<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/NCT03030651</url>
  </required_header>
  <id_info>
    <org_study_id>BFESI</org_study_id>
    <nct_id>NCT03030651</nct_id>
  </id_info>
  <brief_title>Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding</brief_title>
  <official_title>Effect of Breastfeeding Education and Support Intervention on Timely Initiation and Exclusive Breastfeeding in Southwest Ethiopia: a Cluster Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jimma University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop and test Breastfeeding Education and Support&#xD;
      Intervention for improving timely initiation and Exclusive Breastfeeding rate.&#xD;
&#xD;
      Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the&#xD;
      simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does&#xD;
      not meet the international recommendation for exclusive breastfeeding (EBF) for the first six&#xD;
      months of life. Community-based educational and support interventions provided prenatally and&#xD;
      postnatally are effective in increasing BF rates. However, there is paucity of such&#xD;
      information in Ethiopia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample size was calculated using Sample Size Calculator (SSC) a Windows based software&#xD;
      package (93) with the following assumptions: to detect an increase in exclusive breastfeeding&#xD;
      for 6 month from 52% to 72% (44), with 95% Confidence Intervals and 80% power, assuming an&#xD;
      intra-cluster correlation coefficient of 0•1 from Ugandan study (94) for a cluster size of&#xD;
      ten, it is calculated that we will need thirty six clusters. Adding 20% of the sample size&#xD;
      for loss to follow-up, the final sample size is 432 pregnant women (216 in intervention, and&#xD;
      216 in control).&#xD;
&#xD;
      Standard operating procedure will be prepared and used for data collection. Data will be&#xD;
      entered into Epi-data version 3.1 and analyzed using STATA version 12.0. Frequency&#xD;
      distributions will be run to identify outliers. In relation to the trial hypotheses,&#xD;
      intervention group will be compared to the routine education using intention to treat&#xD;
      analysis. For the outcomes, proportions of women who initiated BF timely and who exclusively&#xD;
      breastfed their babies at 72 hours and at 6 month will be compared using odds ratios derived&#xD;
      using logistic regression between intervention and control groups. In all analyses,&#xD;
      adjustment will be made for clustering at the zone level since randomization was done at&#xD;
      cluster level rather than individual level. Generalized linear models will be used to&#xD;
      calculate prevalence ratios (PR) for the categorical anthropometric outcomes. In the&#xD;
      longitudinal analysis, the correlated nature of the data from the repeated measurements will&#xD;
      be taken into account by adjusting for repeated measurements in the same individual as well&#xD;
      as the above-mentioned design effect resulting from the cluster randomization. A linear mixed&#xD;
      effects regression model will be used in the longitudinal analysis of z-scores with cluster&#xD;
      as a random effect and the repeated measurements in each child accounted for through a first&#xD;
      order autocorrelation structure. Least Squares Means (LSM) are reported at 3, 6 months,&#xD;
      corresponding to the scheduled data collection visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Actual">September 8, 2018</completion_date>
  <primary_completion_date type="Actual">September 8, 2018</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>at six month</time_frame>
    <description>Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timely initiation of breastfeeding</measure>
    <time_frame>within 72 hours after delivery</time_frame>
    <description>Prevalence of timely initiation of breastfeeding at month one in the intervention and control clusters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>at months 3 and 6</time_frame>
    <description>WHO Child Growth Standards (2006) will be used to estimate anthropometric status at months 3 and 6: weight-for-length z-scores (WLZ), length-for-age z-scores (LAZ) and weight-for-age z-scores (WAZ). Children who had WLZ below-2 (WLZ&lt;-2) will be considered wasted, those with LAZ below -2(LAZ&lt;-2) stunted, and those with WAZ below-2(WAZ&lt;-2) underweight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge towards breastfeeding</measure>
    <time_frame>Baseline, at month 3 and 6</time_frame>
    <description>Knowledge towards breastfeeding will be measured using the breastfeeding knowledge questionnaire after validating it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitude towards breastfeeding</measure>
    <time_frame>Baseline, at month 3 and 6</time_frame>
    <description>Attitude towards breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS) after validating it.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">469</enrollment>
  <condition>Breastfeeding, Exclusive</condition>
  <condition>Nutrition Status</condition>
  <arm_group>
    <arm_group_label>Breastfeeding Education and Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual or routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pregnant women in the intervention arm will continue to receive the usual/routine care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breastfeeding Education and Support</intervention_name>
    <description>Women Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary.</description>
    <arm_group_label>Breastfeeding Education and Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        During pregnancy&#xD;
&#xD;
          -  pregnant women in the third trimester&#xD;
&#xD;
          -  Live in the selected cluster and&#xD;
&#xD;
          -  Have no plans to move away during the intervention period&#xD;
&#xD;
          -  Without psychiatric illness&#xD;
&#xD;
          -  Capable of giving informed consent and willing to be visited by supervisors and data&#xD;
             collectors After delivery&#xD;
&#xD;
          -  Singleton live birth with no severe malformation that could interfere with&#xD;
             breastfeeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        During pregnancy&#xD;
&#xD;
          -  women with severe psychological illness which could interfere with consent and study&#xD;
             participation&#xD;
&#xD;
          -  Severely ill After delivery&#xD;
&#xD;
          -  Severely ill or have clinical complications warranting hospitalization&#xD;
&#xD;
          -  Stillbirth&#xD;
&#xD;
          -  Infant death or maternal death&#xD;
&#xD;
          -  Twin gestation&#xD;
&#xD;
          -  Preterm birth (at &lt;37 weeks gestation).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanette H. Magnus, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atle Fretheim, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mana district, Jimma zone, Southwest Ethiopia</name>
      <address>
        <city>Jimma</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jimma University</investigator_affiliation>
    <investigator_full_name>Misra Abdulahi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Education and support</keyword>
  <keyword>Ethiopia</keyword>
  <keyword>Timely initiation of breastfeeding</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>participants flow, baseline characteristics, outcome measure statistical analysis</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/NCT03030651
org study id: BFESI
nct id: NCT03030651
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop and test Breastfeeding Education and Support
      Intervention for improving timely initiation and Exclusive Breastfeeding rate.

      Infant mortality rates are still high in Ethiopia. Breastfeeding (BF) is regarded as the
      simplest and least expensive strategy for reduction of infant mortality rates. Ethiopia does
      not meet the international recommendation for exclusive breastfeeding (EBF) for the first six
      months of life. Community-based educational and support interventions provided prenatally and
      postnatally are effective in increasing BF rates. However, there is paucity of such
      information in Ethiopia.
Sample size was calculated using Sample Size Calculator (SSC) a Windows based software
      package (93) with the following assumptions: to detect an increase in exclusive breastfeeding
      for 6 month from 52% to 72% (44), with 95% Confidence Intervals and 80% power, assuming an
      intra-cluster correlation coefficient of 0•1 from Ugandan study (94) for a cluster size of
      ten, it is calculated that we will need thirty six clusters. Adding 20% of the sample size
      for loss to follow-up, the final sample size is 432 pregnant women (216 in intervention, and
      216 in control).

      Standard operating procedure will be prepared and used for data collection. Data will be
      entered into Epi-data version 3.1 and analyzed using STATA version 12.0. Frequency
      distributions will be run to identify outliers. In relation to the trial hypotheses,
      intervention group will be compared to the routine education using intention to treat
      analysis. For the outcomes, proportions of women who initiated BF timely and who exclusively
      breastfed their babies at 72 hours and at 6 month will be compared using odds ratios derived
      using logistic regression between intervention and control groups. In all analyses,
      adjustment will be made for clustering at the zone level since randomization was done at
      cluster level rather than individual level. Generalized linear models will be used to
      calculate prevalence ratios (PR) for the categorical anthropometric outcomes. In the
      longitudinal analysis, the correlated nature of the data from the repeated measurements will
      be taken into account by adjusting for repeated measurements in the same individual as well
      as the above-mentioned design effect resulting from the cluster randomization. A linear mixed
      effects regression model will be used in the longitudinal analysis of z-scores with cluster
      as a random effect and the repeated measurements in each child accounted for through a first
      order autocorrelation structure. Least Squares Means (LSM) are reported at 3, 6 months,
      corresponding to the scheduled data collection visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Exclusive breastfeeding
time frame: at six month
description: Prevalence of exclusive breastfeeding (24-h recall) at month one, three and six in the intervention and control clusters.
measure: Timely initiation of breastfeeding
time frame: within 72 hours after delivery
description: Prevalence of timely initiation of breastfeeding at month one in the intervention and control clusters.
measure: Nutritional status
time frame: at months 3 and 6
description: WHO Child Growth Standards (2006) will be used to estimate anthropometric status at months 3 and 6: weight-for-length z-scores (WLZ), length-for-age z-scores (LAZ) and weight-for-age z-scores (WAZ). Children who had WLZ below-2 (WLZ<-2) will be considered wasted, those with LAZ below -2(LAZ<-2) stunted, and those with WAZ below-2(WAZ<-2) underweight.
measure: Knowledge towards breastfeeding
time frame: Baseline, at month 3 and 6
description: Knowledge towards breastfeeding will be measured using the breastfeeding knowledge questionnaire after validating it.
measure: Attitude towards breastfeeding
time frame: Baseline, at month 3 and 6
description: Attitude towards breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS) after validating it.
arm group label: Breastfeeding Education and Support
arm group type: Experimental
description: Pregnant women in the intervention arm will receive breastfeeding education and support intervention for nine months starting in their third trimester
arm group label: Usual or routine care
arm group type: No Intervention
description: Pregnant women in the intervention arm will continue to receive the usual/routine care.
intervention type: Behavioral
intervention name: Breastfeeding Education and Support
description: Women Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary.
arm group label: Breastfeeding Education and Support
criteria: 
gender: Female
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeanette H. Magnus, PhD
role: Study Director
affiliation: University of Oslo
last name: Atle Fretheim, PhD
role: Study Director
affiliation: University of Oslo
facility: 
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: Jimma University
investigator full name: Misra Abdulahi
investigator title: Associate Professor
sharing ipd: Yes
ipd description: participants flow, baseline characteristics, outcome measure statistical analysis