Randomized Controlled Trial

. 2019 Apr 2;19(1):211.

doi: 10.1186/s12913-019-4000-x.

The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa

Maya Adam^{1

2

3}, Mark Tomlinson⁴, Ingrid Le Roux⁵, Amnesty E LeFevre^{6

7}, Shannon A McMahon^{6

8}, Jamie Johnston⁹, Angela Kirton^{10

11}, Nokwanele Mbewu⁵, Stacy-Leigh Strydom⁵, Charles Prober^{12

10

11}, Till Bärnighausen^{8

13

14}

Affiliations

¹ The Department of Pediatrics, Stanford University, Stanford, CA, USA. madam@stanford.edu.
² Stanford University's Digital Medical Education International Collaborative (Digital MEdIC), Cape Town, South Africa. madam@stanford.edu.
³ Stanford Center for Health Education, Stanford, CA, USA. madam@stanford.edu.
⁴ Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Stellenbosch, South Africa.
⁵ Philani Maternal Child Health and Nutrition Trust, Cape Town, South Africa.
⁶ Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.
⁷ Division of Epidemiology and Biostatistics, University of Cape Town School of Public Health, Cape Town, South Africa.
⁸ Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.
⁹ Stanford University, Stanford, CA, USA.
¹⁰ Stanford University's Digital Medical Education International Collaborative (Digital MEdIC), Cape Town, South Africa.
¹¹ Stanford Center for Health Education, Stanford, CA, USA.
¹² The Department of Pediatrics, Stanford University, Stanford, CA, USA.
¹³ Department of Global Health and Population, Harvard T.H Chan School of Public Health, Boston, USA.
¹⁴ Africa Health Research Institute (AHRI), Somkhele, KwaZulu-Natal, South Africa.

PMID: 30940132
PMCID: PMC6444854
DOI: 10.1186/s12913-019-4000-x

Randomized Controlled Trial

The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa

Maya Adam et al. BMC Health Serv Res. 2019.

. 2019 Apr 2;19(1):211.

doi: 10.1186/s12913-019-4000-x.

Authors

Affiliations

¹ The Department of Pediatrics, Stanford University, Stanford, CA, USA. madam@stanford.edu.
² Stanford University's Digital Medical Education International Collaborative (Digital MEdIC), Cape Town, South Africa. madam@stanford.edu.
³ Stanford Center for Health Education, Stanford, CA, USA. madam@stanford.edu.
⁴ Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Stellenbosch, South Africa.
⁵ Philani Maternal Child Health and Nutrition Trust, Cape Town, South Africa.
⁶ Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.
⁷ Division of Epidemiology and Biostatistics, University of Cape Town School of Public Health, Cape Town, South Africa.
⁸ Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany.
⁹ Stanford University, Stanford, CA, USA.
¹⁰ Stanford University's Digital Medical Education International Collaborative (Digital MEdIC), Cape Town, South Africa.
¹¹ Stanford Center for Health Education, Stanford, CA, USA.
¹² The Department of Pediatrics, Stanford University, Stanford, CA, USA.
¹³ Department of Global Health and Population, Harvard T.H Chan School of Public Health, Boston, USA.
¹⁴ Africa Health Research Institute (AHRI), Somkhele, KwaZulu-Natal, South Africa.

PMID: 30940132
PMCID: PMC6444854
DOI: 10.1186/s12913-019-4000-x

Abstract

Background: In South Africa, rates of exclusive breastfeeding remain low and breastfeeding promotion is a national health priority. Mobile health and narrative entertainment-education are recognized strategies for health promotion. In-home counseling by community health workers (CHWs) is a proven breastfeeding promotion strategy. This protocol outlines a cluster-randomized controlled trial with a nested mixed-methods evaluation of the MObile Video Intervention for Exclusive breastfeeding (MOVIE) program. The evaluation will quantify the causal effect of the MOVIE program and generate a detailed understanding of the context in which the intervention took place and the mechanisms through which it enacted change. Findings from the study will inform the anticipated scale-up of mobile video health interventions in South Africa and the wider sub-Saharan region.

Methods: We will conduct a stratified cluster-randomized controlled trial in urban communities of the Western Cape, to measure the effect of the MOVIE intervention on exclusive breastfeeding and other infant feeding practices. Eighty-four mentor-mothers (CHWs employed by the Philani Maternal Child Health and Nutrition Trust) will be randomized 1:1 into intervention and control arms, stratified by neighborhood type. Mentor-mothers in the control arm will provide standard of care (SoC) perinatal in-home counseling. Mentor-mothers in the intervention arm will provide SoC plus the MOVIE intervention. At least 1008 pregnant participants will be enrolled in the study and mother-child pairs will be followed until 5 months post-delivery. The primary outcomes of the study are exclusive breastfeeding at 1 and 5 months of age. Secondary outcomes are other infant feeding practices and maternal knowledge. In order to capture human-centered underpinnings of the intervention, we will conduct interviews with stakeholders engaged in the intervention design. To contextualize quantitative findings and understand the mechanisms through which the intervention enacted change, end-line focus groups with mentor-mothers will be conducted.

Discussion: This trial will be among the first to explore a video-based, entertainment-education intervention delivered by CHWs and created using a community-based, human-centered design approach. As such, it could inform health policy, with regards to both the routine adoption of this intervention and, more broadly, the development of other entertainment-education interventions for health promotion in under-resourced settings.

Trial registration: The study and its outcomes were registered at clinicaltrials.gov ( #NCT03688217 ) on September 27th, 2018.

Keywords: Breastfeeding; Community health worker; Community-based; Entertainment-education; Human-centered design; Maternal child health behavior; Mobile health; Narrative; South Africa; Video.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been granted by the Stanford University IRB (Protocol #46667) and the University of Stellenbosch IRB (Project ID #6318 HREC/UREC Reference #: N18/02/013), both recognized Ethical Review Committees. The investigators will consistently respect the principles of ethical research on human subjects, including respect for persons, beneficence and justice. Informed consent will be obtained in writing from all eligible participants before data collection begins and after the participants have been fully informed about the study.

Consent for publication

Not applicable. (This manuscript contains no identifiable data.)

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Regions of Operation of the Philani Maternal Child Health and Nutrition Trust, Western Cape, South Africa. (Illustrations by Shân Fischer. Map data© 2018 Google and© 2018 AfriGIS (Pty) Ltd.)

**Fig. 2**
Trial Design for the Philani MObile Video Intervention for Exclusive breastfeeding (MOVIE) Study

**Fig. 3**
Intersection of the Elaboration Likelihood Model (ELM) and the extended ELM (eELM) theoretical models with desired long-term health outcomes

See this image and copyright information in PMC

References

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The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa

Affiliations

The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

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