Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health and Survival Outcomes, a Group Sequential Randomised Standard of Care Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Number of participants who are exclusively breastfeeding
研究概览
简要总结
Background
Lack of breastfeeding, at a minimum, doubles the risk of infant death in the first six months of life. Many infants in low resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, 8% in infants under 6 months of age. Mobile phone text messaging as a simple, low-cost intervention improves medication adherence among patients with HIV, diabetes and tuberculosis. Motivational interviewing has been beneficial across many health problems, including HIV viral load suppression, body weight loss, and alcohol and tobacco use. Combining a number of intervention approaches is more likely to influence behaviour change than an individual approach. Investigators assume that continued breastfeeding is sustained among women living with HIV receiving weekly text messages combined with motivational interviewing and that this contributes to improved infant health outcomes.
Objectives:
- To determine the effects of mobile phone text messaging combined with motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age.
- To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all -cause hospitalization) and death (all -causes, (b) Infant growth.
Methods
Investigators propose a group sequential clinical trial to determine whether text messaging combined with motivational interviewing will prolong breastfeeding and the contribution of the combined intervention on improved infant health outcomes. The study will recruit 275 women living with HIV and HIV exposed infants at birth and randomly assign study interventions for 6 months.
详细描述
Background
In 2010, following changes to global HIV and infant feeding guidelines, the South African vertical transmission prevention program stopped provision of formula milk and adopted breastfeeding as the recommended infant feeding modality. However, in reality, there are short-falls in attaining optimal infant feeding practices, which are contributing to failure to achieving the Sustainable Development under-five child health targets in South Africa. It is essential for the well-being of women living with HIV and their infants to establish models for supporting optimal infant feeding practices to achieve the desired child health outcomes.
Despite several proven interventions to improve breastfeeding practices, in practice there is lack of progress in implementing these interventions to achieve optimal breastfeeding practices. Telephonic support and motivational interviewing have been beneficial across many health problems, including medication adherence among people living with HIV and to reduce alcohol and tobacco use. Investigators propose to combine telephonic support with motivational interviewing to support infant feeding among women living with HIV. Combining these two interventions has great potential; it is likely to be cost-effective, simple to implement and easily integrated within the established infant feeding counselling conventional models.
Objectives
- To determine the effects of mobile phone text messaging plus motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age.
- To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all -cause hospitalization) and all -cause death, (b) Infant growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Women living with HIV and HIV exposed infants
- •initiating breastfeeding soon after delivery
- •18 years and older
- •ownership of a mobile phone
- •infant judged to be in good health who are discharged soon after delivery
排除标准
- •initiating formula feeding soon after delivery
- •multiple birth deliveries
- •birthweight <2500
- •gestational age <36 weeks
结局指标
主要结局
Number of participants who are exclusively breastfeeding
时间窗: from birth to 6 month of child age
Number of participants who report giving only breast milk and no other liquid or solid based foods to infants as assessed by the infant feeding questionnaire
Number of participants who are practicing any form of breastfeeding
时间窗: from birth to 6 months of child age
Number of participants who report giving breast milk and other liquid or solid based foods to infants as assessed by the infant feeding questionnaire
次要结局
- Infant weight in kilograms(from birth to 6 months of child age)
- Infant length in centimetres(from birth to 6 months of child age)
- Infant morbidity(from birth to 6 months of child age)
研究者
Moleen Zunza
Dr
University of Stellenbosch