Clinical trial NCT06286176: Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention
Official title: Enhancing Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Exclusive Breastfeeding
Salutogenesis
Keywords: Breastfeeding
Salutogenesis
Sense of coherence
Lead sponsor: Lebanese International University
Sponsor class: OTHER
Collaborators: name: Universitat de Girona
First posted: 2024-02-29
Enrollment: 101
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: breastfeeding initiation
timeFrame: 1 hour after birth
measure: Duration of Exclusive breastfeeding
timeFrame: at 6 months postpartum
Secondary outcomes:
measure: Mean change in Self- esteem in participants from baseline to 6 months postpartum
timeFrame: The first measurement was taken 10 days before delivery and the second measurement was taken at 6 months postpartum
measure: The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum
timeFrame: 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.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Lebanese International University
Study officials:
References: