<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/NCT03297190</url>
  </required_header>
  <id_info>
    <org_study_id>20171</org_study_id>
    <nct_id>NCT03297190</nct_id>
  </id_info>
  <brief_title>Impact on Nutritional Practices: SMS and Interpersonal Communication</brief_title>
  <acronym>RISE</acronym>
  <official_title>Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helen Keller International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tanzania Food and Nutrition Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helen Keller International</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>
      This cluster randomized controlled study aims to add to the evidence base on mHealth&#xD;
      interventions by assessing the main effects of delivering nutrition messages on key maternal,&#xD;
      infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative&#xD;
      behavior change strategies. The strategies compared will be: (i) an interpersonal&#xD;
      communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant&#xD;
      and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based&#xD;
      channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni&#xD;
      program, and (iii) the combination of both of these strategies (interpersonal and SMS&#xD;
      messaging). They will be compared with the current standard of care in Tanzania. The goal&#xD;
      will be to determine which has the greatest impact on key MIYCN and hygiene practices and&#xD;
      care-seeking behaviors. It will be paired with a costing analysis so that these effects can&#xD;
      be understood in the context of their costs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Children's Dietary Diversity</measure>
    <time_frame>24 h</time_frame>
    <description>% of children 6-29 mo. who consumed the minimum dietary diversity (received foods from ≥4 food groups on the previous day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Women's dietary diversity</measure>
    <time_frame>24 h</time_frame>
    <description>% who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Minimum Meal Frequency</measure>
    <time_frame>24 h</time_frame>
    <description>% of children 6-29 mo. who consumed the minimum meal frequency the prior day (2/day for breastfed infants 6-8 mo.; 3/day for breastfed infants 9-29 mo.; 4/day for non-breastfed infants 6-29 mo.)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2245</enrollment>
  <condition>Nutritional Deficiency</condition>
  <arm_group>
    <arm_group_label>SMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive SMS messages on nutrition and health related topics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interpersonal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive interpersonal counselling on nutrition and health related topics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS + Interpersonal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS</intervention_name>
    <description>Receipt of SMS messages on nutrition and health topics</description>
    <arm_group_label>SMS</arm_group_label>
    <arm_group_label>SMS + Interpersonal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpersonal Counselling</intervention_name>
    <description>Interpersonal counselling on health and nutrition topics</description>
    <arm_group_label>Interpersonal</arm_group_label>
    <arm_group_label>SMS + Interpersonal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers of children aged 0-12 mo. or pregnant at time of enrollment&#xD;
&#xD;
          -  Consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HKI-Tanzania</name>
      <address>
        <city>Dar es Salaam</city>
        <zip>11</zip>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <removed_countries>
    <country>Senegal</country>
  </removed_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous data to be shared after data analysis is completed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Approximately 12 mo. after completion, indefinitely</ipd_time_frame>
    <ipd_access_criteria>Fill out data use agreement.</ipd_access_criteria>
  </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/NCT03297190
org study id: 20171
nct id: NCT03297190
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This cluster randomized controlled study aims to add to the evidence base on mHealth
      interventions by assessing the main effects of delivering nutrition messages on key maternal,
      infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative
      behavior change strategies. The strategies compared will be: (i) an interpersonal
      communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant
      and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based
      channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni
      program, and (iii) the combination of both of these strategies (interpersonal and SMS
      messaging). They will be compared with the current standard of care in Tanzania. The goal
      will be to determine which has the greatest impact on key MIYCN and hygiene practices and
      care-seeking behaviors. It will be paired with a costing analysis so that these effects can
      be understood in the context of their costs.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
primary purpose: Prevention
masking: None (Open Label)
measure: Children's Dietary Diversity
time frame: 24 h
description: % of children 6-29 mo. who consumed the minimum dietary diversity (received foods from ≥4 food groups on the previous day)
measure: Women's dietary diversity
time frame: 24 h
description: % who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)
measure: Children's Minimum Meal Frequency
time frame: 24 h
description: % of children 6-29 mo. who consumed the minimum meal frequency the prior day (2/day for breastfed infants 6-8 mo.; 3/day for breastfed infants 9-29 mo.; 4/day for non-breastfed infants 6-29 mo.)
arm group label: SMS
arm group type: Active Comparator
description: Participants will receive SMS messages on nutrition and health related topics
arm group label: Interpersonal
arm group type: Active Comparator
description: Participants will receive interpersonal counselling on nutrition and health related topics
arm group label: SMS + Interpersonal
arm group type: Active Comparator
description: Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics
arm group label: Usual Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: SMS
description: Receipt of SMS messages on nutrition and health topics
arm group label: SMS
arm group label: SMS + Interpersonal
intervention type: Behavioral
intervention name: Interpersonal Counselling
description: Interpersonal counselling on health and nutrition topics
arm group label: Interpersonal
arm group label: SMS + Interpersonal
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Tanzania
country: Senegal
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: Yes
ipd description: Anonymous data to be shared after data analysis is completed.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Approximately 12 mo. after completion, indefinitely
ipd access criteria: Fill out data use agreement.