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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,504
- 试验地点
- 2
- 主要终点
- Short-term Exclusive Breastfeeding (24-hour recall)
研究概览
简要总结
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.
详细描述
Background
The health benefits of exclusive breastfeeding (EBF), especially in low- and middle-income countries (LMIC), have been well documented. These include protection against infectious diseases, improved measures of intelligence and decreased risk of becoming overweight and developing diabetes. Globally, EBF could save the lives of an estimated 823 000 children under the age of five each year. Yet, despite World Health Organization recommendations that children should be exclusively breastfed for the first six months of life, EBF rates hover at only 37% in LMIC.
South Africa has one of the lowest rates of EBF in the world. Estimates of EBF rates under six months in South Africa range from 8% to the most generous estimate, 32% reported in the South Africa Demographic and Health Survey 2016. The health problems that result are largely due to unsafe formula feeding and the widespread practice of introducing solid foods early (often before three months) into the infant's diet. In South Africa, more than 70% of infants are given solid foods before reaching six months, the recommended age for initiating complementary feeding. Unsafe formula feeding and early introduction of solid foods can lead to diarrheal disease from pathogens entering the gut, as well as nutrient deficiencies when the foods introduced displace breastmilk without providing adequate nutrient density. The limited availability of reliable national data on infant feeding in South Africa complicates the design and evaluation of infant feeding interventions. However, systematic reviews of the literature suggest that large-scale interventions focused on educating mothers can increase the prevalence of EBF and decrease infant mortality.
Narrative, entertainment-education (E-E) approaches to health education have emerged as potentially powerful strategies for promoting positive health behavior change. E-E involves the delivery of health messages by embedding them in an entertainment media framework. A substantial body of research suggests that E-E is an effective way of influencing beliefs, attitudes and behaviors. The characteristics of particularly impactful E-E media include: a) appealing narratives, b) high-quality production, c) persuasive messages that are unobtrusive and d) high potential for involvement or identification with the presenters or characters portrayed. While E-E can take many forms, a video-based approach readily supports the optimized integration of these characteristics.
Video-based content, optimized for mobile devices, may also facilitate broad dissemination of health education, especially as the global penetration of mobile technology increases. Recent advances in mobile health (mHealth) messaging have already begun to facilitate the delivery of health messages at scale and researchers are increasingly recognizing the potential for mobile phones and tablets to play an important role in health education interventions in LMIC. South Africa is an example of a LMIC at the forefront of mHealth initiatives, due to its rapidly expanding penetration of mobile phones. National, maternal-child mHealth initiatives built around free, text-based messaging have attracted global attention and been well received. General "tech-savviness" in South Africa continues to grow, with 37% of adults reporting "smartphone" ownership and 42% reporting daily internet usage in 2016. Active experimentation with "WhatsApp", a widely used mobile communication tool that supports the transfer of videos, is also underway in many sectors, including health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •non-pregnant
- •younger than 18 years of age
结局指标
主要结局
Short-term Exclusive Breastfeeding (24-hour recall)
时间窗: 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
Long-term Exclusive Breastfeeding (24-hour recall)
时间窗: 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
次要结局
- Early introduction of complementary foods at 5 months (since birth recall)(Measured at 5 months post-delivery by phone survey)
- 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)
- Any breastfeeding at 5 months(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)
- Bottle-feeding at 1 month(Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week)
- Early introduction of complementary foods at 5 months (24-hour recall)(Measured at 5 months post-delivery by phone survey)
- Any breastfeeding at 1 month(Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week)
- Bottle-feeding at 5 months(Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
- Early introduction of complementary foods at 1 month (24-hour recall)(Measured at 1 month post-delivery by phone survey)
- Early introduction of complementary foods at 1 month (since birth recall)(Measured at 1 month post-delivery by phone survey)
- Maternal knowledge at 1 month post-delivery(Measured at 1 month post-delivery by phone survey)
- Maternal knowledge at 5 months post-delivery(Measured at 5 months post-delivery by phone survey)
研究者
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
