Effectiveness of Web-based Educational Intervention on Breastfeeding Self-efficacy and Breastfeeding Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Maternal breastfeeding self and paternal breastfeeding self-efficacy
研究概览
简要总结
Background: Maternal and paternal breastfeeding self-efficacy is an important factor and could be modified in improving breastfeeding outcomes. Conducting breastfeeding educational intervention that involves the husband as well as incorporating a web-based platform based on breastfeeding self-efficacy theory is needs to be explored.
Objectives: The aim to investigate the effectiveness of the web-based educational intervention on breastfeeding self-efficacy and breastfeeding outcomes.
Methods: A randomized control trial will be conducted to investigate the effectiveness of the web-based educational intervention on breastfeeding self-efficacy and breastfeeding outcomes. 80 mothers and fathers from primary health care and public hospital in Jakarta will be recruited in this study and will randomly allocate using block randomization. The participants in the intervention group will receive standard usual care and web-based educational intervention, while the control group will receive usual care. The outcomes of this study are breastfeeding self-efficacy, depression, anxiety, infant feeding attitude, as well as breastfeeding outcomes that will be measured at baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months. A generalized Linear Model will be used to test the effect of the intervention for the group, time as well as group and time interaction.
Anticipatory result:The educational intervention will be effective in helping mothers and fathers receiving interventions to have higher breastfeeding self-efficacy, lower levels of depression and anxiety, higher breastfeeding attitude as well as exclusive breastfeeding rate compared to mothers and fathers in the control group.
Keywords: Breastfeeding self-efficacy, breastfeeding, web-based, reliability, validity, Indonesia.
详细描述
Study Design A randomized controlled trial design, two-arm, with a 1:1 allocation ratio, will be conducted. The participants will be allocated in the intervention group or control group using block randomization with a block size of 4. The statistician, who will not join in the recruitment process, will generate the sequence of random allocation. To maintain the allocation concealment, we will use opaque sealed envelopes that contain the sequence numbers. Due to the nature of the study, it is difficult to blind the participants. Only the data collector will be blinded to the participant's group assignment.
Participants and setting The mother and her spouse will be invited to participate in this study during the prenatal period from a public hospital and health care center in Jakarta. The inclusion criteria of mothers are: (a) primiparous and singleton pregnancy at 12-34 weeks' gestation, (b) age ≥ 20 years, (c) tend to breastfeed the infant, (d) the husband willing to participate in the educational program, (e) capable to use a cell phone, (f) can access the internet, (g) fluent in reading and writing Bahasa. We will not include the mothers and their partners in the study if they have no time to join in the online educational intervention. Mothers will be excluded if they have conditions as follows: (a) presence of congenital anomaly for the baby, (b) chronic disease or high-risk complications during pregnancy and after delivery. To recruit suitable participants, we will approach the eligible mothers and fathers using online recruitment via whatsapp from the patient list during antenatal check-up and flyer at the hospital and health center. All participants will be provided online informed consent.
Sample size calculation The sample size will be estimated based on a previous study of breastfeeding self-efficacy intervention (Ansari, Abedi, Hasanpoor, & Bani, 2014). A two-sided two-sample unequal variance t-test is needed (Julious, 2004) to detect a medium effect size in self-efficacy between intervention and control group (Ansari, Abedi, Hasanpoor, & Bani, 2014) using 80% power at a 5% significance level (alpha). Considering the drop-outs rate and pandemic situation in Indonesia, we will recruit 160 pairs of participants (200 pairs of mothers and fathers for each group) in this study.
Intervention The intervention program will be pilot tested before the formal study. The content validity of the intervention will be conducted by the breastfeeding expert panel including one obstetric specialist, two lactation consultants, one educator and one pediatrician (Appendix 7). The participants in the intervention group will receive standard usual care in primary health care and the web-based educational intervention. The development of the educational intervention is based on the Breastfeeding Self-Efficacy Theory (BSE) (Dennis, 1999) The strategies will be developed from the four sources of breastfeeding self-efficacy framework (Dennis, 1999) including (a) performance accomplishment (past breastfeeding experience); (b) vicarious experience for example observation of others individual performance, whether live, recorded, or printed) (Dennis, 1999; Kingston et.al., 2007); (c) verbal persuasion (i.e. encouragement from a lactation consultant); (d) physiological and emotional arousal (i.e. reducing negative interpretation like pain, fatigue, anxiety or stress). The educational program will be consisted of six sessions which cover 4 elements of breastfeeding self-efficacy theory.
To support the educational program, the researchers will discuss with the expert of information system to prepare the website. The website will be created by using hosting and domain services. Each session of education program will be delivered by written information and video. Additionally, massage board for each session will be provided to allow mothers to ask the question regarding the topic. The website will be designed to be compatible with mobile phone, computer, and also tablets. After the expert approve the applicability of the website, the pilot study will be conducted with 10 mothers and fathers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to participants allocation.
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primiparous with singleton pregnancy at 12-34 weeks' gestation
- •Age ≥ 20 years
- •Plan to breastfeed the infant
- •The husband willing to participate in the educational program
- •Capable to use a cell phone
- •Can access the internet .Fluent in reading and writing Bahasa.
排除标准
- •.Presence of congenital anomaly for the baby .Chronic disease or high-risk complications during pregnancy and after delivery.
研究组 & 干预措施
web-based educational program
Consist of 6 education session during 1 month and will be followed up by telephone counselling at 2, 4, and 6 weeks postpartum.
干预措施: Web-based educational program (Other)
control (usual care)
Mothers in the control group will receive standard treatment with pamphlets during the prenatal period. After delivery, standard postpartum care will be provided by the midwife, including pamphlets, rooming in and encourage mothers to breastfeed the baby.
结局指标
主要结局
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: 6 months after delivery
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: baseline
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: 38 weeks of pregnancy
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: 1 week after delivery
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: 1 months after delivery
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
Maternal breastfeeding self and paternal breastfeeding self-efficacy
时间窗: 3 months after delivery
confidence of a mother in her ability to feed the baby and fathers confident in assisting breastfeeding mother that will be measured using BSES-SF. This questionnaire consist of 14 items.
次要结局
- Breastfeeding rate(1 week, 1, 3, and 6 months of infant age)
- Anxiety(baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery)
- Iowa Infant Feeding Attitude Scale (IIFAS)(baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery)
- Depression(baseline, 38 weeks of pregnancy, 1 week, 1, 3, and 6 months after delivery)
研究者
Shu Yu Kuo
Principal investigator
Taipei Medical University
