AnemiaMCHNCT04414527
Effects of Video-based Health Education on Maternal and Child Health in Ethiopia
A study testing Standard counselling and Health-Video in people with Anemia and Antenatal Care, run by University Ghent at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia, Antenatal Care, Birth Outcomes
- What is being tested?
- Standard counselling and Health-Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 1 siteEthiopia
- Study dates
- 13 Mar 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Aged at least 18 years
- Permanent resident of the village of the study intervention/control
- Planned availability during the whole period of the study (12 months)
- Acceptance of the intervention package including home visits for data collection and morbidity follow up.
Who cannot join
- Severe anemia (hemoglobin <70 g/L),
- Under nutrition (defined as body mass index before pregnancy of <18.5 kg/m2),
- Chronically ill mothers with tuberculosis or other chronic diseases,
- Reported HIV-positive mother.
- Individuals with anatomical deformity will be excluded due to the difficulty of measurement of height.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
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
- 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.
- 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.
- 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.
- Conditions
- Anemia, Antenatal Care, Birth Outcomes, Worm Infection, Bacterial Vaginoses, Exclusive Breastfeeding
- Being tested
- Standard counselling, Health-Video
- Keywords
- Video-based behavior change communication, Iron and folic acid supplementation, Antenatal care, Soil transmitted helminths, Bacterial vaginoses, Exclusive breastfeeding
- Medical subject headings
- Anemia, Trematode Infections, Vaginosis, Bacterial, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard counsellingBehavioural
Also called Control
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.
Health-VideoBehavioural
Also called Video-based counselling
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard counseling | Other | 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. Receives: Behavioral: Standard counselling |
| Health-Video | Experimental | 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. Receives: Behavioral: Health-Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to iron and folic acid supplementation during pregnancy
Monthly disappearance rate of IFA tablets
Measured: Monthly during six months pregnancy
Adherence to iron and folic acid supplementation post-partum
Monthly disappearance rate of IFA tablets
Measured: Monthly during three months postpartum
Maternal anemia during pregnancy
Hemoglobin concentrations (g/dL)
Measured: Hemoglobin concentrations will be measured at 9 months pregnancy
Maternal anemia post-partum
Hemoglobin concentrations (g/dL)
Measured: Hemoglobin concentrations will be measured at six months postpartum
Early initiation
Prevalence of newborns put to the breast in the first hour after birth
Measured: At birth (six months after the enrollment)
Exclusive breastfeeding
Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
Measured: Birth to six months postpartum
Dietary intake during six months pregnancy
Prevalence of women with adequate dietary intake during six months pregnancy
Measured: Assessed at 6 months and 9 months pregnancy
Dietary intake at six months post-partum
Prevalence of women with adequate dietary intake at six months post-partum
Measured: Assessed at six months postpartum
Secondary outcomes (16)
Gestational weight gain
Weight gain at term (Kg)
Measured: Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
Maternal genital infections
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.
Measured: Maternal genital infections will be assessed at nine months pregnancy
Birth weight
Birth weight (g)
Measured: Birth weight will be assessed in all newborns
Infant weight
Infant weight (g) on a monthly basis
Measured: Weight of infants will be assessed monthly from birth until six months of age
Infant length
Infant length (cm) on a monthly basis
Measured: Length of infants will be assessed monthly from birth until six months of age
Infant anemia
Hemoglobin concentrations (g/dL)
Measured: Hemoglobin concentrations will be measured at six months of age
Maternal parasitic infections
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).
Measured: Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum
Infant parasitic infections
The prevalence of Giarida and Cryposporidium will be assessed in all infants
Measured: Infant parasitic infections will be assessed at 6 months of age.
Maternal plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Measured: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Measured: Plasma ferritin is assessed in a subgroup of infants at six months of age
Maternal soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Measured: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Measured: Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
Maternal serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Measured: Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Measured: Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
Maternal serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Measured: Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Measured: Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start13 Mar 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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. 1. 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. 2. 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.
- Masking
- None (open label)
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University GhentSouheila Abbeddou, MSc. PhD, Principal investigator, University GhentBruno Levecke, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414527
- Sponsor's protocol ID
- BC-06756
- Acronym
- MCH
- Status last verified
- Dec 2021
- First submitted
- 21 Apr 2020
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 23543547Rasmussen 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.
PubMed 14522723Brooker 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.
PubMed 15603764Prociv 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.
PubMed 7570868Asundep 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.
PubMed 25414840Kavle 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.
PubMed 28836343Verstraelen 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.
PubMed 16000177Tuddenham 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.
PubMed 31640725Ashorn 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.
PubMed 29316198Bhutta 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.
PubMed 23746776Boynito WG, Worsa KT, Gutema BT, Yeshitila YG, Tessema GY, Yohanis T, Henauw S, Cools P, Levecke B, Abbeddou S. Effects of Video-Based Health Education on Birth Outcomes and Anaemia Status of Mothers in Dirashe District South Ethiopia: A Cluster Randomized Controlled Trial. Matern Child Nutr. 2025 Sep 24:e70122. doi: 10.1111/mcn.70122. Online ahead of print.
PubMed 40990120Godana Boynito W, Tessema GY, Temesgen K, De Henauw S, Abbeddou S. Acceptability and feasibility of video-based health education for maternal and infant health in Dirashe District, South Ethiopia: A qualitative study. PLOS Glob Public Health. 2023 Jun 29;3(6):e0000821. doi: 10.1371/journal.pgph.0000821. eCollection 2023.
PubMed 37384600
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04414527
- Acronym / sponsor ID
- MCH / BC-06756
- Conditions
- Anemia, Antenatal Care, Birth Outcomes, Worm Infection, Bacterial Vaginoses, Exclusive Breastfeeding
- Keywords
- Video-based behavior change communication, Iron and folic acid supplementation, Antenatal care, Soil transmitted helminths, Bacterial vaginoses, Exclusive breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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. 1. 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. 2. 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.
| Arm | Type | Receives |
|---|---|---|
| Standard counseling | Other | Behavioral: Standard counsellingPregnant 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. |
| Health-Video | Experimental | Behavioral: Health-VideoWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form
- Aged at least 18 years
- Permanent resident of the village of the study intervention/control
- Planned availability during the whole period of the study (12 months)
- Acceptance of the intervention package including home visits for data collection and morbidity follow up.
Key exclusion criteria (5 listed)
- Severe anemia (hemoglobin <70 g/L),
- Under nutrition (defined as body mass index before pregnancy of <18.5 kg/m2),
- Chronically ill mothers with tuberculosis or other chronic diseases,
- Reported HIV-positive mother.
- Individuals with anatomical deformity will be excluded due to the difficulty of measurement of height.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard counsellingAlso: ControlThe control cohort will receive national standard counseling during four ante-natal care visits. Women in the control group will receive additionally 1. national nutrition and health care including IFA supplementation, 2. treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, 3. Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis. | Behavioural | Standard counseling |
| Health-VideoAlso: Video-based counsellingThe intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education. Women in this group will receive additionally: 1. National nutrition and health care including IFA supplementation 2. treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, 3. Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis. | Behavioural | Health-Video |
Primary outcome
Adherence to iron and folic acid supplementation during pregnancy
Time frame: Monthly during six months pregnancy
Monthly disappearance rate of IFA tablets
Adherence to iron and folic acid supplementation post-partum
Time frame: Monthly during three months postpartum
Monthly disappearance rate of IFA tablets
Maternal anemia during pregnancy
Time frame: Hemoglobin concentrations will be measured at 9 months pregnancy
Hemoglobin concentrations (g/dL)
Maternal anemia post-partum
Time frame: Hemoglobin concentrations will be measured at six months postpartum
Hemoglobin concentrations (g/dL)
Early initiation
Time frame: At birth (six months after the enrollment)
Prevalence of newborns put to the breast in the first hour after birth
Exclusive breastfeeding
Time frame: Birth to six months postpartum
Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
Dietary intake during six months pregnancy
Time frame: Assessed at 6 months and 9 months pregnancy
Prevalence of women with adequate dietary intake during six months pregnancy
Dietary intake at six months post-partum
Time frame: Assessed at six months postpartum
Prevalence of women with adequate dietary intake at six months post-partum
16 secondary outcomes
Gestational weight gain
Time frame: Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
Maternal genital infections
Time frame: Maternal genital infections will be assessed at nine months pregnancy
Birth weight
Time frame: Birth weight will be assessed in all newborns
Infant weight
Time frame: Weight of infants will be assessed monthly from birth until six months of age
Infant length
Time frame: Length of infants will be assessed monthly from birth until six months of age
Infant anemia
Time frame: Hemoglobin concentrations will be measured at six months of age
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
Infant parasitic infections
Time frame: Infant parasitic infections will be assessed at 6 months of age.
Maternal plasma ferritin
Time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant plasma ferritin
Time frame: Plasma ferritin is assessed in a subgroup of infants at six months of age
Maternal soluble transferrin receptor
Time frame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Infant soluble transferrin receptor
Time frame: Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
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
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
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
Infant serum concentrations in vitamin B12
Time frame: Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Background: PubMed 23543547Lassi 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.
- Background: PubMed 14522723Rasmussen 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.
- Background: PubMed 15603764Brooker 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.
- Background: PubMed 7570868Prociv 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.
- Background: PubMed 25414840Asundep 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.
- Background: PubMed 28836343Kavle 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.
- Background: PubMed 16000177Verstraelen 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.
- Background: PubMed 31640725Tuddenham 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.
- Background: PubMed 29316198Ashorn 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.
- Results publication: PubMed 23746776Bhutta 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.
- Derived from this study: PubMed 40990120Boynito WG, Worsa KT, Gutema BT, Yeshitila YG, Tessema GY, Yohanis T, Henauw S, Cools P, Levecke B, Abbeddou S. Effects of Video-Based Health Education on Birth Outcomes and Anaemia Status of Mothers in Dirashe District South Ethiopia: A Cluster Randomized Controlled Trial. Matern Child Nutr. 2025 Sep 24:e70122. doi: 10.1111/mcn.70122. Online ahead of print.
- Derived from this study: PubMed 37384600Godana Boynito W, Tessema GY, Temesgen K, De Henauw S, Abbeddou S. Acceptability and feasibility of video-based health education for maternal and infant health in Dirashe District, South Ethiopia: A qualitative study. PLOS Glob Public Health. 2023 Jun 29;3(6):e0000821. doi: 10.1371/journal.pgph.0000821. eCollection 2023.
- Evidence of Effective Approaches to Social and Behavior Change Communication for Preventing and Reducing Stunting and Anemia: Report from a Systematic Literature ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
Souheila Abbeddou, MSc. PhD principal investigator
University Ghent
Bruno Levecke, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard counselling and Health-Video in people with Anemia and Antenatal Care, run by University Ghent at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to iron and folic acid supplementation during pregnancy (time frame: Monthly during six months pregnancy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414527, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.