The Philani Mobile Video Intervention for Exclusive Breastfeeding (MOVIE) Study

NCT03688217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2020-10-22

No results posted yet for this study

Summary

This cluster-randomized controlled trial seeks to evaluate the impact of a mobile video intervention for exclusive breastfeeding (MOVIE) on the infant feeding practices of mothers living in under-resourced communities in the Western Cape, South Africa. The trial will compare infant feeding practices in two groups of participants, enrolled in the Philani Mentor-Mother Outreach Program, a home-visiting program focused on community-based health promotion through peer-to-peer counseling. The participants in the intervention arm will receive the Philani Intervention Model (PIM), a perinatal health promotion intervention, together with the additional mobile, video intervention for exclusive breastfeeding. The participants in the control arm will receive only the standard PIM. Participants will be exposed to either the intervention or the control condition during pregnancy and the first five months after delivery. The central hypothesis in this trial is that, when compared with the control group, infant feeding practices in the intervention group will be significantly better aligned with current World Health Organization recommendations, after exposure to the Philani MOVIE intervention. The primary outcomes in this study are short-term exclusive breastfeeding, in the first month of life, and long-term exclusive breastfeeding, in the fifth month of life, (based on maternal 24-hour recall). Secondary outcomes include other infant feeding practices, such as early initiation of breastfeeding, any breastfeeding in the first month and in the fifth month of life, bottle-feeding, early introduction of complementary foods in the first month and in the fifth month of life and maternal knowledge in the first month and the fifth month post delivery.

Conditions

  • Exclusive Breastfeeding
  • Infant Feeding Practices

Interventions

BEHAVIORAL

Philani Intervention Model+MOVIE (PIM+M)

The PIM+M intervention will involve the integration of the mobile video intervention into the standard perinatal counseling program offered by the intervention mentor-mothers. MOVIE intervention videos are narrated in English and isiXhosa, the languages spoken most widely among the study participants. Teaching videos are short (2-5 min.) and use simple language, avoiding medical jargon. The modularity of the videos facilitates delivery in any order and thus, they can be deployed at the discretion of each skilled mentor-mother, such that the health messages delivered are aligned with the individual needs of each participant at each perinatal stage. All videos will be administered at least once to each participant in the intervention group during the study period.

BEHAVIORAL

Philani Intervention Model (PIM)

The Philani Intervention Model (PIM) describes a structured program of antenatal and postnatal home-visits covering foundational health promotion topics including nutrition in pregnancy, infant feeding, newborn care and maternal mental health among others.

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER
  • University of Stellenbosch

    collaborator OTHER
  • University of Cape Town

    collaborator OTHER
  • Stanford University

    collaborator OTHER
  • Charles G. Prober

    lead OTHER

Principal Investigators

  • Maya Adam, MD · Stanford University

  • Till Bärnighausen, MD, ScD · Heidelberg University

  • Charles Prober, MD · Stanford University

  • Mark Tomlinson, PhD · University of Stellenbosch

  • Amnesty E LeFevre, PhD · University of Cape Town

  • Shannon McMahon, PhD · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • South Africa

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688217 on ClinicalTrials.gov