Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06286176
• Other study ID #: LIUIRB-200311-NR1
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Lebanese International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women

• Singleton

• Healthy

• 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

Related Conditions & MeSH terms

• Breast Feeding
• Exclusive Breastfeeding
• Salutogenesis

Intervention

Behavioral:
• Videos with breastfeeding education material and encouraging messages
Distributed videos aim to increase breastfeeding related knowledge and to receive support
• Whatsapp group
The Whatsapp group is used in the intervention as a platform for interpersonal exchange of information and experience, in addition to peer support.

Locations

Country	Name	City	State
Lebanon	Lebanese International University	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Nabiha Ramadan	Universitat de Girona

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breastfeeding initiation	Number of women who breastfed their infants within 1 hour after birth	1 hour after birth
Primary	Duration of Exclusive breastfeeding	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.	at 6 months postpartum
Secondary	Mean change in Self- esteem in participants from baseline to 6 months postpartum	Measuring the scores of the Rosenberg Self Esteem Scale- 10 items. Scores are from 0 to 30. Higher scores indicate higher self esteem	The first measurement was taken 10 days before delivery and the second measurement was taken at 6 months postpartum
Secondary	The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum	The score of the "Sense of Coherence- 13 items" questionnaire. The minimum score is 13, and the maximum score is 91. Higher score indicates higher sense of coherence	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.