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Clinical Trials/NCT06286176
NCT06286176
Completed
N/A

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

Nabiha Ramadan1 site in 1 country101 target enrollmentNovember 17, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Feeding
Sponsor
Nabiha Ramadan
Enrollment
101
Locations
1
Primary Endpoint
breastfeeding initiation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Nabiha Ramadan
Responsible Party
Sponsor Investigator
Principal Investigator

Nabiha Ramadan

M.Sc, Lecturer in Nutrition and Dietetics

Lebanese International University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

breastfeeding initiation

Time Frame: 1 hour after birth

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

Duration of Exclusive breastfeeding

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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