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临床试验/NCT06286176
NCT06286176已完成不适用

Enhancing Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention: A Clinical Trial

Nabiha Ramadan2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
2
主要终点
breastfeeding initiation

研究概览

简要总结

The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis.

详细描述

Pregnant women were recruited in their 3rd trimester of pregnancy and were randomly assigned to either an intervention or control group.

Both groups received standard breastfeeding education at the maternity ward. Additionally, the intervention is based on informative and supportive videos and a whatsapp group for interpersonal support. Videos and whatsapp groups were created and moderated by Infant Feeding Helpers. These are women from the same socio-economical background as the subjects, and have previous history of breastfeeding a minimum of 6 months exclusive breastfeeding.

The aim of the intervention was to increase initiation and duration of breastfeeding by increasing comprehensibility, manageability and meaningfulness of the breastfeeding period and therefore by enhancing their sense of coherence.

Chi-squared tests were used for descriptive statistics, Wilcoxon test was used for pre- post results of SOC and (SE) within each group. The change in pre-post SOC, SOC parameters and SE scores between control and intervention groups was analyzed with Quade non parametric.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Singleton
  • New born not admitted to Neonatal Intensive Care Unit
  • Residing in Lebanon

排除标准

  • Pregnant with more than 1 fetus
  • Mothers with a health condition contraindicating breastfeeding
  • Newborn admitted to NICU

研究组 & 干预措施

Behavioral: videos

Experimental

4 videos are created and distributed to subjects in the intervention group. Video 1: 10 days before delivery Video 2: the day of the delivery Video 3: 1 week postpartum Video 4: 1 month postpartum Videos content: encouraging message, information related to breastfeeding management This is arm in applied in all subjects on the intervention group

干预措施: Videos with breastfeeding education material and encouraging messages (Behavioral)

Behavioral: Whatsapp group

Experimental

4 Whatsapp groups were created. Each Whatsapp group was moderated by 1 infant feeding helper. Each whatsapp group consisted of 10-15 subjects.

Mothers asked breastfeeding related questions to infant feeding helpers and also exchange experience with the other mothers on the group.

This is arm in applied in all subjects on the intervention group. Mothers of the intervention group joined their corresponding whatsapp group 10 days before expected delivery date and the duration of the intervention involving the whatsapp group was until 6 months postpartum.

干预措施: Whatsapp group (Behavioral)

结局指标

主要结局

breastfeeding initiation

时间窗: 1 hour after birth

Number of women who breastfed their infants within 1 hour after birth

Duration of Exclusive breastfeeding

时间窗: at 6 months postpartum

number of women who are exclusively breastfeeding at 6 months postpartum. Exclusive breastfeeding indicates feeding infants only breastmilk without any other complementary food nor beverage.

次要结局

  • Mean change in Self- esteem in participants from baseline to 6 months postpartum(The first measurement was taken 10 days before delivery and the second measurement was taken at 6 months postpartum)
  • The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum(1st measurement: 10 days before delivery. 2nd measurement: 6 months postpartum. Score measurements were taken twice per subject for comparison at the end of the intervention.)

研究者

发起方
Nabiha Ramadan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nabiha Ramadan

M.Sc, Lecturer in Nutrition and Dietetics

Lebanese International University

研究点 (2)

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