<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/NCT04414527</url>
  </required_header>
  <id_info>
    <org_study_id>BC-06756</org_study_id>
    <nct_id>NCT04414527</nct_id>
  </id_info>
  <brief_title>Effects of Video-based Health Education on Maternal and Child Health in Ethiopia</brief_title>
  <acronym>MCH</acronym>
  <official_title>Effects of Video-based Health Education on Health Status of Pregnant Mothers and Their Infants (From 0 to 6 Months) in Dirashe District Southern Ethiopia - a Cluster Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Flemish Interuniversity Council (VLIR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>College of Medicine and Health Sciences, Arba Minch University, Ethiopia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</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>
      Low adherence to recommended health and nutrition strategies during the critical 1000&#xD;
      day-window of opportunity is multifactorial but low quality communication is key limitation.&#xD;
      Innovative strategies to improve interpersonal communication can reduce the burden and the&#xD;
      fatigue of community health workers and may result in a greater change. The findings of this&#xD;
      project will support governments and other stakeholders in their delivery of high impact&#xD;
      nutrition and health practices.&#xD;
&#xD;
      This intervention aims to improve adherence to ante- and post-natal care practices and&#xD;
      recommendations by the use of our video-based health education. These videos will be&#xD;
      implemented through home-based counseling by trained assistants, and video-based forum&#xD;
      participation led by community nurses and health extension workers (HEWs). During the monthly&#xD;
      forums, the educational package will be delivered in a video form - locally prepared using&#xD;
      multiple approaches like testimony, comedy, dramas in the form of questions and answers,&#xD;
      group discussions and deductive approaches. Cordless projectors and locally created videos&#xD;
      give the health community more quality control over the end message, expand the number of&#xD;
      people reached, allow for the use of minimally trained non-expert facilitators such as the&#xD;
      hews, and allow for contextually appropriate information. They can also be used in areas&#xD;
      without access to electricity, helping to bridge the digital divide, and serving as a&#xD;
      leapfrog technology for areas that would otherwise not have access to media.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Ante- and post-natal care, low adherence to recommended health and nutrition strategies&#xD;
      during the critical 1,000 day-window of opportunity is multifactorial, but low-quality&#xD;
      communication is key limitation. Innovative strategies to improve interpersonal communication&#xD;
      can reduce the burden and the fatigue of community health workers and may result in a greater&#xD;
      change. The findings of this project will support governments and other stakeholders in their&#xD;
      delivery of high impact nutrition and health practices.&#xD;
&#xD;
      Focused antenatal care (FANC), including iron and folic acid supplementation (IFA) is one of&#xD;
      the main strategies to reduce maternal and child deaths. The WHO recommends at least four&#xD;
      hospital visits during the pregnancy. Supplementation with IFA during pregnancy improves&#xD;
      birth weight and reduces megaloblastic anemia by 79%. The uptake of nutritional and health&#xD;
      practices is influenced by complex, contextual determinants at the individual and community&#xD;
      levels. Evidence showed that Social and Behavior Change Communication (SBCC) is an effective&#xD;
      approach to increase the uptake of key strategies and to sustain behavior change.&#xD;
&#xD;
      Ethiopia, a low-income country in sub-Saharan Africa, has one of the highest maternal and&#xD;
      infant mortality rates. It is estimated that 676 mothers die per 100,000 live births and that&#xD;
      59 infants die per 1,000 live births. Maternal anemia is associated with an increased risk of&#xD;
      maternal death. Iron deficiency anemia is a strong risk factor for low birthweight (LBW) and&#xD;
      perinatal mortality. genital infections such as bacterial vaginosis, candidiasis and worm&#xD;
      infections (such as intestinal hookworm infections) are considered important infections that&#xD;
      possibly could confound the study results. Bacterial vaginosis and candidiasis are a known&#xD;
      risk factor for preterm birth. these infections are also linked with anemia and maternal&#xD;
      nutritional status. Hookworm infections are highly prevalent in Ethiopia and are associated&#xD;
      with undernutrition and anemia.&#xD;
&#xD;
      The reports of the Ethiopian Demographic and Health Survey showed an increase in women aged&#xD;
      15-49 years in Ethiopia receiving antenatal care (ANC) from a skilled provider up to 62% in&#xD;
      2016 (EDHS, 2016). The percentage of women taking IFA supplements for 90 days or more remains&#xD;
      at a substandard level of only 5% (EDHS, 2016). Antenatal care coverage for at least one&#xD;
      visit is 28% but coverage for at least four visits declines to 12%, suggesting systemic&#xD;
      barriers that potentially prevent the mothers from returning to the health centers. One of&#xD;
      the barriers may be perceived failure of the existing interventions to make a meaningful&#xD;
      impact that could stimulate the desired behavioral change.&#xD;
&#xD;
      This intervention aims to improve adherence to ante- and post-natal care practices and&#xD;
      recommendations by the use of our video-based health education. These videos will be&#xD;
      implemented through home-based counseling by trained assistants, and video-based forum&#xD;
      participation led by community nurses and Health Extension Workers (HEWs). The&#xD;
      nutrition-specific education packages will be based on the WHO-UNICEF key messages booklet on&#xD;
      the community, infant and young child feeding counseling package and will be culturally&#xD;
      adjusted to fit the local context and translated into the main four local languages. The&#xD;
      videos will also include some hygienic aspects that reduce the risk of both genital and&#xD;
      parasitic infections, that are also causing undernutrition, anemia and/or adverse pregnancy&#xD;
      outcomes. During the monthly forums, the educational package will be delivered in a video&#xD;
      form - locally prepared using multiple approaches like testimony, comedy, dramas in the form&#xD;
      of questions and answers, group discussions and deductive approaches (more details can be&#xD;
      found on OMPT website https://www.ompt.org/).&#xD;
&#xD;
      The main objective of this project is to assess the effects of this innovative video-based&#xD;
      health education on reproductive health, and on birth outcomes and the nutritional status of&#xD;
      women and their infants from birth to six months of age.&#xD;
&#xD;
      PRIMARY OBJECTIVES&#xD;
&#xD;
        1. To assess the effects of video-based health education package provided to pregnant and&#xD;
           lactating women on the knowledge, attitude and practice on recommended health including&#xD;
           adherence to ANC visits and to IFA supplementation.&#xD;
&#xD;
        2. To assess the effects of video-based health education on birth outcomes and anemia&#xD;
           status of women during pregnancy, at delivery and six-month postpartum.&#xD;
&#xD;
        3. To evaluate the effect of video-based health education on early initiation and exclusive&#xD;
           breastfeeding (EBF) of infants from 0-6 months of age In this two-arm cluster randomized&#xD;
           trial, 675 pregnant women in their first trimester (12 weeks of gestation) will be&#xD;
           recruited and followed up until delivery and then with their infants for six months&#xD;
           postpartum.&#xD;
&#xD;
      The intervention will include home to home visit for delivery of healthy nutrition and&#xD;
      hygienic messages using prepared video-based messages. participation in monthly forums will&#xD;
      be facilitated by nurses using also videos for demonstration of nutritional and hygienic care&#xD;
      and will be delivered at the homes of the participants every month by trained HEW until&#xD;
      delivery, in addition to the ANC regular visits. During the monthly forums (six in total&#xD;
      during the pregnancy and the post-partum periods), the messages will all be given as a video&#xD;
      show, coordinated by a nurse/ health professional who will further answer any questions.&#xD;
      During the postnatal period, two counseling sessions will be organized within the first two&#xD;
      weeks after birth, and a further six sessions ( every month) till 6 months postnatally.&#xD;
&#xD;
      The HEW will distribute the IFA 30 tablets (30 mg elemental iron and 400 µg of folic acid)&#xD;
      every month, and will provide counseling on the importance of- and instructions on adherence&#xD;
      and other recommendations as detailed earlier. Pregnant women in the control group will&#xD;
      receive the standard education package as per the Ethiopian guidelines. In the standard&#xD;
      health care, pregnant women receive a minimum of four ANC visits at the health centers during&#xD;
      which they also receive IFA supplementation. The control and the intervention groups receive&#xD;
      the same amount of tablets (i.e. 30 tablets containing 30 mg elemental iron and 400 µg of&#xD;
      folic acid, every month). Monthly IFA utilization will be checked through HEW or our trained&#xD;
      service delivery workers during home to home visit. Women who test positive for&#xD;
      soil-transmitted helminth will be treated according to the national protocol starting from&#xD;
      the second trimester (treatment is not advised during the first trimester). Women who&#xD;
      experience odor, itching or discharge will be treated for candidiasis and bacterial&#xD;
      vaginosis.&#xD;
&#xD;
      Data will be collected in pregnant women at baseline, at six and at 9 months of pregnancy .&#xD;
      After delivery data will be collected in the pairs mother-infant within two weeks and at 3&#xD;
      and 6 months postpartum. At the different time points, biological samples will be collected&#xD;
      to assess the micronutrient status, the presence of inflammations and the presence of genital&#xD;
      and parasitic infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>
    <intervention_model_description>In a two-arm cluster randomized trial, 675 eligible pregnant women in their first trimester (12 weeks of gestation) will be recruited and followed up until delivery, and in pair with their infant up-to six months postpartum.&#xD;
Eligible pregnant women in the intervention group will receive video-based nutritional and hygienic education package (Health-Video) for six months until delivery and then for another six-month postpartum.&#xD;
Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines.&#xD;
The intervention will include home-to-home visit for delivery of healthy nutrition and hygiene messages using prepared video-based messages, and participation in monthly forums facilitated by nurses using also videos for demonstration of nutritional and hygienic care.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to iron and folic acid supplementation during pregnancy</measure>
    <time_frame>Monthly during six months pregnancy</time_frame>
    <description>Monthly disappearance rate of IFA tablets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to iron and folic acid supplementation post-partum</measure>
    <time_frame>Monthly during three months postpartum</time_frame>
    <description>Monthly disappearance rate of IFA tablets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal anemia during pregnancy</measure>
    <time_frame>Hemoglobin concentrations will be measured at 9 months pregnancy</time_frame>
    <description>Hemoglobin concentrations (g/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal anemia post-partum</measure>
    <time_frame>Hemoglobin concentrations will be measured at six months postpartum</time_frame>
    <description>Hemoglobin concentrations (g/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early initiation</measure>
    <time_frame>At birth (six months after the enrollment)</time_frame>
    <description>Prevalence of newborns put to the breast in the first hour after birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exclusive breastfeeding</measure>
    <time_frame>Birth to six months postpartum</time_frame>
    <description>Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary intake during six months pregnancy</measure>
    <time_frame>Assessed at 6 months and 9 months pregnancy</time_frame>
    <description>Prevalence of women with adequate dietary intake during six months pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary intake at six months post-partum</measure>
    <time_frame>Assessed at six months postpartum</time_frame>
    <description>Prevalence of women with adequate dietary intake at six months post-partum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational weight gain</measure>
    <time_frame>Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy</time_frame>
    <description>Weight gain at term (Kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal genital infections</measure>
    <time_frame>Maternal genital infections will be assessed at nine months pregnancy</time_frame>
    <description>The presence of genital infections that are known to affect a healthy pregnancy, including but not limited to bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Listeria monocytogenes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>Birth weight will be assessed in all newborns</time_frame>
    <description>Birth weight (g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight</measure>
    <time_frame>Weight of infants will be assessed monthly from birth until six months of age</time_frame>
    <description>Infant weight (g) on a monthly basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length</measure>
    <time_frame>Length of infants will be assessed monthly from birth until six months of age</time_frame>
    <description>Infant length (cm) on a monthly basis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant anemia</measure>
    <time_frame>Hemoglobin concentrations will be measured at six months of age</time_frame>
    <description>Hemoglobin concentrations (g/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal parasitic infections</measure>
    <time_frame>Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum</time_frame>
    <description>The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant parasitic infections</measure>
    <time_frame>Infant parasitic infections will be assessed at 6 months of age.</time_frame>
    <description>The prevalence of Giarida and Cryposporidium will be assessed in all infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal plasma ferritin</measure>
    <time_frame>Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum</time_frame>
    <description>Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant plasma ferritin</measure>
    <time_frame>Plasma ferritin is assessed in a subgroup of infants at six months of age</time_frame>
    <description>Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal soluble transferrin receptor</measure>
    <time_frame>Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum</time_frame>
    <description>Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant soluble transferrin receptor</measure>
    <time_frame>Soluble transferrin receptor is assessed in a subgroup of infants at six months of age</time_frame>
    <description>Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum concentrations in Vitamin A (retinol)</measure>
    <time_frame>Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum</time_frame>
    <description>Retinol concentrations in serum is an indicator of vitamin A status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant serum concentrations in Vitamin A (retinol)</measure>
    <time_frame>Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age</time_frame>
    <description>Retinol concentrations in serum is an indicator of vitamin A status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal serum concentrations in vitamin B12</measure>
    <time_frame>Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum</time_frame>
    <description>Serum concentrations in vitamin B12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant serum concentrations in vitamin B12</measure>
    <time_frame>Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age</time_frame>
    <description>Serum concentrations in vitamin B12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">675</enrollment>
  <condition>Anemia</condition>
  <condition>Antenatal Care</condition>
  <condition>Birth Outcomes</condition>
  <condition>Worm Infection</condition>
  <condition>Bacterial Vaginoses</condition>
  <condition>Exclusive Breastfeeding</condition>
  <arm_group>
    <arm_group_label>Standard counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines. In the standard health care, pregnant women receive a minimum of four ante-natal care visits at the health centers during which they also receive iron and folic acid supplementation. They participate in monthly forums facilitated by nurses to answer questions and concerns regarding nutritional care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health-Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the Health-Video group will receive home visits for delivery of healthy nutrition messages using prepared video-based messages every two weeks. They will also participate in monthly forums facilitated by nurses using also videos for demonstration of nutritional care. During the monthly forums (six in total during the pregnancy and the post-partum periods), the messages will all be given as a video show coordinated by a nurse/ health professional for any questions. During postnatal period, two counseling sessions will be delivered within two weeks of birth, and 12 sessions or twice every month till 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard counselling</intervention_name>
    <description>The control cohort will receive national standard counseling during four ante-natal care visits.&#xD;
Women in the control group will receive additionally&#xD;
national nutrition and health care including IFA supplementation,&#xD;
treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,&#xD;
Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.</description>
    <arm_group_label>Standard counseling</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health-Video</intervention_name>
    <description>The intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education.&#xD;
Women in this group will receive additionally:&#xD;
National nutrition and health care including IFA supplementation&#xD;
treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,&#xD;
Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.</description>
    <arm_group_label>Health-Video</arm_group_label>
    <other_name>Video-based counselling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
          -  Aged at least 18 years&#xD;
&#xD;
          -  Permanent resident of the village of the study intervention/control&#xD;
&#xD;
          -  Planned availability during the whole period of the study (12 months)&#xD;
&#xD;
          -  Acceptance of the intervention package including home visits for data collection and&#xD;
             morbidity follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe anemia (hemoglobin &lt;70 g/L),&#xD;
&#xD;
          -  Under nutrition (defined as body mass index before pregnancy of &lt;18.5 kg/m2),&#xD;
&#xD;
          -  Chronically ill mothers with tuberculosis or other chronic diseases,&#xD;
&#xD;
          -  Reported HIV-positive mother.&#xD;
&#xD;
          -  Individuals with anatomical deformity will be excluded due to the difficulty of&#xD;
             measurement of height.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefaan De Henauw, Md. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Souheila Abbeddou, MSc. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ghent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Levecke, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arba Minch University</name>
      <address>
        <city>Arba Minch</city>
        <state>Dirashe District</state>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <link>
    <url>https://www.fantaproject.org/sites/default/files/resources/FANTA-Review-Incorporation-ENA-Jan2008.pdf</url>
    <description>Review of Incorporation of Essential Nutrition Actions in Public Health Programs in Ethiopia. Washington, DC: Food and Nutrition Technical Assistance Project (FANTA)</description>
  </link>
  <link>
    <url>https://www.spring-nutrition.org/sites/default/files/publications/series/spring_sbcc_lit_review.pdf</url>
    <description>Evidence of Effective Approaches to Social and Behavior Change Communication for Preventing and Reducing Stunting and Anemia: Report from a Systematic Literature Review</description>
  </link>
  <reference>
    <citation>Lassi ZS, Salam RA, Haider BA, Bhutta ZA. Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD006896. doi: 10.1002/14651858.CD006896.pub2.</citation>
    <PMID>23543547</PMID>
  </reference>
  <reference>
    <citation>Rasmussen KM, Stoltzfus RJ. New evidence that iron supplementation during pregnancy improves birth weight: new scientific questions. Am J Clin Nutr. 2003 Oct;78(4):673-4. doi: 10.1093/ajcn/78.4.673. No abstract available.</citation>
    <PMID>14522723</PMID>
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  <reference>
    <citation>Brooker S, Bethony J, Hotez PJ. Human hookworm infection in the 21st century. Adv Parasitol. 2004;58:197-288. doi: 10.1016/S0065-308X(04)58004-1.</citation>
    <PMID>15603764</PMID>
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    <PMID>7570868</PMID>
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  <reference>
    <citation>Asundep NN, Jolly PE, Carson AP, Turpin CA, Zhang K, Wilson NO, Stiles JK, Tameru B. Effect of Malaria and Geohelminth Infection on Birth Outcomes in Kumasi, Ghana. Int J Trop Dis Health. 2014;4(5):582-594. doi: 10.9734/IJTDH/2014/7573.</citation>
    <PMID>25414840</PMID>
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  <reference>
    <citation>Kavle JA, Landry M. Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. Matern Child Nutr. 2018 Jan;14(1):e12508. doi: 10.1111/mcn.12508. Epub 2017 Aug 24.</citation>
    <PMID>28836343</PMID>
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  <reference>
    <citation>Verstraelen H, Delanghe J, Roelens K, Blot S, Claeys G, Temmerman M. Subclinical iron deficiency is a strong predictor of bacterial vaginosis in early pregnancy. BMC Infect Dis. 2005 Jul 6;5:55. doi: 10.1186/1471-2334-5-55.</citation>
    <PMID>16000177</PMID>
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  <reference>
    <citation>Tuddenham S, Ghanem KG, Caulfield LE, Rovner AJ, Robinson C, Shivakoti R, Miller R, Burke A, Murphy C, Ravel J, Brotman RM. Associations between dietary micronutrient intake and molecular-Bacterial Vaginosis. Reprod Health. 2019 Oct 22;16(1):151. doi: 10.1186/s12978-019-0814-6.</citation>
    <PMID>31640725</PMID>
  </reference>
  <reference>
    <citation>Ashorn P, Hallamaa L, Allen LH, Ashorn U, Chandrasiri U, Deitchler M, Doyle R, Harjunmaa U, Jorgensen JM, Kamiza S, Klein N, Maleta K, Nkhoma M, Oaks BM, Poelman B, Rogerson SJ, Stewart CP, Zeilani M, Dewey KG. Co-causation of reduced newborn size by maternal undernutrition, infections, and inflammation. Matern Child Nutr. 2018 Jul;14(3):e12585. doi: 10.1111/mcn.12585. Epub 2018 Jan 8.</citation>
    <PMID>29316198</PMID>
  </reference>
  <results_reference>
    <citation>Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.</citation>
    <PMID>23746776</PMID>
  </results_reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>April 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Video-based behavior change communication</keyword>
  <keyword>Iron and folic acid supplementation</keyword>
  <keyword>Antenatal care</keyword>
  <keyword>Soil transmitted helminths</keyword>
  <keyword>Bacterial vaginoses</keyword>
  <keyword>Exclusive breastfeeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary.&#xD;
Data on helminthic infection will use household characteristics and women and infants nutritional status</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/NCT04414527
org study id: BC-06756
nct id: NCT04414527
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low adherence to recommended health and nutrition strategies during the critical 1000
      day-window of opportunity is multifactorial but low quality communication is key limitation.
      Innovative strategies to improve interpersonal communication can reduce the burden and the
      fatigue of community health workers and may result in a greater change. The findings of this
      project will support governments and other stakeholders in their delivery of high impact
      nutrition and health practices.

      This intervention aims to improve adherence to ante- and post-natal care practices and
      recommendations by the use of our video-based health education. These videos will be
      implemented through home-based counseling by trained assistants, and video-based forum
      participation led by community nurses and health extension workers (HEWs). During the monthly
      forums, the educational package will be delivered in a video form - locally prepared using
      multiple approaches like testimony, comedy, dramas in the form of questions and answers,
      group discussions and deductive approaches. Cordless projectors and locally created videos
      give the health community more quality control over the end message, expand the number of
      people reached, allow for the use of minimally trained non-expert facilitators such as the
      hews, and allow for contextually appropriate information. They can also be used in areas
      without access to electricity, helping to bridge the digital divide, and serving as a
      leapfrog technology for areas that would otherwise not have access to media.
In Ante- and post-natal care, low adherence to recommended health and nutrition strategies
      during the critical 1,000 day-window of opportunity is multifactorial, but low-quality
      communication is key limitation. Innovative strategies to improve interpersonal communication
      can reduce the burden and the fatigue of community health workers and may result in a greater
      change. The findings of this project will support governments and other stakeholders in their
      delivery of high impact nutrition and health practices.

      Focused antenatal care (FANC), including iron and folic acid supplementation (IFA) is one of
      the main strategies to reduce maternal and child deaths. The WHO recommends at least four
      hospital visits during the pregnancy. Supplementation with IFA during pregnancy improves
      birth weight and reduces megaloblastic anemia by 79%. The uptake of nutritional and health
      practices is influenced by complex, contextual determinants at the individual and community
      levels. Evidence showed that Social and Behavior Change Communication (SBCC) is an effective
      approach to increase the uptake of key strategies and to sustain behavior change.

      Ethiopia, a low-income country in sub-Saharan Africa, has one of the highest maternal and
      infant mortality rates. It is estimated that 676 mothers die per 100,000 live births and that
      59 infants die per 1,000 live births. Maternal anemia is associated with an increased risk of
      maternal death. Iron deficiency anemia is a strong risk factor for low birthweight (LBW) and
      perinatal mortality. genital infections such as bacterial vaginosis, candidiasis and worm
      infections (such as intestinal hookworm infections) are considered important infections that
      possibly could confound the study results. Bacterial vaginosis and candidiasis are a known
      risk factor for preterm birth. these infections are also linked with anemia and maternal
      nutritional status. Hookworm infections are highly prevalent in Ethiopia and are associated
      with undernutrition and anemia.

      The reports of the Ethiopian Demographic and Health Survey showed an increase in women aged
      15-49 years in Ethiopia receiving antenatal care (ANC) from a skilled provider up to 62% in
      2016 (EDHS, 2016). The percentage of women taking IFA supplements for 90 days or more remains
      at a substandard level of only 5% (EDHS, 2016). Antenatal care coverage for at least one
      visit is 28% but coverage for at least four visits declines to 12%, suggesting systemic
      barriers that potentially prevent the mothers from returning to the health centers. One of
      the barriers may be perceived failure of the existing interventions to make a meaningful
      impact that could stimulate the desired behavioral change.

      This intervention aims to improve adherence to ante- and post-natal care practices and
      recommendations by the use of our video-based health education. These videos will be
      implemented through home-based counseling by trained assistants, and video-based forum
      participation led by community nurses and Health Extension Workers (HEWs). The
      nutrition-specific education packages will be based on the WHO-UNICEF key messages booklet on
      the community, infant and young child feeding counseling package and will be culturally
      adjusted to fit the local context and translated into the main four local languages. The
      videos will also include some hygienic aspects that reduce the risk of both genital and
      parasitic infections, that are also causing undernutrition, anemia and/or adverse pregnancy
      outcomes. During the monthly forums, the educational package will be delivered in a video
      form - locally prepared using multiple approaches like testimony, comedy, dramas in the form
      of questions and answers, group discussions and deductive approaches (more details can be
      found on OMPT website https://www.ompt.org/).

      The main objective of this project is to assess the effects of this innovative video-based
      health education on reproductive health, and on birth outcomes and the nutritional status of
      women and their infants from birth to six months of age.

      PRIMARY OBJECTIVES

        1. To assess the effects of video-based health education package provided to pregnant and
           lactating women on the knowledge, attitude and practice on recommended health including
           adherence to ANC visits and to IFA supplementation.

        2. To assess the effects of video-based health education on birth outcomes and anemia
           status of women during pregnancy, at delivery and six-month postpartum.

        3. To evaluate the effect of video-based health education on early initiation and exclusive
           breastfeeding (EBF) of infants from 0-6 months of age In this two-arm cluster randomized
           trial, 675 pregnant women in their first trimester (12 weeks of gestation) will be
           recruited and followed up until delivery and then with their infants for six months
           postpartum.

      The intervention will include home to home visit for delivery of healthy nutrition and
      hygienic messages using prepared video-based messages. participation in monthly forums will
      be facilitated by nurses using also videos for demonstration of nutritional and hygienic care
      and will be delivered at the homes of the participants every month by trained HEW until
      delivery, in addition to the ANC regular visits. During the monthly forums (six in total
      during the pregnancy and the post-partum periods), the messages will all be given as a video
      show, coordinated by a nurse/ health professional who will further answer any questions.
      During the postnatal period, two counseling sessions will be organized within the first two
      weeks after birth, and a further six sessions ( every month) till 6 months postnatally.

      The HEW will distribute the IFA 30 tablets (30 mg elemental iron and 400 µg of folic acid)
      every month, and will provide counseling on the importance of- and instructions on adherence
      and other recommendations as detailed earlier. Pregnant women in the control group will
      receive the standard education package as per the Ethiopian guidelines. In the standard
      health care, pregnant women receive a minimum of four ANC visits at the health centers during
      which they also receive IFA supplementation. The control and the intervention groups receive
      the same amount of tablets (i.e. 30 tablets containing 30 mg elemental iron and 400 µg of
      folic acid, every month). Monthly IFA utilization will be checked through HEW or our trained
      service delivery workers during home to home visit. Women who test positive for
      soil-transmitted helminth will be treated according to the national protocol starting from
      the second trimester (treatment is not advised during the first trimester). Women who
      experience odor, itching or discharge will be treated for candidiasis and bacterial
      vaginosis.

      Data will be collected in pregnant women at baseline, at six and at 9 months of pregnancy .
      After delivery data will be collected in the pairs mother-infant within two weeks and at 3
      and 6 months postpartum. At the different time points, biological samples will be collected
      to assess the micronutrient status, the presence of inflammations and the presence of genital
      and parasitic infections.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In a two-arm cluster randomized trial, 675 eligible pregnant women in their first trimester (12 weeks of gestation) will be recruited and followed up until delivery, and in pair with their infant up-to six months postpartum.
Eligible pregnant women in the intervention group will receive video-based nutritional and hygienic education package (Health-Video) for six months until delivery and then for another six-month postpartum.
Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines.
The intervention will include home-to-home visit for delivery of healthy nutrition and hygiene messages using prepared video-based messages, and participation in monthly forums facilitated by nurses using also videos for demonstration of nutritional and hygienic care.
primary purpose: Prevention
masking: None (Open Label)
measure: Adherence to iron and folic acid supplementation during pregnancy
time frame: Monthly during six months pregnancy
description: Monthly disappearance rate of IFA tablets
measure: Adherence to iron and folic acid supplementation post-partum
time frame: Monthly during three months postpartum
description: Monthly disappearance rate of IFA tablets
measure: Maternal anemia during pregnancy
time frame: Hemoglobin concentrations will be measured at 9 months pregnancy
description: Hemoglobin concentrations (g/dL)
measure: Maternal anemia post-partum
time frame: Hemoglobin concentrations will be measured at six months postpartum
description: Hemoglobin concentrations (g/dL)
measure: Early initiation
time frame: At birth (six months after the enrollment)
description: Prevalence of newborns put to the breast in the first hour after birth
measure: Exclusive breastfeeding
time frame: Birth to six months postpartum
description: Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
measure: Dietary intake during six months pregnancy
time frame: Assessed at 6 months and 9 months pregnancy
description: Prevalence of women with adequate dietary intake during six months pregnancy
measure: Dietary intake at six months post-partum
time frame: Assessed at six months postpartum
description: Prevalence of women with adequate dietary intake at six months post-partum
measure: Gestational weight gain
time frame: Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
description: Weight gain at term (Kg)
measure: Maternal genital infections
time frame: Maternal genital infections will be assessed at nine months pregnancy
description: The presence of genital infections that are known to affect a healthy pregnancy, including but not limited to bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Listeria monocytogenes.
measure: Birth weight
time frame: Birth weight will be assessed in all newborns
description: Birth weight (g)
measure: Infant weight
time frame: Weight of infants will be assessed monthly from birth until six months of age
description: Infant weight (g) on a monthly basis
measure: Infant length
time frame: Length of infants will be assessed monthly from birth until six months of age
description: Infant length (cm) on a monthly basis
measure: Infant anemia
time frame: Hemoglobin concentrations will be measured at six months of age
description: Hemoglobin concentrations (g/dL)
measure: Maternal parasitic infections
time frame: Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum
description: The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).
measure: Infant parasitic infections
time frame: Infant parasitic infections will be assessed at 6 months of age.
description: The prevalence of Giarida and Cryposporidium will be assessed in all infants
measure: Maternal plasma ferritin
time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
description: Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
measure: Infant plasma ferritin
time frame: Plasma ferritin is assessed in a subgroup of infants at six months of age
description: Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
measure: Maternal soluble transferrin receptor
time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
description: Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
measure: Infant soluble transferrin receptor
time frame: Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
description: Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
measure: Maternal serum concentrations in Vitamin A (retinol)
time frame: Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
description: Retinol concentrations in serum is an indicator of vitamin A status
measure: Infant serum concentrations in Vitamin A (retinol)
time frame: Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
description: Retinol concentrations in serum is an indicator of vitamin A status
measure: Maternal serum concentrations in vitamin B12
time frame: Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
description: Serum concentrations in vitamin B12
measure: Infant serum concentrations in vitamin B12
time frame: Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age
description: Serum concentrations in vitamin B12
arm group label: Standard counseling
arm group type: Other
description: Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines. In the standard health care, pregnant women receive a minimum of four ante-natal care visits at the health centers during which they also receive iron and folic acid supplementation. They participate in monthly forums facilitated by nurses to answer questions and concerns regarding nutritional care.
arm group label: Health-Video
arm group type: Experimental
description: Women in the Health-Video group will receive home visits for delivery of healthy nutrition messages using prepared video-based messages every two weeks. They will also participate in monthly forums facilitated by nurses using also videos for demonstration of nutritional care. During the monthly forums (six in total during the pregnancy and the post-partum periods), the messages will all be given as a video show coordinated by a nurse/ health professional for any questions. During postnatal period, two counseling sessions will be delivered within two weeks of birth, and 12 sessions or twice every month till 6 months.
intervention type: Behavioral
intervention name: Standard counselling
description: The control cohort will receive national standard counseling during four ante-natal care visits.
Women in the control group will receive additionally
national nutrition and health care including IFA supplementation,
treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,
Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
arm group label: Standard counseling
other name: Control
intervention type: Behavioral
intervention name: Health-Video
description: The intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education.
Women in this group will receive additionally:
National nutrition and health care including IFA supplementation
treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,
Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
arm group label: Health-Video
other name: Video-based counselling
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefaan De Henauw, Md. PhD
role: Principal Investigator
affiliation: University of Ghent
last name: Souheila Abbeddou, MSc. PhD
role: Principal Investigator
affiliation: University of Ghent
last name: Bruno Levecke, PhD
role: Principal Investigator
affiliation: University of Ghent
facility: 
country: Ethiopia
url: https://www.fantaproject.org/sites/default/files/resources/FANTA-Review-Incorporation-ENA-Jan2008.pdf
description: Review of Incorporation of Essential Nutrition Actions in Public Health Programs in Ethiopia. Washington, DC: Food and Nutrition Technical Assistance Project (FANTA)
url: https://www.spring-nutrition.org/sites/default/files/publications/series/spring_sbcc_lit_review.pdf
description: Evidence of Effective Approaches to Social and Behavior Change Communication for Preventing and Reducing Stunting and Anemia: Report from a Systematic Literature Review
citation: Lassi ZS, Salam RA, Haider BA, Bhutta ZA. Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD006896. doi: 10.1002/14651858.CD006896.pub2.
PMID: 23543547
citation: Rasmussen KM, Stoltzfus RJ. New evidence that iron supplementation during pregnancy improves birth weight: new scientific questions. Am J Clin Nutr. 2003 Oct;78(4):673-4. doi: 10.1093/ajcn/78.4.673. No abstract available.
PMID: 14522723
citation: Brooker S, Bethony J, Hotez PJ. Human hookworm infection in the 21st century. Adv Parasitol. 2004;58:197-288. doi: 10.1016/S0065-308X(04)58004-1.
PMID: 15603764
citation: Prociv P, Luke RA. Evidence for larval hypobiosis in Australian strains of Ancylostoma duodenale. Trans R Soc Trop Med Hyg. 1995 Jul-Aug;89(4):379. doi: 10.1016/0035-9203(95)90016-0. No abstract available.
PMID: 7570868
citation: Asundep NN, Jolly PE, Carson AP, Turpin CA, Zhang K, Wilson NO, Stiles JK, Tameru B. Effect of Malaria and Geohelminth Infection on Birth Outcomes in Kumasi, Ghana. Int J Trop Dis Health. 2014;4(5):582-594. doi: 10.9734/IJTDH/2014/7573.
PMID: 25414840
citation: Kavle JA, Landry M. Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. Matern Child Nutr. 2018 Jan;14(1):e12508. doi: 10.1111/mcn.12508. Epub 2017 Aug 24.
PMID: 28836343
citation: Verstraelen H, Delanghe J, Roelens K, Blot S, Claeys G, Temmerman M. Subclinical iron deficiency is a strong predictor of bacterial vaginosis in early pregnancy. BMC Infect Dis. 2005 Jul 6;5:55. doi: 10.1186/1471-2334-5-55.
PMID: 16000177
citation: Tuddenham S, Ghanem KG, Caulfield LE, Rovner AJ, Robinson C, Shivakoti R, Miller R, Burke A, Murphy C, Ravel J, Brotman RM. Associations between dietary micronutrient intake and molecular-Bacterial Vaginosis. Reprod Health. 2019 Oct 22;16(1):151. doi: 10.1186/s12978-019-0814-6.
PMID: 31640725
citation: Ashorn P, Hallamaa L, Allen LH, Ashorn U, Chandrasiri U, Deitchler M, Doyle R, Harjunmaa U, Jorgensen JM, Kamiza S, Klein N, Maleta K, Nkhoma M, Oaks BM, Poelman B, Rogerson SJ, Stewart CP, Zeilani M, Dewey KG. Co-causation of reduced newborn size by maternal undernutrition, infections, and inflammation. Matern Child Nutr. 2018 Jul;14(3):e12585. doi: 10.1111/mcn.12585. Epub 2018 Jan 8.
PMID: 29316198
citation: Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
PMID: 23746776
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
sharing ipd: No
ipd description: All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary.
Data on helminthic infection will use household characteristics and women and infants nutritional status