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

NCT03688217 | Completed DMC

• 1 other identifier: 46667
• Study Type: interventional
• Target: 1,504
• Locations: 1 country
• Sites: 1

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.

Conditions

Exclusive Breastfeeding; Infant Feeding Practices

Keywords

exclusive breastfeeding; health education; entertainment-education; low- and middle-income countries; video-based; narrative; community-based

Outcome Measures

Primary Outcomes (2)

• Short-term Exclusive Breastfeeding (24-hour recall)

  Infant, age 1 month, was exclusively breastfed in the past 24 hours, per maternal report

  Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week

• Long-term Exclusive Breastfeeding (24-hour recall)

  Infant, age 5 months, was exclusively breastfed in the past 24 hours, per maternal report

  Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week

Secondary Outcomes (13)

• Short-term Exclusive Breastfeeding (since birth recall)

  Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week

• Long-term Exclusive Breastfeeding (since birth recall)

  Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week

• Early initiation of breastfeeding

  Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week

• Any breastfeeding at 1 month

  Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week

• Any breastfeeding at 5 months

  Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week

Study Arms (2)

Philani Intervention Model+MOVIE (PIM+M)

EXPERIMENTAL

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)

Philani Intervention Model (PIM)

ACTIVE COMPARATOR

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)

Interventions

Philani Intervention Model+MOVIE (PIM+M) BEHAVIORAL

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.

Philani Intervention Model+MOVIE (PIM+M)

Philani Intervention Model (PIM) BEHAVIORAL

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.

Philani Intervention Model (PIM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non-pregnant
• younger than 18 years of age

Sponsors & Collaborators

• Charles G. Prober: lead
• Heidelberg University: collaborator
• University of Stellenbosch: collaborator
• University of Cape Town: collaborator
• Stanford University: collaborator

Study Sites (1)

Philani Maternal Child Health and Nutrition Trust

Khayelitsha, Western Cape, 7784, South Africa

Location

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MeSH Terms

Conditions

Breast Feeding; Health Education; Narration

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Communication

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Founding Executive Director, Stanford Center for Health Education, Senior Associate Vice Provost for Health Education, Co-Senior Author, Professor of Pediatrics Microbiology and Immunology

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 28, 2018
• Study Start: November 5, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)