Multi-modal Intervention for Lactation Care (MILC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- Any breastfeeding rate(EBF)
研究概览
简要总结
The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF behaviors in low-income Hispanic women. Formative research conducted for the development of MILC and results from pilot testing will help guide the completion of the development and testing of this prototype that specifically caters to Hispanic women. In the long term, MILC has the potential to increase the rates of EBF and any BF up to 12 months.
详细描述
Breastfeeding (BF) is positively associated with health benefits for infants. It reduces an infant's risks for various conditions such as respiratory tract infections, non-specific gastroenteritis, diarrhea, asthma, and sudden infant death syndrome (SIDS).
Despite high breastfeeding (BF) initiation of approximately 80% among the Hispanic population in the United States (US), less than 25% of infants were exclusively breastfed (EBF) through 6 months, further perpetuating ethnic disparities in chronic diseases such as diabetes, obesity, and hypertension. Hispanic women are more likely to supplement feeding with formula, than non-Hispanic or African American (AA) mothers. Research has reported that barriers such as insufficient BF education, lack of BF technical support (i.e. latching issues, sore nipples), returning to work, easy access to free or discounted formula milk from Women Infants and Children (WIC), lack of social support, perceived inconvenience, cultural belief that both formula and breastmilk (los-dos) is best for the babies, perception that the infant is not satiated, and embarrassment associated with breastfeeding result in premature weaning off BF among low-income Hispanic mothers. Therefore, increasing the duration of EBF and continuous BF among low-income Hispanic women would require an innovative and comprehensive approach that addresses the diverse range of barriers listed above.
The investigators hypothesize that MILC will show significantly higher percentages of BF mothers in the intervention group at each time (1 month, 3 months, and 6 months) point compared with the control group. In the short term, MILC will be shown to be usable and acceptable by Hispanic BF mothers to receive BF support, education, and guidance from primary care providers (PCP) and certified lactation consultants/international board certified lactation consultants (CLC/IBCLC). In the long term, the impact of MILC will increase the rates of EBF for up to 6 months along with increasing rates of any BF up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for focus groups:
- •Mothers who successfully exclusively breastfed for up to 6 months, at least one child OR mothers who attempted EBF but were unsuccessful at breastfeeding, in the past 3 years
- •Self-identify as Hispanic
- •Be WIC-eligible
- •Voluntarily consent
- •Speak English
- •Inclusion Criteria for Randomized Control Trial (RCT):
- •In their late third trimester (approximately 4 weeks from delivery)
- •Can initiate BF immediately
- •Self-identify as Hispanic
- •Be WIC-eligible
- •Voluntarily consent
- •Not have psychiatric hospitalization within the last 3 months
- •Not have current or suicidal thoughts or past attempts
- •Own a smartphone device
- •Speak English
排除标准
- •for focus groups and Randomized Control Trial (RCT):
- •Participants who are under the age of 18 or over 44
- •Women experiencing a fetal demise or infant death
- •Women who report the following conditions also will be excluded:
- •Human immunodeficiency virus (HIV)
- •Taking antiretroviral medication or chemotherapy agents
- •Untreated, active tuberculosis
- •T-Cell lymphotropic virus type I or type II
- •Illicit drug use
- •Receiving radiation therapy
- •Exposed to anthrax
- •Undergone breast surgery
- •Known exposure to environmental toxins
- •Active hepatitis B and C
- •Prescription drug use incompatible with lactation
研究组 & 干预措施
Intervention group: MILC application
Eligible Hispanic participants in their third trimester will be recruited for the study. The intervention group will receive standard WIC services plus the MILC application.
干预措施: MILC application (Behavioral)
Control Group: Usual Care
Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Any breastfeeding rate(EBF)
时间窗: 1 month, 3 months and 6 months
Investigators will assess if participants are continuous breastfeeding through monthly breastfeeding videos uploaded in the system. Investigators will report information on any breastfeeding at 1 month, 3 months and 6 months.
Exclusive breastfeeding
时间窗: 1 month, 3 months and 6 months
Investigators will assess if participants are breastfeeding exclusively (EBF)through monthly self-reported information. Investigators will record information on EBF at 1 month, 3 months and 6 months among women in the intervention arm.
次要结局
- Infant weight (Medical outcomes)(Baseline, 1 month, 3 months and 6 months)
- Emergency department visit (Medical outcomes)(Baseline, 1 month, 3 months and 6 months)
研究者
Tony Ma
Project Director or Principal Investigator
Benten Technologies, Inc.