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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688217
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Heidelberg University
University of Stellenbosch
University of Cape Town
Stanford University
Information provided by (Responsible Party):
Charles G. Prober, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Exclusive Breastfeeding Infant Feeding Practices Behavioral: Philani Intervention Model+MOVIE (PIM+M) Behavioral: Philani Intervention Model (PIM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a cluster-randomized controlled trial with baseline covariate adjustment and stratification.The randomization unit is the mentor-mother. The clusters are pregnant participants enrolled by each mentor-mother over the course of the trial. The randomization will be stratified by neighborhood type, to ensure balance of intervention versus control assignment by this covariate. The following baseline characteristics will be measured and adjusted for in the main analysis of the primary and secondary outcomes to increase statistical efficiency: 1. participant's number of previous children, 2. participant's age, 3. running water in the home, 4. electricity in the home, 5. participant's employment status, 6. participant's education level
Masking: Single (Outcomes Assessor)
Masking Description: Since data will be entered directly into a tablet device by the participant, the outcomes assessor (ie: the tablet) will have no knowledge of the interventions assigned to individual participants. Additionally, the phone survey company performing the follow-up surveys will be blinded to the interventions assigned to individual participants.
Primary Purpose: Prevention
Official Title: The Philani Mobile Video Intervention for Exclusive Breastfeeding (MOVIE) Study: a Cluster-randomized Controlled Trial of a Mobile Video Entertainment-education Intervention to Promote Exclusive Breastfeeding in South Africa
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Philani Intervention Model+MOVIE (PIM+M)
Participants will receive the standard PIM perinatal home visiting program together with the MOVIE intervention (13 entertainment-education videos about infant feeding). The PIM is 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. The MOVIE videos will be integrated into the regular home visiting program.
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.

Active Comparator: Philani Intervention Model (PIM)
Participants will receive the standard PIM perinatal home visiting program, which is 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.
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.




Primary Outcome Measures :
  1. Short-term Exclusive Breastfeeding (24-hour recall) [ Time Frame: Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 1 month, was exclusively breastfed in the past 24 hours, per maternal report

  2. Long-term Exclusive Breastfeeding (24-hour recall) [ Time Frame: Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 5 months, was exclusively breastfed in the past 24 hours, per maternal report


Secondary Outcome Measures :
  1. Short-term Exclusive Breastfeeding (since birth recall) [ Time Frame: Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 1 month, was exclusively breastfed since birth, per maternal report

  2. Long-term Exclusive Breastfeeding (since birth recall) [ Time Frame: Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 5 months, was exclusively breastfed since birth, per maternal report

  3. Early initiation of breastfeeding [ Time Frame: Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant was breastfed within the first hour of life (based on maternal recall)

  4. Any breastfeeding at 1 month [ Time Frame: Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 1 month, received any breastmilk in the past 24 hours, even if not exclusively breastfed

  5. Any breastfeeding at 5 months [ Time Frame: Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 5 months, received any breastmilk in the past 24 hours, even if not exclusively breastfed

  6. Bottle-feeding at 1 month [ Time Frame: Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 1 month, was fed using a bottle with a nipple in the past 24 hours

  7. Bottle-feeding at 5 months [ Time Frame: Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week ]
    Infant, age 5 months, was fed using a bottle with a nipple in the past 24 hours

  8. Early introduction of complementary foods at 1 month (24-hour recall) [ Time Frame: Measured at 1 month post-delivery by phone survey ]
    Infant, age 1 month, received complementary foods in the past 24 hours

  9. Early introduction of complementary foods at 5 months (24-hour recall) [ Time Frame: Measured at 5 months post-delivery by phone survey ]
    Infant, age 5 months, received complementary foods in the past 24 hours

  10. Early introduction of complementary foods at 1 month (since birth recall) [ Time Frame: Measured at 1 month post-delivery by phone survey ]
    Infant, age 1 month, received complementary foods at some point since birth

  11. Early introduction of complementary foods at 5 months (since birth recall) [ Time Frame: Measured at 5 months post-delivery by phone survey ]
    Infant, age 5 months, received complementary foods at some point since birth

  12. Maternal knowledge at 1 month post-delivery [ Time Frame: Measured at 1 month post-delivery by phone survey ]
    Short-term maternal knowledge of breastfeeding current recommendations and basic health principles relevant to infant feeding

  13. Maternal knowledge at 5 months post-delivery [ Time Frame: Measured at 5 months post-delivery by phone survey ]
    Long-term maternal knowledge of breastfeeding current recommendations and basic health principles



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consenting pregnant clients, 20-40 weeks pregnant
  • at least 18 years of age
  • living within the catchment areas of the 84 mentor-mother CHWs taking part in this study
  • enrolled in the Philani Mentor Mother Outreach Program

Exclusion Criteria:

  • non-pregnant
  • younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688217


Locations
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South Africa
Philani Maternal Child Health and Nutrition Trust
Khayelitsha, Western Cape, South Africa, 7784
Sponsors and Collaborators
Charles G. Prober
Heidelberg University
University of Stellenbosch
University of Cape Town
Stanford University
Investigators
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Principal Investigator: Maya Adam, MD Stanford University
Principal Investigator: Till Bärnighausen, MD, ScD Heidelberg University
Principal Investigator: Charles Prober, MD Stanford University
Principal Investigator: Mark Tomlinson, PhD University of Stellenbosch
Principal Investigator: Amnesty E LeFevre, PhD University of Cape Town
Principal Investigator: Shannon McMahon, PhD Heidelberg University
Publications:
Du Plessis L, Peer N, English R, Honikman S. Breastfeeding in South Africa: are we making progress? South African Health Review. 2016;2016(1):109-23.
Slater MD, Rouner D. Entertainment-education and elaboration likelihood: Understanding the processing of narrative persuasion. Communication Theory. 2002;12(2):173-91.
Shen F, Han J. Effectiveness of entertainment education in communicating health information: A systematic review. Asian Journal of Communication. 2014;24(6):605-16.
World Health Organization. mHealth: New horizons for health through mobile technologies: second global survey on eHealth. 2011. Geneva: WHO Google Scholar. 2014.
Diamond L. Liberation technology. In Search of Democracy: Routledge; 2015. p. 148-62.
Kakihara M, editor Grasping a Global View of Smartphone Diffusion: An Analysis from a Global Smartphone Study. ICMB; 2014.
Kreutzer T. Generation mobile: online and digital media usage on mobile phones among low-income urban youth in South Africa. Retrieved on March. 2009;30(2009):903-20.
Seebregts C, Barron P, Tanna G, Benjamin P, Fogwill T. MomConnect: an exemplar implementation of the health normative standards framework in South Africa. South African Health Review. 2016;2016(1):125-35.
Poushter J. Smartphone ownership and internet usage continues to climb in emerging economies. Pew Research Center. 2016;22.
Shambare R. The adoption of WhatsApp: Breaking the vicious cycle of technological poverty in South Africa. Journal of economics and behavioral studies. 2014;6(7):542.
World Health Organization. Indicators for assessing infant and young child feeding practices. Part I: definition. Geneva: 2008.
Use CfMPfH. Guideline on adjustment for baseline covariates. European Medicines Agency; 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Charles G. Prober, Founding Executive Director, Stanford Center for Health Education, Senior Associate Vice Provost for Health Education, Co-Senior Author, Professor of Pediatrics Microbiology and Immunology, Stanford University
ClinicalTrials.gov Identifier: NCT03688217    
Other Study ID Numbers: 46667
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles G. Prober, Stanford University:
exclusive breastfeeding
health education
entertainment-education
low- and middle-income countries
video-based
narrative
community-based