Breastfeeding Education Support Tool for Baby: BEST4BABY Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,152
- 试验地点
- 3
- 主要终点
- Aim 1
研究概览
简要总结
Optimal infant feeding practices play a critical role in determining the nutritional status, health, growth, and development of children. Exclusive breastfeeding (EBF), defined as breast milk as an infant’s only intake, is a global child health survival strategy for infancy and early childhood. Despite the significant positive results of this natural intervention, a large portion of the world’s infants, including those in India, lack the benefits of EBF and other optimal breastfeeding practices. In India, nearly half of women do not follow the World Health Organization (WHO) recommendation of EBF for 6 months. Given that inappropriate feeding practices may have considerable adverse implications for infant growth, development, morbidity and mortality, efforts to increase EBF and other optimal infant feeding practices in India are needed.
Globally, interventions for EBF promotion have been implemented using different approaches. Peer counselor and mobile health (mHealth) programs are promising strategies to improve maternal infant feeding behaviors in low-income and middle-income countries (LMICs). There is insufficient evidence, however, that mHealth-supported peer counseling breastfeeding interventions significantly improve such behaviors of mothers in India, a country with the largest number of deliveries worldwide. Moreover, the impact of such interventions on infant clinical outcomes, including infant growth and development, remains unknown.
The long-term objectives of the BEST4BABY Study are to improve the infant feeding practices of mothers in India, and thus the health of mothers and infants and growth and development of infants. Widespread implementation of an effective infant feeding intervention has a great potential benefit to individual patients as well as the medical care system. Results of this study will have implications for future adoption and implementation of BEST4Baby nationally and in other low resources settings, and will be relevant, not only to the mothers in India, but to mothers in other LMICs, and the practitioners, policymakers, and healthcare systems that serve this population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •At least 18 years of age 2) Pregnant and having reached 20-27 weeks of gestation at study enrollment 3) Singleton pregnancy with no major antepartum complications 4) Living in a research area site 5) Planning to deliver in the cluster area 6) Capable of giving informed consent 7) Willing to be visited by peer counselors and research personnel for up to 12 months post-delivery.
排除标准
- •Comorbidities impacting breastfeeding 2) Severe psychological illness that could interfere with consent and study participation.
结局指标
主要结局
Aim 1
时间窗: 6 months after delivery, 12 months after delivery
EBF at 6 months: proportion of infants exclusively breastfed at 6 months, as measured with the infant feeding behavior questionnaire. EBF will be defined as receiving breast milk as the only source of nourishment for the first 6 month of life, except for oral rehydration solution, vitamins, medicines)
时间窗: 6 months after delivery, 12 months after delivery
Aim 2
时间窗: 6 months after delivery, 12 months after delivery
Infant growth velocity: mean change in length from birth to 6 months, and birth to 12 month. Length at the 3 day and the 6 month and 12 month study visits will be used
时间窗: 6 months after delivery, 12 months after delivery
Infant cognitive development: mean BSID-IV cognitive domain scores at 12 months.
时间窗: 6 months after delivery, 12 months after delivery
次要结局
- Infant feeding behaviors: measured with infant feeding behavior questionnaire
- Maternal infant feeding knowledge, attitudes, and self-efficacy: mean scores on infant feeding knowledge items, the IIFAS, and the BSES-SF at baseline, 6 and 12 months; mean changes in scores from baseline to 6 and 12 months.(3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery)
- Infant health: measured with infant morbidity questionnaire(3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery)
- Infant weight: mean change in weight from birth to 6 months, and birth to 12 months. Weight at 3 day, 6 month, and 12 month study visits will be used.(3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery)
- Infant language, motor, social-emotional and adaptive skill development: mean BSID-IV language, motor, social-emotional and adaptive skill domain scores at 12 months.(12 months after delivery)
研究者
Dr Niranjana S Mahantashetti
Jawaharlal Nehru Medical College