<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/NCT02249754</url>
  </required_header>
  <id_info>
    <org_study_id>879/13</org_study_id>
    <nct_id>NCT02249754</nct_id>
  </id_info>
  <brief_title>Nutrition Education Package for Infants and Young Child Feeding and Health in Rural Tanzania</brief_title>
  <acronym>NECTAc</acronym>
  <official_title>Effectiveness of a Nutrition Education Package in Improving Feeding Practices, Dietary Adequacy and Growth of Infants and Young Children in Rural Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sokoine University of Agriculture</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schlumberger Foundation - Faculty for the Future Programme</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nutrition Third World, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nestlé Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sokoine University of Agriculture</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Building on the success of community-based peer education and counselling in breastfeeding,&#xD;
      it is possible to address young child feeding and health practices in the surveyed district.&#xD;
      Opportunities that can optimise success and encourage behaviour change in the district&#xD;
      include mothers willingness to modify some feeding options; support of family members;&#xD;
      seasonal availability and accessibility of foods; established set-up of village peers and&#xD;
      existence of health centres and health staff in some villages. This study has developed a&#xD;
      feasible, context-specific nutrition education package for use in rural Tanzania. The package&#xD;
      is composed of 4 components, namely 1) education and counselling of mothers, 2) training of&#xD;
      community-based nutrition counsellors, 3) sensitisation meetings with health staff and family&#xD;
      members, and 4) supervision of community-based nutrition counsellors. The intervention will&#xD;
      use a parallel cluster-randomised controlled trial design where infants will be recruited&#xD;
      when aged 6 months and followed up for 9 months. The intervention expects to provide&#xD;
      information and, where appropriate, recommendations to strengthen the nutrition component in&#xD;
      the health education programme of the Tanzania child health services.&#xD;
&#xD;
      The study hypothesises that the nutrition education package will be more effective than the&#xD;
      routine health education in improving feeding practices, dietary adequacy and growth of&#xD;
      infants and young children. Specific objectives of the study include:&#xD;
&#xD;
        -  To evaluate the effectiveness of a nutrition education package on feeding practices and&#xD;
           dietary adequacy&#xD;
&#xD;
        -  To determine the effectiveness of a nutrition education package in improving growth and&#xD;
           health of infants and young children&#xD;
&#xD;
        -  To document the process of implementation of the nutrition education package to promote&#xD;
           optimal feeding and health practice&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design:&#xD;
&#xD;
      A parallel cluster randomised controlled trial will be conducted in rural central Tanzania in&#xD;
      9 intervention and 9 control villages. A simple randomisation with a 1:1 allocation using a&#xD;
      list of random numbers generated in Microsoft Excel 2007 will be used to randomise villages&#xD;
      to either control or intervention group. Generation of allocation sequence and randomisation&#xD;
      of clusters will be done by a statistician blinded to study groups and not participating in&#xD;
      the research.&#xD;
&#xD;
      Recruitment and collection of baseline information:&#xD;
&#xD;
      After cluster randomisation, sub-village leaders will identify all infants aged 6 months and&#xD;
      their parents in a systematic door-to-door survey. Parents will be invited to a meeting where&#xD;
      the nature and purpose of the trial and eligibility criteria will be explained. Thereafter,&#xD;
      their infants will be screened for eligibility.&#xD;
&#xD;
      Parents and infants who meet the inclusion criteria, agree to participate in the trial and&#xD;
      give a written informed consent will have their infants recruited. Baseline information of&#xD;
      recruited infants and their parents (i.e. household's, parents' and infant's characteristics)&#xD;
      will be collected using a structured questionnaire. Structured interviews with village and&#xD;
      sub-village leaders will also be conducted to collect village information (i.e. population,&#xD;
      health facility, water supply, schools, livelihoods, resources, economic opportunities).&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The control group will receive routine health education offered monthly by health staff at&#xD;
      health facilities. Routine health education is a standard government health service for&#xD;
      children below the age of five years. It is offered to mothers during growth monitoring and&#xD;
      immunisation contacts. The sessions usually take 10-15 minutes and focus on general health&#xD;
      issues including child feeding, prevention of diseases such as malaria and importance of&#xD;
      immunisations. The intervention group will receive a nutrition education package in addition&#xD;
      to the routine health education. With the nutrition education package, mothers and caregivers&#xD;
      will receive 3 sessions of education and counselling on optimal infant and young child&#xD;
      feeding and health, when a child is aged 6, 9 and 12 months. Nutrition counsellors will&#xD;
      receive training at baseline and the session will be repeated after 6 months. After training,&#xD;
      the nutrition counsellors will conduct monthly home visits to counsel and support mothers and&#xD;
      their families. Supervisory visits will be conducted by the research team after every 2&#xD;
      months to assess counsellors' work. Separate sensitisation meetings with families and health&#xD;
      staff responsible for child health will be conducted at baseline and meeting will be repeated&#xD;
      after 6 months.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      Data collection forms (structured questionnaires, observation checklists, etc.) have been&#xD;
      pre-tested in a neighbouring district and standardised. Interviewers will administer the&#xD;
      surveys in national language, Kiswahili. After data collection, all filled forms will be&#xD;
      manually checked for completeness and consistency. To enhance blinding, precise objectives of&#xD;
      the study and village allocation to trial will not be disclosed to data collectors; nutrition&#xD;
      counsellors will not be responsible for data collection; and data collection schedule will be&#xD;
      randomised.&#xD;
&#xD;
      Impact evaluation data: In the intervention group, data on primary and secondary outcomes&#xD;
      will be collected at baseline and ages 9, 12 and 15 months. In the control group, the same&#xD;
      variables will be collected at baseline, and ages 12 and 15 months.&#xD;
&#xD;
      Process evaluation data: A process evaluation will document the intervention implementation&#xD;
      process so as to 1) assess whether the intervention activities are implemented as planned&#xD;
      (i.e. fidelity), 2) evaluate the extent to which the intervention reaches the intended&#xD;
      mothers and their families (i.e. reach), 3) determine the degree to which targeted mothers&#xD;
      are exposed to intervention components and extent to which they use intervention resources&#xD;
      (i.e. exposure or dose received), and 4) describe the setting (i.e. contextual factors,&#xD;
      facilitators, barriers, contamination) into which the intervention is being implemented that&#xD;
      may have an influence on intervention effectiveness. In control villages, process evaluation&#xD;
      will identify and describe actions, events and context which may reveal new interventions,&#xD;
      evidence of contamination or other factors external to the intervention. Process evaluation&#xD;
      data will be collected two months after baseline (when infants are 8 months-old) and at the&#xD;
      end of intervention (when infants are 15 months-old). Structured and semi-structured&#xD;
      interviews, review of records (e.g. training and education attendance sheet, activity logs,&#xD;
      training test scores, etc) and structured observations will be carried out with mothers,&#xD;
      nutrition counsellors, health workers and village leaders.&#xD;
&#xD;
      Monitoring:&#xD;
&#xD;
      The research team will visit intervention villages every 2 weeks in the first 2 months of&#xD;
      intervention, and thereafter visits will be made at 2-months interval. Researchers will log&#xD;
      and report all activities related to the delivery and quality of training, education,&#xD;
      supervision and sensitisation meetings using monitoring tools (e.g. forms, logs, observation&#xD;
      checklists, supervisory reports). Nutrition counsellors will document home visits in&#xD;
      workbooks. Actions or events external to the intervention which happen in the intervention&#xD;
      villages will be documented in event forms and semi-structured interviews.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Data will be entered in Epi-data version 3.1 and consistency analysed by range checks of data&#xD;
      values. Data will be analysed using STATA release 12.0 (STATA Corporation, Texas, 2007).&#xD;
      Frequency distributions will be run to identify outliers. Impact evaluation data will be&#xD;
      compared between intervention and control villages using hierarchical or multi-level models&#xD;
      and presented at the cluster and individual levels. The methods will provide adjustment for&#xD;
      potential covariates and confounders at the cluster and individual levels. Data will be&#xD;
      analysed by intention to treat. The process evaluation data will use both inductive and&#xD;
      deductive approaches to analyse qualitative data using NVivo 10 for Windows (QSR&#xD;
      International, Australia).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old</measure>
    <time_frame>Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15</time_frame>
    <description>Linear growth (length-for-age Z-scores): WHO 2006 Growth Standards</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight-for-length: Mean change from baseline in weight-for-length Z-scores at 9-, 12- and 15-months-old</measure>
    <time_frame>Weight-for-length Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15</time_frame>
    <description>Weight-for-length Z-scores: WHO 2006 Growth Standards</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean intake of energy, fat, iron and zinc from complementary foods at 12 months-old</measure>
    <time_frame>Mean intake of energy, fat, iron and zinc from complementary foods: Baseline (6 months-old), Month 12</time_frame>
    <description>Mean intake of energy, fat, iron and zinc from complementary foods: Interactive 24-hour dietary recall and WHO recommended intakes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children consuming foods from 4 or more food groups at 9-, 12- and 15-months-old</measure>
    <time_frame>Proportion of children consuming foods from 4 or more food groups: Baseline (6 months-old), Month 9, Month 12 and Month 15</time_frame>
    <description>Proportion of children consuming foods from 4 or more food groups: Structured questionnaire, PAHO/WHO Guiding principles and WHO Indicators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day at 9-, 12- and 15-months-old</measure>
    <time_frame>Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Baseline (6 months-old), Month 9, Month 12 and Month 15</time_frame>
    <description>Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Structured questionnaire, PAHO/WHO Guiding principles and WHO Indicators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal level of knowledge and practice of recommended feeding and health practices at 9-, 12- and 15-months-old</measure>
    <time_frame>Maternal level of knowledge and practice of recommended feeding and health practices: Month 9, Month 12 and Month 15</time_frame>
    <description>Maternal level of knowledge and practice of recommended feeding and health practices: Structured/open-ended questionnaire and structured observation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Growth Retardation</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Routine health education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine health education alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition education package</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition education package and routine health education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition education</intervention_name>
    <description>This group will receive the nutrition education package. The package is composed of: 1) education and counselling of mothers when the child is aged 6 (baseline), 9 and 12 months; 2) training community-based nutrition counsellors at baseline and 12 months and monthly home visits, 3) supervision of community-based nutrition counsellors' work every 2 months, and 4) sensitisation meetings with family members and health staff responsible for child health at baseline and repeated at 12 months. In addition, the group will continue to attend routine health education given at health facilities every month.</description>
    <arm_group_label>Nutrition education package</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine health education</intervention_name>
    <description>This group will receive routine health education every month. It is a standard government health service offered monthly in all health facilities by health staff. It is given to mothers of children below the age of five years during growth monitoring and immunisation contacts. The sessions take 10-15 minutes focusing on general health issues including child feeding, prevention of diseases such as malaria and importance of immunisations.</description>
    <arm_group_label>Nutrition education package</arm_group_label>
    <arm_group_label>Routine health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants aged 6-7 months at the time of recruitment into the study&#xD;
&#xD;
          -  Infants currently being breastfed&#xD;
&#xD;
          -  Parents (or caregivers) anticipated local residence for the study duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital or chronic abnormalities impairing feeding or physical growth measurements&#xD;
&#xD;
          -  Oedema&#xD;
&#xD;
          -  Severely ill or clinical complications warranting hospitalisation&#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>Prof. Patrick W. Kolsteren, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Tropical Medicine (Belgium) and Ghent University (Belgium)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kissa BM Kulwa, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sokoine University of Agriculture and Ghent University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kissa BM Kulwa, MSc.</last_name>
    <phone>+255 23 2603511 -</phone>
    <email>kissakulwa@yahoo.com; kissa.kulwa@ugent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Prof. Patrick W. Kolsteren, PhD</last_name>
    <phone>+32 3 2476389</phone>
    <email>pkolsteren@itg.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mpwapwa District</name>
      <address>
        <city>Mpwapwa</city>
        <state>Dodoma</state>
        <country>Tanzania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kissa BM Kulwa, MSc.</last_name>
      <phone>+255 23 2603511 - 4</phone>
      <email>kissakulwa@yahoo.com; kissa.kulwa@ugent.be</email>
    </contact>
    <investigator>
      <last_name>Kissa BM Kulwa, MSc.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sokoine University of Agriculture</investigator_affiliation>
    <investigator_full_name>Kissa B.M. Kulwa, MSc.</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Nutrition education</keyword>
  <keyword>Maternal counselling</keyword>
  <keyword>Complementary feeding</keyword>
  <keyword>Infant growth</keyword>
  <keyword>Micronutrients</keyword>
  <keyword>Tanzania</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT02249754
org study id: 879/13
nct id: NCT02249754
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Building on the success of community-based peer education and counselling in breastfeeding,
      it is possible to address young child feeding and health practices in the surveyed district.
      Opportunities that can optimise success and encourage behaviour change in the district
      include mothers willingness to modify some feeding options; support of family members;
      seasonal availability and accessibility of foods; established set-up of village peers and
      existence of health centres and health staff in some villages. This study has developed a
      feasible, context-specific nutrition education package for use in rural Tanzania. The package
      is composed of 4 components, namely 1) education and counselling of mothers, 2) training of
      community-based nutrition counsellors, 3) sensitisation meetings with health staff and family
      members, and 4) supervision of community-based nutrition counsellors. The intervention will
      use a parallel cluster-randomised controlled trial design where infants will be recruited
      when aged 6 months and followed up for 9 months. The intervention expects to provide
      information and, where appropriate, recommendations to strengthen the nutrition component in
      the health education programme of the Tanzania child health services.

      The study hypothesises that the nutrition education package will be more effective than the
      routine health education in improving feeding practices, dietary adequacy and growth of
      infants and young children. Specific objectives of the study include:

        -  To evaluate the effectiveness of a nutrition education package on feeding practices and
           dietary adequacy

        -  To determine the effectiveness of a nutrition education package in improving growth and
           health of infants and young children

        -  To document the process of implementation of the nutrition education package to promote
           optimal feeding and health practice
Design:

      A parallel cluster randomised controlled trial will be conducted in rural central Tanzania in
      9 intervention and 9 control villages. A simple randomisation with a 1:1 allocation using a
      list of random numbers generated in Microsoft Excel 2007 will be used to randomise villages
      to either control or intervention group. Generation of allocation sequence and randomisation
      of clusters will be done by a statistician blinded to study groups and not participating in
      the research.

      Recruitment and collection of baseline information:

      After cluster randomisation, sub-village leaders will identify all infants aged 6 months and
      their parents in a systematic door-to-door survey. Parents will be invited to a meeting where
      the nature and purpose of the trial and eligibility criteria will be explained. Thereafter,
      their infants will be screened for eligibility.

      Parents and infants who meet the inclusion criteria, agree to participate in the trial and
      give a written informed consent will have their infants recruited. Baseline information of
      recruited infants and their parents (i.e. household's, parents' and infant's characteristics)
      will be collected using a structured questionnaire. Structured interviews with village and
      sub-village leaders will also be conducted to collect village information (i.e. population,
      health facility, water supply, schools, livelihoods, resources, economic opportunities).

      Intervention:

      The control group will receive routine health education offered monthly by health staff at
      health facilities. Routine health education is a standard government health service for
      children below the age of five years. It is offered to mothers during growth monitoring and
      immunisation contacts. The sessions usually take 10-15 minutes and focus on general health
      issues including child feeding, prevention of diseases such as malaria and importance of
      immunisations. The intervention group will receive a nutrition education package in addition
      to the routine health education. With the nutrition education package, mothers and caregivers
      will receive 3 sessions of education and counselling on optimal infant and young child
      feeding and health, when a child is aged 6, 9 and 12 months. Nutrition counsellors will
      receive training at baseline and the session will be repeated after 6 months. After training,
      the nutrition counsellors will conduct monthly home visits to counsel and support mothers and
      their families. Supervisory visits will be conducted by the research team after every 2
      months to assess counsellors' work. Separate sensitisation meetings with families and health
      staff responsible for child health will be conducted at baseline and meeting will be repeated
      after 6 months.

      Data collection:

      Data collection forms (structured questionnaires, observation checklists, etc.) have been
      pre-tested in a neighbouring district and standardised. Interviewers will administer the
      surveys in national language, Kiswahili. After data collection, all filled forms will be
      manually checked for completeness and consistency. To enhance blinding, precise objectives of
      the study and village allocation to trial will not be disclosed to data collectors; nutrition
      counsellors will not be responsible for data collection; and data collection schedule will be
      randomised.

      Impact evaluation data: In the intervention group, data on primary and secondary outcomes
      will be collected at baseline and ages 9, 12 and 15 months. In the control group, the same
      variables will be collected at baseline, and ages 12 and 15 months.

      Process evaluation data: A process evaluation will document the intervention implementation
      process so as to 1) assess whether the intervention activities are implemented as planned
      (i.e. fidelity), 2) evaluate the extent to which the intervention reaches the intended
      mothers and their families (i.e. reach), 3) determine the degree to which targeted mothers
      are exposed to intervention components and extent to which they use intervention resources
      (i.e. exposure or dose received), and 4) describe the setting (i.e. contextual factors,
      facilitators, barriers, contamination) into which the intervention is being implemented that
      may have an influence on intervention effectiveness. In control villages, process evaluation
      will identify and describe actions, events and context which may reveal new interventions,
      evidence of contamination or other factors external to the intervention. Process evaluation
      data will be collected two months after baseline (when infants are 8 months-old) and at the
      end of intervention (when infants are 15 months-old). Structured and semi-structured
      interviews, review of records (e.g. training and education attendance sheet, activity logs,
      training test scores, etc) and structured observations will be carried out with mothers,
      nutrition counsellors, health workers and village leaders.

      Monitoring:

      The research team will visit intervention villages every 2 weeks in the first 2 months of
      intervention, and thereafter visits will be made at 2-months interval. Researchers will log
      and report all activities related to the delivery and quality of training, education,
      supervision and sensitisation meetings using monitoring tools (e.g. forms, logs, observation
      checklists, supervisory reports). Nutrition counsellors will document home visits in
      workbooks. Actions or events external to the intervention which happen in the intervention
      villages will be documented in event forms and semi-structured interviews.

      Data analysis:

      Data will be entered in Epi-data version 3.1 and consistency analysed by range checks of data
      values. Data will be analysed using STATA release 12.0 (STATA Corporation, Texas, 2007).
      Frequency distributions will be run to identify outliers. Impact evaluation data will be
      compared between intervention and control villages using hierarchical or multi-level models
      and presented at the cluster and individual levels. The methods will provide adjustment for
      potential covariates and confounders at the cluster and individual levels. Data will be
      analysed by intention to treat. The process evaluation data will use both inductive and
      deductive approaches to analyse qualitative data using NVivo 10 for Windows (QSR
      International, Australia).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old
time frame: Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15
description: Linear growth (length-for-age Z-scores): WHO 2006 Growth Standards
measure: Weight-for-length: Mean change from baseline in weight-for-length Z-scores at 9-, 12- and 15-months-old
time frame: Weight-for-length Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15
description: Weight-for-length Z-scores: WHO 2006 Growth Standards
measure: Mean intake of energy, fat, iron and zinc from complementary foods at 12 months-old
time frame: Mean intake of energy, fat, iron and zinc from complementary foods: Baseline (6 months-old), Month 12
description: Mean intake of energy, fat, iron and zinc from complementary foods: Interactive 24-hour dietary recall and WHO recommended intakes
measure: Proportion of children consuming foods from 4 or more food groups at 9-, 12- and 15-months-old
time frame: Proportion of children consuming foods from 4 or more food groups: Baseline (6 months-old), Month 9, Month 12 and Month 15
description: Proportion of children consuming foods from 4 or more food groups: Structured questionnaire, PAHO/WHO Guiding principles and WHO Indicators
measure: Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day at 9-, 12- and 15-months-old
time frame: Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Baseline (6 months-old), Month 9, Month 12 and Month 15
description: Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Structured questionnaire, PAHO/WHO Guiding principles and WHO Indicators
measure: Maternal level of knowledge and practice of recommended feeding and health practices at 9-, 12- and 15-months-old
time frame: Maternal level of knowledge and practice of recommended feeding and health practices: Month 9, Month 12 and Month 15
description: Maternal level of knowledge and practice of recommended feeding and health practices: Structured/open-ended questionnaire and structured observation
arm group label: Routine health education
arm group type: Active Comparator
description: Routine health education alone
arm group label: Nutrition education package
arm group type: Experimental
description: Nutrition education package and routine health education
intervention type: Behavioral
intervention name: Nutrition education
description: This group will receive the nutrition education package. The package is composed of: 1) education and counselling of mothers when the child is aged 6 (baseline), 9 and 12 months; 2) training community-based nutrition counsellors at baseline and 12 months and monthly home visits, 3) supervision of community-based nutrition counsellors' work every 2 months, and 4) sensitisation meetings with family members and health staff responsible for child health at baseline and repeated at 12 months. In addition, the group will continue to attend routine health education given at health facilities every month.
arm group label: Nutrition education package
intervention type: Behavioral
intervention name: Routine health education
description: This group will receive routine health education every month. It is a standard government health service offered monthly in all health facilities by health staff. It is given to mothers of children below the age of five years during growth monitoring and immunisation contacts. The sessions take 10-15 minutes focusing on general health issues including child feeding, prevention of diseases such as malaria and importance of immunisations.
arm group label: Nutrition education package
arm group label: Routine health education
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Prof. Patrick W. Kolsteren, PhD
role: Study Chair
affiliation: Institute of Tropical Medicine (Belgium) and Ghent University (Belgium)
last name: Kissa BM Kulwa, MSc.
role: Principal Investigator
affiliation: Sokoine University of Agriculture and Ghent University
last name: Kissa BM Kulwa, MSc.
phone: +255 23 2603511 -
email: kissakulwa@yahoo.com; kissa.kulwa@ugent.be
last name: Prof. Patrick W. Kolsteren, PhD
phone: +32 3 2476389
email: pkolsteren@itg.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Tanzania
responsible party type: Principal Investigator
investigator affiliation: Sokoine University of Agriculture
investigator full name: Kissa B.M. Kulwa, MSc.
investigator title: Lecturer
mesh term: Malnutrition