Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
研究概览
简要总结
The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.
详细描述
The proposed study will test if a mobile device based intervention program, called "Happy, Healthy, Loved (HHL)", will impact breast feeding rates and breastfeeding self-efficacy when compared to care as usual. Primiparous women and their partners will be randomly assigned to the HHL program or usual care.
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
- Single (Participant)
盲法说明
Study staff will randomize patients to the intervention or control arm and not inform subjects of their randomization assignment. Intervention group participants will receive text messages that provide resources and encouragement related to breast-feeding. Control group participants will receive text messages with non-breast-feeding related content.
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
- •primiparous mothers,
- •living with a partner or spouse,
- •have an intention to breastfeed their infant for at least 6-weeks postpartum;
- •whose infant is not in the Neonatal Intensive Care Unit,
- •have a mobile phone with text message capability,
- •have no current self-reported depressive episode, and;
- •English as a primary language
排除标准
- •mothers who have other biological children,
- •have infants in the Neonatal Intensive Care Unit,
- •do not have a mobile phone with text message capabilities,
- •report current episodes of depression, or are receiving antidepressant treatment or psychotherapy for depression,
- •have initial study survey that indicates suicide risks (participants who are identified as suicidal ideation at 6 weeks or 6 months will receive further assessment and referral but not be excluded from the program because it may be more harmful and penalizing to remove them from the program if they find it helpful. We will remind the participant that continuing is voluntary and there is no penalty if they wish to discontinue participation)
- •do not speak, read and write English
结局指标
主要结局
Breastfeeding Self-Efficacy: Breastfeeding self-efficacy scale short form
时间窗: 6 months postpartum
Breastfeeding self-efficacy scale short form (McCarter-Spaulding \& Dennis, 2010)- The Breastfeeding self-efficacy scale short form (BSES-SF) will be used to measure breastfeeding self-efficacy. The scores for this scale range from 1-5, with higher scores indicating greater self-efficacy related to breastfeeding.
Breastfeeding Rate
时间窗: 6 months postpartum
Index of breastfeeding status - Women will be asked to identify the level that accurately described their breastfeeding behaviors within the previous 24 hours. Four levels will be reported: exclusive breastfeeding (breast milk only), partial breastfeeding (breast milk and at least 1 bottle of formula per day), token breastfeeding (breast given to comfort baby not for nutrition), and no breastfeeding. Higher values represent more exclusive breastfeeding.
次要结局
- Hair Cortisol(0-2 days postpartum)
- Mood(6 months postpartum)
- Postnatal Depression(6 months postpartum)
- Coping Behavior(6 months postpartum)
- Postpartum Partner Support(6 months postpartum)
- Partner Support(6 months postpartum)
- Sleep Quality (hair cortisol covariate): Pittsburgh Sleep Quality Index (PSQI)(0-2 days postpartum)
- Depression, Anxiety, Stress(6 months postpartum)