight measurements at 12 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 15 months</measure>
    <time_frame>Constructed from weight measurements at 15 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 18 months</measure>
    <time_frame>Constructed from weight measurements at 18 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 21 months</measure>
    <time_frame>Constructed from weight measurements at 21 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight gain rate at 24 months</measure>
    <time_frame>Constructed from weight measurements at 24 months of age</time_frame>
    <description>Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Measurement of hemoglobin concentration in blood using blood biometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Measurement of hemoglobin concentration in blood using blood biometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Measurement of hemoglobin concentration in blood using blood biometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Measurement of hemoglobin concentration in blood using blood biometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 9 months</measure>
    <time_frame>Measured at 9 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 15 months</measure>
    <time_frame>Measured at 15 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 21 months</measure>
    <time_frame>Measured at 21 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of obesity in children at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Population estimation of obesity using Body Mass Index (BMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 9 months</measure>
    <time_frame>Measured at 9 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 15 months</measure>
    <time_frame>Measured at 15 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 21 months</measure>
    <time_frame>Measured at 21 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of stunting at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Population estimation of stunting using height-for age &lt;-2 SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of anemia at 6 months</measure>
    <time_frame>Measured at 6 months of age</time_frame>
    <description>Population estimation of anemia using hemoglobin concentration in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of anemia at 12 months</measure>
    <time_frame>Measured at 12 months of age</time_frame>
    <description>Population estimation of anemia using hemoglobin concentration in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of anemia at 18 months</measure>
    <time_frame>Measured at 18 months of age</time_frame>
    <description>Population estimation of anemia using hemoglobin concentration in blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of anemia at 24 months</measure>
    <time_frame>Measured at 24 months of age</time_frame>
    <description>Population estimation of anemia using hemoglobin concentration in blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to Nutritional Supplement Regime</measure>
    <time_frame>Measured every month from 6 months of age until 24 months of age</time_frame>
    <description>Consumption of the nutritional supplement measured as the number of packets consumed in one month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive Breastfeeding</measure>
    <time_frame>Measured 24 months after the start of the intervention</time_frame>
    <description>Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Exclusive Breastfeeding</condition>
  <condition>Feeding Patterns</condition>
  <condition>Stunting</condition>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard health care services provided by the Health Secretary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPOON behavioral change strategy+SQ-LNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive SQ-LNS supplement from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits and group sessions. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SQ-LNS</intervention_name>
    <description>SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study will not include sugar.</description>
    <arm_group_label>SPOON behavioral change strategy+SQ-LNS</arm_group_label>
    <other_name>Small Quantity Lipid Nutrient Supplements</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SPOON behavioral change strategy</intervention_name>
    <description>An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits and group sessions.</description>
    <arm_group_label>SPOON behavioral change strategy+SQ-LNS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in the third trimester and children up to 6 months of age at the moment&#xD;
             of recruitment (or children with a maximum age of 6 months at the beginning of the&#xD;
             first visit of the program)&#xD;
&#xD;
          -  Children with no chronic diseases or congenital malformations&#xD;
&#xD;
          -  Resident population from Tepic and the adjacent areas of Xalisco, Lomas Verdes, and&#xD;
             Cerro Blanco&#xD;
&#xD;
          -  The residents have no plans to move away from Tepic in the following 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Population belonging to the PROSPERA program&#xD;
&#xD;
          -  Children with chronic diseases or congenital malformations&#xD;
&#xD;
          -  Children with severe acute malnutrition&#xD;
&#xD;
          -  Planning on moving far from the intervention area in the next 24 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Martinez</last_name>
    <role>Study Director</role>
    <affiliation>Inter-American Development Bank</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SPOON Mexico</name>
      <address>
        <city>Tepic</city>
        <state>Nayarit</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stunting</keyword>
  <keyword>Obesity</keyword>
  <keyword>Lipid-based Nutrient Supplements (LNS)</keyword>
  <keyword>Latin America</keyword>
  <keyword>Child nutrition</keyword>
  <keyword>Feeding practices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study</ipd_description>
  </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/NCT03752762
org study id: Inter-AmericanDB Mexico
nct id: NCT03752762
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary goal of this study is to assess the impact of an innovative strategy to prevent
      undernutrition and obesity in early childhood in children 0-24 months in Mexico. This study
      is designed to evaluate the impact of promoting adequate infant an young child feeding
      practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the
      nutritional status of infants and young children. The study will be conducted in peri-urban
      areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México
      Federico Gómez and the Nayarit Secretariat of Health.
SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged
      0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to
      improve infant and young children feeding practices, including exclusive breastfeeding, and
      promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based
      nutrient supplements) through a novel behavior change strategy.

      The study will recruit children between 0 and 6 months of age as well as pregnant women in
      the third trimester. Mothers or caregivers of eligible children will be invited to
      participate and a consent form obtain. Participation will start at 0-6 months and the
      intervention will last until children are up to 24 months. Participants will be randomly
      assigned at the household level to one of two groups: a control group and a treatment group.
      Participants in the control group will receive the standard services provided by their local
      health clinics according to the national protocol. Participants in Treatment Group 1 will
      receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy
      designed using ethnographic and marketing methods to promote adequate infant and young child
      feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or
      caregivers through individual home-visits and group sessions.

      A sample size of 600 children per group has been calculated to detect a minimum effect size
      of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has
      been included in the sample size calculation.

      Main outcomes include infant and young child feeding practices, height, weight, hemoglobin,
      prevalence of anemia, prevalence of stunting, prevalence of obesity, and weight gain rate. A
      baseline and final survey will be conducted to collect data for these variables, as well as
      sociodemographic information. Impact estimation will be done comparing the average results
      and the distribution of indicators between the treatment and control group. Differences of
      simple means and regression models including co-variables of the child's age and sex, and
      characteristics of the primary caregiver and household will be estimated. In addition to
      potential changes in indicator averages, changes in the distribution of variables will be
      explored under the hypothesis that the intervention might not only improve average value for
      a given indicator, but compress the distribution over a range of values closer to an optimal
      range. Changes to distributions will be checked by applying the Kolmogorov-Smirnov test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Infant and young child feeding practices at 6 months
time frame: Measured at 6 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices at 9 months
time frame: Measured at 9 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices at 12 months
time frame: Measured at 12 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices 15 months
time frame: Measured 15 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices at 18 months
time frame: Measured at 18 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices at 21 months
time frame: Measured at 21 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Infant and young child feeding practices at 24 months
time frame: Measured at 24 months of age
description: Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
measure: Height at 6 months
time frame: Measured at 6 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 9 months
time frame: Measured at 9 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 12 months
time frame: Measured at 12 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 15 months
time frame: Measured at 15 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 18 months
time frame: Measured at 18 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 21 months
time frame: Measured at 21 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Height at 24 months
time frame: Measured at 24 months of age
description: Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
measure: Weight gain rate at 6 months
time frame: Constructed from weight measurements at 6 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 9 months
time frame: Constructed from weight measurements at 9 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 12 months
time frame: Constructed from weight measurements at 12 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 15 months
time frame: Constructed from weight measurements at 15 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 18 months
time frame: Constructed from weight measurements at 18 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 21 months
time frame: Constructed from weight measurements at 21 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Weight gain rate at 24 months
time frame: Constructed from weight measurements at 24 months of age
description: Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
measure: Hemoglobin at 6 months
time frame: Measured at 6 months of age
description: Measurement of hemoglobin concentration in blood using blood biometry
measure: Hemoglobin at 12 months
time frame: Measured at 12 months of age
description: Measurement of hemoglobin concentration in blood using blood biometry
measure: Hemoglobin at 18 months
time frame: Measured at 18 months of age
description: Measurement of hemoglobin concentration in blood using blood biometry
measure: Hemoglobin at 24 months
time frame: Measured at 24 months of age
description: Measurement of hemoglobin concentration in blood using blood biometry
measure: Prevalence of obesity in children at 6 months
time frame: Measured at 6 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 9 months
time frame: Measured at 9 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 12 months
time frame: Measured at 12 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 15 months
time frame: Measured at 15 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 18 months
time frame: Measured at 18 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 21 months
time frame: Measured at 21 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of obesity in children at 24 months
time frame: Measured at 24 months of age
description: Population estimation of obesity using Body Mass Index (BMI)
measure: Prevalence of stunting at 6 months
time frame: Measured at 6 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 9 months
time frame: Measured at 9 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 12 months
time frame: Measured at 12 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 15 months
time frame: Measured at 15 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 18 months
time frame: Measured at 18 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 21 months
time frame: Measured at 21 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of stunting at 24 months
time frame: Measured at 24 months of age
description: Population estimation of stunting using height-for age <-2 SD
measure: Prevalence of anemia at 6 months
time frame: Measured at 6 months of age
description: Population estimation of anemia using hemoglobin concentration in blood
measure: Prevalence of anemia at 12 months
time frame: Measured at 12 months of age
description: Population estimation of anemia using hemoglobin concentration in blood
measure: Prevalence of anemia at 18 months
time frame: Measured at 18 months of age
description: Population estimation of anemia using hemoglobin concentration in blood
measure: Prevalence of anemia at 24 months
time frame: Measured at 24 months of age
description: Population estimation of anemia using hemoglobin concentration in blood
measure: Adherence to Nutritional Supplement Regime
time frame: Measured every month from 6 months of age until 24 months of age
description: Consumption of the nutritional supplement measured as the number of packets consumed in one month
measure: Exclusive Breastfeeding
time frame: Measured 24 months after the start of the intervention
description: Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
arm group label: Standard Care
arm group type: No Intervention
description: Participants will receive standard health care services provided by the Health Secretary
arm group label: SPOON behavioral change strategy+SQ-LNS
arm group type: Experimental
description: Participants will receive SQ-LNS supplement from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits and group sessions. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar.
intervention type: Dietary Supplement
intervention name: SQ-LNS
description: SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study will not include sugar.
arm group label: SPOON behavioral change strategy+SQ-LNS
other name: Small Quantity Lipid Nutrient Supplements
intervention type: Behavioral
intervention name: SPOON behavioral change strategy
description: An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits and group sessions.
arm group label: SPOON behavioral change strategy+SQ-LNS
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian Martinez
role: Study Director
affiliation: Inter-American Development Bank
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
mesh term: Growth Disorders
sharing ipd: Yes
ipd description: Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study