Clinical trial NCT04414527: Effects of Video-based Health Education on Maternal and Child Health in Ethiopia
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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Flemish Interuniversity Council (VLIR)
name: Arba Minch University
First posted: 2020-06-04
Enrollment: 675
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.

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.
Primary purpose: PREVENTION

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

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.

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.

Primary outcomes:
measure: Adherence to iron and folic acid supplementation during pregnancy
timeFrame: Monthly during six months pregnancy
measure: Adherence to iron and folic acid supplementation post-partum
timeFrame: Monthly during three months postpartum
measure: Maternal anemia during pregnancy
timeFrame: Hemoglobin concentrations will be measured at 9 months pregnancy
measure: Maternal anemia post-partum
timeFrame: Hemoglobin concentrations will be measured at six months postpartum
measure: Early initiation
timeFrame: At birth (six months after the enrollment)
measure: Exclusive breastfeeding
timeFrame: Birth to six months postpartum
measure: Dietary intake during six months pregnancy
timeFrame: Assessed at 6 months and 9 months pregnancy
measure: Dietary intake at six months post-partum
timeFrame: Assessed at six months postpartum
Secondary outcomes:
measure: Gestational weight gain
timeFrame: Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
measure: Maternal genital infections
timeFrame: Maternal genital infections will be assessed at nine months pregnancy
measure: Birth weight
timeFrame: Birth weight will be assessed in all newborns
measure: Infant weight
timeFrame: Weight of infants will be assessed monthly from birth until six months of age
measure: Infant length
timeFrame: Length of infants will be assessed monthly from birth until six months of age
measure: Infant anemia
timeFrame: Hemoglobin concentrations will be measured at six months of age
measure: Maternal parasitic infections
timeFrame: Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum
measure: Infant parasitic infections
timeFrame: Infant parasitic infections will be assessed at 6 months of age.
measure: Maternal plasma ferritin
timeFrame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
measure: Infant plasma ferritin
timeFrame: Plasma ferritin is assessed in a subgroup of infants at six months of age
measure: Maternal soluble transferrin receptor
timeFrame: Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
measure: Infant soluble transferrin receptor
timeFrame: Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
measure: Maternal serum concentrations in Vitamin A (retinol)
timeFrame: Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
measure: Infant serum concentrations in Vitamin A (retinol)
timeFrame: Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
measure: Maternal serum concentrations in vitamin B12
timeFrame: Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
measure: Infant serum concentrations in vitamin B12
timeFrame: Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age
Other outcomes:
Locations:
city: Arba Minch
country: Ethiopia
facility: Arba Minch University
state: Dirashe District
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, Md. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Souheila Abbeddou, MSc. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Bruno Levecke, PhD
role: PRINCIPAL_INVESTIGATOR
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