NCT04414527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
675

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

April 21, 2020

Last Update Submit

December 3, 2021

Conditions

Keywords

Video-based behavior change communicationIron and folic acid supplementationAntenatal careSoil transmitted helminthsBacterial vaginosesExclusive breastfeeding

Outcome Measures

Primary Outcomes (8)

  • Adherence to iron and folic acid supplementation during pregnancy

    Monthly disappearance rate of IFA tablets

    Monthly during six months pregnancy

  • Adherence to iron and folic acid supplementation post-partum

    Monthly disappearance rate of IFA tablets

    Monthly during three months postpartum

  • Maternal anemia during pregnancy

    Hemoglobin concentrations (g/dL)

    Hemoglobin concentrations will be measured at 9 months pregnancy

  • Maternal anemia post-partum

    Hemoglobin concentrations (g/dL)

    Hemoglobin concentrations will be measured at six months postpartum

  • Early initiation

    Prevalence of newborns put to the breast in the first hour after birth

    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)

    Birth to six months postpartum

  • Dietary intake during six months pregnancy

    Prevalence of women with adequate dietary intake during six months pregnancy

    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

    Assessed at six months postpartum

Secondary Outcomes (16)

  • Gestational weight gain

    Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy

  • Maternal genital infections

    Maternal genital infections will be assessed at nine months pregnancy

  • Birth weight

    Birth weight will be assessed in all newborns

  • Infant weight

    Weight of infants will be assessed monthly from birth until six months of age

  • Infant length

    Length of infants will be assessed monthly from birth until six months of age

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Health-Video

Interventions

The 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.

Also known as: Control
Standard counseling
Health-VideoBEHAVIORAL

The 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.

Also known as: Video-based counselling
Health-Video

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arba Minch University

Arba Minch, Dirashe District, Ethiopia

Location

Related Publications (12)

  • Lassi ZS, Salam RA, Haider BA, Bhutta ZA. Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD006896. doi: 10.1002/14651858.CD006896.pub2.

    PMID: 23543547BACKGROUND
  • Rasmussen KM, Stoltzfus RJ. New evidence that iron supplementation during pregnancy improves birth weight: new scientific questions. Am J Clin Nutr. 2003 Oct;78(4):673-4. doi: 10.1093/ajcn/78.4.673. No abstract available.

    PMID: 14522723BACKGROUND
  • Brooker S, Bethony J, Hotez PJ. Human hookworm infection in the 21st century. Adv Parasitol. 2004;58:197-288. doi: 10.1016/S0065-308X(04)58004-1.

    PMID: 15603764BACKGROUND
  • Prociv P, Luke RA. Evidence for larval hypobiosis in Australian strains of Ancylostoma duodenale. Trans R Soc Trop Med Hyg. 1995 Jul-Aug;89(4):379. doi: 10.1016/0035-9203(95)90016-0. No abstract available.

    PMID: 7570868BACKGROUND
  • Asundep NN, Jolly PE, Carson AP, Turpin CA, Zhang K, Wilson NO, Stiles JK, Tameru B. Effect of Malaria and Geohelminth Infection on Birth Outcomes in Kumasi, Ghana. Int J Trop Dis Health. 2014;4(5):582-594. doi: 10.9734/IJTDH/2014/7573.

    PMID: 25414840BACKGROUND
  • Kavle JA, Landry M. Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. Matern Child Nutr. 2018 Jan;14(1):e12508. doi: 10.1111/mcn.12508. Epub 2017 Aug 24.

    PMID: 28836343BACKGROUND
  • Verstraelen H, Delanghe J, Roelens K, Blot S, Claeys G, Temmerman M. Subclinical iron deficiency is a strong predictor of bacterial vaginosis in early pregnancy. BMC Infect Dis. 2005 Jul 6;5:55. doi: 10.1186/1471-2334-5-55.

    PMID: 16000177BACKGROUND
  • Tuddenham S, Ghanem KG, Caulfield LE, Rovner AJ, Robinson C, Shivakoti R, Miller R, Burke A, Murphy C, Ravel J, Brotman RM. Associations between dietary micronutrient intake and molecular-Bacterial Vaginosis. Reprod Health. 2019 Oct 22;16(1):151. doi: 10.1186/s12978-019-0814-6.

    PMID: 31640725BACKGROUND
  • Ashorn P, Hallamaa L, Allen LH, Ashorn U, Chandrasiri U, Deitchler M, Doyle R, Harjunmaa U, Jorgensen JM, Kamiza S, Klein N, Maleta K, Nkhoma M, Oaks BM, Poelman B, Rogerson SJ, Stewart CP, Zeilani M, Dewey KG. Co-causation of reduced newborn size by maternal undernutrition, infections, and inflammation. Matern Child Nutr. 2018 Jul;14(3):e12585. doi: 10.1111/mcn.12585. Epub 2018 Jan 8.

    PMID: 29316198BACKGROUND
  • Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.

  • Boynito 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.

  • Godana 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.

Related Links

MeSH Terms

Conditions

AnemiaTrematode InfectionsVaginosis, BacterialBreast Feeding

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesHelminthiasisParasitic DiseasesInfectionsBacterial InfectionsBacterial Infections and MycosesVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Stefaan De Henauw, Md. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Souheila Abbeddou, MSc. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Bruno Levecke, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

June 4, 2020

Study Start

March 13, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

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

Locations