Exclusive Breastfeeding Clinical Trial
— MOVIEOfficial 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
NCT number | NCT03688217 |
Other study ID # | 46667 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 5, 2018 |
Est. completion date | March 31, 2020 |
Verified date | October 2020 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1504 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Philani Maternal Child Health and Nutrition Trust | Khayelitsha | Western Cape |
Lead Sponsor | Collaborator |
---|---|
Charles G. Prober | Heidelberg University, Stanford University, University of Cape Town, University of Stellenbosch |
South Africa,
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* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Short-term Exclusive Breastfeeding (since birth recall) | Infant, age 1 month, was exclusively breastfed since birth, per maternal report | Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Long-term Exclusive Breastfeeding (since birth recall) | Infant, age 5 months, was exclusively breastfed since birth, per maternal report | Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Early initiation of breastfeeding | Infant was breastfed within the first hour of life (based on maternal recall) | Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Any breastfeeding at 1 month | Infant, age 1 month, received any breastmilk in the past 24 hours, even if not exclusively breastfed | Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Any breastfeeding at 5 months | Infant, age 5 months, received any breastmilk in the past 24 hours, even if not exclusively breastfed | Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Bottle-feeding at 1 month | Infant, age 1 month, was fed using a bottle with a nipple in the past 24 hours | Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Bottle-feeding at 5 months | Infant, age 5 months, was fed using a bottle with a nipple in the past 24 hours | Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week | |
Secondary | Early introduction of complementary foods at 1 month (24-hour recall) | Infant, age 1 month, received complementary foods in the past 24 hours | Measured at 1 month post-delivery by phone survey | |
Secondary | Early introduction of complementary foods at 5 months (24-hour recall) | Infant, age 5 months, received complementary foods in the past 24 hours | Measured at 5 months post-delivery by phone survey | |
Secondary | Early introduction of complementary foods at 1 month (since birth recall) | Infant, age 1 month, received complementary foods at some point since birth | Measured at 1 month post-delivery by phone survey | |
Secondary | Early introduction of complementary foods at 5 months (since birth recall) | Infant, age 5 months, received complementary foods at some point since birth | Measured at 5 months post-delivery by phone survey | |
Secondary | Maternal knowledge at 1 month post-delivery | Short-term maternal knowledge of breastfeeding current recommendations and basic health principles relevant to infant feeding | Measured at 1 month post-delivery by phone survey | |
Secondary | Maternal knowledge at 5 months post-delivery | Long-term maternal knowledge of breastfeeding current recommendations and basic health principles | Measured at 5 months post-delivery by phone survey |
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