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临床试验/NCT04816383
NCT04816383已完成不适用

A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy: A Randomized Controlled Clinical Trial

Augusta University2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Breastfeeding duration

研究概览

简要总结

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.

详细描述

The benefits of breastfeeding for both mother and neonate have been well documented and extensively researched. Breastfeeding rates remain suboptimal despite known advantages including reduced lifetime risk of maternal ovarian cancer, more rapid return to pre-gestational weight, improvement in maternal/neonatal bonding, reduction in neonatal allergic/immunologic conditions. Both non-modifiable and modifiable factors affecting a mother's decision regarding breastfeeding have been identified. Modifiable factors include breastfeeding knowledge, self-efficacy, and confidence. Breastfeeding self-efficacy has been positively correlated with breastfeeding duration. There is a lack of local data on breastfeeding rates, duration, and self-efficacy in the Augusta University women's health population as well as a lack of documented improvement of these factors following educational programs. Our study aims to create a program that is easily accessible and available to our patient population in the form of a free application available on Apple devices capable of accessing the internet (e.g., i-phone, i-pad, etc.). This study will be a randomized control trial. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve long-term breastfeeding rates, duration, and self-efficacy if offered to patients at 32 through 36 weeks gestation. This will be assessed by comparing initial self-efficacy survey results with survey results at 12 months postpartum for the intervention versus control groups. We will also measure breastfeeding duration during the first 12 months postpartum and exclusive breastfeeding rates at 6 months postpartum.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

The participant cannot be blinded as they will be using the application. The investigator cannot be blinded as they have to provide the application to the patient, teach them how to use it, and perform their surveys about the application use.

The outcomes assessor and care provider will be blinded.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Primiparous and multiparous females receiving prenatal care at Augusta University Obstetrics and Gynecology clinic at 32 through 36 weeks gestation.
  • No documented anatomic differences in mother's chest anatomy.
  • Access to the internet via an Apple® device (such as i-phone or i-pad).
  • Delivery at Augusta University Medical Center

排除标准

  • Significant maternal intrapartum or postpartum complications (i.e., postpartum hemorrhage > 2000 mL, uterine inversion, retained products, ICU admission, postpartum psychosis).
  • Infants admitted to neonatal intensive care unit >48 hours
  • Pre-term deliveries prior to 37 weeks gestation
  • Infants with cleft palate, or other palate/facial defects
  • Patients without email access or internet access
  • Patients without an Apple® device (i-phone, i-pad)
  • Non-English speaker
  • Mothers unable to breastfeed secondary to contraindicated communicable disease (i.e.
  • Mothers unable to breastfeed secondary to contraindicated medications
  • Mothers of infants up for adoption

结局指标

主要结局

Breastfeeding duration

时间窗: 12 months postpartum

We will assess total breastfeeding duration

次要结局

  • Breastfeeding Self-Efficacy Rates(12 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Zahler-Miller

Assistant Professor

Augusta University

研究点 (2)

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