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Effects of Video-based Health Education on Maternal and Child Health in Ethiopia (MCH)

Primary Purpose

Anemia, Antenatal Care, Birth Outcomes

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Standard counselling
Health-Video
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Video-based behavior change communication, Iron and folic acid supplementation, Antenatal care, Soil transmitted helminths, Bacterial vaginoses, Exclusive breastfeeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Arba Minch University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard counseling

Health-Video

Arm 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.

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.

Outcomes

Primary Outcome Measures

Adherence to iron and folic acid supplementation during pregnancy
Monthly disappearance rate of IFA tablets
Adherence to iron and folic acid supplementation post-partum
Monthly disappearance rate of IFA tablets
Maternal anemia during pregnancy
Hemoglobin concentrations (g/dL)
Maternal anemia post-partum
Hemoglobin concentrations (g/dL)
Early initiation
Prevalence of newborns put to the breast in the first hour after birth
Exclusive breastfeeding
Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
Dietary intake during six months pregnancy
Prevalence of women with adequate dietary intake during six months pregnancy
Dietary intake at six months post-partum
Prevalence of women with adequate dietary intake at six months post-partum

Secondary Outcome Measures

Gestational weight gain
Weight gain at term (Kg)
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.
Birth weight
Birth weight (g)
Infant weight
Infant weight (g) on a monthly basis
Infant length
Infant length (cm) on a monthly basis
Infant anemia
Hemoglobin concentrations (g/dL)
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).
Infant parasitic infections
The prevalence of Giarida and Cryposporidium will be assessed in all infants
Maternal plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Infant plasma ferritin
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Maternal soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Infant soluble transferrin receptor
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Maternal serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Infant serum concentrations in Vitamin A (retinol)
Retinol concentrations in serum is an indicator of vitamin A status
Maternal serum concentrations in vitamin B12
Serum concentrations in vitamin B12
Infant serum concentrations in vitamin B12
Serum concentrations in vitamin B12

Full Information

First Posted
April 21, 2020
Last Updated
December 3, 2021
Sponsor
University Ghent
Collaborators
Flemish Interuniversity Council (VLIR), College of Medicine and Health Sciences, Arba Minch University, Ethiopia
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1. Study Identification

Unique Protocol Identification Number
NCT04414527
Brief Title
Effects of Video-based Health Education on Maternal and Child Health in Ethiopia
Acronym
MCH
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Flemish Interuniversity Council (VLIR), College of Medicine and Health Sciences, Arba Minch University, Ethiopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard counseling
Arm Type
Other
Arm 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 Title
Health-Video
Arm Type
Experimental
Arm 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(s)
Standard counselling
Other Intervention Name(s)
Control
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Health-Video
Other Intervention Name(s)
Video-based counselling
Intervention 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.
Primary Outcome Measure Information:
Title
Adherence to iron and folic acid supplementation during pregnancy
Description
Monthly disappearance rate of IFA tablets
Time Frame
Monthly during six months pregnancy
Title
Adherence to iron and folic acid supplementation post-partum
Description
Monthly disappearance rate of IFA tablets
Time Frame
Monthly during three months postpartum
Title
Maternal anemia during pregnancy
Description
Hemoglobin concentrations (g/dL)
Time Frame
Hemoglobin concentrations will be measured at 9 months pregnancy
Title
Maternal anemia post-partum
Description
Hemoglobin concentrations (g/dL)
Time Frame
Hemoglobin concentrations will be measured at six months postpartum
Title
Early initiation
Description
Prevalence of newborns put to the breast in the first hour after birth
Time Frame
At birth (six months after the enrollment)
Title
Exclusive breastfeeding
Description
Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)
Time Frame
Birth to six months postpartum
Title
Dietary intake during six months pregnancy
Description
Prevalence of women with adequate dietary intake during six months pregnancy
Time Frame
Assessed at 6 months and 9 months pregnancy
Title
Dietary intake at six months post-partum
Description
Prevalence of women with adequate dietary intake at six months post-partum
Time Frame
Assessed at six months postpartum
Secondary Outcome Measure Information:
Title
Gestational weight gain
Description
Weight gain at term (Kg)
Time Frame
Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
Title
Maternal genital infections
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.
Time Frame
Maternal genital infections will be assessed at nine months pregnancy
Title
Birth weight
Description
Birth weight (g)
Time Frame
Birth weight will be assessed in all newborns
Title
Infant weight
Description
Infant weight (g) on a monthly basis
Time Frame
Weight of infants will be assessed monthly from birth until six months of age
Title
Infant length
Description
Infant length (cm) on a monthly basis
Time Frame
Length of infants will be assessed monthly from birth until six months of age
Title
Infant anemia
Description
Hemoglobin concentrations (g/dL)
Time Frame
Hemoglobin concentrations will be measured at six months of age
Title
Maternal parasitic infections
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).
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
Title
Infant parasitic infections
Description
The prevalence of Giarida and Cryposporidium will be assessed in all infants
Time Frame
Infant parasitic infections will be assessed at 6 months of age.
Title
Maternal plasma ferritin
Description
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time Frame
Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Title
Infant plasma ferritin
Description
Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores
Time Frame
Plasma ferritin is assessed in a subgroup of infants at six months of age
Title
Maternal soluble transferrin receptor
Description
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time Frame
Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Title
Infant soluble transferrin receptor
Description
Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings
Time Frame
Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
Title
Maternal serum concentrations in Vitamin A (retinol)
Description
Retinol concentrations in serum is an indicator of vitamin A status
Time Frame
Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Title
Infant serum concentrations in Vitamin A (retinol)
Description
Retinol concentrations in serum is an indicator of vitamin A status
Time Frame
Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
Title
Maternal serum concentrations in vitamin B12
Description
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
Title
Infant serum concentrations in vitamin B12
Description
Serum concentrations in vitamin B12
Time Frame
Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefaan De Henauw, Md. PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Souheila Abbeddou, MSc. PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Levecke, PhD
Organizational Affiliation
University of Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arba Minch University
City
Arba Minch
State/Province
Dirashe District
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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
Citations:
PubMed Identifier
23543547
Citation
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Results Reference
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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.
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PubMed Identifier
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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.
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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.
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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.
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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.
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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.
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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

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Effects of Video-based Health Education on Maternal and Child Health in Ethiopia

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